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Trials

NU 05H6: Acute Leukemias and Map Kinase

Normally, white blood cells are produced in a controlled way by the bone marrow. In someone with AML or ALL, this production process is abnormal and immature cells are produced and sent into the blood stream. In this immature state, the cells affect the production of other normal cells and …

Normally, white blood cells are produced in a controlled way by the bone marrow. In someone with AML or ALL, this production process is abnormal and immature cells are produced and sent into the blood stream. In this immature state, the cells affect the production of other normal cells and these cannot perform their usual functions. Therefore patients with AML or ALL are vulnerable to infection, anemia, and bleeding.

The purpose of this study is to understand what causes the white blood cells to grow abnormally, and to determine if there are novel agents that can be used to stop this abnormal growth. In this research project, a sample of blood and bone marrow will be studied in the laboratory to learn more about the nature of the disease, and to understand what causes the defect in the growth of these cells.

You may be eligible for this research study if you have been diagnosed with acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL), which are cancers of the blood that affect white blood cells.

Platanias, Leonidas CPlatanias, Leonidas C
  • Map it 201 E. Huron St.
    Chicago, IL
STU00004841
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NCI 02X3: SPORE in Pancreatic Cancer Tissue Core

The purpose of this research study is to examine many aspects of gastrointestinal disease including pancreatic and colon cancer, including its genetics, its early stages, and the effects of cancer on other tissues such as muscle and adipose (fat) tissue. Tissues from patients (with cancer as well as from those …

The purpose of this research study is to examine many aspects of gastrointestinal disease including pancreatic and colon cancer, including its genetics, its early stages, and the effects of cancer on other tissues such as muscle and adipose (fat) tissue. Tissues from patients (with cancer as well as from those without), who are undergoing pancreatic surgery, will be used in this research.

You may be eligible for this research study if you are visiting the high risk clinic and/or are undergoing surgery to remove a portion of your pancreas.

Yang, Guang-YuYang, Guang-Yu
  • Map it 201 E. Huron St.
    Chicago, IL
STU00007180
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NUGene: Gene-Disease Associations and Treatment Outcomes

Share your health data and a little blood to help with studies on all kinds of diseases— cancer, diabetes, heart disease. A ready pool of samples and treatment histories speeds up research. It’s simple to help. And your info is so important to the search for new ways to …

Share your health data and a little blood to help with studies on all kinds of diseases— cancer, diabetes, heart disease. A ready pool of samples and treatment histories speeds up research. It’s simple to help. And your info is so important to the search for new ways to prevent and treat illnesses.

Want to make an impact in just 20 minutes? Give some blood, answer some questions, and share your health records with your study team’s database. Researchers use it to find disease patterns and search for new ways to prevent and treat illnesses.

Must be a patient at Northwestern or one of its affiliates.
Chisholm, Rex LChisholm, Rex L
  • Map it 201 E. Huron St. Suite 12 160​
    Chicago, IL
STU00010003
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Genetics of BRCA2-related Prostate Cancer

Recruiting Research Participants for a New Study on the “Genetics of Prostate Cancer”At the time of conception, fertilization of the egg by the sperm brings together the genetic material (DNA) from both parents, half from the mother and half from the father, producing the embryo. In the very early …

Recruiting Research Participants for a New Study on the “Genetics of Prostate Cancer”

At the time of conception, fertilization of the egg by the sperm brings together the genetic material (DNA) from both parents, half from the mother and half from the father, producing the embryo. In the very early stages of embryonic development, the embryo is made up of cells that have the potential to develop into all types of cells, like skin, muscle, liver, brain, pancreas, breast, ovary, fallopian tube, or prostate cells. Because of this ability, these cells are called “pluripotent” embryonic stem cells (ESCs). However, about a week after fertilization, the embryonic cells lose their ability to develop into all of the different cells and tissues of the body and gradually “differentiate” into the various tissues and organs that have different specific functions. So, there is a relatively narrow window during which pluripotent ESCs exist in the embryo.

At the end of the in vitro fertilization (IVF) process for couples undergoing subfertility treatment, the doctors are usually left with one-week-old embryos. In 1998, using such embryos for research, scientists figured out how to grow pluripotent ESCs in the lab that can stay in their pluripotent state if the right growth conditions are present. Changing the growth conditions in certain ways, scientists learned how to stimulate the ESCs to go through a process called “differentiation,” in which the stem cells can develop into any of the different cell types present in the body. ESCs were used in the early animal cloning experiments that produced the cloned ewe named “Dolly;” however, cloning human cells is illegal. While ESCs offer promising and exciting opportunities, like the possibility of growing organs in the lab, because their production involves technical and ethical problems, efforts were directed to produce pluripotent stem cells from mature cells to avoid the use of embryos.

In 2007, Japanese researchers found an amazing way (for which they received a Nobel Prize) to transform mature cells, like regular skin or blood cells, directly into stem cells without using human eggs. They found a combination of proteins that, if injected into mature cells, gradually reprogrammed them into induced pluripotent stem cells, abbreviated iPSCs.

Research Project

Drs. Dan Theodorescu and Clive Svendsen, the Principal Investigators at the Cedars-Sinai Medical Center in Los Angeles, California in collaboration with Dr. William Catalona, the Principal Investigator at Northwestern University are engaged in research using iPSCs to develop a model of human prostate cancer using iPSCs from men who carry BRCA2 mutations that are related to a higher risk for developing aggressive prostate cancer (the Cedars-Sinai team has already accomplished this for ovarian cancer in women who carry BRCA1 mutations). As study controls, they will also enroll men with non-BRCA2-related prostate cancer and those without prostate cancer. They will not use embryos.

In the laboratory, the researchers will take the white blood cells from a blood sample back in time to when they were capable of making any cell type in the body and differentiate them forward into prostate cells carrying (or for non-BRCA2-mutation carriers, not carrying) the BRCA2 mutation in a petri dish. Using these transformed prostate cells, they will use current genetic engineering and molecular biology research methods to study the mechanisms of the transformation of normal prostate cells into aggressive prostate cancer cells. This model also can be used in cell-signaling studies and drug screening studies for designing future therapies. The bank of prostate iPSCs that they will create may be shared with research institutions around the world.

These researchers are now recruiting men and their male family members who carry a BRCA2 mutation and other prostate cancer patients and controls without prostate cancer to participate in this study. This research is being performed to discover the causes of prostate cancer and how it is passed down in families using the BRCA2 mutation as a model system and also can be applied to non-BRCA2-related cancers.

This study is called “The genetics of prostate cancer” and is approved by the Institutional Review Boards at Northwestern University (STU00018651) and Cedars Sinai, whose function is to protect the rights of research subjects and to oversee ethical issues. Participation in this study will involve having up to 50 ml of your blood drawn (10 teaspoons), and completing family history questionnaires (baseline and follow-ups) and clinical follow-up questionnaires, if applicable. The time involved includes the time required to read the 10-page consent form, and the time required to travel to Northwestern Memorial Hospital, Galter Pavilion, 675 North St. Clair Street, Chicago, IL 60611 for the research blood draw.If it is not convenient for you to come to our clinic you may be able to get blood drawn at a clinic of your choice and we will arrange to have it shipped to Cedars-Sinai in Los Angeles, California. It will take about 20 to 40 minutes to complete the questionnaire. In the case that your family history suggests familial prostate cancer, Dr. Catalona may want your family members to participate in the study as well. You may be asked to contact your relative(s) about the study. We will follow up with a family history follow-up questionnaire annually, which takes 15 to 30 minutes to finish, to update the file. If you develop prostate cancer, we will want you to fill out a clinical follow-up questionnaire about prostate cancer and follow you up with the questionnaire annually as well, which takes 10 minutes to finish.

In addition, we may request up one or more additional blood samples of 10 to 20 ml (2-4 teaspoons) from you at a later date, depending on the evolving needs of the study. You may refuse to provide these follow-up blood samples without affecting your participation in this study. The blood sample(s) will be saved for future analysis. Efforts will be made to limit the use and disclosure of your personal information, including research studies and medical records, to people who have a need to review this information. We cannot promise complete secrecy. Organizations that may inspect and copy your information include the IRB and other representatives of this institution.

Research results will not be available to you or your physician except under extraordinary circumstances. These are situations in which a life-threatening medical disorder is discovered for which medical treatment is available to prevent or alleviate long-term medical complications. If such a situation should occur, we will contact you via phone, email or mail.

Those interested in participating may contact Dr. Catalona at 312 695-4471 or william.catalona@nm.org.

Further background information on stem cells is available from the author who created the background information for this article: Meshorer E (2020) What Are Embryonic Stem Cells and How Can They Help Us?. Front. Young Minds. 8:32. doi: 10.3389/frym.2020.00032. Copyright © 2020 Meshorer

Male carriers of BRCA2 mutations with prostate cancer and men with metastases aged 18 years or older

Catalona, William JCatalona, William J
  • Map it 675 N. Saint Clair St. Twentieth Floor, Suite 150
    Chicago, IL
STU00018651
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NU 00X3: Pathology Core Facility

The main purpose of this project is to collect samples for research. The samples will be stored at the Pathology Core Facility (PCF) of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University Medical School (NUMS). PCF serves as the centralized resource that addresses the sample collection needs for …

The main purpose of this project is to collect samples for research. The samples will be stored at the Pathology Core Facility (PCF) of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University Medical School (NUMS). PCF serves as the centralized resource that addresses the sample collection needs for the research community. The samples collected can be used by researchers at Northwestern University and third party commercial and non-profit institutions who have approval from their Institutional Review Board (a committee which is responsible for the ethical oversight of the study) for their projects.

You will be asked to donate a sample of blood. In addition, any extra tissue or fluid from what has been collected from you for your routine care will be used. Examples of samples include but are not limited to tissue, blood, urine, and bone marrow.

Horbinski, Craig MichaelHorbinski, Craig Michael
  • Map it 201 E. Huron St.
    Chicago, IL
STU00020989
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RTOG 0724 - A Phase III Randomized Study of Concurrent Chemotherapy and Pelvic Radiation Therapy with or without Adjuvant Chemotherapy in High-Risk Patients with Early-Stage Cervical Carcinoma Following Radical Hysterecotmy

RATIONALE: Drugs used in chemotherapy, such as cisplatin, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether chemotherapy and radiation therapy are more effective when given with or without additional chemotherapy in treating cervical cancer. PURPOSE: This randomized phase III trial is studying chemotherapy and pelvic radiation therapy to see how well they work when given with or without additional chemotherapy in treating patients with high-risk early-stage cervical cancer after radical hysterectomy.
Some of the eligibility criteria include:

- Participants must be 18 years old or older.
- Participants must have undergone radical hysterectomy prior to entering the study.
- Participants cannot be allergic to carboplatin, paclitaxel and/ or cisplatin.

Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Donnelly, Eric DonaldDonnelly, Eric Donald
  • Map it 201 E. Huron St.
    Chicago, IL
NCT00980954 STU00021457
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NU 99G8: Northwestern Ovarian Cancer Early Detection and Prevention Program: A Specimen and Data Study

RATIONALE: To improve strategies for detection and prevention of early-stage disease. PURPOSE: This research study is collecting specimens and data to develop better methods for early detection and prevention of ovarian cancer among the high risk population and those who have the disease.
Shulman, Lee PShulman, Lee P
NCT00005095 STU00005421
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NCI 01X1: Breast Cancer Program: Tissue and Specimen Collection Facility

The purpose of this research study is to help advance the scientific understanding of breast cancer. A portion of breast or skin tissue and a sample of blood, along with clinical information, will be collected and stored in a database for research purposes only. Only tissue or fluid in excess …

The purpose of this research study is to help advance the scientific understanding of breast cancer. A portion of breast or skin tissue and a sample of blood, along with clinical information, will be collected and stored in a database for research purposes only.

Only tissue or fluid in excess of that required for clinical diagnosis and/or staging will be collected. Specific clinical data will include: treatment for cancer (surgical procedures, chemo or hormone therapy, radiation), cancer outcome (recurrence, metastases, death due to disease, and death without disease, alive, alive with disease).

You may be eligible for this research study if you are a woman with breast cancer undergoing biopsy or surgical procedures for the diagnosis, treatment, or prevention of your cancer. 
Wei, Jian-JunWei, Jian-Jun
  • Map it 201 E. Huron St.
    Chicago, IL
NCT00898131 STU00023488
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Peripheral Neuropathy Research Registry (PNRR)

National Peripheral Neuropathy Research Registry (PNRR), a collection of different types ofinformation, such as patient medical, family, and social histories and blood samples. Theinformation is carefully maintained so that it can be studied repeatedly in the future. The registryaims to help researchers’ access large amounts of information about people with …
National Peripheral Neuropathy Research Registry (PNRR), a collection of different types ofinformation, such as patient medical, family, and social histories and blood samples. Theinformation is carefully maintained so that it can be studied repeatedly in the future. The registryaims to help researchers’ access large amounts of information about people with PN. By using thisregistry, researchers will facilitate both basic and clinical research studies that will bring improvedunderstandings of the etiology (origination) and pathogenesis (development) of PN. They willspecifically ask why some patients with peripheral neuropathy develop neuropathic pain and othersdo not, and what the characteristics of patients with painful peripheral neuropathy are in terms oftheir symptoms, examination findings, and blood tests. Ultimately this research may result inimproved diagnosis, more effective treatments, and possibly prevention.
Inclusion criteria: 1. Diabetic Peripheral Neuropathy 2. Chemo-therapy Induced Peripheral Neuropathy 3. HIV-induced Peripheral Neuropathy 4. Idiopathic Peripheral Neuropathy; Exclusion criteria: Any other type of Peripheral Neuropathy
Ajroud-Driss, SendaAjroud-Driss, Senda
  • Map it 675 N. St. Clair St. Suite 20 100
    Chicago, IL
STU00048864
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NU 04H7: Molecular Mechanisms of Disease Progression in Myeloid Malignancy

In this research project, samples of blood and bone marrow will be studied in the laboratory to learn more about the nature of chronic myelogenous leukemia (CML) cells and how various medications and chemical agents affect them.The purpose of this study is to learn about how CML leukemia cells …

In this research project, samples of blood and bone marrow will be studied in the laboratory to learn more about the nature of chronic myelogenous leukemia (CML) cells and how various medications and chemical agents affect them.

The purpose of this study is to learn about how CML leukemia cells become resistant to medications or progress to acute leukemia (blast crisis). This may prove to be helpful in the design of new more effective drugs for the treatment of CML in the future.

You may be eligible to take part in this research study if you have been diagnosed with chronic myelogenous leukemia (CML), a chronic form of leukemia, OR if you are a normal individual without any blood disorders.

Eklund, Elizabeth AEklund, Elizabeth A
  • Map it 201 E. Huron St.
    Chicago, IL
STU00039629
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NCI 12H13: Molecular Mechanisms of Relapse After Therapy Discontinuation in Chronic Myeloid Leukemia

In this research study, samples of bone marrow or peripheral blood will be collected from patients with chronic myeloid leukemia (CML) to learn more about the effect of some new drugs on CML cells in the laboratory. The purpose of this study is to understand how these new drugs stop …

In this research study, samples of bone marrow or peripheral blood will be collected from patients with chronic myeloid leukemia (CML) to learn more about the effect of some new drugs on CML cells in the laboratory. The purpose of this study is to understand how these new drugs stop leukemia cells from growing. This research may prove to be helpful in the design of new and more effective treatments for leukemia in the future.

You may be eligible for this research study if you have been diagnosed with chronic myeloid leukemia, a cancer of the blood and are scheduled to have a bone marrow biopsy.

Eklund, Elizabeth AEklund, Elizabeth A
  • Map it 201 E. Huron St.
    Chicago, IL
STU00074258
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NUDB 13C03: Northwestern Brain Tumor Institute Research Database

The Northwestern Brain Tumor Institute (NBTI) currently uses an electronic database to collect and store information about patients who come to the NBTI for evaluations, including diagnosis, treatment, follow-up, and/or to obtain additional opinions. This database is called the Northwestern Brain Tumor Institute Database or NBTIDB, and it …

The Northwestern Brain Tumor Institute (NBTI) currently uses an electronic database to collect and store information about patients who come to the NBTI for evaluations, including diagnosis, treatment, follow-up, and/or to obtain additional opinions. This database is called the Northwestern Brain Tumor Institute Database or NBTIDB, and it was developed to replace older paper methods for collecting and storing information.

The purpose of this study is to allow researchers involved with the NBTIDB to use data stored in it for future research studies and projects. The NBTIDB also allows researchers to track whether or not patients have agreed to allow their information to be linked to their leftover tissue samples, which are kept in the hospital’s pathology department, for future research studies.

You may be eligible to take part in the research component of the NBTIDB if you are either a new or returning patient, over the age of 18, who is being seen by one of the clinicians at the NBTI and are or will be entered into the NBTIDB, or a patient who is not coming to the NBTI for evaluation, but would still like to participate in the NBTIDB.

Kumthekar, Priya UKumthekar, Priya U
  • Map it 201 E. Huron St.
    Chicago, IL
STU00087359
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Development of a Kidney Cancer Patient Outcomes Database

Purpose This study is evaluating an on-line registry for kidney cancer patients called ‰ÛÏMyQOL,‰Û which stands for My Quality of Life. Overview A registry is a repository (database) of information about a group of people who share a common characteristic - in this case, kidney cancer. MYQOL registry participants enter …
Purpose This study is evaluating an on-line registry for kidney cancer patients called ‰ÛÏMyQOL,‰Û which stands for My Quality of Life. Overview A registry is a repository (database) of information about a group of people who share a common characteristic - in this case, kidney cancer. MYQOL registry participants enter information about their disease, treatment, symptoms, health status, and quality of life into an on-line, password-protected database on a regularly scheduled basis. Participants can use the registry to track many of their symptoms and their health status over time and to compare themselves (anonymously) with other groups of people (for example, how their level of fatigue compares with the average level of fatigue reported by other participants in the registry). Participants can also choose to share relevant information about themselves (from the registry) with their health care provider(s), by printing copies of their completed forms. Registry participants will be offered opportunities to join in other research studies when available. Description of Treatment Participants in this study will be asked to do the following for a 1-year trial period: 1) enroll in the on-line registry; 2) complete questionnaires about their health and treatment every 3 months ; and 3) be willing to have MYQOL researchers contact them confidentially about participating in other research studies. This does not mean that participants are obligated to participate in future research studies; only that they agree to be contacted.
Some of the eligibility criteria include:

- Participants must have a kidney cancer diagnosis.
- Participants must be 18 or older.
- Participants must be able to read English well enough to complete questionnaires.

Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Cella, DavidCella, David
  • Map it 201 E. Huron St.
    Chicago, IL
STU00070200
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Ex vivo interactions between high-density-like nanoparticles and human blood

This research is significant because the high-density lipoprotein like nanoparticles (HDL-NPs) being investigated have been shown to have tremendous therapeutic properties when evaluated in in vitro and in vivo settings. Prior to initiating large-scale in vivo animal and human studies it is imperative that we obtain an …
This research is significant because the high-density lipoprotein like nanoparticles (HDL-NPs) being investigated have been shown to have tremendous therapeutic properties when evaluated in in vitro and in vivo settings. Prior to initiating large-scale in vivo animal and human studies it is imperative that we obtain an in-depth knowledge of the interaction of the HDL-NPs with human blood cells using safe ex vivo experiments.
Healthy, non-pregnant adult (age >18-75 years) volunteers.
Thaxton, Colby SThaxton, Colby S
  • Map it 201 E. Huron St.
    Chicago, IL
STU00200368
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NCI 15H01: Triad1 Regulates Myelopoiesis and Functions as a Leukemia Suppressor

Researchers have found that about 60% of patients with acute myeloid leukemia (AML) will obtain a remission following treatment with combinations of chemotherapy drugs. However, relapse after treatment remains a problem, and can be as high as 80% in some types of AML patients. Therefore, it would be beneficial to …

Researchers have found that about 60% of patients with acute myeloid leukemia (AML) will obtain a remission following treatment with combinations of chemotherapy drugs. However, relapse after treatment remains a problem, and can be as high as 80% in some types of AML patients. Therefore, it would be beneficial to identify specific treatment approaches for patients at a high risk for relapse. One characteristic associated with high relapse rates is an increase in proteins that are referred to as Hox proteins in the leukemia cells. Increase in Hox proteins prevents production of some other proteins, including a protein referred to as Triad1. An increase in Triad1 protein in bone marrow cells may be important to control the growth of such cells. Decreased Triad1 in leukemia cells may therefore promote their growth, but this has not been previously studied.

The purpose of this study is to investigate if the lack of Triad1 in leukemia cells contributes to resistance of some leukemias to chemotherapy drugs. This research may prove to be helpful in the design of new and more effective treatments for leukemia in the future.

At a time when you are having a bone marrow biopsy and aspirate performed as part of your standard medical care, about an additional 2.5 teaspoons (12.5 mL) of bone marrow will be collected for this research study.

You may be eligible for this research study if you have been diagnosed with acute myeloid leukemia (AML), a cancer of the blood.

Eklund, Elizabeth AEklund, Elizabeth A
  • Map it 201 E. Huron St.
    Chicago, IL
STU00200435
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NU 15N01: Head and Neck Tissue Bank

Researchers would like to create a bio-specimen bank of tissue, blood, urine and saliva, which would then be used to study cancer and find better ways to detect, prevent, diagnose, treat and provide better care for future patients. Some of these studies may be about how genes affect the …

Researchers would like to create a bio-specimen bank of tissue, blood, urine and saliva, which would then be used to study cancer and find better ways to detect, prevent, diagnose, treat and provide better care for future patients. Some of these studies may be about how genes affect the development of cancer, response or resistance to treatment as well as prognosis (course of disease and overall outcome including survival). Other studies may aim to identify measurable substances in the blood and/or urine (known as biomarkers) that can indicate early development of cancer, worsening or relapse of disease and response to treatment. Some studies may lead to new products, such as drugs or tests for detection of cancer.

You may be eligible to take part in our head and neck specimen banking study if you have one of the following conditions:

a) You have a tumor or an abnormal area in the head and neck area, suspicious for cancer, or pre-cancerous condition or other pathology of interest, and you’re scheduled to have biopsy and/or surgery at Northwestern Memorial Hospital.

b) You will receive treatment and/or regular follow up for further management for your head and neck cancer or precancerous condition, or other pathology at Northwestern Memorial Hospital and/or Northwestern Medicine Developmental Therapeutics Institute (NMDTI).

Samant, SandeepSamant, Sandeep
  • Map it 201 E. Huron St.
    Chicago, IL
STU00202177
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NU 15N02: Northwestern Head and Neck Cancer Registry

The purpose of this registry is to collect clinical information on all consenting head and neck cancer patients seen at the Northwestern Medical Group (NMG) or Northwestern Memorial Hospital (NMH). With this information, researchers will conduct studies to learn more about the subtypes of head and neck cancers and determine …

The purpose of this registry is to collect clinical information on all consenting head and neck cancer patients seen at the Northwestern Medical Group (NMG) or Northwestern Memorial Hospital (NMH). With this information, researchers will conduct studies to learn more about the subtypes of head and neck cancers and determine the most effective treatments. The registry will also allow us to identify possible subjects for future studies.

You may be eligible to take part in this research study if you are being treated or have been treated for a tumor or cancer of the head and neck.

Samant, SandeepSamant, Sandeep
  • Map it 201 E. Huron St.
    Chicago, IL
STU00202162
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A Phase 2, single arm, multi-center, open label trial Combining Optune with concurrent Bevacizumab in the setting of Recurrent or Progressive Meningioma

Purpose The purpose of this research study is to determine the effects (good and bad) bevacizumab (the study drug) combined with Optune (the study device) tumor treatment field therapy has on meningiomas. Overview Bevacizumab (the study drug) is considered investigational because the US Food and Drug Administration (FDA) has not …
Purpose The purpose of this research study is to determine the effects (good and bad) bevacizumab (the study drug) combined with Optune (the study device) tumor treatment field therapy has on meningiomas. Overview Bevacizumab (the study drug) is considered investigational because the US Food and Drug Administration (FDA) has not approved its use for the treatment of meningiomas. The study drug is a medication that blocks the growth of new blood vessels. In order for tumors to grow they need to have a blood supply. Tumor cells have been shown to produce substances that stimulate the abnormal growth of new blood vessels that allow the tumor to grow. It is thought that the study drug may interfere with the growth of new blood vessels and therefore might stop tumor growth, and possibly shrink the tumor by keeping it from receiving nutrients and oxygen supplied by the blood vessels. Optune (the study device) is also considered investigational because the US Food and Drug Administration (FDA) has not approved its use for the treatment of meningiomas. The study device, Optune is a device that the patient will wear and use for at least 18 hours of each day. It delivers alternating electrical current to the patient‰Ûªs brain tumor and by doing so interrupts a process called mitosis. Mitosis needs to occur in order for cell division to occur and allows tumors to grow. By slowing this process, we hypothesize that meningioma growth may also be slowed. Description of Treatment Tumor treatment field therapy with Optune will be initiated at the same time as bevacizumab, with both treatments to start within a one-week period of each other. Bevacizumab will be given at current standard central nervous system (CNS) dosing of 10mg/kg q2 weeks in an outpatient setting. After 4 cycles (1 cycle=28days) of therapy (Cycle 5 day 1) patients may choose to switch to bevacizumab at a dose of 15 mg/kg q3 weeks. For patients who chose to make this switch, they have to do it on Day1 of a new cycle. Tumor treatment fields with Optune will be delivered for at least 18 hours a day at a frequency of 200 KHz and intensity of 1-3V/cm. Treatment will be continued until disease progression or up to 1 year.
"Some of the eligibility criteria include:

- Patients must be age = 18 years. Both males and females and patients from all

ethnic backgrounds are eligible.
- Patients must have a histologic diagnosis of meningioma, WHO grade 2 or 3 (atypical or anaplastic).
- All patients must have developed recurrent disease/progression after receiving all standard treatments.

Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial."
Kumthekar, Priya UKumthekar, Priya U
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02847559 STU00203030
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NU 16B06: Investigation of Blood-Based Prognostic Biomarkers in Patients with Advanced Breast Cancer for Molecular Mechanisms Underlying Circulating Tumor Cell Clusters

This study is being done to help improve the knowledge on the biology of breast cancer in the future. Blood specimens from patients with breast cancer will be collected and utilized for future research projects known as biomarker studies. These blood based laboratory tests will ultimately evaluate molecules present in …

This study is being done to help improve the knowledge on the biology of breast cancer in the future. Blood specimens from patients with breast cancer will be collected and utilized for future research projects known as biomarker studies. These blood based laboratory tests will ultimately evaluate molecules present in the blood of patients with breast cancer. These molecules could be, for example, a protein, tumor DNA, or tumor cells circulating in the blood. As research technology advances, blood samples from patients with breast cancer may help in understanding the course of disease and to check as to how effective a treatment is.

You may be eligible for this research study if you have advanced stage (III/IV)breast cancer.

Gradishar, William JGradishar, William J
  • Map it 201 E. Huron St.
    Chicago, IL
STU00203283
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NUDB 16Z01: The OncoSET Program Database and Biobank - Combining Clinical Outcomes with Next Generation Sequencing and other Advanced Molecular Testing for Genetic Aberrations in Patients with Advanced Solid Malignancies

The purpose of the study is to gather information about your cancer and the treatment you receive as a part of your routine clinical care. In this study, we are developing a research registry, which is a bank of information about many patients.We are interested in learning about the …

The purpose of the study is to gather information about your cancer and the treatment you receive as a part of your routine clinical care. In this study, we are developing a research registry, which is a bank of information about many patients.

We are interested in learning about the relationship between your cancer and the different types of tests available to identify the best treatment option for you. That is, we are interested in the tests that identify possible ‘mutations’ (e.g., changes) or ‘drivers’ within your tumor, what treatments you receive after getting these tests, and how your cancer responds to the treatments.

The tests known as next generation sequencing or “NGS” are usually done on your cancer tissue or blood samples as a part of your routine clinical care. Your doctor can use the information to identify the best treatment option for you after discussing it with other doctors. These routine tests will be performed whether you participate in this study or not, but we want to collect the information about this process for this study.

If you participate in this study, extra samples of your blood will be collected and stored, and your health information from your medical record and NGS lab results will be collected and stored.

You may be eligible for this research study if you have a diagnosis of cancer and are being treated at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University.

VanderWeele, David JamesVanderWeele, David James
  • Map it 201 E. Huron St.
    Chicago, IL
STU00203944
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Physical activity and DNA methylation among women with high breast density

The purpose of this study is to learn more about how physical activity may influence your genes through a mechanism called DNA methylation. Our goal is to determine if being physically active may be associated with a healthy pattern of DNA methylation in your immune system cells. Exercising and being …
The purpose of this study is to learn more about how physical activity may influence your genes through a mechanism called DNA methylation. Our goal is to determine if being physically active may be associated with a healthy pattern of DNA methylation in your immune system cells. Exercising and being physically active are believed to be important for preventing cancer. It may be particularly important for women with high breast density, and may help reduce risk for breast cancer. However, we do not understand what physical activity changes within the body to alter risk of breast cancer. DNA methylation is a biological process that may help explain the relationship between physical activity and cancer risk.
Generally healthy women with a history of heterogeneously or extremely dense breasts, aged 40-74 with no history of cancer (other than non-melanoma skin cancer), diabetes, and cardiovascular disease.
Hibler, Elizabeth AHibler, Elizabeth A
  • Map it 680 N. Lake Shore Drive Suite 1410
    Chicago, IL
STU00204639
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Melanoma and Skin Cancer Tissue Repository

The purpose of this study is to allow researchers studying and treating melanoma and other cancers to have access to tissue for research purposes only. Northwestern University may use your medical record information, as well as tumor, blood, saliva, urine, and fecal samples (collectively called “tissue”) for research studies to …

The purpose of this study is to allow researchers studying and treating melanoma and other cancers to have access to tissue for research purposes only. Northwestern University may use your medical record information, as well as tumor, blood, saliva, urine, and fecal samples (collectively called “tissue”) for research studies to help us understand melanoma and other skin cancers. Biopsies and surgery of your cancer will not be a part of this study but will be performed as part of your standard care.

You may be eligible to take part in the research component of the Northwestern Melanoma and Skin Cancer Tissue Repository if you are either a new or returning patient and have a skin cancer or pre-cancer lesion.

Chandra, SunandanaChandra, Sunandana
  • Map it 201 E. Huron St.
    Chicago, IL
STU00204151
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The Role of Positron Emission Tomography and Magnetic Resonance Imaging (without Fluorodeoxyglucose or Gadolinium) in Yttrium-90 Radioembolization Treatment Planning for Patients with Liver Malignancies

Patients who are already scheduled to receive Y90 radioembolization, will first be treated with Y90 radioembolization for liver cancer or metastasis in the liver.  They will then have a Positron Emission Tomography (PET/MR) scan done a few hours after the treatment. You will be placed inside a small …
Patients who are already scheduled to receive Y90 radioembolization, will first be treated with Y90 radioembolization for liver cancer or metastasis in the liver.  They will then have a Positron Emission Tomography (PET/MR) scan done a few hours after the treatment. You will be placed inside a small tube for 2-3 hours for the PET/MR scan.  There is no contrast or radiation involved in the PET/MR scan.  The purpose of the PET/MR scan is to capture specific images of the liver to see where the Y90 radioactive particles are a few hours after treatment.  These images will be used to compare determine how much of the radioactive particles went to the tumor(s) compared to how much of them went to healthy liver tissue.  We hope to use this information to help develop care that is more specific to the patient.
Inclusion Criteria (patients must meet these criteria):

1. 18 years of age or older.

2. Diagnosed with primary liver cancer or metastasis in the liver.

3. Planning to have Y90 radioembolization treatment at Northwestern Medicine.

4. Be able to have an MRI- not claustrophobic or have any other contraindications to MRI.

Riaz, AhsunRiaz, Ahsun
STU00205918
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Clinical Database of Prostate Cancer at Northwestern University

The goal of this study is to create a database of prostate cancer patients at Northwestern Memorial Group to better understand, learn about, prevent, treat or cure prostate cancer.
Men ages 18-89 years daignosed with prostate cancer.
Schaeffer, Edward MatthewSchaeffer, Edward Matthew
STU00206270
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The effect of inflammatory bowel disease flares on serum prostate specific antigen

This study will measure PSA values in men with IBD before, during, and following a flare. In addition, the effect of any PSA increase will be analyzed and correlated to the location of the disease (rectal vs. other). Study findings may help men with IBD by identifying pitfalls in prostate …
This study will measure PSA values in men with IBD before, during, and following a flare. In addition, the effect of any PSA increase will be analyzed and correlated to the location of the disease (rectal vs. other). Study findings may help men with IBD by identifying pitfalls in prostate cancer screening for this population and help to stratify and understand the effect IBD has on the prostatic milieu. By optimizing how men with IBD are screened for prostate cancer, future unnecessary healthcare encounters and expenditures may be reduced for this patient group.
Men with a confirmed diagnosis of inflammatory bowel disease (IBD) between the ages of 40-69 years old.
Kundu, Shilajit DKundu, Shilajit D
NCT03558048 STU00207583
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NU 18B05: A Phase II Study of the Determinants of Transdermal Drug Delivery to the Normal and the Radiated Breast

The benefits of anti-estrogen medications taken by mouth as pills (such as tamoxifen) are well-proven to reduce the risk of breast cancer in studies with more than 10 years of follow up. However, because tamoxifen is taken by mouth, it circulates through the whole body and may cause …
The benefits of anti-estrogen medications taken by mouth as pills (such as tamoxifen) are well-proven to reduce the risk of breast cancer in studies with more than 10 years of follow up. However, because tamoxifen is taken by mouth, it circulates through the whole body and may cause harmful effects to other organs. When tamoxifen is taken by mouth, it is broken down by the liver into two main active forms, one of which is 4-hydroxytamoxifen, also called 4-OHT. Tamoxifen is approved by the Food and Drug Administration (FDA) while 4-OHT is not and is, therefore, considered investigational. However, 4-OHT has anti-cancer activity, and has been developed as a quick drying medicated gel that can be applied to the breast skin. Early results from two previous studies show that 4-OHT gel, when applied to the skin, gets into the breast and blocks breast cancer cell growth as effectively as oral tamoxifen. Unlike oral tamoxifen, the gel is concentrated in the breasts and therefore very little tamoxifen reaches the blood or other parts of the body. Also, some women lack the proteins that are responsible for the break-down of tamoxifen. It is possible that the use of 4-OHT gel will be more effective than oral tamoxifen in these women.
Patients who had radiation for breast cancer in one breast and their other breast has not undergone radiation
Khan, Seema AhsanKhan, Seema Ahsan
  • Map it 250 E. Superior St.
    Chicago, IL
NCT04009044 STU00208708
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Characterization of the microbiome in cutaneous T cell lymphoma

The purpose of this study is to investigate the organisms that reside on the skin, in the gut, and nasal cavity and study their relationship with Cutaneous T-Cell Lymphoma (CTCL).
  • Be between the ages of 18-89
  • Be able and willing to provide informed consent
  • You must not have cutaneous t-cell lymphoma (CTCL)
  • You must not be currently pregnant
  • You must not be on or exposed to systemic antibiotics with 4 weeks of beginning study participation
Zhou, AlanZhou, Alan
  • Map it 676 N. St. Clair St.
    Chicago, IL
STU00209226
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A Master Protocol To Evaluate Biomarker-Driven Therapies And Immunotherapies In Previously-Treated Non-Small Cell Lung Cancer (Lung-MAP Screening Study)

The purpose of this study is to test your tumor tissue for certain biomarker (which may be the cause of your cancers, such as specific mutations in certain proteins). This will help determine your eligibility to participate in either matched sub-studies involving investigational agents that targets the specific mutated protein or alternatively to un-matched sub-studies.

  • Participants must be18 years or older
  • Participants must bediagnosed with non-small cell lung cancer
Chae, Young KwangChae, Young Kwang
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03851445 STU00209659
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NU MTBC 18M02: International Melanoma Tissue Bank Consortium Site at Northwestern University

The purpose of this research study is to create a MTBC biorepository (the “MTBC Biobank”) of human biospecimens (the “Biospecimens”) and medical and health history information, for example, test and treatment results, age, gender, history of sun exposure (the “Annotating Data”). This part of the project is called the “Biobanking …

The purpose of this research study is to create a MTBC biorepository (the “MTBC Biobank”) of human biospecimens (the “Biospecimens”) and medical and health history information, for example, test and treatment results, age, gender, history of sun exposure (the “Annotating Data”). This part of the project is called the “Biobanking Study”. The second purpose is for MTBC to provide the Biospecimens and/or Annotating Data from the MTBC Biobank to researchers around the world for them to use in specific studies in order to study melanoma (“Future Use Study).

Melanoma is a lethal form of skin cancer and more research is necessary to help scientists to understand what causes it, how to diagnose it, how it can be prevented, and how it can be treated. To do this research, scientists need biospecimens (like biopsied tissue and blood samples) from people who have been diagnosed with melanoma and other skin disorders. This study will help scientists learn about melanoma and the projects being conducted on behalf of the Melanoma Tissue Bank Consortium(“MTBC”).

We are asking you to take part in this research study because you have melanoma or another skin disorder.Your participation is completely voluntary. You may choose not to take part.Your decision to sign this informed consent and authorization form in order to participate in the Biobanking Study and to allow the use of your Biospecimens and Annotating Data in a Future Use Study will not change the treatment you receive for your skin disorder.

Wayne, Jeffrey DWayne, Jeffrey D
  • Map it 201 E. Huron St.
    Chicago, IL
STU00209847
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Alliance A041703: A Phase II Study of Inotuzumab Ozogamicin Followed by Blinatumomab for Ph-negative CD22-positive B-lineage Acute Lymphoblastic Leukemia in Newly Diagnosed Older Adults or Adults with Relapsed or Refractory Disease

Thepurpose of this study is to test the good and bad effects of the combination ofdrugs called inotuzumab ozogamicin and blinatumomab. The study doctors hope tolearn if the combination of study drugs will cause cancer to go away andprevent leukemia from coming back. Inotuzumabozogamicin and blinatumomab have already been approved …

Thepurpose of this study is to test the good and bad effects of the combination ofdrugs called inotuzumab ozogamicin and blinatumomab. The study doctors hope tolearn if the combination of study drugs will cause cancer to go away andprevent leukemia from coming back.

Inotuzumabozogamicin and blinatumomab have already been approved by the FDA to treatrelapsed or refractory ALL as well as other cancers. The combination ofinotuzumab ozogamicin and blinatumomab is considered investigational for thisstudy.

Participantswith ‘untreated ALL’ or ‘relapsed or refractory ALL’, will get a combination ofdrugs called inotuzumab ozogamicin and blinatumomab. This combination of drugsis known to be effective in patients with relapsed or refractory leukemia, butit is not the usual chemotherapy for patients with ‘untreated ALL.’Participants will also get a drug called methotrexate to prevent cancer cellsfrom entering the central nervous system.

Diagnosed with Acute Lymphoblastic Leukemia (ALL) that is untreated or has come back. Participants with untreated ALL must be 60 years of age or older. Participants with ALL that has relapsed or come back must be at least 18 years of age or older. 
Dinner, Shira NaomiDinner, Shira Naomi
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03739814 STU00210163
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A041702: A Randomized Phase III Study of Ibrutinib Plus Obinutuzumab Versus Ibrutinib Plus Venetoclax and Obinutuzumab in Untreated Older Patients (= 70 Years of Age) with Chronic Lymphocytic Leukemia (CLL)

This study is being done to answer the following questions:1. Is adding a new anti-cancer drug (venetoclax) to the usual treatment (ibrutinib plusobinutuzumab) better, the same as, or worse than the usual treatment alone for untreatedolder patients with CLL?2. Can patients who have no detectable CLL after …
This study is being done to answer the following questions:1. Is adding a new anti-cancer drug (venetoclax) to the usual treatment (ibrutinib plusobinutuzumab) better, the same as, or worse than the usual treatment alone for untreatedolder patients with CLL?2. Can patients who have no detectable CLL after a year of receiving the usual treatmentplus the new anti-cancer drug discontinue therapy? 
Some of the eligibility criteria include: - Participants must have intermediate or high-risk chronic lymphocyticleukemia that has not been treated before - Participants must be 18 or older - Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Ma, ShuoMa, Shuo
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03737981 STU00210225
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Yttrium-90 Radiation Lobectomy: Dose Optimization and Prediction of FLR Hypertrophy to Enable Resection of Hepatic Malignancies

In the study, there will be many patients, like you, with hepatocellular carcinoma (HCC) who are eligible to receive a treatment called Y90 radioembolization and who may also be liver resection candidates.Y90 radioembolization is a non-invasive, out-patient treatment that uses radioactive beads (microspheres), which are tiny glass …

In the study, there will be many patients, like you, with hepatocellular carcinoma (HCC) who are eligible to receive a treatment called Y90 radioembolization and who may also be liver resection candidates.

Y90 radioembolization is a non-invasive, out-patient treatment that uses radioactive beads (microspheres), which are tiny glass particles that are loaded with radiation. The beads are injected into an artery of the liver that supplies blood to the tumor(s). The beads flow to the tumor(s) and become trapped inside. The beads release the Y90 radiation inside the tumor(s).

Liver resection is used to remove the part of the liver that has the liver tumor(s). It has been shown that Y90 radioembolization can increase the untreated liver’s size and volume. Patients with HCC may be liver resection candidates if they have a large enough liver.

The purpose of this research is to determine if there is an ideal Y90 dose to increase liver volume. This research may help determine the best Y90 dose for future patients who need a larger liver to have a liver resection.

If you participate in this study, you will have standard-of-care Y90 radioembolization as well as study-specific imaging and two optional liver biopsies. You will participate in the study for up to 3 months. Your health status will continue to be followed for up to 5 years.

Patients enrolled in the study will receive up to $195.00 for their participation.

You are eligible to participate in this study if:

1. You are an adult 18 years of age or older

2. You have been diagnosed with hepatocellular cancer and may be a liver resection candidate to remove your disease

Lewandowski, Robert JLewandowski, Robert J
  • Map it 201 E. Huron St.
    Chicago, IL
NCT04390724 STU00209629
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BTCRC HN17-111: Phase II trial of androgen deprivation therapy (ADT) and pembrolizumab for advanced stage androgen receptor-positive salivary gland carcinoma

This study is being done to study two investigational drugs called pembrolizumab and goserelin to see if they shrink your cancer or stop it from growing. …
This study is being done to study two investigational drugs called pembrolizumab and goserelin to see if they shrink your cancer or stop it from growing. 
You may be eligible for this research study if you have salivary gland carcinoma that has grown or has come back after treatment.
Lorch, Jochen Hanns-MartinLorch, Jochen Hanns-Martin
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03942653 STU00210435
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PD-inhibitor (Nivolumab) and Ipilimumab followed by nivolumab vs. VEGF TKI cabozantinib with nivolumab in metastatic untreated REnal Cell CancEr [PDIGREE]

This study is being done to answer the following question: Can we prolong life for patients withadvanced kidney cancer, by adding a drug called cabozantinib to another treatment afterreceiving the standard treatment?We are doing this study because we want to find out if this approach isbetter or worse than …

This study is being done to answer the following question: Can we prolong life for patients with

advanced kidney cancer, by adding a drug called cabozantinib to another treatment after

receiving the standard treatment?

We are doing this study because we want to find out if this approach isbetter or worse than the usual approach for your advanced kidney cancer. The usual approach is defined as care mostpeople get for advanced kidney cancer.

-Participants must be 18 years of age or older

-Participants must be diagnosed with advanced kidney cancer

VanderWeele, David JamesVanderWeele, David James
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03793166 STU00210884
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(xIRB) NCI CIRB NRG GY019: A Randomized Phase III, Two-Arm Trial of Paclitaxel/Carboplatin/Maintenance Letrozole Versus Letrozole Monotherapy in Patients with Stage II-IV, Primary Low-Grade Serous Carcinoma of the Ovary or Peritoneum

The purpose of this study is to compare the treatment of carboplatin/paclitaxel and letrozole hormonal therapy to letrozole alone. The use of the hormonal therapy drug letrozole without chemotherapy may shrink or stabilize cancer in the same way that chemotherapy also does, but without the added side effects of …

The purpose of this study is to compare the treatment of carboplatin/paclitaxel and letrozole hormonal therapy to letrozole alone. The use of the hormonal therapy drug letrozole without chemotherapy may shrink or stabilize cancer in the same way that chemotherapy also does, but without the added side effects of chemotherapy. Letrozole is a drug called an aromatase inhibitor, which indirectly stops the body from producing estrogen.

This study will investigate if this approach is better, the same, or worse than the usual approach. In order to determine if the use of letrozole alone helps to improve treatment for patients with low-grade serous ovarian or peritoneal cancer compared to combined chemotherapy and letrozole, half of patients in this study will receive letrozole with paclitaxel/carboplatin and the other half will receive letrozole alone. The study doctors will be looking to see if the letrozole alone prolongs the time cancer is in remission, or the duration of time participants are alive after treatment.

Letrozole is approved by the FDA for breast cancer, but is not FDA approved for ovarian cancer and is therefore considered experimental in this setting.

Participants will get either the combination of paclitaxel and carboplatin for four and a half months followed by letrozole or letrozole alone. Patients who are assigned to letrozole monotherapy will continue taking the letrozole for as long as they are tolerating the drug (i.e., have not developed any allergies or severe side effects with the medication) and have not experienced a recurrence or progression of their disease.

After participants finish their study treatment, their doctor and study team will continue to follow their condition and watch for side effects during clinic visits or by phone. Participants will be checked every 3 months for the first 3 years after treatment. After that, this will happen every 6 months for two years.

  • New diagnosis of stage II-IV low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum.
  • At least 18 years old.
  • Must start within 8 weeks of primary surgery
Barber, Emma LongleyBarber, Emma Longley
  • Map it 250 E. Superior St.
    Chicago, IL
NCT04095364 STU00211055
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(xIRB) NCI CIRB: Alliance A071701: Genomically-Guided Treatment Trial in Brain Metastases

The purpose of this study is to test good and bad effects of different drugs against metastatic brain tumors with altered genes. This trial is trying to see if tumor genetic testing would be helpful at guiding treatment in patients such as you. Researchers have looked at the DNA material (genes) that can be affected in brain metastases and have found several genes that are altered, or mutated. There are medications that target these genes.

We are doing this study because we want to find out if this approach is better or worse than the usual approach for your metastatic cancer. The usual approach is defined as care most people get for your metastatic cancer.

  • Participantsmust be 18 years or older

  • Participants must have a confirmed diagnosis of cancermetastasized to the brain
Kumthekar, Priya UKumthekar, Priya U
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03994796 STU00211229
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(xIRB) NCI CIRB ECOG-ACRIN 2182: A Randomized Phase II Study of De-Intensified ChemoRadiation for EarlyStage Anal Squamous Cell Carcinoma (DECREASE)

This study will helpthe study doctors find out if this different approach is the same as the usualapproach. To decide if it is aseffective, the study doctors will be looking to see if the study approach showsat least the same results as the normal approach. This study has 2 studygroups. · …

This study will helpthe study doctors find out if this different approach is the same as the usualapproach. To decide if it is aseffective, the study doctors will be looking to see if the study approach showsat least the same results as the normal approach.

This study has 2 studygroups.

· Participants in groupA will get the standard dose of chemoradiation therapy: this includesMitomycin-C and 5-Fluorouracil or Capecitabine, as well as radiation. Therewill be 28 radiation treatment sessions in this group.

· Group 2 (Arm B)

Participants in group2 you will get the lower dose of chemoradiation therapy: this includesMitomycin-C and 5-Fluorouracil or Capecitabine, as well as radiation. Therewill be 20 or 23 radiation treatment sessions in this group, depending on thesize of the tumor.

Participants who are 18 years of age or older with anal cancer will beinvited to participant in this study.
Kircher, Sheetal MehtaKircher, Sheetal Mehta
  • Map it 201 E. Huron St.
    Chicago, IL
NCT04166318 STU00211554
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DRUG KO-MEN-001: A Phase 1/2 First in Human Study of the Menin-MLL(KMT2A) Inhibitor KO-539 in Patients with Relapsed or Refractory Acute Myeloid Leukemia

The main purpose of this study is to determine the tolerability and the potential safety of a new drug called KO-539 in treating your cancer. 
You may be eligible to take part in this research study if you have a type of cancer called acute myeloid leukemia (AML) that has not responded to standard therapy.
Altman, Jessica KAltman, Jessica K
  • Map it 201 E. Huron St.
    Chicago, IL
NCT04067336 STU00211062
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NU 19H08: Signal Transduction of Type I Interferons in Malignant Cells

This is a lab study of a group of diseases called myeloproliferative neoplasms (MPN). MPN is abnormal blood coagulation (abnormal or irregular blood clotting) and includes polycythemia vera (PV) and essential thrombocytosis (ET). The purpose of this research is to learn more about how a drug called interferon stops the …
This is a lab study of a group of diseases called myeloproliferative neoplasms (MPN). MPN is abnormal blood coagulation (abnormal or irregular blood clotting) and includes polycythemia vera (PV) and essential thrombocytosis (ET). The purpose of this research is to learn more about how a drug called interferon stops the growth of MPN blood cells in the laboratory. Alpha-interferon is a natural protein present in the body in small amounts. Treatment with interferon is known to have significant activity in MPN, but the way that this drug works is not fully known.
  • Patients must have a diagnosis of either polycythemia vera (PV) or essential thrombocytosis (ET)
  • Patients must be age 18 years or older.
Platanias, Leonidas CPlatanias, Leonidas C
  • Map it 201 E. Huron St.
    Chicago, IL
STU00211647
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Randomized controlled trial assessing transperineal prostate biopsy to reduce infection complications

Prostate cancer is the most commonly diagnosed malignancy in U.S. men. There are approximately 1 million prostate biopsy performed annually in the U.S. Almost all biopsies are performed as an office based procedure in under 15 minutes. The precision of biopsy has improved over the last decade with …

Prostate cancer is the most commonly diagnosed malignancy in U.S. men. There are approximately 1 million prostate biopsy performed annually in the U.S. Almost all biopsies are performed as an office based procedure in under 15 minutes. The precision of biopsy has improved over the last decade with the introduction of MRI guidance/targeting of suspicious lesions within the prostate.

However, significant limitations remain with this approach, including a significantly increasing risk of post-biopsy infection. This arises because more than 97% of all prostate biopsy are performed via a transrectal approach that introduces rectal bacteria with each pass of the biopsy needle into the sterile urinary tract. The current risk of post-transrectal biopsy infection, even with antimicrobial prophylaxis, is high at approximately 7% overall with 3% (30,000 men) requiring hospitalization annually.

Transperineal biopsy is an alternate approach that eliminates the direct introduction of bacteria from the rectum to the prostate. This approach, which is perfomed without antimicrobial prophylaxis, instead passes the biopsy needle through the perineal skin and pelvic floor.

Transperineal biopsy has not been widely adopted for several reasons. Historically, it has been considered too painful for patients in the clinic and thus was traditionally performed under general anesthesia. The added time, inconvenience and cost has limited its national adoptance. Second, when transrectal biopsy was initially adopted over 40 years ago, antibiotic resistance of rectal flora was not a challenge.

Beyond the potential for in-office transperineal biopsy to significantly reduce or eliminate biopsy infections, transperineal biopsy may also improve cancer detection: studies of transperineal biopsy (performed under general anesthesia) demonstrate higher detection rates for prostate cancer, particularly for anterior zone tumors, compared to transrectal biopsy. This is notable, as anterior tumors are difficult to sample with transrectal. Anterior tumors are also twice as likely to occur in African American men. In fact, our research demonstrates that some of the outcomes disparities in African American men may stem from an underdiagnosis of anterior prostate cancers.

Although transrectal biopsy is used widely, it is associated with a significant and increasing risk of biopsy infections due to growing antibiotic resistance, highlighting the urgent need for a safer alternative approach to prostate biopsy. The study investigators have refined a transperineal approach under local anesthesia with MRI-targeting/guidance without the need for antibiotic prophylaxis. The investigators hypothesize that transperineal MRI targeted biopsy will: (1) largely eliminate post-biopsy infections and costly hospitalizations for urosepsis; (2) be performed in the office with similar discomfort and non-infectious complications compared to transrectal MRI targeted biopsy; and (3) have significantly better detection of prostate cancer.

This multi-center randomized controlled trial will be conducted to evaluate in-office transperineal MRI targeted vs. transrectal MRI targeted biopsy, the current gold standard. This has transformative impact to change current standard of practice.

This study will include allmen who are recommended to undergo prostate biopsy as part of routine clinicalcare.
Schaeffer, Edward MatthewSchaeffer, Edward Matthew
NCT04815876 STU00211699
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A PHASE II STUDY TO EVALUATE THE SAFETY AND EFFICACY OF OQL011 ON VEGFR INHIBITOR-ASSOCIATED HAND-FOOT SKIN REACTION IN CANCER PATIENTS

This study is trying to determine whether an ointment is safe and effective for the treatment of hand-foot skin reaction induced by VEGRF inhibitors. 
Participants must be over the age of 18 and have hand-foot skin reaction after taking anti-cancer medications calls VEGRF inhibitors. 
Choi, Jennifer NamChoi, Jennifer Nam
  • Map it 676 N. St. Clair St.
    Chicago, IL
NCT04088318 STU00211322
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NU COVID-19 MSK20H04: Examining COVID19 Course and Outcomes in Patients Previously Diagnosed with Chronic Lymphocytic Leukemia (CLL)

This multicenter, retrospective cohort study will include patientstreated at national and international medical centers. Patients will be included if they have a prior diagnosis of CLL, havebeen diagnosed with COVID19, and received care at a participating medicalcenter. Primary Aim: To determine the 28-daymortality rate from the time of COVID …
This multicenter, retrospective cohort study will include patientstreated at national and international medical centers. Patients will be included if they have a prior diagnosis of CLL, havebeen diagnosed with COVID19, and received care at a participating medicalcenter.

Primary Aim:

To determine the 28-daymortality rate from the time of COVID 19 diagnosis for CLL patients infectedwith SARS-CoV2 at MSKCC and other institutions.

Secondary Aims:

To describe baseline characteristics, prior and current CLL directed therapies, COVID19 clinical course and outcomes for CLL patients infected with SARS-CoV2.

To examine relationships between CLL directed therapy and COVID19 disease course and outcomes.

To examine current practices regarding management of CLL directed therapy in CLL patients infected with SARS-CoV2.

Chronic lymphocytic leukemia (CLL) patients diagnosed with COVID19.
Ma, ShuoMa, Shuo
  • Map it 201 E. Huron St.
    Chicago, IL
STU00212455
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NU FC19L02: Phase II randomized trial of carboplatin + pemetrexed + bevacizumab, with or without atezolizumab in stage IV non-squamous NSCLC patients who harbor a sensitizing EGFR mutation or have never smoked

The purpose of this research study is to determine if the combination therapy of carboplatin, pemetrexed, bevacizumab (Avastin) and atezolizumab (Tecentriq) is better at controlling disease progression in patients with sensitizing EGFR mutation induced NSCLC or patients with NSCLC who are never-smokers as compared to the combination without Tecentriq. …
The purpose of this research study is to determine if the combination therapy of carboplatin, pemetrexed, bevacizumab (Avastin) and atezolizumab (Tecentriq) is better at controlling disease progression in patients with sensitizing EGFR mutation induced NSCLC or patients with NSCLC who are never-smokers as compared to the combination without Tecentriq.

All prospective patients will undergo screening tests to determine if they are eligible to take part in the study. A computer will by chance assign patients to one of the two arms in the study. This is called randomization.

•Arm A: Carboplatin + Pemetrexed + Avastin + Tecentriq

•Arm B: Carboplatin + Pemetrexed + Avastin

Arm A: Participants will receive carboplatin, pemetrexed, Avastin and Tecentriq for 4 cycles in the treatment phase, followed by pemetrexed, Avastin and Tecentriq for the rest of the cycles, called the maintenance phase.

Arm B: Participant will receive carboplatin, pemetrexed and Avastin for 4 cycles in treatment phase, followed by pemetrexed and Avastin during the following cycles of the maintenance phase.

Participants will be asked to take the study drugs as long as they are benefitting from the treatment or their disease does not get worse. Participants will be removed from the study if the study doctor thinks that they have unacceptable toxicities due to the study drug/s and it is in their best interest to stop participating in the study.

All the drugs will be administered intravenously on Day 1 of each cycle. Each cycle is made of 21 days. The number of cycles will depend on how participants respond to treatment. During the study, participants will have a CT scan every 6 weeks (every 9 weeks during the maintenance phase). Participants will also undergo a physical exam, blood tests, performance status, and vital signs. Blood will be collected during the study. A biopsy for tissue will be collected if the participant agrees.

Note: This is only a partial description of treatment. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

Some of the eligibility criteria include:

•Stage IV advanced non-small cell lung cancer (NSCLC) with a sensitizing EGFR mutation or without a history of smoking

•Age of at least 18 years

Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

Patel, Jyoti DPatel, Jyoti D
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03786692 STU00211923
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Immune checkpoint inhibitor-associated acute kidney injury

Since 2011, six immune checkpoint inhibitors (ICIs), a type of immunotherapy, have been approved by the Federal Drug Administration for use in patients with cancer.  These medications have been demonstrated to have great promise for treating a variety of cancers.  However, there are toxicities associated with these agents, …
Since 2011, six immune checkpoint inhibitors (ICIs), a type of immunotherapy, have been approved by the Federal Drug Administration for use in patients with cancer.  These medications have been demonstrated to have great promise for treating a variety of cancers.  However, there are toxicities associated with these agents, known as immune-related adverse events (AKI), some of which can be fatal.  Affected organs include the skin (rash), gastrointestinal tract(diarrhea), and the kidneys (acute kidney injury [AKI]). This study, led by Drs. Shruti Gupta and David Leaf at Brigham and Women’s Hospital, has the goal of collecting data on over 300 ICI-associated acute kidney injury cases from more than 30 academic medical centers worldwide.  We will characterize the clinical features of ICI-associated AKI in the hope that this will help us to determine predictors  of toxicity and best practices for management. 
Aggarwal, VikramAggarwal, Vikram
STU00212602
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Phase 1/2 trial of blood-brain barrier opening with the SonoCloud-9 implantable ultrasound device and treatment with albumin-bound paclitaxel in patients with recurrent glioblastoma

Eligible patients will undergo craniotomy for tumor resection. During the tumor resection and when possible, an initial low dose of albumin-bound paclitaxel will be given following sonication. In select patients, the sonication procedure may occur immediately after the test dose of chemotherapy is administered. The sonication device will be …

Eligible patients will undergo craniotomy for tumor resection. During the tumor resection and when possible, an initial low dose of albumin-bound paclitaxel will be given following sonication. In select patients, the sonication procedure may occur immediately after the test dose of chemotherapy is administered. The sonication device will be implanted at the end of the procedure. In phase 1, about two weeks after surgery, patients will undergo sonication and albumin-bound paclitaxel administration with MRI to quantify extent of blood brain barrier opening. Sonication and administration of albumin-bound paclitaxel will continue every 3 weeks until disease progression. The planned albumin-bound paclitaxel starting dose is 40 mg/m2, to be escalated in the absence of significant toxicity up to 260 mg/m2. Blood samples for circulating tumor DNA will also be collected before and after each sonication. In phase 2, pre-sonication carboplatin at AUC 5 will be added to the regimen, with a safety run-in for the first 6 patients.

Inclusion Criteria:

  • Confirmed diagnosis of Isocitrate Dehydrogenase 1 (IDH1) wild-type glioblastoma on pathology from initial surgery (e.g. IDH R132H neg); morphologic or molecular determination of grade 4
  • Ability to undergo contrast-enhanced MRI
  • Radiographic evidence of tumor recurrence/progression after failure of 1 - 2 lines of prior therapy
  • Measurable or evaluable disease

  • Measurable: contrast-enhancement (bidirectional diameters ≥ 1cm) on MRI
  • Non-measurable/evaluable: contrast-enhancement diameters < 1 cm
  • Maximal tumor diameter pre-surgery ≤ 70 mm on T1wMRI
  • Candidate for at least partial surgical resection
  • Greater 12 weeks from completion of radiation therapy
  • Age ≥ 18 years
  • If receiving dexamethasone for mass effect, a stable daily dose of dexamethasone at < 6 mg within 7 days of registration, or if dexamethasone dose is decreasing, average daily dose of < 6 mg in the 7 days prior to registration. Patients on dexamethasone for reasons other than mass effect may still be enrolled.
  • WHO performance status ≤ 2 (equivalent to Karnofsky Performance Status (KPS) of ≥70)
  • Adequate hepatic, renal and bone marrow function, documented with normal laboratory values or no more than grade 1 outside the norm performed within 14 days prior to registration
  • For patients with a childbearing potential

  • Negative pregnancy test within 14 days prior to registration
  • Agreement to use adequate contraception for the duration of study participation, and for 3 and 6 months after the last dose of albumin-bound paclitaxel for men and women of childbearing potential, respectively.
  • Have the ability to understand and the willingness to sign a written informed consent prior to registration on study
  • Be willing and able to comply with the protocol for the duration of the study
  • Provide written, signed and dated informed consent prior to study registration. NOTE: no study-specific screening procedures may be performed until written consent has been obtained
  • Exclusion Criteria:

  • Have multifocal disease that cannot be encompassed in the ultrasound fields:

  • e.g. > 70-mm apart
  • tumor located in the posterior fossa
  • Patients at risk of cranial wound dehiscence
  • Have uncontrolled epilepsy or require treatment with enzyme-inducing antiepileptics
  • Have clinical evidence of peripheral neuropathy on examination
  • Have received any other investigational agents within 4 weeks of registration
  • Have received prior therapy with or have history of allergic reactions attributed to compounds of similar chemical or biologic composition to paclitaxel or carboplatin
  • Medical contraindications to Abraxane® or carboplatin
  • Have an uncontrolled intercurrent illness
  • Are pregnant or nursing
  • Have a history of active malignancy within 3 years prior to registration.
  • Have a known history of hypersensitivity reactions to perflutren lipid microsphere components or to any of the inactive ingredients in Definity® (the FDA-approved ultrasound contrast agent to be used in this study)
  • Patients with coils, clips, shunts, intravascular stents, and/or non-removable wafer, non resorbable dura substitute, or reservoirs.
  • Patients with medical need to continue antiplatelet therapy.
  • Patients with known significant cardiac disease, known to have right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure > 90 mmHg), uncontrolled systemic hypertension, or adult respiratory distress syndrome (patient at risk for microbubble reaction).
  • Patients with impaired thermo-regulation or temperature sensation (due to device)
  • Sonabend Worthalter, Adam MendelSonabend Worthalter, Adam Mendel
    • Map it 675 N. Saint Clair St. Twentieth Floor
      Chicago, IL
    NCT04528680 STU00212298
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    (xIRB) DRUG 7465-CL-202 : An Open-label, Multicenter, Multicohort, Phase 2 Study to Evaluate Enfortumab Vedotin in Subjects with Previously Treated Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)

    The primary purpose of this study is to determine the antitumor activity of enfortumab vedotin as measured by confirmed objective response rate (ORR) per RECIST v1.1.This study will also assess other measures of antitumor activity; overall survival (OS); as well as the safety and tolerability of enfortumab vedotin …

    The primary purpose of this study is to determine the antitumor activity of enfortumab vedotin as measured by confirmed objective response rate (ORR) per RECIST v1.1.

    This study will also assess other measures of antitumor activity; overall survival (OS); as well as the safety and tolerability of enfortumab vedotin for cohorts 1 to 8 and enfortumab vedotin + pembrolizumab in cohort 9.

    • Participants must have a diagnosis of breast, lung, head and neck (HNSCCs), gastric, gastroesophageal junction, or esophageal cancer

    • Participants must be 18 or older

    Lorch, Jochen Hanns-MartinLorch, Jochen Hanns-Martin
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04225117 STU00213246
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    NRG HN006: Randomized Phase II/III Trial of Sentinel Lymph Node Biopsy Versus Elective Neck Dissection for Early-Stage Oral Cavity Cancer

    This study is being done to answer the following questions: 1) will neck and shoulder function and discomfort be better if you have a procedure called sentinel lymph node (SLN) biopsy instead of the usual surgery for this type of cancer; and 2) is SLN biopsy the same as the …

    This study is being done to answer the following questions: 1) will neck and shoulder function and discomfort be better if you have a procedure called sentinel lymph node (SLN) biopsy instead of the usual surgery for this type of cancer; and 2) is SLN biopsy the same as the usual surgery in extending the time you have without cancer returning? The usual approach is defined as care most people get for this cancer.

    This study has 2 parts. In the first part,doctors will try to learn the answer to question #1 above. If the answer shows that neck and shoulder function and discomfort is better in patients who have the SLN biopsy, then the study will go on to the second part, and doctors will try to answer question #2.
    • Participants must be 18 years or older
    • Participants must have a confirmed diagnosis of early-stage oral cavity cancer
    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.
    Samant, SandeepSamant, Sandeep
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04333537 STU00213298
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    Impact of immunotherapy-related skin diseases on quality of life

    The purpose of this study is to characterize the effects of cutaneous side effects from immunotherapies on quality of life. Participants will complete a one time survey. 
    Participants need to be 18 years and older, receiving immunotherapy, and may be experiencing a dermatologic side effect. 
    Choi, Jennifer NamChoi, Jennifer Nam
    • Map it 676 N. St. Clair St.
      Chicago, IL
    STU00212205
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    DRUG CCTL019B2003I: Managed Access Program (MAP) Cohort Treatment Plan CCTL019B2003I to provide access for patients with out of specification leukapheresis product and/or out of specification manufactured tisagenlecleucel (CTL019; Kymriah®).

    The purpose of this Managed Access Program(MAP), which is an intermediate size patientpopulation Expanded Access, is to allowtreatment with tisagenlecleucel (CTL019) for eligiblepatients diagnosed with B-cell acutelymphoblastic leukemia (ALL) or large B-cell lymphomas who meet all of thefollowing criteria: are 1) consistent with the approved prescribing information,…

    The purpose of this Managed Access Program(MAP), which is an intermediate size patient

    population Expanded Access, is to allowtreatment with tisagenlecleucel (CTL019) for eligible

    patients diagnosed with B-cell acutelymphoblastic leukemia (ALL) or large B-cell lymphomas who meet all of thefollowing criteria: are 1) consistent with the approved prescribing information,2) unable to receive commercially manufactured product due to failure of the incomingapheresis material to meet acceptance specifications or final outgoing productto meet the commercial release specifications or other specification within theprescribing information, and 3) where no overwhelming safety concerns has beenidentified for manufacture and release of the out of specification product.

    Participation inthis treatment plan involves an experimental approach called gene transfer forALL or large B-cell lymphoma that involves cells in your blood called B cells(your tumor cells and also normal antibody-producing cells). During thistreatment, some of your own white blood cells (T cells) will be taken andchanged to turn against your tumor cells. T cells from your body will bechanged in a way that may allow them to identify and kill your tumor cells.This change may allow your T cells to go to the tumor cells, turn"on" and potentially kill the tumor cells. The modification is doneby gene transfer and results in a genetic change to your T cells. This mayallow the changed T cells to recognize your tumor cells but also normalantibody-producing cells called B cells. These changed cells are calledtisagenlecleucel cells.

    If you are eligible andchoose to participate in this MAP, you will be asked to come to the doctor’soffice/clinic/study site at least 3 times in order to make sure you areeligible to receive the tisagenlecleucel cells, and to prepare you for theexperimental treatments. Once you receive the tisagenlecleucel cells, acaregiver, relative, or friend should be in your presence at all times for thefirst 10 days to monitor your well-being and contact your study physician incase of fever or changes in your condition. If you become ill, immediatelycontact your study physician. Additionally, you may be required to spend about4 weeks after you have received tisagenlecleucel cells in close proximity tothe trial treatment center while the doctor and study team see how thetreatment is working and monitor your safety.

    Note:This is only a partial description of treatment. Please contact the Robert H.Lurie Comprehensive Cancer Center of Northwestern University if you areinterested in this Managed Access Plan (MAP).

    Some of the eligibility criteria include:

    · Age of at least 18 years

    Diagnosis of acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse or have been diagnosed with relapsed or refractory large B-cell lymphoma after two or more lines of therapies including diffuse large B cell lymphoma not otherwise specified, high grade B cell lymphoma and Diffuse large B-cell lymphoma (DLBCL) arising from follicular lymphoma.

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this Managed Access Plan (MAP).

    Karmali, ReemKarmali, Reem
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03601442 STU00213101
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    Evaluating the EVO treatment optimized for resource constraints: Elements Vital to treat Obesity

    EVO is a 12-month healthy lifestyle and weight loss research study taking place in the Department of Preventive Medicine at Northwestern University. Researchers are looking to determine the best strategy for weight loss and healthy living. Participants enroll in the 12-month study and receive a free 6-month …
    EVO is a 12-month healthy lifestyle and weight loss research study taking place in the Department of Preventive Medicine at Northwestern University. Researchers are looking to determine the best strategy for weight loss and healthy living. Participants enroll in the 12-month study and receive a free 6-month health program.

    You are between the ages of 18 - 70 years old. You are NOT currently pregnant, trying to become pregnant, or breastfeeding.You do NOT have an unstable medical condition.You own an Android or iPhone smartphone.You are willing to track your lifestyle behaviors for 6 months, and attend remote sessions with study staff over the course of 12 months.
    Pfammatter, Angela FidlerPfammatter, Angela Fidler
    • Map it 680 N. Lake Shore Drive Suite 1410
      Chicago, IL
    STU00212742
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    (xIRB) NCI CIRB ETCTN 10276: A Phase I/II Study of M3814 and Avelumab in Combination with Hypofractionated Radiation in Patients with Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies

    Phase 1:The purpose of this study is to test the safety of a drugcalled M3814 in combination with avelumab and hypofractionated radiation. This combination of drugs has been tested inanimals but has not been tested in people. This study tests different doses of the drug to see which dose …
    Phase 1:

    The purpose of this study is to test the safety of a drugcalled M3814 in combination with avelumab and hypofractionated radiation. This combination of drugs has been tested inanimals but has not been tested in people. This study tests different doses of the drug to see which dose is saferfor people.

    Participants enrolled in Phase 1 will get standard dose ofradiation therapy every other day over 10 days. This will be followed by a combination of avelumab and M3814 for as long as your doctor feels that the combination ishelping you and you are not experiencing too many side effects.

    Phase 2:

    Phase 2 has twostudy groups:

    Group 1 Participants in Group 1 will receive radiation therapy and the study drugsavelumab and M3814. These drugs are not approved by the FDA for treatment of your disease.

    Group 2 Participants in Group 2 will receive radiation therapy and the study drug avelumab.Avelumab is not approved by the FDA for treatment of yourdisease.

    All participants, regardless of which phase they areenrolled in, will be followed for 12 months and watched for side effects.Participants will be asked to return to the clinic approximately 30 days aftertheir last dose of study treatment. Afterthat time, participants will be contacted by telephone at regular intervals forup to five years.

    This study hastwo phases. Participants will participate in either Phase 1 or Phase 2.

    Phase 1:

    Participants whoare 18 years of age or older who have an advanced/metastatic solid tumor willbe enrolled.

    Phase 2:

    Participants whoare 18 years of age or older who have an advanced/metastatic hepatobiliarytumor will be enrolled.

    Kalyan, AparnaKalyan, Aparna
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04068194 STU00213617
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    Alliance A021806: A Phase III Trial of Perioperative Versus Adjuvant Chemotherapy for Resectable Pancreatic Cancer

    This study is being done to answer the following question: Can we increase the chance of your pancreatic cancer staying away by giving you chemotherapy before and after surgery? We are doing this study because we want to find out if this approach is better or worse than the usual …

    This study is being done to answer the following question:

    Can we increase the chance of your pancreatic cancer staying away by giving you chemotherapy before and after surgery?

    We are doing this study because we want to find out if this approach is better or worse than the usual approach for your pancreatic cancer. The usual approach is defined as care most people get for removable pancreatic cancer.

    • Participants must be 18 years or olderParticipants must have a confirmed diagnosis of pancreatic cancer that can be removed by surgery

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Chawla, AkhilChawla, Akhil
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04340141 STU00213664
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    OPT2MOVE

    About the StudyOpt2Move is a 6-month smartphone-based study to help adolescent and young adult cancer survivors become more active.What’s involved? AssessmentsComplete before starting study and at 3 and 6 months: 45-min online surveyWear activity monitor 24/7 for 7 days You will be compensated for …

    About the Study

    Opt2Move is a 6-month smartphone-based study to help adolescent and young adult cancer survivors become more active.

    What’s involved?

    Assessments

    Complete before starting study and at 3 and 6 months:

    • 45-min online survey
    • Wear activity monitor 24/7 for 7 days
    • You will be compensated for assessment completion

    Physical Activity Program

    All Participants

    • Receive Fitbit, Opt2Move app, exercise prescription, 15-min orientation call
    • Track physical activity with Fitbit and use Opt2Move app daily
    • Additionally, you may receive 0-4 additional Opt2Move features focused on mindfulness and/or social support.

    How can I learn more?

    For questions: Phone: 312-503-3465; Email: O2M@nm.org

    To complete online screening: https://redcap.link/O2M

    Who can participate?

    • Adults (18-39) diagnosed with cancer (except non-melanoma skin cancer) at age 18-39
    • 5 years or less since cancer diagnosis
    • 3 months or more since completed primary treatment (i.e., surgery, chemotherapy, and/or radiation); may still be undergoing endocrine or hormonal therapies
    • Fluent in spoken and written English
    • Own a smartphone that is either an iPhone (version 5 or greater) or an Android (version 5.0 or greater)
    • Have internet access
    • Have no absolute contraindications to exercise (e.g., acute myocardial infarction, severe orthopedic conditions, or metastatic disease) OR willing to obtain medical clearance from a primary care physician if necessary
    • Engage in less than 60 minutes total each week of moderate to vigorous intensity physical activities such as walking, biking, or swimming
    • Willing to find a Buddy (someone who knows about your cancer and participation in this study and who is willing to participate by supporting you during the 6-month study)
    Phillips, Siobhan MPhillips, Siobhan M
    NCT05375162 STU00210628
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    Serial Monitoring of Circulating Tumor Cells During Radiotherapy for Women with Non-Metastatic Breast Cancer: A Prospective Observational Cohort Study

    The purpose of this research is to determine whether radiotherapy after surgery to remove a breast cancer can help decrease the number of circulating tumor cells (CTCs) in the blood. Circulating tumor cells are cancer cells that are shed from the tumor into the blood stream and are believed to …

    The purpose of this research is to determine whether radiotherapy after surgery to remove a breast cancer can help decrease the number of circulating tumor cells (CTCs) in the blood. Circulating tumor cells are cancer cells that are shed from the tumor into the blood stream and are believed to be one of the first indicators that breast cancer cells may remain after surgery. Approximately 20% of women with early-stage breast cancer can be found to have CTCs in a small sample of blood taken several weeks after surgery. Radiotherapy is used after surgery to remove a breast cancer in order to sterilize any cancer cells that may be remaining in the breast. It is not known if radiotherapy can help decrease or eliminate CTCs that are found in the blood. This study aims to find out if testing for CTCs can be clinically useful for guiding radiotherapy treatment decisions. Another aim of this study is to evaluate whether CTCs can be used to measure the effectiveness of radiotherapy in an individual patient.

    Eligible participants are post-menopausal women that have been diagnosed with non-metastatic, ER-positive and Her2-nonamplifed breast cancer and are planning on receiving radiation and hormone therapy.

    Strauss, Jonathan BStrauss, Jonathan B
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00212971
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    (xIRB) NCI CIRB ECOG-ACRIN 8191: Phase III Study of PET-Directed Local or Systemic Therapy Intensification in Prostate Cancer Patients with Post-Prostatectomy Biochemical Recurrence

    The purpose of this study is to compare the usual treatment alone to using PET/CT imaging to look for cancer that has spread to the pelvis plus the usual treatment. We want to see if we can provide a more targeted treatment to this type of cancer by treating …

    The purpose of this study is to compare the usual treatment alone

    to using PET/CT imaging to look for cancer that has spread to the pelvis plus the usual treatment.

    We want to see if we can provide a more targeted treatment to this type of cancer by treating up to 5

    specific lesions that are seen on the PET/CT scan. Part of the purpose of this study is also to see

    whether adding apalutamide and directed radiation works better than the usual approach to help treat

    prostate cancer that has returned after surgery.

    This study will help the study doctors find out if this different approach is better than the usual

    approach. To decide if it is better, the study doctors will be looking to see if the study approach

    increases the time before cancer growth or if the cancer causes major additional symptoms.

    This study has 4 study groups. Participants will be assigned to 1 of 4 possible treatment groups

    depending on the results of your PET/CT scan. After you finish your study treatment, your doctor will

    continue to follow your condition for up to 10 years and watch you for side effects and monitor the

    progression of your cancer.

    Group 1 (Negative for Extra Pelvic-Metastases)

    If you are in this group, it means your PET/CT scan did not show evidence that your cancer has spread

    to outside of the pelvis. You will get the usual appropriate care that is used to treat this type of

    cancer, the planned standard of care treatment with radiation therapy (SOC RT) and STAD for 6 months.

    Group 2 (Negative for Extra Pelvic-Metastases)

    If you are in this group, it means your PET/CT scan did not show evidence that your cancer has spread

    to areas outside of the pelvis. You will get a study treatment, planned SOC RT + STAD + apalutamide

    for 6 months.

    Group 3 (Positive for Extra Pelvic-Metastases)

    If you are in this group, it means that your cancer has spread to areas outside of your pelvis.

    You will get planned SOC RT + STAD + apalutamide for 6 months.

    Group 4 (Positive for Extra Pelvic-Metastases)

    If you are in this group, your cancer has spread to areas outside of your pelvis.

    You will get a planned SOC RT + STAD + apalutamide for 6 months + directed radiation therapy to

    where the cancer has spread. Each patient will undergo another (or additional) PET/CT scan,

    which will take place about one year after starting treatment or if clinically necessary at an

    earlier time point.

    Male participants 18 years of age or older who have prostate cancer that has come back after surgery

    will be enrolled into this study.

    Sachdev, SeanSachdev, Sean
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04423211 STU00214021
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    Social Correlates Of Variation In Intestinal And Oral Microbiome Among Hematopoietic Stem Cell Transplant Patients: A Geographic Exploration In The City Of Chicago

    This study is being done to learn how the microbiome evolves through stem cell transplantation, how it can be shaped by socioeconomic status, the neighborhoods that people reside in, and their diet, as well as certain clinical factors (such as antibiotic usage). Study participants will be asked to provide a …

    This study is being done to learn how the microbiome evolves through stem cell transplantation, how it can be shaped by socioeconomic status, the neighborhoods that people reside in, and their diet, as well as certain clinical factors (such as antibiotic usage). Study participants will be asked to provide a saliva sample and complete a questionnaire.

    You may be eligible for this study if you have been diagnosed with a hematologic malignancy (also known as a blood cancer) and are being considered for an allogeneic hematopoietic stem cell transplantation (sometimes also referred to as a bone marrow transplant).

    Moreira, JonathanMoreira, Jonathan
    STU00213358
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    Testing Atorvastatin to Lower Colon Cancer Risk in Longstanding Ulcerative Colitis

    Patients with ulcerative colitis are at higher than average risk of developing cancer of the large intestine (bowel) or colorectal cancer. Doctors at Northwestern Medicine are doing this study to find out if taking the drug atorvastatin might decrease that risk. We are studying atorvastatin because research suggests that it …

    Patients with ulcerative colitis are at higher than average risk of developing cancer of the large intestine (bowel) or colorectal cancer. Doctors at Northwestern Medicine are doing this study to find out if taking the drug atorvastatin might decrease that risk. We are studying atorvastatin because research suggests that it may interfere with cancer development. Atorvastatin is a cholesterol-lowering drug used to treat cardiovascular disease.

    Better ways to control ulcerative colitis and more knowledge about how to prevent colon cancer are needed. The usual approach for ulcerative colitis patients is to be followed closely by their doctor to watch for the development of cancer, usually with yearly colonoscopy. Drugs proven to help control inflammation (swelling, tenderness, irritation, and abnormal changes) in the colon and a special diet are usually given to ulcerative colitis patients with active inflammation.

    In this study, you will receive either 20 mg of atorvastatin, or placebo pills, by mouth once a day for up to one year, in addition to your standard of care. This will allow researchers to see if participants taking atorvastatin show changes in their colon, which may indicate a lower risk of developing cancer.

    After one year of treatment with either atorvastatin or placebo, your study doctor will continue to follow your condition and watch you for side effects for up to 21 days. You should continue your routine yearly surveillance colonoscopy examination.

    · Are between 18 and 70 years old

    · Have chronic ulcerative colitis (diagnosed at least 8 years ago)

    Yang, Guang-YuYang, Guang-Yu
    NCT04767984 STU00214121
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    Megestrol Acetate Compared With Megestrol Acetate and Metformin to Prevent Endometrial Cancer

    Endometrial intraepithelial neoplasia (EIN), also known as Complex Atypical Hyperplasia (CAH), is a change in the lining of the uterus (also called the endometrium) that can lead to cancer of the uterus. Uterine/endometrial cancer is the most common gynecologic cancer and its incidence is increasing rapidly.The usual approach …

    Endometrial intraepithelial neoplasia (EIN), also known as Complex Atypical Hyperplasia (CAH), is a change in the lining of the uterus (also called the endometrium) that can lead to cancer of the uterus. Uterine/endometrial cancer is the most common gynecologic cancer and its incidence is increasing rapidly.

    The usual approach for women diagnosed with EIN/CAH is surgical - hysterectomy (removal of the uterus) without any prior medical treatment with pills. But some women may want to avoid hysterectomy because they want to have children, or because there are health risks to major surgery. We are doing this study to see if it is possible to treat EIN by changing the lining of the uterus at the cellular level and prevent it from turning into uterine cancer, without doing a hysterectomy.

    Currently, a drug called megestrol acetate, also called megace, can be used for treatment of EIN without surgery. Megestrol acetate is a synthetic version of the human hormone progesterone. It treats breast cancer and endometrial cancer by affecting female hormones involved in cancer growth. However, it has a high failure rate in preventing cancer growth from EIN, and hysterectomy is still needed for most women. The goal of this study is to improve the results of megestrol acetate treatment, by combining it with an anti-diabetes drug called metformin. Although research suggests that metformin may have anti-cancer properties, it has not yet been proven to be safe and effective to treat EIN. We will compare the effectiveness of megestrol acetate alone with the combination of megestrol acetate and metformin in reducing the growth of EIN. If we find that the combination of megestrol acetate with metformin is better at reducing EIN growth than megestrol acetate alone, we will plan further research with this combination to try and prevent EIN from turning into uterine/endometrial cancer. This study is looking for volunteers who have been diagnosed with EIN and are planning a hysterectomy or progestin intrauterine device (IUD) placement. We will enroll 50 participants at institutions across the country.

    You may be eligible if:

    • You have been diagnosed with EIN/CAH, endometrial intraepithelial neoplasia or atypical hyperplasia
    • You are over 18 years of age
    Barber, Emma LongleyBarber, Emma Longley
    NCT04576104 STU00214124
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    (xIRB) DRUG BB2121-EAP-001: Expanded Access Protocol (EAP) for Subjects Receiving Idecabtagene Vicleucel That Is Nonconforming for Commercial Release

    The purpose of this study is to provide patients access to their nonconforming ide-cel as a treatment option for their disease. The study will evaluate the safety and effectiveness of this therapy through the collection of information. Participants will be asked to take part in this study if they …

    The purpose of this study is to provide patients access to their nonconforming ide-cel as a treatment option for their disease. The study will evaluate the safety and effectiveness of this therapy through the collection of information.

    Participants will be asked to take part in this study if they previously agreed to receive idecabtagene vicleucel (ide-cel), for the treatment of their disease as part of routine care and not a clinical research study. Participants already had the blood collection (leukapheresis) procedure, and your T cells were collected and genetically modified in a laboratory in order to manufacture the ide-cel T cells for your disease treatment.

    The ide-cel T cells that were produced do not meet all of the prespecified release criteria to be used as a routine prescription drug as required by the governing health authority. After review of its attributes, this product has been assessed by the Sponsor and your study doctor as potentially effective to treat your disease with potential benefits that outweigh the risks and is being offered to you as a treatment option in a research study.

    Approximately 3 months after receiving your nonconforming ide-cel, your participation in this study will end.

    Some of the eligibility criteria include:1) documented diagnosis of Multiple Myeloma who was eligible for treatment with ide-cel. 2) Participant had ide-cel manufactured to be used for commercial treatment, however, the final product was nonconforming. 3) Participants must be 18 or older.

    Singhal, SeemaSinghal, Seema
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04771078 STU00214128
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    (xIRB) NCI CIRB NRG BN009: Phase III Trial of Salvage Stereotactic Radiosurgery (SRS) or SRS + Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) for First or Second Distant Brain Relapse After Upfront SRS With Brain Metastasis Velocity >/= 4 Brain Metastases/Year

    The purpose of this study is to compare the usual treatment of SRS alone to SRS plus HA-WBRT (whole brain radiation therapy with hippocampus avoidance) and memantine for patients with cancer that has spread to the brain and come back in other areas of the brain after earlier treatment …

    The purpose of this study is to compare the usual treatment of SRS alone to SRS plus HA-WBRT

    (whole brain radiation therapy with hippocampus avoidance) and memantine for patients with cancer

    that has spread to the brain and come back in other areas of the brain after earlier treatment with SRS.

    The addition of HA-WBRT and memantine to the usual treatment could better control your brain cancer.

    This study will help the study doctors find out if this different approach is better, the same,

    or worse than the usual approach.

    Memantine is FDA approved for treating dementia and is commonly used off-label

    (that is, for a purpose for which it is not FDA approved) for patients receiving whole-brain

    radiation therapy for cancer that has spread to the brain.

    This study has 2 study groups. You will be told which group you are in.

    Group 1

    If you are in this group, you will get the usual treatment, SRS. In addition to the usual

    SRS treatment, you will also receive HA-WBRT. You will also be given the drug memantine,

    which has also been shown to preserve memory function. Memantine will be taken for up to 6 months.

    Group 2

    If you are in this group, you will get the usual treatment of SRS.

    After you finish your treatment, your doctor and study team will watch you for side effects and

    follow your condition. They will check you every 2 to 3 months for at least 1 year after you finish

    SRS. If you are receiving memantine, your doctor will continue to see you in the clinic as needed.

    Participants age 18 years or older who have receivedstereotactic radiosurgery to treat cancer that spread to the brain, and now thecancer has returned in other areas of the brain will be enrolled into thisstudy.

    Lukas, Rimas VincasLukas, Rimas Vincas
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04588246 STU00214371
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    DRUG JCAR017-EAP-001: Expanded Access Protocol (EAP) for Patients Receiving Lisocabtagene Maraleucel That Is Nonconforming for Commercial Release

    The purpose of this expanded access protocol is to allow patients to receive lisocabtagene maraleucel T cells that did not meet all of the prespecified release criteria (nonconforming) to be used as a routine prescription drug. The study will evaluate the safety and effectiveness of this therapy through the collection …

    The purpose of this expanded access protocol is to allow patients to receive lisocabtagene maraleucel T cells that did not meet all of the prespecified release criteria (nonconforming) to be used as a routine prescription drug. The study will evaluate the safety and effectiveness of this therapy through the collection of information.

    Participation in this treatment plan involves receiving the nonconforming product and performing tests as part of your routine clinical care. The information or results from these evaluations will be collected for research purposes.

    If you are eligible and choose to participate in this EAP, you will be asked to complete test as part of routine care, you will undergo lymphodepleting therapy (chemotherapy administered to help prepare your bone marrow and immune system to receive lisocabtagene maraleucel), and receive the nonconforming lisocabtagene maraleucel product through your vein as an intravenous (IV) infusion.

    Approximately 3 months after receiving your nonconforming lisocabtagene maraleucel, your participation in this study will end.

    Note: This is only a partial description of treatment. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    •Age of at least 18 years

    Karmali, ReemKarmali, Reem
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04400591 STU00214152
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    NRG GU009: Parallel Phase III Randomized Trials for High Risk Prostate Cancer Evaluating De-Intensification for Lower Genomic Risk and Intensification of Concurrent Therapy for Higher Genomic Risk with Radiation (PREDICT-RT*)

    Participants ages 18 years or older who have high-risk prostate cancer will be enrolled into this study. This study is being done to answer the following questions: If you have high risk prostate cancer, a low gene risk score and plan to receive radiation therapy, is a shorter hormone …

    Participants ages 18 years or older who have high-risk prostate cancer will be enrolled into this study.

    This study is being done to answer the following questions:

    If you have high risk prostate cancer, a low gene risk score and plan to receive radiation therapy, is a shorter hormone therapy treatment as effective at controlling your cancer compared to the usual 24 month hormone therapy treatment?

    If you have high risk prostate cancer, a high gene risk score and plan to receive radiation therapy, does adding two new hormone therapy drugs to the usual treatment increase the length of time without your prostate cancer spreading as compared to the usual treatment?

    The study doctors want to find out if these approaches are better, similar, or worse than the usual approach for your type of prostate cancer.

    This study has 4 study groups.

    If you have a low Decipher risk score, you will be randomly assigned to one of these two study groups:

    · Group 1: If you are in this group, you will get the usual approach, hormone therapy and radiation therapy, used to treat this type of cancer.

    · Group 2: If you are in this group, you will get the usual radiation treatment and a shorter period of hormone therapy used to treat this type of cancer.

    If you have a high Decipher risk score and/or positive pelvic node(s), you will be randomly assigned to one of these two study groups:

    · Group 3: If you are in this group, you will get the usual approach, hormone therapy and radiation therapy, used to treat this type of cancer.

    · Group 4: If you are in this group, you will get study drugs called apalutamide and abiraterone acetate with prednisone plus the usual approach (hormone therapy and radiation therapy) used to treat this type of cancer.

    After you finish your study treatment, your doctor will continue to follow your condition for at least annually and watch you for side effects.

    Sachdev, SeanSachdev, Sean
    NCT04513717 STU00214649
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    A multi-center single arm Phase II study to evaluate the safety and efficacy of genetically engineered autologous cells expressing anti-CD20 and anti-CD19 specific chimeric antigen receptor in subjects with relapsed and/or refractory diffuse large B cell lymphoma (DLBCL)

    The purpose of this research study is to evaluate an investigational cell and gene treatment called MB-CART2019.1 that may help to eliminate cancer cells in subjects who have relapsed (responded to treatment but then returns) and/or refractory (has not responded to initial treatment) DLBCL. In order to …

    The purpose of this research study is to evaluate an investigational cell and gene treatment called MB-CART2019.1 that may help to eliminate cancer cells in subjects who have relapsed (responded to treatment but then returns) and/or refractory (has not responded to initial treatment) DLBCL. In order to produce the investigational treatment, white blood cells (T-cells) will be collected at the study center by a process called leukapheresis.

    Participation in this study is for up to two years, and additionally subjects must enroll in the separate Gene Therapy Long-Term Follow Up protocol for 13 years (total study participation to equal up to 15 years).

    The T‑cells (obtained from blood) will be modified in order for them to express molecules called chimeric antigen receptors (CARs) on their surfaces. When the modified cells, called CAR T‑cells, are reinfused into the body, the new receptors will enable them to bind onto specific antigens on cancer cells and by doing so destroy them. The CAR T-cells act as a “living drug” against your cancer cells.

    Before your cells are reinfused, participants will first receive a conditioning regimen consisting of two chemotherapy drugs, fludarabine and cyclophosphamide. The conditioning regimen helps make room in the bone marrow for new blood stem cells to grow, and helps prevent rejection of the transplanted cells, as well as helps kill any cancer cells that are in the body.

    Note: This is only a partial description of treatment. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Age of at least 18 years

    · Diagnosis of diffuse large B cell lymphoma (DLBCL).

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Karmali, ReemKarmali, Reem
    NCT04792489 STU00214654
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    (xIRB) NCI CIRB ETCTN 10285: Phase 1/2 Study of an EZH2 Inhibitor (Tazemetostat) in Combination with Dual BRAF/MEK Inhibition in Patients with BRAF- Mutated Metastatic Melanoma Who Progressed on Prior BRAF/MEK Inhibitor Therapy

    Participants 18 years or older who have metastatic melanoma, and the cancer has a change in the gene called the BRAF, and is not responsive to treatment with MEK and BRAF inhibitors will be enrolled. This study has two phases. Phase 1 and Phase 2. The purpose of Phase 1 …

    Participants 18 years or older who have metastatic melanoma, and the cancer has a change in the gene called the BRAF, and is not responsive to treatment with MEK and BRAF inhibitors will be enrolled.

    This study has two phases. Phase 1 and Phase 2.

    The purpose of Phase 1 is to test the safety of the study drug, tazemetostat, in combination with the usual treatment, dabrafenib and trametinib. This study tests different doses of tazemetostat with the usual dose of dabrafenib and trametinib to see which dose of tazemetostat is safest for people. Tazmetostatis not approved by the FDA for treatment of this type of cancer.

    All people taking part in this study will get the same dose of the usual intervention, dabrafenib and trametinib. However, people in this study will get different doses of the study drug, tazemetostat. Once the highest safe dose is found, phase 1 of the study is stopped.

    The purpose of Phase II is to compare the combination of tazemetostat, dabrafenib, and trametinib to tazemetostat alone. This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. Another purpose of this study is for the study doctors to learn if a genetic test is helpful to decide if tazemetostat is more effective in patients whose cancer has an abnormal EZH2 gene. The combination of tazemetostat, trametinib, and dabrafenib, has not been administered together in patients and the combination of these agents are not FDA approved for the treatment of this type of cancer.

    Participants who take part in this study will either get a combination of usual approach of dabrafenib and trametinib, and the study drug, tazemetostat or will get the study drug, tazemetostat alone, until their disease gets worse or the side effects become too severe.

    Patient must be ≥18 years.

    Patient must have a diagnosis of BRAFV600E/K-mutated metastatic melanoma.

    Chandra, SunandanaChandra, Sunandana
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04557956 STU00214795
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    (xIRB) NCI CIRB SWOG 1925: Randomized, Phase III Study of Early Intervention with Venetoclax and Obinutuzumab Versus Delayed Therapy with Venetoclax and Obinutuzumab in Newly Diagnosed Asymptomatic High-Risk Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL): EVOLVE CLL/SLL Study

    The purpose of this study is to compare the early treatment(before you have symptoms) of venetoclax and obinutuzumab (V-O) to the usual treatment of V-O after you have symptoms. This study will help the study doctors find out if this different approach is better, the same, or …

    The purpose of this study is to compare the early treatment(before you have symptoms) of venetoclax and obinutuzumab (V-O) to the usual treatment of V-O after you have symptoms. This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. Another purpose of this study is to find out how early V-O treatment affects patients’ physical, social, and emotional well-being, compared to patients receiving the standard delayed V-O treatment.

    The antibody, obinutuzumab, and the drug, venetoclax are already approved by the FDA for use in patients with previously untreated CLL or SLL. Most of the time these drugs are not used until a patient has symptoms that make treatment necessary.

    Participants who decide to take part in this study will either get treatment with venetoclax and obinutuzumab (V-O) that starts before symptoms start (now), or participants will get treatment with venetoclax and obinutuzumab (V-O) that will start after symptoms start (later). For all patients, the treatment with V-O will continue for 12 months or until the cancer gets worse, or the side effects are too great.

    After treatment is finished, participants will be followed for up to 10 years after enrollment.

    Participants ages 18 years or older who have chronic lymphocytic leukemia or small lymphocytic lymphoma and who do not have symptoms and do not need to start treatment now will be enrolled into this study.

    Ma, ShuoMa, Shuo
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04269902 STU00214799
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    (xIRB) NCI CIRB Alliance A011801: The COMPASSHER2 Trials (COMprehensive Use of Pathologic Response ASSessment to Optimize Therapy in HER2-Positive Breast Cancer): COMPASSHER2 Residual Disease (RD), A Double-Blinded, Phase III Randomized Trial of T-DM1 and Placebo Compared with T-DM1 and Tucatinib

    The purpose of this study is to compare the usual treatment with T-DM1 alone toT-DM1 plus tucatinib. This study will help the study doctors find out if this different approach is better than the usual approach. T-DM1 is already approved by the FDA for use in patients …

    The purpose of this study is to compare the usual treatment with T-DM1 alone toT-DM1 plus tucatinib. This study will help the study doctors find out if this different approach is better than the usual approach. T-DM1 is already approved by the FDA for use in patients with HER2-positive cancer. Tucatinib has not been FDA-approved to treat breast cancer.

    Participants who decide to participate will either get treatment with T-DM1 and placebo (a pill that looks like the study drug but contains no medication) or T-DM1 and tucatinib, for up to 14 cycles, unless the breast cancer returns or the side effects become too severe.

    After study treatment is finished, the study doctor will follow participants to watch for side effects and for signs of breast cancer returning. This may include a clinic visit every 6 months for 10 years.

    Participants age 18 years or older who have HER2-positive breast cancer, and who have already received treatment with chemotherapy and anti-HER2 targeted therapies followed by surgery. At the time of the surgery, cancer was still present in the breast and/or lymph nodes and was removed by a surgeon, will be enrolled into this study.

    Stein, Regina MStein, Regina M
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04457596 STU00214807
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    NU MSK20C04: PROTECT Study: A Phase II, Open-Label Trial of PROphylactic Skin Toxicity ThErapy with Clindamycin and Triamcinolone in Glioblastoma Patients Treated with Tumor Treating Fields

    Studyparticipants are being treated with Tumor Treating Fields (TTFields) formalignant glioma. The TTFields device uses low-intensity electrical fields totreat cancer, and this type of therapy can cause skin side effects, such asitching, sores, or infections. Researchers want to know if using clindamycingel and triamcinolone topical (on the skin) lotion …

    Studyparticipants are being treated with Tumor Treating Fields (TTFields) formalignant glioma. The TTFields device uses low-intensity electrical fields totreat cancer, and this type of therapy can cause skin side effects, such asitching, sores, or infections. Researchers want to know if using clindamycingel and triamcinolone topical (on the skin) lotion before these side effectsoccur may be able to prevent their appearance, so that TTFields can be usedwith less need for interruptions

    Key eligibility criteria include:

    • Diagnosis of newly diagnosed GBM or any malignant glioma with plan to initiate treatment with TTFields with or without systemic therapy, confirmed by the enrolling institution
    • Able to self-administer topical interventions or has available another person who can apply the topical agents
    • Treatment with TTF should be initiated within 7 days of planned initiation in this trial
    • Age of at least 18 years old

    All prospective patients will undergo screening tests to determine if they are eligible to take part in the study.

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Kumthekar, Priya UKumthekar, Priya U
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04469075 STU00213944
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    (xIRB) NU MC21B02: Phase IIB Randomized Trial of Oral Tamoxifen vs. Topical 4-hydroxytamoxifen gel vs. Control in Women with Atypical Hyperplasia or Lobular Carcinoma In Situ

    The purpose of this research is to evaluate short-term changes in background breast tissue induced by oral tamoxifen or 4-OHT gel in women with atypical hyperplasia or LCIS.Study participation involves taking Tamoxifen or a placebo capsule by mouth and applying 4-OHT or placebo gel topically to …

    The purpose of this research is to evaluate short-term changes in background breast tissue induced by oral tamoxifen or 4-OHT gel in women with atypical hyperplasia or LCIS.

    Study participation involves taking Tamoxifen or a placebo capsule by mouth and applying 4-OHT or placebo gel topically to your breast daily for 4 weeks.

    Prior to starting the drug and 4 weeks later participants will be asked to complete some tests and exams.

    If eligible and willing to participate in this study participants will be randomized to either oral tamoxifen, 4-OHT gel, or a placebo. Neither the participant nor the investigator will know which one he/she is receiving. Participants will be taking a capsule (with or without Tamoxifen) and using a gel (with or without 4- OHT). This study will take about 4-6 weeks to complete.

    Note: This is only a partial description of treatment. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    •Age of at least 18 years

    •Diagnosis of Atypical Hyperplasia or Lobular Carcinoma in Situ

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Khan, Seema AhsanKhan, Seema Ahsan
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04570956 STU00214918
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    Training Swallowing Initiation during Expiration: Impact on Safety and Efficiency Following Treatment for Oropharyngeal Head and Neck Cancer

    Dr. Bonnie Martin-Harris and her team are studying a new swallowing therapy to improve eating, drinking, health, and quality-of-life of individuals with head and neck cancer. Therapy will be conducted remotely. …
    Dr. Bonnie Martin-Harris and her team are studying a new swallowing therapy to improve eating, drinking, health, and quality-of-life of individuals with head and neck cancer. Therapy will be conducted remotely. 

    If you were recently diagnosed with head and neck cancer, you might be eligible to participate in this study.

    Martin-Harris, BonnieMartin-Harris, Bonnie
    NCT05278039 STU00214730
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    (xIRB) DRUG MORAb 202-G000-201: A Multicenter, Open-Label Phase 1/2 Trial Evaluating the Safety, Tolerability, and Efficacy of MORAb-202, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC) in Subjects With Selected Tumor Types

    There are two parts to this study: The Dose Escalation part, was toidentify the highest tolerable safe dose of MORAb-202 and is now complete.The DoseConfirmation part is to further evaluate the safety, tolerability and effectivenessof MORAb-202 in subjects with ovarian cancer and endometrial cancer at selecteddoses.…

    There are two parts to this study:

    The Dose Escalation part, was toidentify the highest tolerable safe dose of MORAb-202 and is now complete.

    The DoseConfirmation part is to further evaluate the safety, tolerability and effectivenessof MORAb-202 in subjects with ovarian cancer and endometrial cancer at selecteddoses.

    Ovarian cancer or primary peritoneal cancer orfallopian tube cancer and had progression of disease after previous treatmentwith a platinum-containing chemotherapy regimen.

    · · Age of at least 18 years.

    Note: This is only apartial list of eligibility criteria. Please contact the Robert H. LurieComprehensive Cancer Center of Northwestern University for complete screeninginformation if you are interested in this clinical trial.

    Allprospective patients will undergo screening tests to determine if they areeligible to take part in the study

    Matei, Daniela ElenaMatei, Daniela Elena
    NCT04300556 STU00215228
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    NU 21B01: Volumetric Lumpectomy Specimen Image Visualization for Intraoperatively Directing Cavity Shaves, a Phase II Study (VIVID)

    The purpose of this study is to assess if the use of a 3D imaging device called the Clarix Imaging Volumetric Specimen Imager (VSI) can help guide and assist surgeons in identifying and removing all positive margins while in the operating room for breast conservation surgery.If you are undergoing …

    The purpose of this study is to assess if the use of a 3D imaging device called the Clarix Imaging Volumetric Specimen Imager (VSI) can help guide and assist surgeons in identifying and removing all positive margins while in the operating room for breast conservation surgery.

    If you are undergoing breast conservation surgery and meet all criteria, the 3D imaging device, VSI, will be used to guide and assist the surgeon in identifying and removing all positive margins while in the operating room. The lumpectomy procedure will be performed per standard practice.

    If eligible, the lumpectomy procedure will be performed per standard practice. Promptly after excision, the tumor specimen will be imaged using the VSI device to take additional 3D images of the removed tissue during the standard of care surgery.

    During surgery, after the tumor has been removed, the investigators will use the VSI device to identify the margins on the main sample. The surgeon will use this information to remove additional tissue from the cavity. The surgeon will then complete the standard of care surgery according to standard of care practices which may include additional shaves of the remaining issue. The amount of tissue removed as a result of VSI-directed shaving will not be more than the amount that your surgeon would normally remove as part of standard of care.

    Participants will be asked to come for a post-operative visit as per standard of care and will be followed-up up to 2 months after surgery.

    Note: This is only a partial description of the study procedures. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Age 18 or older

    · Must have histologically confirmed invasive breast cancer, ductal carcinoma in situ (DCIS), or invasive breast cancer with a DCIS component

    · Planning to undergo breast conservation surgery with planned localization and intraoperative imaging for the management of invasive breast cancer

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Kulkarni, SwatiKulkarni, Swati
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT05545150 STU00214652
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    Clinical Trial of Approaches to Prostate Cancer Surgery

    This study will include adult men undergoing radical prostatectomy for clinically localized prostate cancer.

    Inclusion Criteria

    • Age ≥40 years and ≤85 years
    • Scheduled for RP for clinically localized prostate cancer

    Exclusion Criteria

    • Prior major pelvic surgery or radiotherapy
    • Prior focal therapy or radiotherapy for prostate cancer

    Schaeffer, Edward MatthewSchaeffer, Edward Matthew
    • Map it 675 N. Saint Clair St. Twentieth Floor, Suite 150
      Chicago, IL
    NCT05155501 STU00215853
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    NU 20H09: Phase II, Single-arm, Open-label, Multicenter study Evaluating the Efficacy of Adjunctive Zanubrutinib and CAR T-cell therapy in Aggressive B-cell Non-Hodgkin’s Lymphoma

    We are asking you to take part in this research studybecause you have and aggressive B-cell Non-Hodgkin’s Lymphoma that couldbenefit from standard of care , chimeric antigen receptor (CAR) T-cell therapy.CAR T-cell therapy is a promisingtreatment where immune cells originally collected from your body called …
    We are asking you to take part in this research studybecause you have and aggressive B-cell Non-Hodgkin’s Lymphoma that couldbenefit from standard of care , chimeric antigen receptor (CAR) T-cell therapy.CAR T-cell therapy is a promisingtreatment where immune cells originally collected from your body called T-cells (a type of white blood cell), are modifiedand then reintroduced into your body to fight and destroy lymphoma cells.However, CAR T-cell therapy can sustain anti-cancer response beyond 6 months in only 30-40% ofcases. Thus, there is need to enhanceefficacy of CAR T-cell therapy in lymphoma. Lymphoma cells are also known to make a protein called Burton’s TyrosineKinase (“BTK” ), that helps in the proliferation of these cancers. Zanubrutinib is targeted drug that is FDAapproved for a related lymphoma called “Mantel Cell Lymphoma” ( MCL). It isknown to inhibit the BTK protein ( BTK inhibitor ) and can enhance T cell function. Thus, it is expected that it couldenhance CAR T-cell therapy. The investigators of his clinical trialhypothesize that the administration of Zanubrutinib before CAR T-cell therapy and after CAR T-cell therapy can enhance itsanti-cancer effect for your lymphoma

    · Participantsmust be 18 years or older

    The target populationfor this study is patients with aggressive B-cell Non-Hodgkin’s Lymphoma
    Karmali, ReemKarmali, Reem
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT05202782 STU00215064
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    NU SARC041

    Dedifferentiated liposarcoma often has a protein called CDK4 that is over-active. Researchers think that abemaciclib (the study drug), which blocks CDK4, may slow or stop the growth of the liposarcoma tumors. This study is being done to see if the study drug can slow or prevent liposarcoma from growing. …

    Dedifferentiated liposarcoma often has a protein called CDK4 that is over-active. Researchers think that abemaciclib (the study drug), which blocks CDK4, may slow or stop the growth of the liposarcoma tumors. This study is being done to see if the study drug can slow or prevent liposarcoma from growing. The US Food and Drug Administration (FDA) has not approved abemaciclib for liposarcoma, although it is approved for breast cancer. The use of abemaciclib in this study is considered investigational.

    Key eligibility criteria include:

    · Histologically confirmed diagnosis of dedifferentiated liposarcoma which is locally recurrent and/or metastatic.

    · At least one site of measurable disease on CT/MRI scan as defined by RECIST 1.1 criteria. Baseline imaging must be performed within 28 days of Day 1 of study

    · Age of at least 18 years

    All prospective patients will undergo screening tests to determine if they are eligible to take part in the study.

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Pollack, Seth MichaelsPollack, Seth Michaels
    NCT04967521 STU00215929
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    SKIP-Arthralgia

    The main goal of this clinical trial is to test benefits of completing online pain coping skills training program in women who have been diagnosed with stage I-III breast cancer, who have completed their primary cancer treatment, who are taking an AI medication, and who have arthralgia. Arthralgia is …

    The main goal of this clinical trial is to test benefits of completing online pain coping skills training program in women who have been diagnosed with stage I-III breast cancer, who have completed their primary cancer treatment, who are taking an AI medication, and who have arthralgia. Arthralgia is a type of joint, bone, and muscle pain that is a common side effect of AI medications. The main questions it aims to answer are:

  • Whether online pain coping skills training reduces the severity of pain and the interference it causes in women's daily lives.
  • Whether online pain coping skills training improves emotional distress, quality of life, and adherence to AI medications.
  • Whether benefits of online pain coping skills training are at least partially caused by women's increased confidence that they can manage their pain and a reduction in unhelpful thinking patterns about pain.
  • Whether online pain coping skills training improves effects of AI medications on sleep problems and symptoms of menopause like hot flashes and night sweats.
  • Participants can complete all parts of the study at home. They will:

  • Complete four sets of questionnaires throughout the study, which will take about 9 to 10 months.
  • Attend 3 meetings in the first month of the study, all of which can be held via a video conference.
  • Use an electronic pill bottle to track their use of their AI medication.
  • Be randomized (like flipping a coin) to one of two study arms: They will either receive education about AIs and arthralgia or they will receive this education along with access to an online pain coping skills training program.
  • Research will compare the education group to the education plus online pain coping skills training group to see if online pain coping skills training has the benefits mentioned above.

    Inclusion Criteria:

    • Female sex
    • Aged 18 years old or older
    • Diagnosed with Stage I-III hormone receptor positive breast cancer
    • Completed primary cancer treatment (surgery, chemotherapy, and/or radiation therapy)
    • Currently taking AI therapy (letrozole, exemestane, or anastrozole)
    • Meet criteria for likely presence of arthraliga
    • Likely to be able to complete the study protocol
    • ECOG performance status of 0-2
    • English proficient
    • If participants are taking analgesics, they must be on a stable analgesic regimen for at least 14 days prior to enrollment and should not have planned upward dose titration of their analgesics during the study period. (Note: Patients may elect to decrease their analgesic use during the study as per discussion with their provider. Unexpected dose adjustments including dose escalations due to unforeseen clinical need is allowed. Cannabis taken for pain relief would qualify as an analgesic)
    • Comfortable using a tablet computer, a computer, or a smartphone to access online training

    Exclusion Criteria:

    • Evidence of metastatic disease
    • Other active cancer (with the exception of non-melanoma skin cancer)
    • Completed chemotherapy or radiation therapy less than four weeks prior to enrollment (these treatments can cause temporary exacerbation of musculoskeletal symptoms that typically resolve spontaneously)
    • Completed surgery less than 8 weeks prior to enrollment (because surgery can cause temporary post-surgical pain that typically resolves in this period of time); minor surgeries may be allowed more recently than 8 weeks at the discretion of the study team
    • Have diagnosed or suspected condition that would interfere with informed consent or completion of study activities (e.g., significant impairment in cognition or uncorrected hearing/vision)
    Rini, ChristineRini, Christine
    • Map it 250 E. Superior St.
      Chicago, IL
    • Map it 675 N. Saint Clair St. Twenty-First Floor, Suite 100
      Chicago, IL
    NCT05703178 STU00216520
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    NU 21C01: A phase 1/1b adaptive dose escalation study of mycophenolate mofetil (MMF) in combination with standard of care for patients with glioblastoma

    The purpose is to determine if mycophenolate motfetil (MMF) combine with temozolomide (TMZ) can stop glioblatoma. Mycophenolate Mofetil is an antimetabolite immunosuppressant and is FDA approved for the prophylaxis of organ rejection in recipients of allogeneic kidney, heart or liver transplant, and is used in combination with other immunosuppressants.Group …

    The purpose is to determine if mycophenolate motfetil (MMF) combine with temozolomide (TMZ) can stop glioblatoma.

    Mycophenolate Mofetil is an antimetabolite immunosuppressant and is FDA approved for the prophylaxis of organ rejection in recipients of allogeneic kidney, heart or liver transplant, and is used in combination with other immunosuppressants.

    Group S (Pre-surgical): Window of Opportunity Study, pre-operative MMF and temozolomide (TMZ)

    Participants with suspected newly diagnosed or recurrent glioblastoma who plan to have surgical resection are eligible. Study treatment must begin within 7 days after registration. Group S will open in Part 1 after one participant in Group 1 has successfully completed the first dose level DLT period and subsequent DSMB review. The MMF dose for Group S will be adjusted each time DSMB has approved a subsequent dose escalation. The MMF dose for Group S will always be 1 dose level below the current enrolling dose level (the last safe dose level as indicated by the DSMB) in Group 1. Participants will have 5 days of pre-operative MMF (BID) and TMZ (200 mg/m2 QD)

    Group 1 (Adjuvant): Adjuvant therapy+ MMF (dose escalation)

    Four to six weeks after the completion of chemoradiation, participants will be registered to the study. Study treatment must begin within 7 days after registration. On study, participants will receive maintenance TMZ and MMF. Each maintenance cycle is 28 days long.

    TMZ will be taken orally once a day on Days 1-5, at a dose of 150 mg/m2, for up to 6 cycles. On Cycles 2-6, the TMZ dose may be increased to 200 mg/m2 in the absence of toxicity. Starting Cycle 1 Day 1, MMF will be taken orally twice daily for up to 6 cycles (each cycle is 28 days). The dose of MMF will depend on the dose level each participant is accrued to. See MMF Dose Level table in Section 4.2. The DLT period for Group 1 is the duration of Cycle 1 (28 days), and 7 days thereafter.

    Group 2 (Chemoradiation): RT + MMF for MGMT unmethylated tumors (dose escalation)

    About 4 weeks after surgical resection, participants confirmed to have unmethylated glioblastoma will be registered and treated with concurrent MMF and TMZ (75 mg/m2 daily) and 6 weeks of focal radiation therapy (60 Gy). Study treatment must begin within 7 days after registration. MMF will be taken twice daily for the entire 6 week period of focal radiation therapy. The dose of MMF will depend on the dose level each participant is accrued to.

    After radiation therapy, participants will start adjuvant treatment with TMZ. TMZ will be taken orally once a day on Days 1-5, at a dose of 150 mg/m2, for up to 6 cycles. On Cycles 2-6, the TMZ dose may be increased to 200 mg/m2 in the absence of toxicity

    The DLT period for Group 2 is the duration of radiation therapy (6 week period), and 7 days thereafter.

    Group 3 (Expansion): MMF during RT and during adjuvant phase. Enrollment to begin only AFTER the completion of groups 1 and 2.

    About 4 weeks after surgical resection, participants will be registered and treated with concurrent MMF and 6 weeks of focal radiation therapy (60Gy) and concurrent TMZ at a dose of 75 mg/m2 daily. Study treatment must begin within 7 days after registration. After completion of chemoradiation, participants will go on to have adjuvant TMZ (at a dose of 150 mg/m2 on days 1-5 of each cycle, may be up to 200 mg/m2 during cycles 2-6) with concurrent twice-daily MMF for a total of 6 planned cycles (each cycle is 28 days). The dose of MMF during radiation therapy and during adjuvant treatment will be the RP2D determined in dose escalation Groups 1 and 2.

    Optune® Device (Tumor Treating Fields) Concurrent use of the Optune® device (TTFields) is permitted, but not required for participation on this study. It’s use will be according to standard of care.

    Some of the eligibility criteria include:

    •Participants must be 8 years of age or older.

    •For Groups 1-3: Histologically confirmed glioblastoma (GBM), IDH wild-type (by IHC R132H neg or sequencing). Astrocytoma with molecular features of GBM are eligible.

    •For Groups 1-3: Newly diagnosed glioblastoma and:

    a) Group 1: Received surgical resection or biopsy followed by chemoradiation;

    b) Group 2: Received surgical resection or biopsy only and have documented unmethylated glioblastoma (may have been done at an outside facility);

    c) Group 3: Received surgical resection or biopsy only

    •For Group S: Newly suspected glioblastoma or recurrent glioblastoma, and scheduled to undergo a standard of care surgical resection or biopsy

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Kumthekar, Priya UKumthekar, Priya U
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT05236036 STU00215766
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    Drug BNT152-01C: Phase I, first-in-human, open-label, dose escalation trial to evaluate safety, pharmacokinetics, pharmacodynamics, and anti-tumor activity of BNT152+153 in patients with solid tumors

    This research study is ultimately designed to evaluate a new drug called BNT152+153. Since this drug is a combination of two investigational drugs called BNT152 and BNT153, the sponsor must first evaluate each of the two drugs separately (called “monotherapy”). “Investigational” means that BNT152 and BNT153, whether given as …

    This research study is ultimately designed to evaluate a new drug called BNT152+153. Since this drug is a combination of two investigational drugs called BNT152 and BNT153, the sponsor must first evaluate each of the two drugs separately (called “monotherapy”). “Investigational” means that BNT152 and BNT153, whether given as monotherapy or combination therapy, are not approved by the United States (U.S.) Food and Drug Administration (FDA) or by any regulatory authority in the world.

    In this research study, BNT152 monotherapy, BNT153 monotherapy, and BNT152+153 combination therapy will be tested in humans for the first time.

    The overall purpose of this research study is to assess the safety and to establish a safe and effective dose of BNT152 and BNT153 when each is given alone (monotherapy) and when given in combination (BNT152+153). The study will also collect information about how well the drug(s) works against cancer.

    • Histologically or cytologically confirmed solid tumor that is metastatic (Stage IV) or unresectable and for whom there is no available standard therapy likely to confer clinical benefit, or patient who is not a candidate for such available therapy. If there is no contraindication, patients should have exhausted all SoC therapies before entering the trial.

    • Measurable or evaluable disease per RECIST1.1.

    Mahalingam, DevalingamMahalingam, Devalingam
    NCT04710043 STU00216003
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    NRG GU010: PARALLEL PHASE III RANDOMIZED TRIALS OF GENOMICRISK STRATIFIED UNFAVORABLE INTERMEDIATE RISK PROSTATE CANCER: DE-INTENSIFICATION AND INTENSIFICATION CLINICAL TRIAL EVALUATION (GUIDANCE)

    PurposeThe purpose of this study is to determine if radiation therapy alone is as effective at controlling unfavorable intermediate risk prostate cancer, cancer compared to the usual combination of radiation and hormone therapy. Who May be Eligible: Some of the key eligibility criteria include: · Cytologically or histologically confirmed diagnosis of …

    Purpose

    The purpose of this study is to determine if radiation therapy alone is as effective at controlling unfavorable intermediate risk prostate cancer, cancer compared to the usual combination of radiation and hormone therapy.

    Who May be Eligible:

    Some of the key eligibility criteria include:

    · Cytologically or histologically confirmed diagnosis of adenocarcinoma of the prostate.

    · Unfavorable intermediate risk prostate cancer

    · Age ≥18 years

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    All prospective patients will undergo screening tests to determine if they are eligible to take part in the study.

    Sachdev, SeanSachdev, Sean
    NCT05050084 STU00216947
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    Phase II Multicenter Study of Ruxolitinib in Relapsed or Refractory T or NK Cell Lymphoma

    The purpose of this study is to test any good and bad effects of the study drug called ruxolitinib. Ruxolitinib works by blocking a protein called JAK. JAK works along with another protein called STAT and is important for survival of many T or NK-cell lymphomas. By blocking JAK, …

    The purpose of this study is to test any good and bad effects of the study drug called ruxolitinib. Ruxolitinib works by blocking a protein called JAK. JAK works along with another protein called STAT and is important for survival of many T or NK-cell lymphomas. By blocking JAK, ruxolitinib may cause T or NK-cell lymphomas to shrink.

    • Patient must be 18 years of age or older.
    • Patient must have pathologically confirmed T or NK cell lymphoma. For CTCL, patients with stage IB disease or greater are eligible.
    • Relapse or refractory disease after at least 1 systemic therapy
    • No prior therapy with ruxolitinib
    • Patient must not be pregnant
    • No concurrent illness/disease or other systemic therapies unrelated to T-cell lymphoma
    Choi, JaehyukChoi, Jaehyuk
    • Map it 676 N. St. Clair St.
      Chicago, IL
    NCT02974647 STU00216438
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    NU 22H01: Serial Monitoring of Circulating Plasma Cells and Plasma Cell Components in Adults with Plasma Cell Disorders

    This study is being done to collect, process, and store blood samples of plasma cell disorder patients. The collected blood samples will be used for research projects to study the abnormal plasma cells and compare the results to current tests being done. This will provide an opportunity to better understand …

    This study is being done to collect, process, and store blood samples of plasma cell disorder patients. The collected blood samples will be used for research projects to study the abnormal plasma cells and compare the results to current tests being done. This will provide an opportunity to better understand how a patient is responding to treatment and to assess the stage of the patient’s disease.

    This study will use different tests that are not FDA approved. This test is being studied as a less invasive way to monitor amount of disease in a patient (versus invasive bone marrow biopsy). Current blood tests show the levels of the product of the cancer cell - not the levels of the cells themselves. Sometimes the cancer cells do not make this product and can therefore go undetected in standard tests. This study will show the number of cells. These tests will help identify, and analyze circulating plasma cells (CPCs), which are cells that have escaped into the bloodstream (a characteristic of plasma cell disorders). We will also look at any plasma cell components, such as genes in the DNA and RNA. Part of your samples will be used for Next Generation Sequencing (NGS) to evaluate any changes in your genes. NGS is a useful tool that determines the sequence of your DNA.

    You may be eligible for this research study if you have a plasma cell disorder.

    Singhal, SeemaSinghal, Seema
    STU00216869
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    Testing a Combination of Vaccines for Cancer Prevention in Lynch Syndrome

    Lynch Syndrome (LS) increases the risk of colon cancer and can also increase the risk of other cancers, including cancer of the uterus, ovaries, small bowel, stomach, pancreas, urinary tract, skin and brain. Cancer prevention strategies for people with LS are therefore urgently needed. Using vaccines to train the body’…

    Lynch Syndrome (LS) increases the risk of colon cancer and can also increase the risk of other cancers, including cancer of the uterus, ovaries, small bowel, stomach, pancreas, urinary tract, skin and brain. Cancer prevention strategies for people with LS are therefore urgently needed. Using vaccines to train the body’s own immune system to prevent polyps and cancers is a new approach that we plan to test in patients with LS.

    We are asking you to take part in this research study because you have been diagnosed with Lynch syndrome and your doctor has previously found polyps or cancer in your colon or rectum. This study is being done to find out if we can lower your chance of getting colon cancer and other Lynch cancers by giving you three vaccines, an approach called Tri-Ad5, in combination with an injectable immune-enhancer protein called N-803.

    The usual approach for patients with Lynch syndrome is to be followed closely by their doctor with regular colonoscopies, pelvic imaging (ultrasounds), urine tests, computerized tomography scans (CT scans), and skin examinations to watch for the development of cancer. Removal of the colon or uterus before cancer develops is also part of the usual approach. We are doing this study because we want to find out if the vaccines we are testing will be effective at preventing colon polyps and cancers of the colon and other organs.

    The purpose of this study is to compare the safety and effects of the Tri-Ad5 vaccines alone, or in combination with N-803, versus placebo on the risk of developing colon and other cancers in patients with Lynch syndrome. The Tri-Ad5 vaccines and N-803 are not FDA-approved.

    This study is looking for volunteers who have been diagnosed with Lynch syndrome. We will enroll 158 participants at institutions across the country.

    You may be eligible if:

    • You have been diagnosed with Lynch syndrome and have had abnormal growths in your colon or rectum
    • You have not had any cancer treatment in the past 6 months

    · You are 18 years or older

    · You are not pregnant or planning to get pregnant

    Abbass, Mohammad AliAbbass, Mohammad Ali
    NCT05419011 STU00217456
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    (xIRB NCI CIRB) ECOG-ACRIN 9213: A Phase II Study of Daratumumab-Hyaluronidase for Chemotherapy-Relapsed/Refractory Minimal Residual Disease (MRD) in T Cell Acute Lymphoblastic Leukemia (T-ALL)

    This study is being done to answer the following question:Can daratumumab-hyaluronidase reduce the level of MRD in T-ALL patients previously treated with chemotherapy?We are doing this study because we want to find out if this approach is better or worse than the usual approach for your …

    This study is being done to answer the following question:

    Can daratumumab-hyaluronidase reduce the level of MRD in T-ALL patients previously treated with chemotherapy?

    We are doing this study because we want to find out if this approach is better or worse than the usual approach for your T-ALL. The usual approach is defined as care most people get for Acute Lymphoblastic Leukemia (ALL). The usual approach for patients who are not in a study is treatment with chemotherapy, and possibly stem cell transplant. Sometimes, combinations of these treatments are used. Currently there is no SOC treatment for MRD positive T ALL. Many patients if eligible would undergo stem cell transplant, but still have a high risk for T ALL relapse if MRD positive

    The purpose of this study is to test the good and bad effects of the drug called daratumumab and hyaluronidase. Daratumumab and hyaluronidase could be effective in preventing your cancer from returning, but it could also cause side effects. The study doctors hope to learn if the study drug will be effective in treating patients with MRD positive T-ALL and preventing reoccurrence of your disease.

    • Patient must be ≥ 18 years of age
    • Patient must have documented T cell ALL and must be in first or later hematologic CR or CRi after a minimum of 2 blocks of intensive chemotherapy
    • Patients in hematologic CR or CRi must have persistent or recurrent MRD ≥ 10−4
    • Patient may have undergone a prior allogeneic stem cell transplant, but patient may not have Grafts Versus Host Disease (GVHD) that requires ongoing immunosuppressive therapy. Patient may receive prednisone if the dose is ≤ 10 mg per day
    Dinner, Shira NaomiDinner, Shira Naomi
    NCT05289687 STU00217578
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    Evaluating the PD-1 checkpoint inhibitor, Cemiplimab, as neoadjuvant therapy in high risk localized, locally recurrent, and regionally advanced cutaneous squamous cell carcinoma: a Phase II pilot study (NeoPOWER)

    The purpose of this study is to test any good and bad effects of the study drug called Libtayo(cemiplimab) in patients with the diagnosis of Cutaneous Squamous Cell Carcinoma (CSCC,) when given before resection surgery. This investigational approach could shrink your cancer, but it could also cause side effects. …

    The purpose of this study is to test any good and bad effects of the study drug called Libtayo(cemiplimab) in patients with the diagnosis of Cutaneous Squamous Cell Carcinoma (CSCC,) when given before resection surgery. This investigational approach could shrink your cancer, but it could also cause side effects. Researchers hope to learn if the use of this drug before surgery will reduce the amount of cancer cells by at least 50% compared to the original amount in more than 40% of patients. Libtayo (cemiplimab) is FDA-approved to treat metastatic CSCC.

    Cemiplimab will be administered as an IV infusion over 30 minutes in an outpatient setting. Cemiplimab will be used at a flat 350 mg IV dose every 21 days for a total of 9 weeks (or 12 weeks). One cycle is 21 days. After discontinuation of treatment, if the tumor is potentially resectable, the patient will proceed with surgical resection.

    Note: This is only a partial description of treatment. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete description of treatment.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of histologically confirmed, measurable, and potentially resectable Cutaneous Squamous Cell Carcinoma

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Chandra, SunandanaChandra, Sunandana
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04315701 STU00217579
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    SWOG 2015: Melanoma Margins Trial (MelMarT): A Phase III, Multi-Centre, Multi-National Randomised Control Trial Investigating 1cm v 2cm Wide Excision Margins for Primary Cutaneous Melanoma

    Patients with a primary invasive melanoma are recommended to undergo excision of the primary lesion with a wide margin. There is evidence that less radical margins of excision may be just as safe. This is a randomised controlled trial of 1 cm versus 2 cm margin of excision of the …

    Patients with a primary invasive melanoma are recommended to undergo excision of the primary lesion with a wide margin. There is evidence that less radical margins of excision may be just as safe. This is a randomised controlled trial of 1 cm versus 2 cm margin of excision of the primary lesion for adult patients with stage II primary invasive cutaneous melanomas (AJCC 8th edition) to determine differences in disease-free survival. A reduction in margins is expected to improve patient quality of life.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of Cutaneous Melanoma, Stage II

    · Participants must be 18 or older

    · Patient must be able to give informed consent and comply with the treatment protocol and follow-up plan.

    · Surgery (which refers to the staging sentinel node biopsy and wide local excision as these are both to be done on the same day) must be completed within 120 days of the original diagnosis.

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Wayne, Jeffrey DWayne, Jeffrey D
    • Map it 251 E. Huron St. Fifth Floor, Suite 704
      Chicago, IL
    NCT02385214 STU00217691
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    STELLAR

    The STELLAR Program is a healthy lifestyle telehealth program designed for individuals who have been diagnosed with cancer, completed active treatment, and have 2 or 3 of the following health behaviors: 1) have a BMI of 25 or greater, 2) perform less than 90 minutes a week of moderate or …

    The STELLAR Program is a healthy lifestyle telehealth program designed for individuals who have been diagnosed with cancer, completed active treatment, and have 2 or 3 of the following health behaviors: 1) have a BMI of 25 or greater, 2) perform less than 90 minutes a week of moderate or vigorous physical activity, 3) currently smoke.

    Our central mission is to increase the accessibility of equitable health support and resources for cancer survivors within Northwestern Medicine’s network. Spanning over the course of 12 months, trial participants are randomly assigned to one of two distinct study arms. One arm involves telehealth sessions with a health promotionist, fostering a close and supportive partnership between participants and health coaches across a sequence of 16 remote sessions. The second arm offers a self-guided avenue, empowering participants with personalized tools for self-paced progress.

    • 18+ years old
    • Not pregnant
    • Have 2 or 3 of the following: 1) BMI > 25, 2) less than 90 minutes a week of moderate or vigorous physical activity, 3) currently smoke
    • A patient at Northwestern Medicine
    Spring, BonnieSpring, Bonnie
    NCT05687604 STU00217509
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    A Multi-Center, Prospective, Observational Study of Patients Being Treated with ORGOVYX®

    The goal of this study is to generate additional evidence about the safety and effectiveness of ORGOVYX in patients with prostate cancer in routine clinical care and the clinical course during treatment with and following cessation of ORGOVYX.…

    The goal of this study is to generate additional evidence about the safety and effectiveness of ORGOVYX in patients with prostate cancer in routine clinical care and the clinical course during treatment with and following cessation of ORGOVYX.

    • Patients aged 18 or older diagnosed with prostate cancer and initiating treatment with ORGOVYX at the time of enrollment or within the 1 month prior to enrollment and who remain on treatment at enrollment
    • Patients who have reviewed and signed the informed consent form (ICF)
    • Patients who are willing and able to complete PRO assessments during the study
    Ross, Ashley EvanRoss, Ashley Evan
    • Map it 675 N. Saint Clair St. Twentieth Floor, Suite 150
      Chicago, IL
    NCT05467176 STU00217822
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    (xIRB NCI CIRB) Alliance A211801: BRCA-P: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, International Phase 3 Study to determine the Preventive Effect of Denosumab on Breast Cancer in Women carrying a BRCA1 Germline Mutation

    This phase III trial compares denosumab to placebo for the prevention of breast cancer in women with a BRCA1 germline mutation. A germline mutation is an inherited gene change which, in the BRCA1 gene, is associated with an increased risk of breast and other cancers. Denosumab is a monoclonal antibody …

    This phase III trial compares denosumab to placebo for the prevention of breast cancer in women with a BRCA1 germline mutation. A germline mutation is an inherited gene change which, in the BRCA1 gene, is associated with an increased risk of breast and other cancers. Denosumab is a monoclonal antibody that is used to treat bone loss in order to reduce the risk of bone fractures in healthy people, and to reduce new bone growths in cancer patients whose cancer has spread to their bones. Research has shown that denosumab may also reduce the risk of developing breast cancer in women carrying a BRCA1 germline mutation.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    • Participants must have a confirmed deleterious or likely deleterious BRCA 1 germline mutation (variant class 4 or 5)
    • Age >= 25 years and =< 55 years at randomization
    • No evidence of breast cancer by MRI or mammography (MG) and clinical breast examination within the last 6 months prior to randomization
    • Negative pregnancy test at randomization for women of childbearing potential

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Khan, Seema AhsanKhan, Seema Ahsan
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04711109 STU00217826
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    A Multi-Arm, Open Label, Phase II Trial of WP1066 and Radiation Therapy in Patients with Newly Diagnosed Glioblastoma

    The goal of this protocol is to identify the potential for therapeutic efficacy of WP1066 plus RT in newly diagnosed patients with high-grade gliomas. WP 1066 blocks STAT3; STAT3 mediates regulatory signals and activates genes important to tumor-cell survival and proliferation, angiogenesis, evasion of cellular immune response, and …

    The goal of this protocol is to identify the potential for therapeutic efficacy of WP1066 plus RT in newly diagnosed patients with high-grade gliomas. WP 1066 blocks STAT3; STAT3 mediates regulatory signals and activates genes important to tumor-cell survival and proliferation, angiogenesis, evasion of cellular immune response, and metastasis.

     Newly diagnosed, histologically confirmed World Health Organization

    (WHO) glioblastoma multiforme (GBM), IDH wild-type (Documentation of

    isocitrate dehydrogenase (IDH) wild-type status will be by IDH1 R123H

    immunohistochemistry, except for patients ≤ age 54 for whom IDH

    sequencing will be required to detect noncanonical IDH mutations)

     Documentation of O6-methylguanine-DNA methyltransferase (MGMT)

    unmethylated status per testing at any Clinical Laboratory Improvement

    Amendment (CLIA) certified laboratory.

     Able to initiate trial therapy within 8 weeks of the initial brain surgical

    procedure (biopsy or resection) that lead to the patient’s initial diagnosis

    of GBM

     Willing and able to undergo brain MRI with contrast

     Karnofsky Performance Scale score ≥ 60%

     Age ≥ 18 years

     Adequate organ and bone marrow function, as defined in Section 3.1,

    within ≤30 days prior to registration

     Cohort 1 only: Patients with prior gross total resection (GTR)

     Cohort 2 only:

    o Patients without prior GTR

    o Measurable disease in the brain (per RANO criteria) on brain magnetic resonance imaging (MRI) scan conducted within ≤ 4 weeks prior to initiating trial therapy.

    o Patients who would benefit

    Heimberger, Amy BHeimberger, Amy B
    • Map it 201 E. Huron St.
      Chicago, IL
    • Map it 4405 Weaver Pkwy
      Warrenville, IL
    NCT05879250 STU00216108
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    (xIRB NCI CIRB) NRG GI008: Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease (CIRCULATE-NORTH AMERICA)

    This Phase II/III trial will evaluate what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer. Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center …

    This Phase II/III trial will evaluate what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of histologically/pathologically confirmed Stage IIIA or Stage IIIB colon adenocarcinoma

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Mulcahy, Mary FrancesMulcahy, Mary Frances
    NCT05174169 STU00217884
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    SWOG 1918

    A Phase II/III Randomized Study of R-MiniCHOP with or Without CC-486 (Oral Azacitidine) in Participants Age 75 Years or Older with Newly Diagnosed Diffuse Large B Cell Lymphoma, Grade IIIB Follicular Lymphoma, Transformed Lymphoma, and High-Grade B-Cell Lymphomas with MYC AND BCL2 and/or BCL6 …

    A Phase II/III Randomized Study of R-MiniCHOP with or Without CC-486 (Oral Azacitidine) in Participants Age 75 Years or Older with Newly Diagnosed Diffuse Large B Cell Lymphoma, Grade IIIB Follicular Lymphoma, Transformed Lymphoma, and High-Grade B-Cell Lymphomas with MYC AND BCL2 and/or BCL6 Rearrangements

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of lymphoma

    · Participants must be 75 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Karmali, ReemKarmali, Reem
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04799275 STU00217891
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    A Randomized Phase 3 trial of Nivolumab(NSC# 748726 IND# 125462) in Combination with Chemo-immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-cell Lymphoma

    This phase III trial compares the effects of nivolumab with chemo-immunotherapy versus chemo-immunotherapy alone in treating patients with newly diagnosed primary mediastinal B-cell lymphoma (PMBCL). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the …

    This phase III trial compares the effects of nivolumab with chemo-immunotherapy versus chemo-immunotherapy alone in treating patients with newly diagnosed primary mediastinal B-cell lymphoma (PMBCL). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Treatment for PMBCL involves chemotherapy combined with an immunotherapy called rituximab. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving nivolumab with chemo-immunotherapy may help treat patients with PMBCL.

    • Patient must have histologically confirmed primary mediastinal B-cell lymphoma (PMBCL) as defined by World Health Organization (WHO) criteria
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 or ECOG performance status of 3 if poor performance is related to lymphoma
    • Children's Oncology Group (COG) Institutions: Use Karnofsky for patients >= 17 and < 18 years of age and Lansky for patients < 17 years of age
    • Adults (age 18 or older): Creatinine clearance >= 30 mL/min, as estimated by the Cockcroft and Gault formula. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on actual body weight

    Note: This is only a partial description of the

    study. Please contact the Robert H. Lurie

    Comprehensive Cancer Center of

    Northwestern University if you are interested

    in the trial.

    Karmali, ReemKarmali, Reem
    • Map it 201 E. Huron St.
      Chicago, IL
    • Map it 1000 N. Westmoreland Road North Entrance
      Lake Forest, IL
    • Map it 304 Randall Road
      Geneva, IL
    • Map it 4405 Weaver Pkwy
      Warrenville, IL
    • Map it 1 Kish Hospital Drive
      DeKalb, IL
    NCT04759586 STU00217895
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    (xIRB NCI CIRB) NRG GY026: A Phase II/III Study of Paclitaxel/Carboplatin Alone or Combined with Either Trastuzumab and Hyaluronidase-oysk (HERCEPTIN HYLECTA) or Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf (PHESGO) in HER2 Positive, Stage I-IV Endometrial Serous Carcinoma or Carcinosarcoma

    This phase II/III trial tests whether adding trastuzumab and hyaluronidase-oysk (Herceptin HylectaTM) or pertuzumab, trastuzumab and hyaluronidase-zzxf (PhesgoTM) to the usual chemotherapy (paclitaxel and carboplatin) works to shrink tumors in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma. Trastuzumab and pertuzumab are monoclonal antibodies and forms …

    This phase II/III trial tests whether adding trastuzumab and hyaluronidase-oysk (Herceptin HylectaTM) or pertuzumab, trastuzumab and hyaluronidase-zzxf (PhesgoTM) to the usual chemotherapy (paclitaxel and carboplatin) works to shrink tumors in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma. Trastuzumab and pertuzumab are monoclonal antibodies and forms of targeted therapy that attach to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When trastuzumab or pertuzumab attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Hyaluronidase is an endoglycosidase. It helps to keep pertuzumab and trastuzumab in the body longer, so that these medications will have a greater effect. Hyaluronidase also allows trastuzumab and trastuzumab/pertuzumab to be given by injection under the skin and shortens their administration time compared to trastuzumab or pertuzumab alone. Paclitaxel is a taxane and in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Giving Herceptin Hylecta or Phesgo in combination with paclitaxel and carboplatin may shrink the tumor and prevent the cancer from coming back in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of Federation of Gynecology and Obstetrics (FIGO) 2009 stage IA-IVB, non-recurrent, chemotherapy (chemo)-naive, HER2-positive endometrial serous carcinoma or endometrial carcinosarcoma

    · Participants must be 18 or older

    · Patients must be within 8 weeks of primary surgery (or endometrial biopsy in patients who never undergo hysterectomy) at the time of study registration

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Hinchcliff, EmilyHinchcliff, Emily
    • Map it 201 E. Huron St.
      Chicago, IL
    • Map it 4405 Weaver Pkwy
      Warrenville, IL
    • Map it 300 Randall Road
      Geneva, IL
    • Map it 1 Kish Hospital Drive
      DeKalb, IL
    NCT05256225 STU00217949
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    (xIRB NCI CIRB) ETCTN 10486: Phase 2 Trial of the Combination of the BET inhibitor, ZEN003694 (ZEN-3694), and the PARP Inhibitor Talazoparib, in Patients with Molecularly-Selected Solid Tumors (ComBET)

    This phase II trial tests whether ZEN003694 (ZEN-3694) in combination with talazoparib works to shrink tumors in patients with solid tumors that are unlikely to be cured or controlled with treatment and may have spread to other parts of the body. Another aim of this study is to determine …

    This phase II trial tests whether ZEN003694 (ZEN-3694) in combination with talazoparib works to shrink tumors in patients with solid tumors that are unlikely to be cured or controlled with treatment and may have spread to other parts of the body. Another aim of this study is to determine if and how patients' genes influence their response to this specific drug combination. ZEN-3694 is an inhibitor of a family of proteins called the bromodomain and extra-terminal (BET). It may prevent the growth of tumor cells that overproduce BET protein. Talazoparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. It is the accumulation of DNA damage which causes a cell to change into a cancerous cell. Combination therapy with ZEN-3694 and talazoparib may be effective at slowing or stopping tumor growth in patients with advanced cancer.

    • Participants must have a diagnosis of metastatic or unresectable cancer

    • Participants must be 18 or older

    Kalyan, AparnaKalyan, Aparna
    • Map it 251 E. Huron St. Fifth Floor, Suite 704
      Chicago, IL
    NCT05327010 STU00218004
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    NU 22I05

    Colon and rectal cancer are cancers that involve the lowest part of the digestive system: the large intestine and the rectum. A colorectal cancer that has already spread to distant sites by the time it is diagnosed is referred to as metastatic (stage IV) colorectal cancer (CRC). In colorectal cancer, …

    Colon and rectal cancer are cancers that involve the lowest part of the digestive system: the large intestine and the rectum. A colorectal cancer that has already spread to distant sites by the time it is diagnosed is referred to as metastatic (stage IV) colorectal cancer (CRC). In colorectal cancer, mutations in the BRAF gene are present in approximately 10% of patients with metastatic disease. Outcomes in these patients are poor relative to patients with non-BRAF mutated colon cancer. Encorafenib and cetuximab are standard of care therapy for metastatic colorectal cancer (CRC) patients who have disease progression (worsening of disease) after a previous line of therapy. Addition of hydroxychloroquine (HCQ) with encorafenib has shown to overcome the tumor’s resistance to encorafenib in laboratory studies. This study examines adding hydroxychloroquine to encorafenib and cetuximab in patients with worsening metastatic colon cancer on previous therapy. HCQ is an oral drug which is approved by the Food and Drug Administration (FDA) for other indications such as for treatment of uncomplicated malaria, preventive against malaria in select geographic regions, and for treatment of rheumatoid arthritis, systemic lupus erythematosus, and chronic discoid lupus erythematosus in adults. It is not currently FDA approved for the indication to be investigated in this study. As such, hydroxychloroquine will be the drug to be investigated (investigational drug) in this study in combination with encorafenib and cetuximab. Another drug named Panitumumab is also FDA approved for treatment of metastatic CRC in combination with other standard therapy. Panitumumab may also be used instead of Cetuximab in the above-mentioned treatment combination, depending on the choice of your doctor.

    Stage IV colon cancer with progression (disease worsening) on a prior line of therapy

    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT05576896 STU00217727
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    NU 22MH03: Phase II open-label multi-cohort study evaluating CPI-613 (devimistat) in combination with hydroxychloroquine and 5-fluorouracil or gemcitabine in patients with advanced chemorefractory colorectal, pancreatic, or other solid cancers

    The primary objective is to estimate the Overall Response Rate (ORR) of treatment with CPI-613 plus HCQ and, depending on the cohort and indication, either 5-FU or gemcitabine. Under this protocol, patients in cohorts 1 and 2 will be treated with combination of 2000 mg/m2 CPI-613 …

    The primary objective is to estimate the Overall Response Rate (ORR) of treatment with CPI-613 plus HCQ and, depending on the cohort and indication, either 5-FU or gemcitabine.

    Under this protocol, patients in cohorts 1 and 2 will be treated with combination of 2000 mg/m2 CPI-613 Day 1 and Day 15, plus 2400 mg/m2 Fluorouracil (5-FU) IV infusion over 46 hours Day 1 and Day 15, plus 400 mg hydroxychloroquine (HCQ) PO BID over 28-day cycles.

    Patients in cohort 3 will be treated with combination of 2000 mg/m2 CPI-613 Day 1 and Day 15 plus 400 mg HCQ PO BID and, depending on indication, either 1000 mg/m2 gemcitabine or 2400 mg/m2 5-FU.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial

    Some of the eligibility criteria include:

    · Participants must be 18 or older

    · Patients in cohort 1 must have colorectal cancer. Patients in cohort 2 must have pancreatic cancer. Patients in cohort 3 may have any of the following cancers:

    o Biliary

    o Gastroesophageal

    o Urothelial

    o Ovarian

    o Non-small cell lung (adenocarcinoma only)

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Mahalingam, DevalingamMahalingam, Devalingam
    NCT05733000 STU00218203
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    A Single-Arm Phase II Study of Personalized Dose Guidance for Stereotactic Body Radiotherapy (SBRT) in Patients with Lung Tumors, The RADiotherapy Augmented Intelligence Trial (RAD-AI)

    The study is being done to obtain evidence of effectiveness and safety for an imagingand computer technology intended to assist your physician in prescribing the radiationdose for your lung Stereotactic Body Radiotherapy (SBRT) treatment. The duration of radiotherapy is 1-2 weeks after you have been registered. You will be …

    The study is being done to obtain evidence of effectiveness and safety for an imaging

    and computer technology intended to assist your physician in prescribing the radiation

    dose for your lung Stereotactic Body Radiotherapy (SBRT) treatment. The duration of radiotherapy is 1-2 weeks after you have been registered. You will be followed for up to 5 years to check if your cancer has come back after the radiotherapy.

    · Participants must have a diagnosis of Lung cancer solitary or oligometastatic (spread a little)

    · Participants must be 18 or older

    · Who has not had prior radiotherapy

    Abazeed, MohamedAbazeed, Mohamed
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT05802186 STU00217995
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    NRG BN012

    This phase III trial compares the addition of stereotactic radiosurgery before or after surgery in treating patients with cancer that has spread to the brain (brain metastases). Stereotactic radiosurgery is a type of radiation therapy that delivers a high dose of radiation only to the small areas of cancer in …

    This phase III trial compares the addition of stereotactic radiosurgery before or after surgery in treating patients with cancer that has spread to the brain (brain metastases). Stereotactic radiosurgery is a type of radiation therapy that delivers a high dose of radiation only to the small areas of cancer in the brain and avoids the surrounding normal brain tissue. Surgery and radiation may stop the tumor from growing for a few months or longer and may reduce symptoms of brain metastases.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Radiographic confirmation of 1-4 brain metastases

    · Participants must be 18 or older

    · Known active or history of invasive non-central nervous system (CNS) primary cancer based on documented pathologic diagnosis within the past 3 years cancer based on documented pathologic diagnosis within the past 3 years

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Magill, Stephen T.Magill, Stephen T.
    • Map it 201 E. Huron St.
      Chicago, IL
    • Map it 4405 Weaver Pkwy
      Warrenville, IL
    NCT05438212 STU00218228
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    A Randomized Phase II/III Trial of Modern Immunotherapy Based Systemic Therapy with or Without SBRT for PD-L1-Negative, Advanced Non-Small Cell Lung Cancer

    This phase II/III trial compares the addition of radiation therapy to the usual treatment (immunotherapy with or without chemotherapy) versus (vs.) usual treatment alone in treating patients with non-small cell lung cancer that has spread to nearby tissue or lymph nodes (advanced) or has spread to other places …

    This phase II/III trial compares the addition of radiation therapy to the usual treatment (immunotherapy with or without chemotherapy) versus (vs.) usual treatment alone in treating patients with non-small cell lung cancer that has spread to nearby tissue or lymph nodes (advanced) or has spread to other places in the body (metastatic) whose tumor is also negative for a molecular marker called PD-L1. Stereotactic body radiation therapy (SBRT) is a type of radiation therapy that uses high energy x-rays to kill tumor cells and shrink tumors. This method uses special equipment to position a patient and precisely deliver radiation to tumors with fewer doses over a shorter period and may cause less damage to normal tissue than conventional radiation therapy. Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab and pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as carboplatin, pemetrexed, paclitaxel and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The addition of radiation therapy to usual treatment may stop the cancer from growing and increase the life of patients with advanced non-small cell lung cancer who are PD-L1 negative.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of stage IV NSCLC

    · Participants must be 18 or older

    · No prior systemic chemotherapy or immunotherapy for advanced NSCLC

    No prior treatment with checkpoint inhibitors for metastatic lung cancer

    Chae, Young KwangChae, Young Kwang
    • Map it 201 E. Huron St.
      Chicago, IL
    • Map it 4405 Weaver Pkwy
      Warrenville, IL
    • Map it 300 Randall Road
      Geneva, IL
    • Map it 1 Kish Hospital Drive
      DeKalb, IL
    • Map it 1000 N. Westmoreland Road
      Lake Forest, IL
    NCT04929041 STU00218262
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    SWOG 2104: Randomized Phase II Trial of Postoperative Adjuvant Capecitabine and Temozolomide versus Observation in High-Risk Pancreatic Neuroendocrine Tumors

    This study is being done to answer the following question: Can we lower the chance of pNET coming back by giving chemotherapy after surgery? We are doing this study because we want to find out if this approach is better or worse than the usual approach for patients that have …

    This study is being done to answer the following question: Can we lower the chance of pNET coming back by giving chemotherapy after surgery? We are doing this study because we want to find out if this approach is better or worse than the usual approach for patients that have had surgery for pNET. The usual approach is defined as care most people get after surgery for pNET.

    If you decide to take part in this study, you will either get the study drugs capecitabine and temozolomide for up to four months or you will receive the usual approach of observation only. Observation means you will not receive treatment for pNET. After the first four months, your doctor will continue to follow your condition for 5 years, watch you for side effects, and see if your tumor comes back. During this time you will need to visit the clinic every 6 months for the first 3 years, then once every 12 months for 2 more years.

    Prior surgery for pancreatic neuroendocrine tumor (pNET)

    Mulcahy, Mary FrancesMulcahy, Mary Frances
    • Map it 201 E. Huron St.
      Chicago, IL
    • Map it 304 Randall Road
      Geneva, IL
    • Map it 4405 Weaver Pkwy
      Warrenville, IL
    • Map it 1 Kish Hospital Drive
      DeKalb, IL
    • Map it 1000 N. Westmoreland Road
      Lake Forest, IL
    NCT05040360 STU00218449
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    NU 22S08: Northwestern Sarcoma Biorepository and Clinical Database

    The purpose of this study is to collect and store tumor tissue samples and clinical data from participants with any type of sarcoma, obtained when participants undergo routine biopsy and/or surgery, for use in future research. Participants will be asked to allow for blood, tissue and archival tissue samples, …

    The purpose of this study is to collect and store tumor tissue samples and clinical data from participants with any type of sarcoma, obtained when participants undergo routine biopsy and/or surgery, for use in future research. Participants will be asked to allow for blood, tissue and archival tissue samples, and clinical data, to be used for this biorepository. Samples will only be collected during standard of care procedures. Additional blood will be requested at the time of standard of care labs. Leftover tissue will be requested from patients’ standard of care biopsy or surgery. Information related to cancer and its response to therapy, including pathology and radiology results, will be collected.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of any type of known or suspected neoplasm arising from cells of mesenchymal origin. This may be a confirmed malignancy (a sarcoma) or simply an aggressive benign tumor such as a desmoid tumor.

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Pollack, Seth MichaelsPollack, Seth Michaels
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00218245
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    Phase 1 Study of Erdafitinib Intravesical Delivery System (TAR-210) in Participants with Non-Muscle-Invasive or Muscle-Invasive Bladder Cancer and Selected FGFR Mutations or Fusions

    This study will evaluate erdafitinib administered via an intravesical delivery system for both NMIBC and MIBC. The TAR-210 intravesical delivery system has been developed to providecontinuous intravesical drug delivery for prolonged periods over multiple voiding cycles, thereby minimizing the number of intravesical instillations required and providing sustained drug exposure …

    This study will evaluate erdafitinib administered via an intravesical delivery system for both NMIBC and MIBC. The TAR-210 intravesical delivery system has been developed to provide

    continuous intravesical drug delivery for prolonged periods over multiple voiding cycles, thereby minimizing the number of intravesical instillations required and providing sustained drug exposure at the tumor site while minimizing systemic exposure and improving tolerability.

    • Recurrent, non-muscle-invasive or muscle-invasive urothelial carcinoma of the bladder
    • Activating tumor FGFR mutation or fusion, as determined by local* or central testing, approved by the sponsor prior to the start of study treatment
    • Adequate bone marrow, liver, and renal function
    • Must sign an informed consent form (ICF)indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
    • Willing and able to adhere to the lifestyle restrictions specified in this protocol
    • No Concurrent extra-vesical (ie, urethra, ureter, renal pelvis) transitional cell carcinoma of the urothelium
    • No prior treatment with FGFR inhibitor
    • Have not received radiotherapy ≤6 months prior to the planned start of study treatment
    • No Indwelling urinary catheter
    • Bladder post-void residual volume (PVR) >350 mL after second voided urine
    • Cannot have a History of uncontrolled cardiovascular disease
    Meeks, Joshua JMeeks, Joshua J
    • Map it 675 N. Saint Clair St. Twentieth Floor, Suite 150
      Chicago, IL
    NCT05316155 STU00217656
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    ETCTN 10492

    This phase I/Ib trial tests the safety and best dose of ipatasertib in combination with the usual treatment approach using chemotherapy together with radiation therapy ("chemo-radiation") in patients with stage III-IVB head and neck cancer. Ipatasertib is in a class of medications called protein kinase B (AKT) inhibitors. It may stop the growth of tumor cells and may kill them. Cisplatin which is a chemotherapy used in this trial is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Radiation therapy uses high energy to kill tumor cells and shrink tumors. Giving ipatasertib in combination with chemo-radiation may be better than chemo-radiation alone in treating patients with advanced head and neck cancer.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of confirmed HNSCC (including tumors of the oropharynx, hypopharynx, larynx, oral cavity, nasal cavity, maxillary and other paranasal sinuses, and unknown primary of the head and neck), with measurable disease

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Gharzai, LailaGharzai, Laila
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT05172245 STU00218529
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    (xIRB) DRUG BDTX-1535-101: A Phase 1 Study to Assess BDTX-1535, an Oral EGFR Inhibitor, in Patients with Glioblastoma or Non-Small Cell Lung Cancer

    This is a first-in-human, open label, multicenter study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and the preliminary antitumor activity of BDTX-1535 in patients with GBM or NSCLC harboring sensitive EGFR alterations and who have disease progression following standard of care Note: This is only a partial …

    This is a first-in-human, open label, multicenter study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and the preliminary antitumor activity of BDTX-1535 in patients with GBM or NSCLC harboring sensitive EGFR alterations and who have disease progression following standard of care

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of Glioblastoma or Non-Small Cell Lung Cancer

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Patel, Jyoti DPatel, Jyoti D
    NCT05256290 STU00218568
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    Phase II Randomized, Prospective Trial of Lutetium Lu 177 Dotatate PRRT Versus Capecitabine and Temozolomide in Well-Differentiated Pancreatic Neuroendocrine Tumors

    This study is being done to answer the following question: Which standard therapy is better for controlling your cancer for a longer period of time? We are doing this study because we want to find out which approach is better or worse for your advanced pancreatic neuroendocrine cancer. The usual …

    This study is being done to answer the following question: Which standard therapy is better for controlling your cancer for a longer period of time? We are doing this study because we want to find out which approach is better or worse for your advanced pancreatic neuroendocrine cancer. The usual approach is defined as care most people get for advanced pancreatic neuroendocrine cancer.

    If you decide to take part in this study, you will either get lutetium Lu 177 dotatate, a radioactive drug given through your vein, for up to 8 months, or you will get the drugs temozolomide and capecitabine, as tablets you take by mouth, for up to 12 months.

    After you finish your treatment, your doctor will continue to follow your condition at clinic visits and watch you for side effects. If you finish or choose to stop your treatment before your cancer gets worse, they will check on you every 3 months at clinic visits until your cancer gets worse or you start a different treatment. If your cancer gets worse or you start a different cancer treatment, they will check on you every 6 months by phone or medical record for a maximum of 8 years starting from the day you enrolled on the study.

    Participants must have a diagnosis of advanced pancreatic neuroendocrine tumor.

    Benson III, Al BBenson III, Al B
    • Map it 201 E. Huron St.
      Chicago, IL
    • Map it 1000 N. Westmoreland Road North Entrance
      Lake Forest, IL
    • Map it 304 Randall Road
      Geneva, IL
    • Map it 4405 Weaver Pkwy
      Warrenville, IL
    • Map it 10 Health Services Drive
      DeKalb, IL
    NCT05247905 STU00218667
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    DRUG CL1-95032-005: A Phase 1, Safety Lead-in and Randomized, Open-label, Perioperative Study of Vorasidenib in Combination with Pembrolizumab in Subjects with Recurrent or Progressive Enhancing IDH-1 Mutant Astrocytomas

    The study is divided into 2 phases, a Safety Lead-In phase and a randomized perioperative phase. In the Safety Lead-In Phase, the recommended combination dose (RCD) of vorasidenib will be determined. In the Randomized Perioperative Phase, the Lymphocytes infiltration in tumors will be evaluated following pre-surgical treatment …

    The study is divided into 2 phases, a Safety Lead-In phase and a randomized perioperative phase. In the Safety Lead-In Phase, the recommended combination dose (RCD) of vorasidenib will be determined. In the Randomized Perioperative Phase, the Lymphocytes infiltration in tumors will be evaluated following pre-surgical treatment with vorasidenib and pembrolizumab combination, compared to untreated control tumors. Prior to surgery, participants will be randomized to receive vorasidenib at the RCD in combination with pembrolizumab, or vorasidenib only, or no treatment (untreated control group). Following surgery, participants will have the option to receive treatment with vorasidenib in combination with pembrolizumab in 21-day cycles.

    Study treatment will be administered until participant experiences unacceptable toxicity, disease progression, or other discontinuation criteria are met.

    Inclusion Criteria:

  • Have Karnofsky Performance Status (KPS) of ≥ 70%.
  • Have expected survival of ≥ 3 months.
  • Have histologically confirmed Grade 2 or Grade 3 astrocytoma (per the 2016 or 2021 World Health Organization [WHO] Classification of Tumors of the central nervous system)
  • Exclusion Criteria:

  • Have received prior systemic anti-cancer therapy within 1 month of the first dose of IMP, radiation within 12 months of the first dose of IMP, or an investigational agent < 14 days prior to the first dose of IMP. In addition, the first dose of IMP should not occur before a period of ≥ 5 half-lives of the investigational agent has elapsed.
  • Have received 2 or more courses of radiation.
  • Kumthekar, Priya UKumthekar, Priya U
    NCT05484622 STU00217975
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    (xIRB NCI CIRB) ETCTN 10495: Phase I Trial of DS-8201a (Trastuzumab Deruxtecan) in Combination with Neratinib in Solid Tumors with HER2 Alterations

    This phase I trial tests the safety, side effects, and best dose of neratinib in combination with trastuzumab deruxtecan in treating patients with solid tumors that have spread to other parts of the body (metastatic) or that cannot be removed by surgery (unresectable), and have changes in a gene called …

    This phase I trial tests the safety, side effects, and best dose of neratinib in combination with trastuzumab deruxtecan in treating patients with solid tumors that have spread to other parts of the body (metastatic) or that cannot be removed by surgery (unresectable), and have changes in a gene called human epidermal growth factor receptor 2 (HER2). Neratinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. Trastuzumab deruxtecan is in a class of medications called antibody-drug conjugates. It is composed of a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called deruxtecan. Trastuzumab attaches to HER2 positive tumor cells in a targeted way and delivers deruxtecan to kill them. Adding neratinib to trastuzumab deruxtecan may be able to shrink cancer with a change in the HER2 gene.

    · Participants must have a diagnosis of confirmed malignancy that is metastatic or unresectable

    · Participants must be 18 or older

    Kalyan, AparnaKalyan, Aparna
    • Map it 251 E. Huron St. Fifth Floor, Suite 704
      Chicago, IL
    NCT05372614 STU00218747
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    A randomized, double-blind, placebo-controlled Phase 3 study of darolutamide plus androgen deprivation therapy (ADT) compared with placebo plus ADT in patients with high-risk biochemical recurrence (BCR) of prostate cancer

    You are being asked to voluntarily take part in this clinical research study to test an oral drug, darolutamide, in addition to androgen deprivation therapy (ADT), because you have hormone sensitive high-risk biochemical recurrence (BCR) of prostate cancer (a type of cancer that is dependent on androgen hormones, such …

    You are being asked to voluntarily take part in this clinical research study to test an oral drug, darolutamide, in addition to androgen deprivation therapy (ADT), because you have hormone sensitive high-risk biochemical recurrence (BCR) of prostate cancer (a type of cancer that is dependent on androgen hormones, such as testosterone). Testosterone helps prostate cancer to grow. So the most common way to control testosterone levels in the body is to block the gland that stimulates the testosterone production. High risk BCR refers to a stage of prostate cancer where the rise in Prostate Specific Antigen (PSA) levels to a certain threshold and within a specified period of time, during or following prostate cancer local therapies. This means that after local therapies with curative intent (surgery or radiotherapy) of prostate cancer, some cancer cells may have survived and are producing PSA. PSA is a protein that is produced by both cancerous and noncancerous prostate cells.

    ADT is a systemic therapy called hormone therapy which reduces the androgen hormone (testosterone) levels to prevent prostate cancer cells from growing. ADT is frequently given with radiation therapy.

    This study is being done to learn more about a new drug called darolutamide given in combination with ADT for your disease stage.

    Inclusion Criteria:

    • Male ≥18 years of age at the time of signing the informed consent.
    • Histologically or cytologically confirmed adenocarcinoma of prostate.
    • Prostate cancer initially treated by:
    • radical prostatectomy (RP) followed by adjuvant radiotherapy (ART) or salvage radiotherapy (SRT), or
    • RP in participants who are unfit for ART or SRT, or
    • primary radiotherapy (RT)
    • High-risk biochemical recurrence (BCR), defined as
    • Prostate-specific antigen doubling time (PSADT) <12 months AND
    • PSA ≥0.2 ng/mL after ART or SRT post RP or after RP in participants who are unfit for ART or SRT, or
    • PSA ≥2 ng/mL above the nadir after primary RT only
    • Participants must undergo prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT) within the 30-day Screening period using either 18F-DCFPyL (piflufolastat F 18) or 68Ga-PSMA-11
    • Serum testosterone ≥150 ng/dL (5.2 nmol/L).
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    • Blood counts at screening:
    • Hemoglobin ≥9.0 g/dL
    • Absolute neutrophil count (ANC) ≥1.5x109/L
    • Platelet count ≥100x109/L
    • Alanine aminotransferase (ALT) ≤1.5 x upper limit of normal (ULN)
    • Aspartate aminotransferase (AST) ≤1.5 x ULN
    • Total bilirubin (TBL) ≤1.5 ULN, (except participants with a diagnosis of Gilbert’s disease)
    • Estimated glomerular filtration rate (eGFR) >40 ml/min/1.73 m2 calculated by the CKD-EPI formula
    • Sexually active male participants must agree to use contraception during the Treatment period and for at least 3 months after the last dose of study treatment, and refrain from donating sperm during this period.
    Ross, Ashley EvanRoss, Ashley Evan
    • Map it 675 N. Saint Clair St. Twentieth Floor, Suite 150
      Chicago, IL
    NCT05794906 STU00218784
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    ETCTN 10496

    This phase II trial compares the effect of adding ipatasertib to pembrolizumab (standard immunotherapy) vs. pembrolizumab alone in treating patients with squamous cell cancer of the head and neck that has come back (recurrent) or that has spread from where it first started (primary site) to other places in the …

    This phase II trial compares the effect of adding ipatasertib to pembrolizumab (standard immunotherapy) vs. pembrolizumab alone in treating patients with squamous cell cancer of the head and neck that has come back (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Ipatasertib is in a class of medications called protein kinase B (AKT) inhibitors. It may stop the growth of tumor cells and may kill them. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving ipatasertib in combination with pembrolizumab may be more effective than pembrolizumab alone in improving some outcomes in patients with recurrent/metastatic squamous cell cancer of the head and neck.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of head and neck squamous cell cancer (HNSCC)

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Lorch, Jochen Hanns-MartinLorch, Jochen Hanns-Martin
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT05172258 STU00218821
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    A Multicenter Phase I/Ib Dose Escalation Study of WTX-124 as Monotherapy and in Combination with Pembrolizumab in Patients with Selected Advanced or Metastatic Solid Tumors

    This is a first-in-human, Phase I, open-label, multicenter study designed to evaluate the safety, tolerability and preliminary efficacy of WTX-124, a conditionally activated IL-2 prodrug, when administered as monotherapy and in combination with pembrolizumab, for the treatment of patients with advanced solid tumors. Part 1 …

    This is a first-in-human, Phase I, open-label, multicenter study designed to evaluate the safety, tolerability and preliminary efficacy of WTX-124, a conditionally activated IL-2 prodrug, when administered as monotherapy and in combination with pembrolizumab, for the treatment of patients with advanced solid tumors. Part 1 of the study is dose escalation of WTX-124, both as monotherapy and in combination with pembrolizumab. Part 2 is comprised of four arms in which WTX-124 will be administered as monotherapy and in combination with pembrolizumab to patients with advanced or metastatic cutaneous malignant melanoma or advanced or metastatic renal cell carcinoma.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of advanced stage or metastatic solid tumor for which anti-PD(L)-1 is indicated.

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Chandra, SunandanaChandra, Sunandana
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT05479812 STU00218459
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    DRUG QRNT-009: A Phase 1/2 Multicenter, Open-label, Dose-escalation, Safety, Pharmacodynamic, and Pharmacokinetic Study of Q901 Administered via Intravenous Infusion in Adult Patients with Selected Advanced Solid Tumors with a Cohort Expansion at the Recommended Phase 2 Dose

    Multicenter, open-label, dose-escalation, safety, tolerability, PK and pharmacodynamic study with a dose expansion at the RP2D to evaluate safety and potential antitumor activity of Q901 Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if …

    Multicenter, open-label, dose-escalation, safety, tolerability, PK and pharmacodynamic study with a dose expansion at the RP2D to evaluate safety and potential antitumor activity of Q901

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants with histologically or cytologically confirmed advanced or metastatic ovarian, CRPC, HR+ HER2- breast, endometrial, colorectal, small-cell lung, or pancreatic cancer, who have progressed following standard-of-care therapy or for whom there is no standard therapy that confers clinical benefit

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT05394103 STU00218890
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    DRUG XMAB808-01: A Phase 1, First-in-Human, Dose-Finding and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of XmAb®808 in Combination with Pembrolizumab in Selected Advanced Solid Tumors

    The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of intravenous (IV) administration of XmAb808 in combination with pembrolizumab in subjects with selected advanced solid tumors and to identify the minimum safe and biologically effective/recommended dose (RD) and schedule for XmAb808. Note: This is only …

    The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of intravenous (IV) administration of XmAb808 in combination with pembrolizumab in subjects with selected advanced solid tumors and to identify the minimum safe and biologically effective/recommended dose (RD) and schedule for XmAb808.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of

    · Part A:Histologically confirmed advanced/metastatic castration-resistant prostate adenocarcinoma, epithelial ovarian cancer, head and neck squamous cell carcinoma, non-small cell lung cancer, urothelial carcinoma, melanoma, renal cell carcinoma, triple-negative breast cancer, or colorectal cancer that has progressed on standard therapies

    • Part B: Histologically confirmed advanced/metastatic castration-resistant prostate cancer that is PD1-naïve; head and neck squamous cell carcinoma that is PD1-naïve or has progressed on prior PD1 therapy; or melanoma that is PD1-naïve or has progressed on prior PD1 therapy

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Lorch, Jochen Hanns-MartinLorch, Jochen Hanns-Martin
    NCT05585034 STU00218918
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    Development and Validation of an Ancillary Diagnostic Test for Mycosis Fungoides (SIGNAL MF)

    As the number of available treatments for CTCL grow, there is a need to find a way to identify which treatment will work best for each subject. The goal of this study is to develop a test called a gene expression assay to see if the assay can predict treatment …

    As the number of available treatments for CTCL grow, there is a need to find a way to identify which treatment will work best for each subject. The goal of this study is to develop a test called a gene expression assay to see if the assay can predict treatment success and/or failure in subjects with CTCL.

    Patient who has a diagnosis of mycosis fungoides (MF).

    Patient who is between 2-89 years of age.

    Patient who is willing and able to provide new skin samples via superficial scraping at least one affected and non-affected body site.

    Guitart, JoanGuitart, Joan
    STU00217977
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    (xIRB) DRUG 213304: Expanded Access Program for belantamab mafodotin in Patients with Relapsed/Refractory Multiple Myeloma who are Refractory to a Proteasome Inhibitor, and an Immunomodulatory Agent, and an Anti-CD38 Antibody

    Compassionate use access to belantamab mafodotin (GSK2857916) for eligible participants with refractory/relapsing multiple myeloma

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of Multiple Myeloma

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Singhal, SeemaSinghal, Seema
    • Map it 201 E. Huron St. Suite 12 160​
      Chicago, IL
    NCT03763370 STU00218955
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    Fit4Treatment

    This trial tests how well patient tailored physical activity interventions work to improve health and survival among older women with gynecologic cancers undergoing chemotherapy and other systemic therapies. Cancer therapy, as well as underlying cancer, cause accelerated aging and toxicity, leaving women vulnerable to functional decline, increased frailty, decreased health …

    This trial tests how well patient tailored physical activity interventions work to improve health and survival among older women with gynecologic cancers undergoing chemotherapy and other systemic therapies. Cancer therapy, as well as underlying cancer, cause accelerated aging and toxicity, leaving women vulnerable to functional decline, increased frailty, decreased health related quality of life, and ultimately, less systemic therapy completion and inferior cancer survival. Physical activity has been shown to improve functional health, improve quality of life, slow aging, and decrease rates of frailty. Engaging in patient tailored physical activity may safely and gradually increase physical activity in gynecologic cancer patients and lead to improved health and survival among older women with gynecologic cancers who are undergoing systemic treatment.

    Barber, Emma LongleyBarber, Emma Longley
    NCT05743517 STU00218257
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    SWOG 2302: A Prospective Randomized Study of Ramucirumab plus Pembrolizumab versus Standard of Care for Participants Previously Treated with Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer.

    This phase III trial compares the effect of the combination of ramucirumab and pembrolizumab versus standard of care chemotherapy for the treatment of non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). Ramucirumab is a monoclonal antibody that may …

    This phase III trial compares the effect of the combination of ramucirumab and pembrolizumab versus standard of care chemotherapy for the treatment of non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may help doctors find out if giving ramucirumab with pembrolizumab is more effective at treating patients with stage IV or recurrent non-small cell lung cancer than standard chemotherapy.

    • Should Have Non-Small Cell Lung Cancer (NSCLC) which is stage IV or recurrent
    • Must have at least one line of anti-PD-1 or anti-PD-L1 therapy for any stage of NSCLC
    • Must be 18 years or above
    Chae, Young KwangChae, Young Kwang
    • Map it 201 E. Huron St.
      Chicago, IL
    • Map it 1000 N. Westmoreland Road North Entrance
      Lake Forest, IL
    • Map it 304 Randall Road
      Geneva, IL
    • Map it 4405 Weaver Pkwy
      Warrenville, IL
    • Map it 25 N. Winfield Road
      Winfield, IL
    • Map it 4455 Weaver Parkway
      Warrenville, IL
    • Map it 300 Randall Road
      Geneva, IL
    • Map it 1 Kish Hospital Drive
      DeKalb, IL
    • Map it 10 Health Services Drive
      DeKalb, IL
    • Map it 1000 N. Westmoreland Road
      Lake Forest, IL
    NCT05633602 STU00218964
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    DRUG D8410C00001: A Modular Phase I/IIa, Open-Label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD9574 as Monotherapy and in Combination with Anti-cancer Agents in Patients with Advanced Solid Malignancies (CERTIS1)

    This study will assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of AZD9574 individually and in combination with anti-cancer agents in patients with advanced cancer that has recurred/progressed.…

    This study will assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of AZD9574 individually and in combination with anti-cancer agents in patients with advanced cancer that has recurred/progressed.

    Some of the eligibility criteria include:

    · ALL MODULES: Participants must be 18 or older

    · MODULE 1 PART A: Participants must have a diagnosis of advanced/relapsed ovarian, breast, pancreatic, or prostate cancer who are deemed suitable for a PARPi will receive AZD9574 monotherapy at escalating cohorts.

    · MODULE 1 PART b: Participants must have a diagnosis of breast cancer who are PARPi naive at a dose determined in dose-escalation.

    · MODULE 1 PART b: Participants must have a diagnosis of IDH 1/2-mutant glioma who are PARPi naive will receive AZD9574 and TMZ at escalating cohorts

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Stupp, RogerStupp, Roger
    NCT05417594 STU00219059
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    Testing the addition of an anti-cancer drug, irinotecan, to the standard chemotherapy treatment (FOLFOX) after long-course radiation therapy for advanced-stage rectal cancers to improve the rate of complete response and long-term rates of organ preservation

    This study is being done to answer the following question: Can we increase the clinical complete response rate (tumor disappears by exam, endoscopy, and imaging) by adding a 3rd drug (irinotecan) to the standard regimen of FOLFOX or CAPOX given following long-course chemoradiation for patients with locally advanced rectal …

    This study is being done to answer the following question: Can we increase the clinical complete response rate (tumor disappears by exam, endoscopy, and imaging) by adding a 3rd drug (irinotecan) to the standard regimen of FOLFOX or CAPOX given following long-course chemoradiation for patients with locally advanced rectal cancer? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your rectal cancer. The usual approach is defined as care most people get for locally advanced rectal cancer.

    You must have advanced rectal cancer to participate in this study.

    Benson III, Al BBenson III, Al B
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT05610163 STU00219063
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    DRUG OM-GRPR1-02: A Phase 1 Open-Label Dose Escalation and Expansion Study to Determine the Safety, Tolerability, Dosimetry, and Preliminary Efficacy of 212Pb-DOTAM-GRPR1 in Adult Subjects with Recurrent or Metastatic GRPR-expressing Tumors

    A Phase 1 SAD/MAD dose escalation and expansion study to determine the safety and effectiveness of ²¹²Pb-DOTAM-GRPR1 in subjects with various GRPR-expressing Tumors Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if …

    A Phase 1 SAD/MAD dose escalation and expansion study to determine the safety and effectiveness of ²¹²Pb-DOTAM-GRPR1 in subjects with various GRPR-expressing Tumors

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of:

    Cervical Cancer

    Prostate Cancer Metastatic

    Breast Cancer

    Colon Cancer

    NSCLC

    Cutaneous Melanoma

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT05283330 STU00218169
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    Alliance A051902

    A randomized phase II study of CHO(E)P vs CC-486-CHO(E)P vs duvelisib-CHO(E)P in previously untreated CD30 negative peripheral T-cell lymphomas

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of T-cell lymphoma cancer

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Moreira, JonathanMoreira, Jonathan
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04803201 STU00219084
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    DRUG NX-5948-301: A Phase 1, Dose Escalation, and Cohort Expansion Study Evaluating NX-5948, a Bruton’s Tyrosine Kinase (BTK) Degrader, in Adults with Relapsed/Refractory B-cell Malignancies

    There are 2 parts to this study. The phase 1a portion (dose escalation) evaluates the safety and tolerability of NX-5948 in adult patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), …

    There are 2 parts to this study. The phase 1a portion (dose escalation) evaluates the safety and tolerability of NX-5948 in adult patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), or Waldenströms macroglobulinemia (WM), who have received at least 2 prior systemic therapies (or at least 1 prior therapy for WM), and for whom no other therapies are known to provide clinical benefit.

    The phase 1b portion (cohort expansion) investigates the efficacy of NX-5948 at the dose selected in Phase 1a in up to 5 cohorts of patients with R/R B-cell malignancies, who have received at least 2 prior systemic therapies (or at least 1 prior therapy for patients with WM, primary central nervous system lymphoma (PCNSL), or secondary central nervous system involvement.

    • Cohort A: CLL or SLL with disease progression after at least 2 prior systemic therapies
    • Cohort B: CLL or SLL with disease progression after both a BTK inhibitor (BTKi) and BCL-2 inhibitor (may have been individually or in combination)
    • Cohort C: MCL with disease progression on a BTKi and an anti-CD20 monoclonal antibody (mAb)-based regimen
    • Cohort D: DLBCL with disease progression on an anthracycline and an anti-CD20 mAb-based regimen, or FL with disease progression on an anti-CD20 mAb-based regimen, or MZL with disease progression on an anti-CD20 mAb-based regimen, or WM with disease progression on a BTKi, or any of the indications listed in Cohorts A-D with CNS involvement, with disease progression on at least 1 prior therapy
    • Cohort E: PCNSL with disease progression on at least 1 prior therapy

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of

    chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), or Waldenströms macroglobulinemia (WM),

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Dixit, Karan SinghDixit, Karan Singh
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT05131022 STU00218907
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    (xIRB) DRUG SGNTV-001: Open Label Phase 2 Study of Tisotumab Vedotin for Locally Advanced or Metastatic Disease in Solid Tumors

    Open Label Phase 2 Study of Tisotumab Vedotin for Locally Advanced or Metastatic Disease in Solid Tumors. There are 7 parts to this study. In Parts A, B, C, and E, we’re testing different doses of tisotumab vedotin to see how it works to treat solid tumor cancers. Parts …

    Open Label Phase 2 Study of Tisotumab Vedotin for Locally Advanced or Metastatic Disease in Solid Tumors.

    There are 7 parts to this study. In Parts A, B, C, and E, we’re testing different doses of tisotumab vedotin to see how it works to treat solid tumor cancers. Parts A, B, and C are no longer enrolling patients.

    In Parts D, F, and G of the study, we want to learn more about how tisotumab vedotin works with some types of anti-cancer drugs. We’re testing tisotumab vedotin with pembrolizumab and carboplatin.

    In Part D of the study, some patients with head and neck cancer could get tisotumab vedotin with pembrolizumab and cisplatin. Part D of the study is no longer enrolling patients.

    In Part F of the study, we’re testing tisotumab vedotin with pembrolizumab to see if it works for head and neck cancers.

    In Part G of the study, we will use the information we learn in Part F to keep studying tisotumab vedotin with carboplatin and pembrolizumab to see if it works for head and neck cancers.

    In Part E of this study, we’re testing tisotumab vedotin in patients with head and neck cancer that came back or got worse after their last treatment.

    Patients assigned to Group E will receive tisotumab vedotin once every 2 weeks for 4 weeks (28 day cycle)

    If you’re in Part F, we’ll give you tisotumab vedotin once every 2 weeks and pembrolizumab once every 6 weeks.

    If you’re in Part G, we’ll give you tisotumab vedotin and carboplatin once every 2 weeks and pembrolizumab every 6 weeks.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    • Participants must have a diagnosis of non-small cell lung cancer (NSCLC) – Squamous cell histology only, or Squamous cell carcinoma of the head and neck (SCCHN)

    • Participants with inoperable, locally advanced or metastatic cancer

    • Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Lorch, Jochen Hanns-MartinLorch, Jochen Hanns-Martin
    • Map it 304 Randall Road
      Geneva, IL
    • Map it 4405 Weaver Pkwy
      Warrenville, IL
    • Map it 10 Health Services Drive
      DeKalb, IL
    • Map it 675 N. Saint Clair St. Twenty-First Floor, Suite 100
      Chicago, IL
    NCT03485209 STU00219134
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    DRUG M20-638: A Phase 3, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination with Rituximab and Lenalidomide (R2) compared to R2 in Subjects with Relapsed or Refractory Follicular Lymphoma (EPCORE™ FL-1)

    The purpose of this randomized Phase 3 study is to evaluate the efficacy, safety, and tolerability of epcoritamab 48 mg in combination with R 2 compared to R 2 alone in subjects with R/R FL.…

    The purpose of this randomized Phase 3 study is to evaluate the efficacy, safety, and tolerability of epcoritamab 48 mg in combination with R 2 compared to R 2 alone in subjects with R/R FL.

    Subject must have histologically confirmed classic FL (previously Grade 1 to 3a FL) stage II, III, or IV with no evidence of histologic transformation to an aggressive lymphoma and CD20+ on a representative tumor biopsy.

    Ma, ShuoMa, Shuo
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT05409066 STU00218412
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    DRUG 19-12021154

    The purpose of this study is to assess the safety and tolerability and determine the recommended Phase 2 dose of AIC100 Chimeric Antigen Receptor (CAR) T cells in patients with relapsed/refractory poorly differentiated thyroid cancer and anaplastic thyroid cancer.Note: This is only a partial description of the study. …

    The purpose of this study is to assess the safety and tolerability and determine the recommended Phase 2 dose of AIC100 Chimeric Antigen Receptor (CAR) T cells in patients with relapsed/refractory poorly differentiated thyroid cancer and anaplastic thyroid cancer.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of thyroid cancer that expresses ICAM-1 and that meets one of the following diagnoses:

  • ATC BRAF wild-type at any stage, including newly diagnosed
  • ATC BRAF mutant after failure of or inability to tolerate BRAF-specific therapy
  • PDTC that has failed any of the following treatments: surgery RAI, chemotherapy, radiation therapy, and/or targeted therapies
  • · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Lorch, Jochen Hanns-MartinLorch, Jochen Hanns-Martin
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04420754 STU00218807
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    NU MSK22H05: Phase 2 study of Zanubrutinib, Obinutuzumab, and Venetoclax in Previously Untreated Patients with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) and Mantle Cell Lymphoma (MCL)

    This is a single-stage, phase 2 study of the combination of zanubrutinib, obinutuzumab, and venetoclax in previously untreated patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or mantle cell lymphoma (MCL), the latter including patients with evidence of TP53 mutation as well as transplant ineligible patients.The …

    This is a single-stage, phase 2 study of the combination of zanubrutinib, obinutuzumab, and venetoclax in previously untreated patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or mantle cell lymphoma (MCL), the latter including patients with evidence of TP53 mutation as well as transplant ineligible patients.

    The primary aim of this study is to establish the rate of minimum residual disease (MRD) undetectable response in patients with CLL, to establish the 2-year progression free survival (PFS) in patients with TP53 mutated MCL, and to establish the 3-year PFS in transplant ineligible patients. Time to completion of study is estimated at 5 years.

    The secondary objectives are to establish the recommended phase 2/3 duration of therapy, to determine the proportion of patients who successfully discontinue therapy after achieving an MRD undetectable response. Also, to determine the durability of clinical benefit after treatment discontinuation as measured by duration of peripheral blood MRD response and treatment-free survival. In addition, to determine whether induction therapy with 2 cycles of zanubrutinib and obinutuzumab prior to venetoclax reduces TLS risk assignment, and to assess safety and tolerability of the of zanubrutinib, obinutuzumab, and venetoclax regimen in the first-line setting. Finally, to assess safety and tolerability of the of zanubrutinib, obinutuzumab, and venetoclax regimen in the first-line setting.

    The exploratory objectives are to cross validate MRD testing using multiparameter flow cytometry with DNA sequencing-based MRD assays in peripheral blood and bone marrow. To evaluate clonal evolution of CLL and MCL in serial patient samples on therapy with zanubrutinib, obinutuzumab, and venetoclax, during post-treatment surveillance, and at progression. To investigate the effects of zanubrutinib, obinutuzumab, and venetoclax on immune responses.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of mantle cell lymphoma (MCL)

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Karmali, ReemKarmali, Reem
    • Map it 675 N. Saint Clair St. Twenty-First Floor, Suite 100
      Chicago, IL
    NCT03824483 STU00218530
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    CCTG HN11

    This study is being done to answer the following question: Is the chance of cancer spreading or returning the same if radiotherapy to the neck is guided, by using a special imaging study called lymph node mapping (lymphatic mapping) Single Photon Emission Computed Tomography (SPECT-CT), compared to the usual …

    This study is being done to answer the following question: Is the chance of cancer spreading or returning the same if radiotherapy to the neck is guided, by using a special imaging study called lymph node mapping (lymphatic mapping) Single Photon Emission Computed Tomography (SPECT-CT), compared to the usual treatment when radiotherapy is given to both sides of the neck? This study will allow us to determine if this approach is better or worse in controlling cancer and has fewer side effects and better quality of life. The usual practice is the care most people get for your type of oropharyngeal cancer. Participants will either get 1) radiotherapy to cancer and both sides of the neck or 2) radiotherapy to cancer and neck based on Single Photon Emission Computed Tomography (SPECT/CT). The radiotherapy will be given in the usual way. Chemotherapy may be given in addition to radiotherapy as standard care.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    • Participants must have a diagnosis of oropharyngeal cancer

    • Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Stepan, Katelyn OstendorfStepan, Katelyn Ostendorf
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT05451004 STU00219181
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    SWOG 2010

    This study is being done to answer the following question:Will monitoring side effects in between clinic visits help women keep taking their hormone therapy medicine as prescribed for early-stage breast cancer?We are doing this study because we want to find out if this approach is better or …

    This study is being done to answer the following question:

    Will monitoring side effects in between clinic visits help women keep taking their hormone therapy medicine as prescribed for early-stage breast cancer?

    We are doing this study because we want to find out if this approach is better or worse than the usual approach for helping women take their hormone therapy medicine. The usual approach is the follow-up care most people get after they are diagnosed with breast cancer and start hormone therapy.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of Breast Cancer

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Stein, Regina MStein, Regina M
    • Map it 201 E. Huron St.
      Chicago, IL
    • Map it 304 Randall Road
      Geneva, IL
    • Map it 4405 Weaver Pkwy
      Warrenville, IL
    • Map it 10 Health Services Drive
      DeKalb, IL
    NCT05568472 STU00219241
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    (XIRB) DRUG SGNBB228-001: A phase 1 study of SGN-BB228 in advanced melanoma and solid tumors

    This study will test the safety of a drug called SGN-BB228 in participants with melanoma and other solid tumors that are hard to treat or have spread through the body. It will also study the side effects of this drug. A side effect is anything a drug does to …

    This study will test the safety of a drug called SGN-BB228 in participants with melanoma and other solid tumors that are hard to treat or have spread through the body. It will also study the side effects of this drug. A side effect is anything a drug does to the body besides treating the disease.

    This study will have 3 parts. Parts A and B of the study will find out how much SGN-BB228 should be given to participants. Part C will use the information from Parts A and B to see if SGN-BB228 is safe and if it works to treat solid tumor cancers.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    • All Parts: Participants must have disease that is relapsed, refractory, or intolerant to standard of care. Participants must have histologically or cytologically confirmed metastatic malignancy.
    • Participants must have one of the following tumor types:
    • Parts A and B: Participants must have unresectable cutaneous melanoma.
    • Part C: Participants must have one of the following tumor types:
    • Cutaneous Melanoma
    • Non-small Cell Lung Cancer (NSCLC)
    • Colorectal Cancer (CRC)
    • Pancreatic Cancer
    • Mesothelioma

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Chandra, SunandanaChandra, Sunandana
    NCT05571839 STU00219254
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    DRUG R3767-ONC-2055: A Phase 3 Trial of Fianlimab (anti-LAG-3) and Cemiplimab versus Pembrolizumab in the Adjuvant Setting in Patients with Completely Resected High-risk Melanoma

    The primary objective of the study is to demonstrate superiority of fianlimab + cemiplimab compared to pembrolizumab, as measured by relapse free survival (RFS).Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in …

    The primary objective of the study is to demonstrate superiority of fianlimab + cemiplimab compared to pembrolizumab, as measured by relapse free survival (RFS).

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

     All patients must be either stage IIC, III, or stage IV per American Joint Committee on Cancer (AJCC) 8th edition and have histologically confirmed melanoma that is completely surgically resected in order to

    be eligible as defined by the protocol

     Complete surgical resection must be performed within 12 weeks prior to randomization, and enrollment may occur only after satisfactory wound healing from the surgery

     All patients must have disease-free status documented by a complete physical examination and imaging studies within 4 weeks prior to randomization, as described in the protocol

     Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Chandra, SunandanaChandra, Sunandana
    • Map it 201 E. Huron St. Suite 12 160​
      Chicago, IL
    NCT05608291 STU00219272
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    uTRACT Jelmyto® Registry

    The primary objective of the registry is to study the use and impact of Jelmyto in patients with Upper Tract Urothelial Carcinoma in clinical practice in the U.S.

    Inclusion Criteria

    • Adults >18 years old
    • Diagnosis of upper tract urothelial cancer (UTUC).
    • Meet at least one of the following criteria:
    • Have been treated with Jelmyto after April 2020
    • Currently undergoing treatment with Jelmyto
    • Will receive Jelmyto
    Meeks, Joshua JMeeks, Joshua J
    • Map it 675 N. Saint Clair St. Twentieth Floor, Suite 150
      Chicago, IL
    NCT05874921 STU00218931
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    DRUG CA-4948-102: A phase 1/2a, open-label dose escalation and cohort expansion study of orally administered ca-4948 (irak4i) as a monotherapy in patients with acute myelogenous leukemia or myelodysplastic syndrome and in combination with azacitidine or venetoclax

    This study is being done to test the orally administered study drug, CA-4948, either alone (monotherapy) or in combination (combination therapy) with an approved drug (azacitidine (AZA) or venetoclax (VEN)) in adult patients ages 18 and over diagnosed with Acute Myelogenous Leukemia (AML) or high-risk Myelodysplastic Syndrome (MDS). …

    This study is being done to test the orally administered study drug, CA-4948, either alone (monotherapy) or in combination (combination therapy) with an approved drug (azacitidine (AZA) or venetoclax (VEN)) in adult patients ages 18 and over diagnosed with Acute Myelogenous Leukemia (AML) or high-risk Myelodysplastic Syndrome (MDS).

    The study drug is thought to work by blocking a protein in your body called interleukin-1 receptor-associated kinase 4 (IRAK4). IRAK4 plays an essential role in some of the signaling pathways that are frequently not controlled in AML/MDS. When these signals are not working properly, they can trigger cancer growth. By blocking IRAK4, the study drug may stop or reduce these signals and help fight your cancer

    Abaza, YasminAbaza, Yasmin
    NCT04278768 STU00217690
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    DRUG 68284528MMY4006: Intermediate-Size Population Expanded Access Program (EAP) for Ciltacabtagene autoleucel (cilta-cel) Out-of-Specification (OOS) in patients with Multiple Myeloma

    The purpose of this expanded access program (EAP) is to provide ciltacabtagene autoleucel (cilta-cel) that does not meet the commercial release specifications of CARVYKTI and is not available via the local health care system in the country where the treatment is requested. Note: This is only a partial description …

    The purpose of this expanded access program (EAP) is to provide ciltacabtagene autoleucel (cilta-cel) that does not meet the commercial release specifications of CARVYKTI and is not available via the local health care system in the country where the treatment is requested.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of Multiple Myeloma

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Singhal, SeemaSinghal, Seema
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT05346835 STU00218945
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    DRUG WTX-330X2101: A Phase 1 (first-in-human, FIH), multi-site, dose escalation and expansion study of WTX-330 in adult patients with advanced or metastatic solid tumors or lymphoma

    A first-in-human, Phase 1, open-label, multicenter study of WTX-330 administered as a monotherapy to patients with advanced or metastatic solid tumors or non-Hodgkin lymphoma.Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern …

    A first-in-human, Phase 1, open-label, multicenter study of WTX-330 administered as a monotherapy to patients with advanced or metastatic solid tumors or non-Hodgkin lymphoma.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    - Participants must have a diagnosis of advanced or metastatic solid tumors or Non-Hodgkin's lymphoma

    - Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 251 E. Huron St. Fifth Floor, Suite 704
      Chicago, IL
    NCT05678998 STU00218585
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    Multimodality Therapy with Immunotherapy in Stage I-IIIA Sarcomatoid Mesothelioma

    This phase II trial evaluates the safety and effectiveness of giving immunotherapy (nivolumab and ipilimumab) before surgery for controlling disease in patients with stage I-IIIa sarcomatoid mesothelioma. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere …

    This phase II trial evaluates the safety and effectiveness of giving immunotherapy (nivolumab and ipilimumab) before surgery for controlling disease in patients with stage I-IIIa sarcomatoid mesothelioma. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving immunotherapy before surgery may be more effective at controlling disease in patients with sarcomatoid mesothelioma than giving immunotherapy alone.

    This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of stage I-IIIa sarcomatoid mesothelioma

    · Participants must be 18 or older

    This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Chae, Young KwangChae, Young Kwang
    • Map it 201 E. Huron St.
      Chicago, IL
    • Map it 1000 N. Westmoreland Road North Entrance
      Lake Forest, IL
    • Map it 304 Randall Road
      Geneva, IL
    • Map it 4405 Weaver Pkwy
      Warrenville, IL
    • Map it 10 Health Services Drive
      DeKalb, IL
    NCT05647265 STU00219328
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    (xIRB) DRUG STML-ELA-0222: A Phase 1b/2, Open-Label Umbrella Study to Evaluate Safety and Efficacy of Elacestrant in Various Combinations in Patients with Metastatic Breast Cancer (ELEVATE)

    This is a multicenter, Phase 1b/2 trial. The phase 1b part of the trial aims to determine the RP2D of elacestrant when administered in combination with alpelisib, everolimus, palbociclib, and ribociclib. The Phase 2 part of the trial will evaluate the efficacy and safety of the various combinations in patients with ER+/HER2- advanced/metastatic breast cancer.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of Histopathologically or cytologically confirmed ER+, HER2-, breast cancer

    · At least one measurable lesion as per RECIST version 1.1 or a mainly lytic bone lesion.

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete

    Gradishar, William JGradishar, William J
    • Map it 251 E. Huron St. Fifth Floor, Suite 704
      Chicago, IL
    NCT05563220 STU00219475
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    ER+ HER2-
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    ECOG-ACRIN Y191: Molecular Analysis for Combination Therapy Choice (ComboMATCH)

    This ComboMATCH patient registration trial is the gateway to a coordinated set of clinical trials to study cancer treatment directed by genetic testing. Patients with solid tumors that have spread to nearby tissue or lymph nodes (locally advanced) or have spread to other places in the body (advanced) and have progressed on at least one line of standard systemic therapy or have no standard treatment that has been shown to prolong overall survival may be candidates for these trials. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with some genetic changes or abnormalities (mutations) may benefit from treatment that targets that particular genetic mutation. ComboMATCH is designed to match patients to a treatment that may work to control their tumor and may help doctors plan better treatment for patients with locally advanced or advanced solid tumors.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have been deemed potentially eligible for a ComboMATCH Treatment Trial

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT05564377 STU00219487
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    (xirb) DRUG Ph2 INBRX-109 SA CS: A Randomized, Blinded, Placebo-controlled, Phase 2 Study of INBRX-109 in Unresectable or Metastatic Conventional Chondrosarcoma

    Randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of Conventional chondrosarcoma, unresectable (=inoperable) or metastatic.

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Pollack, Seth MichaelsPollack, Seth Michaels
    NCT04950075 STU00219488
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    A Randomized Phase II Study of INC280 (Capmatinib) Plus Osimertinib with or Without Ramucirumab in Participants with EGFR-Mutant, MET-Amplified Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Sub-Study)

    This phase II Lung-MAP treatment trial test the combination of targeted drugs (capmatinib, osimertinib, and/or ramucirumab) in treating patients with non-small cell lung cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and that …

    This phase II Lung-MAP treatment trial test the combination of targeted drugs (capmatinib, osimertinib, and/or ramucirumab) in treating patients with non-small cell lung cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and that has EGFR and MET gene changes. Capmatinib and osimertinib are in a class of medications called kinase inhibitors. They work by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop or slow the spread of cancer cells and may help shrink tumors. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving capmatinib, osimertinib, and/or ramucirumab and targeting abnormal gene changes in tumor cells may be effective in shrinking or stabilizing advanced non-small cell lung cancer.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of Recurrent Lung Non-Small Cell Carcinoma or Stage IV Lung Cancer AJCC v8 .

    · Participants must be 18 or older

    Chae, Young KwangChae, Young Kwang
    • Map it 201 E. Huron St.
      Chicago, IL
    • Map it 1000 N. Westmoreland Road North Entrance
      Lake Forest, IL
    • Map it 304 Randall Road
      Geneva, IL
    • Map it 4405 Weaver Pkwy
      Warrenville, IL
    • Map it 25 N. Winfield Road
      Winfield, IL
    • Map it 4455 Weaver Parkway
      Warrenville, IL
    • Map it 300 Randall Road
      Geneva, IL
    • Map it 1 Kish Hospital Drive
      DeKalb, IL
    • Map it 10 Health Services Drive
      DeKalb, IL
    • Map it 1000 N. Westmoreland Road
      Lake Forest, IL
    NCT05642572 STU00219490
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    Alliance A042001, A Randomized Phase II Study Comparing Inotuzumab Plus Chemotherapy versus Standard Chemotherapy in Older Adults with Philadelphia-Chromosome-Negative B-cell Acute Lymphoblastic Leukemia

    This phase II trial compares the combination of inotuzumab ozogamicin and chemotherapy to the usual chemotherapy in treating patients with B-cell acute lymphoblastic leukemia or B-cell lymphoblastic lymphoma. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a drug called CalichDMH. Inotuzumab is a form of targeted …

    This phase II trial compares the combination of inotuzumab ozogamicin and chemotherapy to the usual chemotherapy in treating patients with B-cell acute lymphoblastic leukemia or B-cell lymphoblastic lymphoma. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a drug called CalichDMH. Inotuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD22 receptors, and delivers CalichDMH to kill them. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing them, stopping them from dividing, or spreading. Giving inotuzumab ozogamicin with chemotherapy may help shrink cancer and stop it from returning. The study subjects will either receive inotuzumab with lower doses of usual chemotherapy or get the usual chemotherapy treatment. In either treatment arm, study participants will receive two or more months (cycles) of more intensive chemotherapy. Both groups will continue with lower doses of chemotherapy for up to two years. Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    • Participants must have a diagnosis of Philadelphia-Chromosome-Negative B-cell Acute Lymphoblastic Leukemia

    • Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Dinner, Shira NaomiDinner, Shira Naomi
    NCT05303792 STU00219495
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    FAST Study

    Endometrial cancer is the most common gynecologic cancer and ovarian cancer is the most lethal. The management of both advanced cancers is a combination of chemotherapy and surgery. Standard of care chemotherapeutic treatment for uterine and ovarian cancers is toxic and severely disruptive to the patient's quality of life …

    Endometrial cancer is the most common gynecologic cancer and ovarian cancer is the most lethal. The management of both advanced cancers is a combination of chemotherapy and surgery. Standard of care chemotherapeutic treatment for uterine and ovarian cancers is toxic and severely disruptive to the patient's quality of life with the potential for devastating short and long-term side effects. The role of fasting and ketogenic diets has been evaluated in a mixed cancer population and previously shown to be safe. There is no data specifically addressing the impact of a fasting diet regimen on side effects of chemotherapy during treatment for ovarian and endometrial cancers in the front-line setting. The information gathered from this study will inform future trials about the role of time-restricted eating and its impact on side-effects associated with chemotherapy as well as its role in improvement of quality of life for women afflicted with these debilitating diseases.

    Marcus, Jenna ZMarcus, Jenna Z
    NCT05990426 STU00217844
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    LCRF Leader Trial: LCMC4 Evaluation of Actionable Drivers in EaRly Stage Lung Cancer

    The primary purpose of this testing is to determine the presence of 11 oncogenic drivers that can serve as targets for neoadjuvant therapies to be administered before surgery. The goal is to use this information from the screening process to select the optimal neoadjuvant therapy and wherever possible enroll patients …

    The primary purpose of this testing is to determine the presence of 11 oncogenic drivers that can serve as targets for neoadjuvant therapies to be administered before surgery. The goal is to use this information from the screening process to select the optimal neoadjuvant therapy and wherever possible enroll patients onto separate but harmonized neoadjuvant therapy trials with genomically matched treatments or other appropriate trials if no driver is detected.

    · Participants must be 18 or older

    . Participants must have a diagnosis at early -stage Lung cancer

    Patel, Jyoti DPatel, Jyoti D
    • Map it 201 E. Huron St.
      Chicago, IL
    • Map it 304 Randall Road
      Geneva, IL
    • Map it 4405 Weaver Pkwy
      Warrenville, IL
    • Map it 300 Randall Road
      Geneva, IL
    • Map it 1 Kish Hospital Drive
      DeKalb, IL
    • Map it 10 Health Services Drive
      DeKalb, IL
    • Map it 1000 N. Westmoreland Road
      Lake Forest, IL
    STU00218793
    More Info
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    (xIRB NCI CIRB) ETCTN 10487: A Phase II Study of Lutetium Lu 177 Dotatate in Metastatic Prostate Cancer with Neuroendocrine Differentiation

    This phase II trial studies how well lutetium Lu 177 dotatate works in treating patients with prostate cancer with neuroendocrine differentiation (formed from cells that release hormones into the blood in response to a signal from the nervous system) that has spread to other places in the body (metastatic). Radioactive …

    This phase II trial studies how well lutetium Lu 177 dotatate works in treating patients with prostate cancer with neuroendocrine differentiation (formed from cells that release hormones into the blood in response to a signal from the nervous system) that has spread to other places in the body (metastatic). Radioactive drugs, such as lutetium Lu 177, may carry radiation directly to tumor cells and not harm normal cells. The study aims to determine if this approach is better or worse than the usual approach for prostate cancer.

    • Participants must have a diagnosis of prostate cancer with neuroendocrine differentiation.

    • Participants must be 18 or older

    Hussain, MahaHussain, Maha
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT05691465 STU00219572
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    (xIRB) DRUG 1454-0001: A first-in-human Phase I, non-randomized, open-label, multicenter dose-escalation trial of BI 765049 and BI 765049 + ezabenlimab administered by parenteral administration(s) in patients with malignant solid tumors expressing B7-H6

    This study is open to adults with advanced solid tumors whose previous cancer treatment was not successful. People can participate if their tumor has the B7-H6 marker or if they have colorectal cancer.

    The study tests 2 medicines called BI 765049 and ezabenlimab (BI 754091). Both medicines may help the immune system fight cancer.

    The purpose of this study is to find out the highest dose of BI 765049 alone and in combination with ezabenlimab the participants can tolerate. In this study, BI 765049 is given to people for the first time.

    Participants can stay in the study for up to 3 years, if they benefit from treatment and can tolerate it. During this time, they get BI 765049 alone or in combination with ezabenlimab as infusion into a vein every 3 weeks.

    The doctors check the health of the participants and note any health problems that could have been caused by BI 765049 or ezabenlimab. The doctors also regularly monitor the size of the tumor

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    • Patients with a histologically or cytologically confirmed diagnosis of an advanced, unresectable, and/or metastatic colorectal carcinoma (CRC), non-small cell lung cancer (NSCLC), hepatocellular carcinoma (HCC), head and neck squamous cell carcinoma (HNSCC), gastric carcinoma, and pancreatic carcinoma. At least 1 patient in each back-fill slot must be a non-CRC patient (i.e., NSCLC, HCC, HNSCC, gastric carcinoma, or pancreatic carcinoma).

    Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Chae, Young KwangChae, Young Kwang
    NCT04752215 STU00219622
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    solid tumors.
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    ETCTN 10538: Venetoclax In Combination with ASTX727, an All-ORal TherapY for Chronic Myelomonocytic Leukemia and Other MDS/MPN with Excess Blasts (VICTORY-MDS/MPN): a Randomized, Phase 2 Trial

    This phase II trial tests whether decitabine and cedazuridine (ASTX727) in combination with venetoclax work better than ASTX727 alone at decreasing symptoms of bone marrow cancer in patients with chronic myelomonocytic leukemia, myelodysplastic syndrome /myeloproliferative neoplasm with excess blasts. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Cobimetinib is used in patients whose cancer has a mutated (changed) form of a gene called BRAF. It is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. The combination of ASTX727 and venetoclax may kill more cancer cells in patients with chronic myelomonocytic leukemia, myelodysplastic syndrome, or myeloproliferative neoplasm with excess blasts.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of bone marrow cancer with chronic myelomonocytic leukemia, myelodysplastic syndrome /myeloproliferative neoplasm with excess blasts

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Shammo, JamileShammo, Jamile
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT05600894 STU00219623
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    A Pilot Study of rhPSMA -PET MRI Imaging For the Detection of Clinically Actionable Prostate Cancer Among Men Who Are Otherwise Candidates for Active Surveillance

    The overall goal of this pilot study is to evaluate whether rhPMSA-7.3-PET-MRI can detect higher grade or stage disease in a population of NCCN low and favorable intermediate risk men. …

    The overall goal of this pilot study is to evaluate whether rhPMSA-7.3-PET-MRI can detect higher grade or stage disease in a population of NCCN low and favorable intermediate risk men.

    Inclusion Criteria:

    • Healthy men (ECOG 0-1)
    • > 18 years old with at least 10 year life expectancy.
    • Histologically proven Gleason Grade Group 1 or 2 adenocarcinoma of the prostate o Last prostate cancer containing biopsy performed within 3-15mo prior to screening. Biopsy must have been ≥10 core biopsy and informed by prior mpMRI
    • Prostate cancer categorized as low risk or favorable risk by NCCN criteria (low risk is defined as T1c-T2a, PSA<10ng/ml, Gleason Grade Group 1 (Gleason 3+3=6) disease) and favorable intermediate risk as having no more than one of the following intermediate risk features, clinical T2b-T2c disease, PSA 10-20ng/ml, Gleason Grade Group 2 (Gleason score 3+4=7)).
    • Decipher genomic classifier score from prior biopsy >0.45
    • Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written Informed Consent and privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures.
    • Concurrent diseases and malignancies are permitted
    • Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on the study
    • Willing to undergo prostate biopsy prior to non-surgical treatment of prostate cancer and within 90 days of PET-MRI imaging

    Exclusion Criteria

    • Prior radiotherapy, surgery, chemotherapy, or hormonal therapy for prostate cancer.
    • NCCN Very low risk category (T1c and Gleason Grade Group 1 (Gleason Score 3+3=6), PSA <10 ng/mL, fewer than 3 prostate biopsy cores positive, ≤50% cancer in any core, PSA density <0.15 ng/mL/g).
    • Decipher score <0.45
    • Prior bladder outlet procedure (i.e. HoLEP, TURP, Urolift, Rezum)
    • Prohibited medications: use of 5 alpha reductase inhibitor or androgen deprivation therapy (i.e. leuprolide, relugolix) within 1 month of screening
    • Contra-indication or relative contra-indication to MRI (i.e. pacemaker) o History of hip replacement
    • Subject has received investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening.
    Ross, Ashley EvanRoss, Ashley Evan
    • Map it 675 N. Saint Clair St. Twentieth Floor, Suite 150
      Chicago, IL
    NCT05852041 STU00218970
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    DRUG CTX-009-002: A Phase 2/3 Randomized, Controlled Study of CTX-009 in Combination with Paclitaxel versus Paclitaxel Alone in Adult Patients with Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers who have received One Prior Systemic Chemotherapy Regimen

    The purpose of this study is to compare the effects of using study drug (CTX-009) along with the chemotherapy paclitaxel to using paclitaxel alone. This study will allow the researchers to know whether this different treatment is better, the same, or worse at shrinking your tumor(s).…

    The purpose of this study is to compare the effects of using study drug (CTX-009) along with the chemotherapy paclitaxel to using paclitaxel alone. This study will allow the researchers to know whether this different treatment is better, the same, or worse at shrinking your tumor(s).

  • 18 years or older
  • Histologically or cytologically confirmed unresectable advanced, metastatic, or recurrent biliary tract cancers (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, and ampullary carcinoma)
  • Patients Must have radiologically documented progression after a prior gemcitabine and platinum containing chemotherapy regimen as initial therapy for locally advanced or metastatic disease. Patients who subsequently receive additional systemic treatment are not eligible. Patients who relapse within 6 months of receiving a gemcitabine and platinum containing chemotherapy regimen in the adjuvant setting are also eligible.
  • Kalyan, AparnaKalyan, Aparna
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT05506943 STU00219156
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    Blue Light Cystoscopy™ with Cysview® Registry

    The purpose of the registry is to study the use of BLC™ with Cysview® in clinical practice in the United States.

    Inclusion Criteria

    • Adult >18 years old
    • Suspected or known non-muscle invasive bladder cancer on the basis of a prior cystoscopy, or undergoing surveillance cystoscopy for carcinoma of the bladder

    Exclusion Criteria

    • Porphyria
    • Gross hematuria
    • Known hypersensitivity to hexaminolevulinate or aminolevulinate derivatives
    Meeks, Joshua JMeeks, Joshua J
    • Map it 675 N. Saint Clair St. Twentieth Floor, Suite 150
      Chicago, IL
    NCT02660645 STU00218901
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    DRUG SOLTI-2101

    HARMONIA is an international, multicenter, randomized, open-label and phase III study. The primary objective of this study is to demonstrate that the combination of ribociclib with endocrine therapy (letrozole or fulvestrant) is superior to palbociclib with endocrine therapy (letrozole or fulvestrant) in prolonging progression-free survival in patients with …

    HARMONIA is an international, multicenter, randomized, open-label and phase III study. The primary objective of this study is to demonstrate that the combination of ribociclib with endocrine therapy (letrozole or fulvestrant) is superior to palbociclib with endocrine therapy (letrozole or fulvestrant) in prolonging progression-free survival in patients with advanced HR+/HER2- and HER2-E breast cancer. The study will enroll approximately 456 patients with HER2-E disease from approximately 95 sites worldwide.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of HR-positive and HER2-negative breast cancer

    · Participants must be 18 or older

    • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
    • advanced (loco regionally recurrent not amenable to curative therapy or metastatic) breast cancer.
    • Availability of FFPE tumor block for biomarker analysis, obtained during metastatic period.
    • HER2-E or Basal-like subtype as per central PAM50 analysis.
    • Measurable disease or non-measurable disease, as defined by RECIST v1.1
    • Adequate hematologic and end-organ function
    • Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures.
    • Women of childbearing potential must have confirmed negative serum pregnancy test within 7 days prior to randomization.
    • Women of CBP must be willing to use highly effective methods of contraception.
    • Patient must have a 6-lead or 12-lead ECG with ALL of the following parameters at screening:
    • QTcF interval (QT interval using Fridericia's correction) at screening < 450 msec.
    • Resting heart rate 50-90 beats per minute (determined from the ECG).

    ·

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Gradishar, William JGradishar, William J
    • Map it 675 N. Saint Clair St. Twenty-First Floor, Suite 100
      Chicago, IL
    NCT05207709 STU00219690
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    (xIRB) DRUG EP0031-101: A Modular, Open-label, Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of EP0031 in Patients with Advanced RET-altered Malignancies

    The aim of this study is to assess the safety, side effectsand effectiveness of EP0031 in patients with advancedRET-altered malignanciesNote: This is only a partial description of thestudy. Please contact the Robert H. LurieComprehensive Cancer Center ofNorthwestern University if you are interestedin the trial…

    The aim of this study is to assess the safety, side effects

    and effectiveness of EP0031 in patients with advanced

    RET-altered malignancies

    Note: This is only a partial description of the

    study. Please contact the Robert H. Lurie

    Comprehensive Cancer Center of

    Northwestern University if you are interested

    in the trial

    Some of the eligibility criteria include:

     Participants must have a diagnosis of

    RET-altered malignancy

     Participants must be 18 or older

    Note: This is only a partial list of eligibility

    criteria. Please contact the Robert H. Lurie

    Comprehensive Cancer Center of

    Northwestern University for complete

    screening information if you are interested in

    this clinical trial.

    Patel, Jyoti DPatel, Jyoti D
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT05443126 STU00219707
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    MA-GVHD-401: A Prospective, Observational Cohort Study of Participants at Risk for Chronic Graft-Versus-Host Disease in the United States (THRIVE)

    The purpose of this prospective observational study is to collect data from participants who have recently had an allogenic Stem Cell Transplant(alloSCT) and are at risk of Chronic Graft Versus Host Disease(cGVHD) Note: This is only a partial description of the study. Please contact the Robert H. Lurie …

    The purpose of this prospective observational study is to collect data from participants who have recently had an allogenic Stem Cell Transplant(alloSCT) and are at risk of Chronic Graft Versus Host Disease(cGVHD)

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial

    • Participants must have a diagnosis of Allogeneic SCT 90 to 180 days prior to enrollment

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Adekola, KehindeAdekola, Kehinde
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT05919511 STU00219877
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    (xIRB NCI CIRB) ECOG-ACRIN EA1211: Interim FDG-PET/CT for PreDIcting REsponse of HER2+ Breast Cancer to Neoadjuvant Therapy: DIRECT Trial

    This phase II trial tests how well an imaging procedure called fludeoxyglucose F-18 (FDG) positron emission tomography/computed tomography (PET/CT) works in predicting response to standard of care chemotherapy prior to surgery in patients with HER2-positive stage IIa-IIIc breast cancer. FDG is a radioactive tracer that …

    This phase II trial tests how well an imaging procedure called fludeoxyglucose F-18 (FDG) positron emission tomography/computed tomography (PET/CT) works in predicting response to standard of care chemotherapy prior to surgery in patients with HER2-positive stage IIa-IIIc breast cancer. FDG is a radioactive tracer that is given in a vein before PET/CT imaging and helps to identify areas of active cancer. PET and CT are imaging techniques that make detailed, computerized pictures of areas inside the body. The use of FDG-PET/CT may help doctors better decide if a patient needs more or less treatment before surgery in order to get the best response. This study evaluates whether FDG-PET/CT is useful in predicting a patient's response to standard of care chemotherapy.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of HER2-positive stage IIa-IIIc breast cancer

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Stein, Regina MStein, Regina M
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT05710328 STU00219917
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    Testing the effectiveness of an anti-cancer drug, triapine, when used with targeted radiation-based treatment (Lutetium Lu 177 Dotatate), compared to Lutetium Lu 177 Dotatate alone for metastatic neuroendocrine tumors

    This phase II trial compares the effect of adding triapine to lutetium Lu 177 dotatate versus lutetium Lu 177 dotatate alone (standard therapy) in shrinking tumors or slowing tumor growth in patients with neuroendocrine tumors that have spread from where they first started (primary site) to other places in the …

    This phase II trial compares the effect of adding triapine to lutetium Lu 177 dotatate versus lutetium Lu 177 dotatate alone (standard therapy) in shrinking tumors or slowing tumor growth in patients with neuroendocrine tumors that have spread from where they first started (primary site) to other places in the body (metastatic). Triapine may stop the growth of tumor cells by blocking some of the enzymes needed for deoxyribonucleic acid synthesis and cell growth. Lutetium Lu 177 dotate is a radioactive drug. It binds to a protein called somatostatin receptor, which is found on some neuroendocrine tumor cells. Lutetium Lu 177 dotatate builds up in these cells and gives off radiation that may kill them. It is a type of radio-conjugate and a type of somatostatin analog. Giving triapine in combination with lutetium Lu 177 dotatate may be more effective at shrinking tumors or slowing tumor growth in patients with metastatic neuroendocrine tumors than the standard therapy of lutetium Lu 177 dotatate alone. Study participants will be assigned to receive lutetium Lu 177 dotatate alone or lutetium Lu 177 dotatate and triapine.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include: • Participants must have a diagnosis of metastatic neuroendocrine tumor • Participants must be 18 or older Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Benson III, Al BBenson III, Al B
    • Map it 201 E. Huron St. Suite 12 160​
      Chicago, IL
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT05724108 STU00219929
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    A study of intravesical enfortumab vedotin for treatment of patients with non-muscle invasive bladder cancer (NMIBC)

    To evaluate the safety and tolerability of intravesical enfortumab vedotin in subjects with non-muscle invasive bladder cancer

    Inclusion Criteria:

    • Subjects must have histologically confirmed, non-muscle invasive urothelial (transitional cell) carcinoma with carcinoma in situ (CIS) (with or without papillary disease). Histological confirmation must occur within 60 days prior to first dose of study treatment.
    • Predominant histologic component (>50%) must be urothelial (transitional cell) carcinoma. Pure variant histologies will be excluded.
    • Subjects must have high-risk Bacillus Calmette-Guerin (BCG)-unresponsive disease.
    • All visible papillary Ta/T1 tumors must be completely resected within 60 days prior to enrollment.
    • Subjects must have satisfactory bladder function and the ability to retain study drug instillation for a minimum of 1 hour, even with premedication.

    Exclusion Criteria:

    • Current or prior history of muscle-invasive urothelial carcinoma (ie, T2, T3, or T4 disease) or metastatic disease.
    • Nodal or metastatic disease as noted on computed tomography (CT) or magnetic resonance imaging (MRI) done within 3 months prior to the start of study treatment.
    • Concomitant upper tract urothelial carcinoma as noted on CT or MRI urogram with contrast of abdomen/pelvis performed within 3 months prior to the start of study treatment.
    • Subjects known to have prior or concomitant urothelial carcinoma of the prostatic urethra, as assessed by investigator within 6 months prior to the start of study treatment.
    • Subject has received any other systemic anticancer therapy (eg, chemotherapy, biologic therapy, immunotherapy, targeted therapy, endocrine therapy, investigational agent) within 4 weeks of the first dose of study treatment or any intravesical therapy for treatment of NMIBC within 6 weeks prior to the start of study treatment.
    • Subject has had any prior radiation to the bladder for urothelial cancer.
    Meeks, Joshua JMeeks, Joshua J
    • Map it 675 N. Saint Clair St. Twentieth Floor, Suite 150
      Chicago, IL
    NCT05014139 STU00219109
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    (xIRB NCI CIRB) CCTG NE1: NET RETREAT: A Phase II Study of 177 Lutetium-DOTATATE Retreatment vs. Everolimus in Metastatic/Unresectable Midgut NET

    This phase II trial compares the effect of retreatment with 177Lu-DOTATATE peptide receptor radionuclide therapy (PRRT) to the usual approach of treatment with everolimus in patients who have previously received 177Lu-DOTATATE for midgut neuroendocrine tumor (NET) that has spread from where it first started (primary site) to other …

    This phase II trial compares the effect of retreatment with 177Lu-DOTATATE peptide receptor radionuclide therapy (PRRT) to the usual approach of treatment with everolimus in patients who have previously received 177Lu-DOTATATE for midgut neuroendocrine tumor (NET) that has spread from where it first started (primary site) to other places in the body (metastatic) and that cannot be removed by surgery (unresectable). PRRT is a type of radiation therapy for which a radioactive chemical is linked to a peptide (small protein) that targets cancer cells. When this radioactive peptide is injected into the body, it binds to a specific receptor found on some cancer cells. The radioactive peptide builds up in these cells and helps kill the cancer cells without harming normal cells. In this trial 177Lu-DOTATATE is used for PRRT. 177Lu-DOTATATE PRRT may increase the length of time until the midgut NET worsens compared to the usual approach. Everolimus is in a class of medications called kinase inhibitors. It is also a type of angiogenesis inhibitor. Everolimus works by stopping cancer cells from reproducing and by decreasing the blood supply to the cancer cells. Retreating with 177Lu-DOTATATE may work better than everolimus in shrinking or stabilizing tumor in patients with metastatic and unresectable NET who were previously treated with 177Lu-DOTATATE.

    · Participants must have a diagnosis of metastatic midgut neuroendocrine tumor

    · Participants must be 18 or older

    Benson III, Al BBenson III, Al B
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT05773274 STU00219981
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    DRUG POLARIS2022-001

    This is a global, multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 3 trial that will compare the efficacy and safety in subjects with advanced or metastatic LMS previously treated with an anthracycline. Note: This is only a partial description of the study. Please contact the Robert H. Lurie …

    This is a global, multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 3 trial that will compare the efficacy and safety in subjects with advanced or metastatic LMS previously treated with an anthracycline.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of Leiomyosarcoma (LMS)

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Pollack, Seth MichaelsPollack, Seth Michaels
    NCT05712694 STU00219993
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    DRUG D926XC00001

    This is a Phase III, 2-arm, randomised, open-label, multicentre, global study assessing the efficacy and safety of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy compared with neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously …

    This is a Phase III, 2-arm, randomised, open-label, multicentre, global study assessing the efficacy and safety of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy compared with neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor-low/HER2-negative breast cancer.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Stein, Regina MStein, Regina M
    • Map it 675 N. Saint Clair St. Twenty-First Floor, Suite 100
      Chicago, IL
    NCT05629585 STU00219995
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    A Phase 2 Evaluation of the Safety and Efficacy of AL8326 in =2nd Line Small Cell Lung Cancer (SCLC) Treatment

    This trial is a Phase II trial designed to evaluate the safety and efficacy of using oral AL8326 , a multi-targeted receptor Tyrosine Kinase Inhibitor( TKI) , to recurrent, advanced, or metastatic small cell lung cancer (SCLC) patients who need ≥2nd line treatment . Note: This is only a partial description of …

    This trial is a Phase II trial designed to evaluate the safety and efficacy of using oral AL8326 , a multi-targeted receptor Tyrosine Kinase Inhibitor( TKI) , to recurrent, advanced, or metastatic small cell lung cancer (SCLC) patients who need ≥2nd line treatment .

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    • Participants must have a diagnosis of Histologically or cytologically confirmed SCLC

    Have at least 1 lesion that meets the criteria for being measurable, as defined by RECIST 1.1

    Have a life expectancy of at least 3 months

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial

    Patel, Jyoti DPatel, Jyoti D
    • Map it 201 E. Huron St.
      Chicago, IL
    • Map it 1000 N. Westmoreland Road North Entrance
      Lake Forest, IL
    • Map it 304 Randall Road
      Geneva, IL
    • Map it 4405 Weaver Pkwy
      Warrenville, IL
    • Map it 300 Randall Road
      Geneva, IL
    • Map it 1 Kish Hospital Drive
      DeKalb, IL
    NCT05363280 STU00219997
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    ECOG-ACRIN 7211

    This is a multicenter, randomized, open label phase lll trial to assess whether preoperative chemotherapy, as an adjunct to curative-intent surgery, improves the prognosis of high risk DDLPS (dedifferentiated Liposarcoma) and LMS (Leiomyosarcoma) patients as measured by disease free survival. After confirmation of eligibility criteria, patients will be randomized …

    This is a multicenter, randomized, open label phase lll trial to assess whether preoperative chemotherapy, as an adjunct to curative-intent surgery, improves the prognosis of high risk DDLPS (dedifferentiated Liposarcoma) and LMS (Leiomyosarcoma) patients as measured by disease free survival.

    After confirmation of eligibility criteria, patients will be randomized to either the standard arm or experimental arm.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of RetroPeritoneal Sarcoma

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Pollack, Seth MichaelsPollack, Seth Michaels
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04031677 STU00219999
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    NU 23H06: A Phase II multi-center open-label trial of six doses of pembrolizumab monotherapy prior to limited chemotherapy as front-line therapy for patients with classical Hodgkin lymphoma, including elderly patients

    This purpose of this trial is to shift the paradigm from chemotherapy to immunotherapy-based regimens and thereby reduce chemotherapy- related toxicities and improve clinical outcomes. We propose a phase II trial to assess the efficacy and safety of PET-directed PEM monotherapy for 6 cycles followed by abbreviated AVD …

    This purpose of this trial is to shift the paradigm from chemotherapy to immunotherapy-based regimens and thereby reduce chemotherapy- related toxicities and improve clinical outcomes. We propose a phase II trial to assess the efficacy and safety of PET-directed PEM monotherapy for 6 cycles followed by abbreviated AVD therapy in newly diagnosed cHL, early unfavorable and advanced stages. We anticipate that six cycles of PEM upfront (three more cycles than in the NU 16H08 study) will increase the rate of complete metabolic response (CMR) to PEM monotherapy and allow the majority of patients to receive an abbreviated course of AVD chemotherapy with clinical outcomes similar to those seen in NU 16H08. We thereby anticipate shifting from chemotherapy-based strategies for cHL to predominantly immunotherapy, with the ultimate goal of eliminating chemotherapy altogether.

    Patients must have confirmed diagnosis of Ann Arbor Stage III or IV classic Hodgkin lymphoma or Ann Arbor Stage I and Stage II classic Hodgkin lymphoma with at least one unfavorable risk factor by NCCN criteria.

    Winter, Jane NormaWinter, Jane Norma
    • Map it 201 E. Huron St.
      Chicago, IL
    • Map it 4405 Weaver Pkwy
      Warrenville, IL
    NCT06164275 STU00219738
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    (XIRB) DRUG TOS-358-001: A Study to Evaluate the Safety and Tolerability of the Covalent Phosphoinositide-3-Kinase (PI3K)-alpha Inhibitor, TOS-358, in Adult Subjects with Select Solid Tumors

    The goal of this clinical trial is to evaluate the safety of TOS-358 in adults with select solid tumors who meet study enrollment criteria. The main questions it aims to answer are:

  • what is the maximum tolerated dose and recommended dose for phase 2?
  • how safe and tolerable is TOS-358 at different dose levels when taken orally once or twice per day?
  • Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    • Participants must have a diagnosis of a locally advanced, recurrent, or metastatic, incurable (any number of previous lines of therapy is allowed), histologically or cytologically confirmed: colorectal cancer; gastric cancer; non-small cell lung cancer; HER2- breast cancer; squamous cell carcinoma of the head and neck; urothelial cancer; or select gynecologic cancer (ovarian cancer, cervical cancer, or endometrial cancer)

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Kalyan, AparnaKalyan, Aparna
    NCT05683418 STU00220036
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    DRUG J2J-MC-JZLH: EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients who have Previously Received 2 to 5 years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer with an Increased Risk of Recurrence

    The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken endocrine therapy for two to five years and …

    The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken endocrine therapy for two to five years and must have a higher-than-average risk for their cancer to return. Study participation could last up to 10 years.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial

    Some of the eligibility criteria include:

    • Participants must Have a diagnosis of ER+, HER2- early-stage, resected, invasive breast cancer without evidence of distant metastasis.
    • Participants must have received at least 24 months but not more than 60 months of any adjuvant ET, from time of adjuvant ET initiation.
    • Participants may have received (neo) adjuvant chemotherapy and/or targeted therapy with a CDK4/6- or PARP- inhibitor.

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Gradishar, William JGradishar, William J
    NCT05514054 STU00220046
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    NU 23S01

    In this study, a standard dose of radiation will be given to the majority of the tumor, while a simultaneously integrated boost of additional radiation will be given to certain areas of the tumor identified as higher risk. This means that a higher radiation dose will be given to the higher risk areas of the tumor.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of primary soft tissue sarcoma of the retroperitoneum

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Pollack, Seth MichaelsPollack, Seth Michaels
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT06327477 STU00220015
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    (xIRB) DRUG MER-XMT-1660-1: A Phase 1, First-in-Human, Dose Escalation and Expansion, Multicenter Study of XMT-1660 in Participants with Solid Tumors

    This first-in-human (FIH) study will test the safety and side effects of a drug called XMT-1660. A side effect is anything a drug does to the body besides treating the disease.Participants in the study will have cancer that has come back after a period of time …

    This first-in-human (FIH) study will test the safety and side effects of a drug called XMT-1660. A side effect is anything a drug does to the body besides treating the disease.

    Participants in the study will have cancer that has come back after a period of time during which the cancer could not be detected (recurrent), spread in the body near where it started(advanced) or spread through the body (metastatic).

    The study will have two parts. The first part called Dose Escalation will find out how much XMT-1660 should be given toparticipants. The second part called Dose Expansion will use the dose found in the first part to find out how safe XMT-1660 is and if it works to treat solid tumor cancers.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Complion Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    -Participant has proven recurrent or advanced solid tumor and has disease progression after treatment with available anti-cancer therapies known to confer benefit or is intolerant to treatment.

    -Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Roque, Dario RRoque, Dario R
    NCT05377996 STU00220069
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    SWOG 2212: Shorter Anthracycline-Free Chemo Immunotherapy Adapted to Pathological Response in Early Triple Negative Breast Cancer (SCARLET), A Randomized Phase III Study

    This phase III trial compares the effects of shorter chemotherapy (chemo)-immunotherapy without anthracyclines to usual chemo-immunotherapy for the treatment of early-stage triple negative breast cancer. Paclitaxel is in a class of medications called anti-microtubule agents. It stops cancer cells from growing and dividing and may kill …

    This phase III trial compares the effects of shorter chemotherapy (chemo)-immunotherapy without anthracyclines to usual chemo-immunotherapy for the treatment of early-stage triple negative breast cancer. Paclitaxel is in a class of medications called anti-microtubule agents. It stops cancer cells from growing and dividing and may kill them. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Docetaxel is in a class of medications called taxanes. It stops cancer cells from growing and dividing and may kill them. Doxorubicin is an anthracycline chemotherapy drug that damages DNA and may kill cancer cells. Pembrolizumab may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Shorter treatment without anthracycline chemotherapy may work the same as the usual anthracycline chemotherapy treatment for early-stage triple negative breast cancer.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of early-stage triple negative breast cancer.

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Flaum, Lisa EllenFlaum, Lisa Ellen
    • Map it 201 E. Huron St.
      Chicago, IL
    • Map it 304 Randall Road
      Geneva, IL
    • Map it 4405 Weaver Pkwy
      Warrenville, IL
    • Map it 10 Health Services Drive
      DeKalb, IL
    NCT05929768 STU00220135
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    (xIRB NCI IRB) SWOG 2012: Randomized Phase II/III Trial of First Line Platinum/Etoposide with or Without Atezolizumab (NSC#783608) in Patients with Poorly Differentiated Extrapulmonary Small Cell Neuroendocrine Carcinomas (NEC)

    This phase II/III trial compares the effect of immunotherapy with atezolizumab in combination with standard chemotherapy with a platinum drug (cisplatin or carboplatin) and etoposide versus standard therapy alone for the treatment of poorly differentiated extrapulmonary (originated outside the lung) neuroendocrine cancer that may have spread from where it …

    This phase II/III trial compares the effect of immunotherapy with atezolizumab in combination with standard chemotherapy with a platinum drug (cisplatin or carboplatin) and etoposide versus standard therapy alone for the treatment of poorly differentiated extrapulmonary (originated outside the lung) neuroendocrine cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). The other aim of this trial is to compare using atezolizumab just at the beginning of treatment versus continuing it beyond the initial treatment. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer and interfere with tumor cells' ability to grow and spread. Cisplatin and carboplatin are in a class of medications known as platinum-containing compounds that work by killing, stopping, or slowing the growth of cancer cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Giving atezolizumab in combination with a platinum drug (cisplatin or carboplatin) and etoposide may work better in treating patients with poorly differentiated extrapulmonary neuroendocrine cancer compared to standard therapy with a platinum drug (cisplatin or carboplatin) and etoposide alone. The study has three arms to which you could be randomly assigned: 1) atezolizumab, platinum drug, etoposide; 2) atezolizumab, platinum drug, etoposide, observation; 3) platinum drug, etoposide, observation.

    · Participants must have a diagnosis with poorly differentiated extrapulmonary neuroendocrine tumor

    · Participants must be 18 or older

    Mulcahy, Mary FrancesMulcahy, Mary Frances
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT05058651 STU00220138
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    Phase III Prospective Randomized Trial of Primary Lung Tumor Stereotactic Body Radiation Therapy Followed by Concurrent Mediastinal Chemoradiation for Locally-Advanced Non-Small Cell Lung Cancer

    This phase III trial compares the effect of adding stereotactic body radiation therapy (SBRT) to standard treatment (image guided radiation therapy [IGRT] and chemotherapy followed by immunotherapy with durvalumab) versus standard treatment alone in treating patients with non-small cell lung cancer that cannot be treated by surgery (inoperable). SBRT …

    This phase III trial compares the effect of adding stereotactic body radiation therapy (SBRT) to standard treatment (image guided radiation therapy [IGRT] and chemotherapy followed by immunotherapy with durvalumab) versus standard treatment alone in treating patients with non-small cell lung cancer that cannot be treated by surgery (inoperable). SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. IGRT is a type of radiation that uses a computer to create picture of the tumor, to help guide the radiation beam during therapy, making it more accurate and causing less damage to healthy tissue. Standard chemotherapy used in this trial consists of combinations of the following drugs: cisplatin, carboplatin, paclitaxel, pemetrexed, and etoposide. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Paclitaxel is in a class of medications called antimicrotubule agents. It works by stopping the growth and spread of tumor cells. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by blocking the action of a certain substance in the body that may help tumor cells multiply. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. Immunotherapy with durvalumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Adding SBRT to the standard treatment of IGRT with chemotherapy and immunotherapy may be more effective at treating patients with inoperable non-small cell lung cancer than giving the standard treatment alone.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of non-small cell lung cancer that has spread to lymph nodes in chest and is not able to be treated by surgery.

    · Participants must be 18 or older

    Abazeed, MohamedAbazeed, Mohamed
    • Map it 201 E. Huron St.
      Chicago, IL
    • Map it 304 Randall Road
      Geneva, IL
    • Map it 4405 Weaver Pkwy
      Warrenville, IL
    • Map it 300 Randall Road
      Geneva, IL
    • Map it 1 Kish Hospital Drive
      DeKalb, IL
    • Map it 10 Health Services Drive
      DeKalb, IL
    NCT05624996 STU00220142
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    NU 23B05 - Randomized phase II study of elacestrant vs elacestrant plus a CDK4/6 inhibitor (palbociclib, abemaciclib, or ribociclib) in patients with ER+/HER2- advanced or metastatic breast cancer with prior exposure to a CKD4/6 inhibitor

    Breast cancer is not only the leading cause of cancer in women, but also the leading cause of cancer deaths in women. Estrogen receptor-positive and HER2-negative breast cancer is the most prevalent breast cancer subtype. Endocrine therapy is the mainstay of treatment; however, due to the varied nature …

    Breast cancer is not only the leading cause of cancer in women, but also the leading cause of cancer deaths in women. Estrogen receptor-positive and HER2-negative breast cancer is the most prevalent breast cancer subtype. Endocrine therapy is the mainstay of treatment; however, due to the varied nature of the disease, development of resistance to this therapeutic approach is very common in the metastatic setting.

    The purpose of this study is to see whether the effectiveness of elacestrant can be enhanced by combining it with a targeted agent such as a CDK4/6 inhibitor to treat patients with ER+/HER2- or metastatic breast cancer with prior exposure to a CDK4/6 inhibitor.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of histologically or cytologically confirmed ER-positive and HER2- negative breast cancer as per the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines.

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Gradishar, William JGradishar, William J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT06062498 STU00219978
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    (xIRB) DRUG CYP-GVHD-P2-01: A Multicenter, Randomized, Double-blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of CYP-001 in Combination with Corticosteroids vs Corticosteroids Alone for the Treatment of High-Risk Acute Graft Versus Host Disease

    This study is a prospective randomized placebo-controlled phase 2 study to compare CYP-001 plus corticosteroids (CS) to placebo plus CS in allogeneic hematologic stem cell transplant recipients with HR-aGvHD. Severity of GvHD will be assessed at screening and throughout the study using Mount Sinai Acute GvHD International …

    This study is a prospective randomized placebo-controlled phase 2 study to compare CYP-001 plus corticosteroids (CS) to placebo plus CS in allogeneic hematologic stem cell transplant recipients with HR-aGvHD. Severity of GvHD will be assessed at screening and throughout the study using Mount Sinai Acute GvHD International Consortium (MAGIC) guidelines. Eligible subjects will be randomized to receive either CYP-001 IV infusion on Days 0 and 4 or placebo on the same days. All subjects will receive ongoing CS therapy as appropriate per institutional guidelines. Subjects will have study visits up to Day 100 during the Primary Evaluation Period. During the Follow-Up Period, subjects will have study visits up to 24 months.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of acute Graft vs Host Disease (GvHD)

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Adekola, KehindeAdekola, Kehinde
    • Map it 675 N. Saint Clair St. Twenty-First Floor, Suite 100
      Chicago, IL
    NCT05643638 STU00220175
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    SOAR - Phase III Randomized Trial of Stereotactic Ablative Radiotherapy (SAbR) for Oligometastatic Advanced Renal Carcinoma

    This study is being done to answer the following question: For kidney cancer patients with limited (2-5) number of metastases like yourself, 1) is radiation therapy equal or better when compared to systemic therapy and 2) can stereotactic ablative radiation have less side effects when compared to systemic therapy. …

    This study is being done to answer the following question: For kidney cancer patients with limited (2-5) number of metastases like yourself, 1) is radiation therapy equal or better when compared to systemic therapy and 2) can stereotactic ablative radiation have less side effects when compared to systemic therapy. We are doing this study because we want to find out if this approach is better or worse than the usual approach for your kidney cancer. The usual approach is defined as care most people get for metastatic kidney cancer.

    If you decide to take part in this clinical trial, you will be randomly assigned to one of the two groups: group 1 or group 2. If you are assigned to group 1, you will receive standard systemic therapy (including Immunotherapy and small molecular inhibitor therapies listed above either by themselves or in combination). If you are assigned to group 2, you will first receive stereotactic ablative radiation to metastatic sites and repeated stereotactic ablative radiation to additional sites until additional radiation is not possible, at which time you will receive standard systemic therapy. Stereotactic ablative” radiotherapy is a standard, non-experimental, way of giving radiotherapy that is very precisely localized and delivered and is given with larger daily doses of radiation than is given using non stereotactic approaches. Given this way radiotherapy treatments are usually more powerful and effective at shrinking and/or ablating (killing) individual spots of cancer. radiation for patients in group 2 may not be possible due to many reasons such as the development of multiple new sites of metastasis or the development of a metastasis at a location not treatable by focused radiation. After you finish your study treatment, your doctor will continue to follow your condition for up to 10 years with a phone call every three months.

    Participants must have metastatic kidney cancer with a limited number of metastatic lesions.

    Sachdev, SeanSachdev, Sean
    • Map it 201 E. Huron St.
      Chicago, IL
    • Map it 304 Randall Road
      Geneva, IL
    • Map it 4405 Weaver Pkwy
      Warrenville, IL
    • Map it 10 Health Services Drive
      DeKalb, IL
    NCT05863351 STU00220265
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    Alliance A012103: OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy with Checkpoint Inhibitor Therapy

    The phase III trial compares the effect of pembrolizumab to observation for the treatment of patients with early-stage triple-negative breast cancer who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system …

    The phase III trial compares the effect of pembrolizumab to observation for the treatment of patients with early-stage triple-negative breast cancer who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial may help researchers determine if observation will result in the same risk of cancer coming back as pembrolizumab after surgery in triple-negative breast cancer patients who achieve pathologic complete response after preoperative chemotherapy with pembrolizumab.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of triple-negative breast cancer (TNBC) and have recently completed preoperative chemotherapy in combination with pembrolizumab, followed by breast surgery

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Tellez, ClaudiaTellez, Claudia
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT05812807 STU00220277
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    (xIRB NCI CIRB) Alliance A092107: A Randomized Phase 2 Trial with a Safety Lead-In to Evaluate Palbociclib Versus Palbociclib and Cemiplimab for the Treatment of Advanced Dedifferentiated Liposarcoma

    This phase II trial compares the effect of treatment with palbociclib alone to treatment with palbociclib plus cemiplimab for treating patients with dedifferentiated liposarcoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Palbociclib may stop the growth …

    This phase II trial compares the effect of treatment with palbociclib alone to treatment with palbociclib plus cemiplimab for treating patients with dedifferentiated liposarcoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Palbociclib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Cemiplimab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. The combination of these two drugs may be more effective in shrinking or stabilizing advanced dedifferentiated liposarcoma compared to palbociclib alone.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of dedifferentiated liposarcoma that cannot be removed by surgery

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    • Map it 1000 N. Westmoreland Road North Entrance
      Lake Forest, IL
    • Map it 304 Randall Road
      Geneva, IL
    • Map it 4405 Weaver Pkwy
      Warrenville, IL
    • Map it 2701 Patriot Blvd.
      Glenview, IL
    • Map it 1475 E. Belvidere Road
      Grayslake, IL
    • Map it 10 Health Services Drive
      DeKalb, IL
    • Map it 251 E. Huron St. Fifth Floor, Suite 704
      Chicago, IL
    NCT05694871 STU00220290
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    (xIRB) DRUG IMSA101-103: Phase 2 Randomized Clinical Trial Comparing the Safety and Efficacy of PULSAR-Integrated Radiotherapy + Pembrolizumab or Nivolumab Administered with or without STING-Agonist IMSA101 in Patients with Oligoprogressive Solid Tumor Malignancies

    Phase 2, open-label, multicenter, randomized study comparing the safety and efficacy of personalized ultra-fractionated stereotactic adaptive radiotherapy (PULSAR) combined with immune checkpoint inhibitor (ICI) immunotherapy (PULSAR-ICI) + IMSA101 and PULSAR-ICI alone in patients with oligoprogressive solid tumor malignancies after prior PD-L1or PD-1-targeted ICI immunotherapy.…

    Phase 2, open-label, multicenter, randomized study comparing the safety and efficacy of personalized ultra-fractionated stereotactic adaptive radiotherapy (PULSAR) combined with immune checkpoint inhibitor (ICI) immunotherapy (PULSAR-ICI) + IMSA101 and PULSAR-ICI alone in patients with oligoprogressive solid tumor malignancies after prior PD-L1or PD-1-targeted ICI immunotherapy.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of oligoprogressive disease

    · Participants must be 18 or older

    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 251 E. Huron St. Fifth Floor, Suite 704
      Chicago, IL
    NCT05846646 STU00220371
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    (xIRB) DRUG ALE.C04.01: A Phase I/II, Open-Label, Multi-Center Study of ALE.C04 (anti-Claudin-1 Antibody) as a Single Agent and in Combination with Pembrolizumab (anti- PD-1 antibody) in Adult Patients with Recurrent or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma

    The purpose of this study is to evaluate the safety profile of ALE.C04 monotherapy and in combination with pembrolizumab, to characterize pharmacokinetics profile of ALE.C04, recommended Phase II dose (RP2D) for ALE.C04 in combination with pembrolizumab and as monotherapy and to assess anti-tumor activity of ALE.C04 monotherapy and in combination with pembrolizumab in patients with Head and Neck Cancer.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of Recurrent or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) that has not responded to treatment.

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Lorch, Jochen Hanns-MartinLorch, Jochen Hanns-Martin
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT06054477 STU00220407
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    DRUG SBI-BSF-001: Collection of Plasma Samples Using Sodium Heparin from Subjects Undergoing Intravenous Busulfan Treatment

    Busulfan (Busulfex®) is an alkylating drug used as a conditioning regimen prior to allogeneic hematopoietic stem cell transplantation. Busulfan has wide inter- and intra-patient pharmacokinetic variability resulting in variable exposure leading to increased risk of toxicities or sub-optimal treatment outcomes. Therapeutic drug monitoring of busulfan using patient plasma samples would benefit clinicians by providing the ability to personalize the dose to achieve a target busulfan exposure.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    • Current treatment with intravenous busulfan with documentation of diagnosed malignant hematologic or non-malignant disease condition requiring treatment;

    ·

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Adekola, KehindeAdekola, Kehinde
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT05711732 STU00220420
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    DRUG SC291-101

    A Phase 1 study evaluating SC291, a hypoimmune allogeneic CD19-directed CAR T cell therapy, in relapsed and/or refractory B-cell malignancies (ARDENT)

    Must be 18

    Diagnosis of NHL (WHO 2016 criteria) or CLL (iwCLL criteria)

    Karmali, ReemKarmali, Reem
    • Map it 251 E. Huron St. Fifth Floor, Suite 704
      Chicago, IL
    NCT05878184 STU00220439
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    (xIRB NCI CIRB) SWOG 1905: A Phase I/II Study of AKR1C3-Activated Prodrug OBI-3424 (OBI-3424) in Patients with Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia (T-ALL)/TCell Lymphoblastic Lymphoma (T-LBL)

    This phase I/II trial studies the side effects and best dose of OBI-3424 and how well it works in treating patients with T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma that has come back (relapsed) or does not respond to treatment (refractory). The study doctors hope to learn if the study drug, OBI-3424, will reduce the amount of leukemia cells or lymphoma in the body.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of leukemia or lymphoma that has come back or did not go away after treatment.

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Dinner, Shira NaomiDinner, Shira Naomi
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04315324 STU00220457
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    (xIRB) DRUG TAK-676-1002: An Open-label, Dose Escalation, Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-676 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Advanced or Metastatic Solid Tumors

    The main aim of this study is to check if people with advanced solid tumors have side effects from dazostinag, and to check how much dazostinag they can receive without getting significant side effects from it when given alone and in combination with pembrolizumab. The study will be conducted in …

    The main aim of this study is to check if people with advanced solid tumors have side effects from dazostinag, and to check how much dazostinag they can receive without getting significant side effects from it when given alone and in combination with pembrolizumab. The study will be conducted in two phases including a dose escalation phase and a dose expansion phase. In the dose escalation phase, escalating doses of dazostinag are being tested alone and in combination with pembrolizumab to treat participants who have advanced or metastatic solid tumors. In the dose expansion phase, dazostinag will be studied with pembrolizumab with or without chemotherapy in participants with untreated metastatic or recurrent, unresectable squamous cell carcinoma of head and neck (SCCHN) and in combination with pembrolizumab in third-line or later recurrent locally advanced or metastatic microsatellite instability-high/mismatch repair deficient (MSI-H/dMMR) and third-line recurrent locally advanced or metastatic microsatellite stable/mismatch repair proficient (MSS/pMMR) colorectal cancer (CRC).

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of Advanced or Metastatic Solid Tumors

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Lorch, Jochen Hanns-MartinLorch, Jochen Hanns-Martin
    • Map it 675 N. Saint Clair St. Twenty-First Floor, Suite 100
      Chicago, IL
    NCT04420884 STU00220466
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    (xIRB) DRUG COVALENT-103: A Phase 1, open-label, dose-escalation, and dose-expansion study of BMF-500, an oral covalent FLT3 inhibitor, in adults with acute leukemia

    A Phase 1 first-in-human dose-escalation and dose-expansion study of BMF-500, an oral FLT3 inhibitor, in adult patients with acute leukemia.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    • Participants must have a diagnosis of histologically or pathologically confirmed diagnosis of relapsed or refractory AML, ALL, or MPAL with documented FLT3 mutation, and/or Individuals with histologically or pathologically confirmed diagnosis of their malignancy with wild-type FLT3 (including those with MLL1-R and NPM1 mutations).

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Abaza, YasminAbaza, Yasmin
    NCT05918692 STU00220468
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    DRUG CP-MVC-101-01

    The main aim of this study is to check for side effects and tolerability of TAK-186 (also known as MVC101) in adults with unremovable advanced or metastatic cancer. Another aim is to characterize and evaluate the activity of TAK-186 (MVC-101). Participants may receive investigational treatment throughout the …

    The main aim of this study is to check for side effects and tolerability of TAK-186 (also known as MVC101) in adults with unremovable advanced or metastatic cancer. Another aim is to characterize and evaluate the activity of TAK-186 (MVC-101). Participants may receive investigational treatment throughout the study for a maximum of 13 months and will be followed up at 30 days and then every 12 weeks for up to 48 weeks after the last treatment.

    · Participants must have a diagnosis of head, neck, or lung cancer.

    · Participants must be 18 or older

    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 251 E. Huron St. Fifth Floor, Suite 704
      Chicago, IL
    NCT04844073 STU00220515
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    lung cancer
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    (xIRB NCI CIRB) Alliance A092105: Randomized Phase 2 Study of Nivolumab and Ipilimumab with or Without Cabozantinib in Patients with Advanced Nasopharyngeal Carcinoma That Have Progressed After Platinum Treatment and Immunotherapy

    This phase II trial compares the effect of treatment with palbociclib alone to treatment with palbociclib plus cemiplimab for treating patients with dedifferentiated liposarcoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Palbociclib may stop the growth …

    This phase II trial compares the effect of treatment with palbociclib alone to treatment with palbociclib plus cemiplimab for treating patients with dedifferentiated liposarcoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Palbociclib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Cemiplimab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. The combination of these two drugs may be more effective in shrinking or stabilizing advanced dedifferentiated liposarcoma compared to palbociclib alone.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of advanced dedifferentiated liposarcoma

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Lorch, Jochen Hanns-MartinLorch, Jochen Hanns-Martin
    • Map it 201 E. Huron St.
      Chicago, IL
    • Map it 304 Randall Road
      Geneva, IL
    • Map it 4405 Weaver Pkwy
      Warrenville, IL
    • Map it 2701 Patriot Blvd.
      Glenview, IL
    • Map it 1475 E. Belvidere Road
      Grayslake, IL
    • Map it 10 Health Services Drive
      DeKalb, IL
    • Map it 1000 N. Westmoreland Road
      Lake Forest, IL
    NCT06010095 STU00220532
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    DRUG KT-US-472-0141

    The goal of this study is to provide access to brexucabtagene autoleucel for patients diagnosed with a disease approved for treatment with brexucabtagene autoleucel, that is otherwise out of specification for commercial release. Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive …

    The goal of this study is to provide access to brexucabtagene autoleucel for patients diagnosed with a disease approved for treatment with brexucabtagene autoleucel, that is otherwise out of specification for commercial release.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of Mantle Cell Lymphona or Acute Lymphoblastic Leukemia

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Karmali, ReemKarmali, Reem
    • Map it 420 E. Superior St.
      Chicago, IL
    NCT05776134 STU00220576
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    NRG GU013: The Phase III ‘High Five Trial’ Five Fraction Radiation For High-Risk Prostate Cancer

    This phase III trial compares stereotactic body radiation therapy (SBRT), (five treatments over two weeks using a higher dose per treatment) to usual radiation therapy (20 to 45 treatments over 4 to 9 weeks) for the treatment of high-risk prostate cancer. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period of time. This trial is evaluating if shorter duration radiation prevents cancer from coming back as well as the usual radiation treatment.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of high-risk prostate cancer

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Sachdev, SeanSachdev, Sean
    NCT05946213 STU00220642
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    DRUG EDGE-Lung: A Phase II, Open-label, Platform Study, to Evaluate Immunotherapy-based Combinations in Participants With Advanced Non-Small Cell Lung Cancer

    The purpose of this study is to assess the objective response rate (ORR) of immunotherapy-based combination therapy and to assess the safety and tolerability of immunotherapy-based combination therapy. Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of …

    The purpose of this study is to assess the objective response rate (ORR) of immunotherapy-based combination therapy and to assess the safety and tolerability of immunotherapy-based combination therapy.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of histologically confirmed, documented diagnosis of Stage IV metastatic, NSCLC

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Patel, Jyoti DPatel, Jyoti D
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT05676931 STU00220667
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    A Phase 1/2 Study of Nivolumab and Ipilimumab in Combination with Sirolimus and Prednisone in Kidney Transplant Recipients with Selected Unresectable or Metastatic Cutaneous Cancers

    This phase I/II trial tests the combination of nivolumab and ipilimumab with sirolimus and prednisone for the treatment of skin (cutaneous) cancer that cannot be removed by surgery (unresectable) or that has spread from where it first started to other places in the body (metastatic) in kidney transplant recipients. …

    This phase I/II trial tests the combination of nivolumab and ipilimumab with sirolimus and prednisone for the treatment of skin (cutaneous) cancer that cannot be removed by surgery (unresectable) or that has spread from where it first started to other places in the body (metastatic) in kidney transplant recipients. Immunotherapy with nivolumab and ipilimumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Sirolimus and prednisone are immunosuppressants that are given to keep the body from rejecting the transplanted kidney. Giving nivolumab and ipilimumab in combination with sirolimus and prednisone may kill more cancer cells, while also keeping the transplanted kidney healthy, in patients with unresectable or metastatic cutaneous cancer who have received a kidney transplant.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of skin cancer after a kidney transplantation.

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Chandra, SunandanaChandra, Sunandana
    • Map it 675 N. Saint Clair St.
      Chicago, IL
    NCT05896839 STU00220681
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    (xIRB) DRUG 1438-0007: DAREON™-7: A Phase I, open-label, dose escalation and expansion trial to investigate safety and tolerability of BI 764532 intravenous infusions in combination with standard of care (platinum and etoposide) in first-line treatment of patients with neuroendocrine carcinomas (NEC)

    This study is open to adults aged 18 and older or above legal age who have a specific type of advanced neuroendocrine cancer (NEC). Their tumours must be positive for a marker called DLL3.

    The purpose of this study is to test a medicine called BI 764532 in addition to chemotherapy. The study has 2 parts. Part A of this study aims to find out the highest dose of BI 764532 that people can tolerate in addition to chemotherapy. The purpose of Part B is to find out how well people can tolerate BI 764532 in combination with different chemotherapies. Researchers also want to find out whether BI 764532 in combination with chemotherapy helps people with NEC.

    Participants get different doses of BI 764532 as an infusion into a vein. In addition, they get platinum-based chemotherapy as infusions into a vein. Participants can continue treatment up to 3 years if they benefit from treatment and can tolerate it.

    Participants visit their doctors regularly. During these visits, the doctors collect information about participants' health and take note of any unwanted effects. Doctors also regularly check the size of the tumour.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    Participants must have a diagnosis of locally advanced or metastatic NEC of following subtypes:

    • extrapulmonary neuroendocrine carcinomas (epNEC)
    • pulmonary large cell NEC (LCNEC)
    • neuroendocrine carcinomas (NEC) of unknown primary site

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial

    Benson III, Al BBenson III, Al B
    NCT06132113 STU00220691
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    (xIRB NCI CIRB) ETCTN 10347: A phase I study with an expansion cohort of duvelisib and nivolumab in mycosis fungoides (MF) and Sézary syndrome (SS)

    This phase I trial identifies the best dose, possible benefits, and/or side effects of duvelisib in combination with nivolumab in treating patients with stage IIB-IVB mycosis fungoides and Sezary syndrome. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. …

    This phase I trial identifies the best dose, possible benefits, and/or side effects of duvelisib in combination with nivolumab in treating patients with stage IIB-IVB mycosis fungoides and Sezary syndrome. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving duvelisib in combination with nivolumab may work better than giving each of these drugs individually, or treating with the usual approach in patients with mycosis fungoides and Sezary syndrome.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of advanced mycosis fungoides or Sézary syndrome that has not responded to at least one type of treatment.

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Moreira, JonathanMoreira, Jonathan
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04652960 STU00220698
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    DRUG IMM1104-101: A Phase 1/2a, Open-Label, Multicenter, Nonrandomized, Safety and Anti-tumor Activity Study of IMM-1-104, a Novel Oral Dual MEK1/2 Inhibitor in Participants with Previously Treated RAS-Mutated Advanced or Metastatic Solid Tumors

    This is an open-label, dose-exploration andexpansion study to determine the safety,tolerability, pharmacokinetics,pharmacodynamics, and preliminary anti-tumor activity of IMM-1-104 whenadministered as monotherapy or incombination with approved agents inparticipants with RAS-mutated or RAS/MAPKactivated advanced or metastatic solidtumors. The dose exploration will identifythe candidate …

    This is an open-label, dose-exploration and

    expansion study to determine the safety,

    tolerability, pharmacokinetics,

    pharmacodynamics, and preliminary anti-

    tumor activity of IMM-1-104 when

    administered as monotherapy or in

    combination with approved agents in

    participants with RAS-mutated or RAS/MAPK

    activated advanced or metastatic solid

    tumors. The dose exploration will identify

    the candidate recommended Phase 2 dose

    (RP2D) of IMM-1-104 to further explore the

    anti-tumor activity of IMM-1-104 as

    monotherapy and in combination with

    approved agents in multiple Phase 2a proof-

    of-concept cohorts in malignancies of

    interest.

    Note: This is only a partial description of the

    study. Please contact the Robert H. Lurie

    Comprehensive Cancer Center of

    Northwestern University if you are interested

    in the trial.

     Participants must have a diagnosis of

    Must have histologically or

    cytologically confirmed diagnosis

    as follows:

    1. Monotherapy Phase 1: A

    locally advanced

    unresectable or metastatic

    solid tumor malignancy that

    harbors a RAS (KRAS, NRAS,

    or HRAS) activating

    mutation.

    2. Monotherapy Phase 2a: A

    locally advanced

    unresectable or metastatic

    solid tumor malignancies:

    pancreatic ductal

    adenocarcinoma (PDAC),

    RAS-mutant melanoma, or

    RAS-mutant non-small cell

    lung cancer (NSCLC)

    3. Combination therapy (both

    phases): A locally advanced

    unresectable or metastatic

    PDAC

     Participants must be treatment

    naive or received prior systemic

    standard-of-care treatment as

    follows:

    1. Monotherapy Phase 1:

    received at least 1 line of

    systemic standard-of-care

    treatment for their

    advanced or metastatic

    disease

    2. Monotherapy Phase 2a:

    1. First-line PDAC

    participants will have

    received no previous

    systemic anti-cancer

    therapy. Second-line

    PDAC participants will

    have received no

    more than one prior

    Public Recruitment Abstract

    Version Date:

    v.02.23.2023

    emic anti-cancer

    therapy.

    2. First-line melanoma

    participants will have

    received no previous

    systemic anti-cancer

    therapy. Second- and

    third-line participants

    will have received and

    failed one or two prior

    systemic anti-cancer

    therapies,

    respectively.

    3. NSCLC participants

    will have received at

    least one and no more

    than two previous

    lines of systemic

    therapy.

    3. Combination therapy (both

    phases): PDAC participants

    will have received no

    previous systemic anti-

    cancer therapy for their

    advanced or metastatic disease.

    Chandra, SunandanaChandra, Sunandana
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT05585320 STU00220797
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    NRG BR009

    This Phase III Trial will determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors …

    This Phase III Trial will determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 (for pN0 patients) and 0-25 (for pN1 patients).

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of early-stage breast cancer that is sensitive to hormones and is HER2-negative, be premenopausal, and have an Oncotype DX Recurrence Score® equal to or less than 25.

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Lu, JaniceLu, Janice
    • Map it 251 E. Huron St. Fifth Floor, Suite 704
      Chicago, IL
    • Map it 304 Randall Road
      Geneva, IL
    • Map it 4405 Weaver Pkwy
      Warrenville, IL
    • Map it 2701 Patriot Blvd.
      Glenview, IL
    • Map it 1475 E. Belvidere Road
      Grayslake, IL
    • Map it 10 Health Services Drive
      DeKalb, IL
    • Map it 1000 N. Westmoreland Road
      Lake Forest, IL
    NCT05879926 STU00220824
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    DRUG M24-311: A Phase 2, Randomized Study to Evaluate Safety, Efficacy, and Optimal Dose of ABBV-400 in Combination with Fluorouracil, Folinic Acid, and Bevacizumab in Previously Treated Subjects with Unresectable Metastatic Colorectal Cancer

    Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events and change in disease activity when ABBV-400 is given in combination with Fluorouracil, Folinic Acid, and Bevacizumab to adult participants to treat unresctable metastatic colorectal cancer.

    ABBV-400 is an investigational drug being developed for the treatment of unresectable metastatic colorectal cancer. Fluorouracil, folinic acid, and bevacizumab is an drug approved for the treatment of unresectable metastatic colorectal cancer. Study doctors put the participants in groups called treatment arms. Each treatment arm receives a different dose of ABBV-400 in combination with fluorouracil, folinic acid, and bevacizumab (FFB) in escalating doses on two different schedules (safety lead in), followed by low or high doses of ABBV-400 in combination with FFB or fluorouracil, folinic acid, irinotecan, and bevacizumab (standard of care [SOC]) [dose optimization] on its own. Approximately 206 adult participants with unresectable metastatic colorectal cancer will be enrolled in the study in 65 sites worldwide.

    In the safety lead in, participants will receive escalating intravenous (IV) ABBV-400 in combination with IV FFB on two different schedules. During the dose optimization participants will receive IV ABBV-400 in combination with FFB at low or high doses determined in the safety lead in on two different dosing schedules. The dose optimization arm will also include a comparator cohort in which participants will receive SOC. The study will run for a duration of approximately 3 years.

    There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    • Participants must have diagnosis of histologically or cytologically confirmed unresectable metastatic colorectal cancer (mCRC).

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Benson III, Al BBenson III, Al B
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT06107413 STU00220833
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    DRUG EFC17757: A randomized, double-blind, multicenter, Phase 3 study to evaluate efficacy and safety of belumosudil in combination with corticosteroids versus placebo in combination with corticosteroids in participants at least 12 years of age with newly diagnosed chronic graft versus host disease (cGVHD)

    This is a parallel, Phase 3, two-arm study for the treatment of newly diagnosed moderate or severe chronic GVHD. The study duration for a participant includes up to 4 weeks for screening; a treatment period until clinically meaningful cGVHD progression (defined as progression requiring addition of new systemic treatment …

    This is a parallel, Phase 3, two-arm study for the treatment of newly diagnosed moderate or severe chronic GVHD.

    The study duration for a participant includes up to 4 weeks for screening; a treatment period until clinically meaningful cGVHD progression (defined as progression requiring addition of new systemic treatment for cGVHD), relapse/recurrence of the underlying disease, participant starts new systemic treatment for cGVHD or experiences an unacceptable toxicity, at the request of the participants or the investigators, or until the end of study is reached, whichever comes first; at least 30 days follow-up of adverse events (AEs) after the last dose until resolution or stabilization, if applicable; and long-term follow-up until death or study close-out, whichever comes first.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of moderate or severe chronic graft versus host disease (cGVHD).

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Moreira, JonathanMoreira, Jonathan
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT06143891 STU00220855
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    DRUG M24-427: A Phase 1 Open-Label Study to Evaluate the Efficacy and Safety of ABBV-400 in Select Advanced Solid Tumor Indications

    Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events and change in disease activity when ABBV-400 is given to adult participants to treat advanced solid tumors.

    ABBV-400 is an investigational drug being developed for the treatment of advanced solid tumors. Study doctors put the participants in groups called cohorts. Each cohort receives ABBV-400 alone (monotherapy) followed by a safety follow-up period. Approximately 220 adult participants with hepatocellular carcinoma (HCC), pancreatic ductal adenocarcinoma (PDAC), biliary tract cancers (BTC), esophageal squamous cell carcinoma (ESCC), triple negative breast cancer (TNBC), hormone receptor+/human epidermal growth factor receptor 2 negative (HER2-) breast cancer (hormone receptor-positive [HR+]/HER2-breast cancer [BC]), head and neck squamous-cell-carcinoma (HNSCC), or advanced solid tumors, will be enrolled in the study in approximately 60 sites worldwide.

    In the each cohorts, participants with the following advanced solid tumor indications: HCC, PDAC, BTC, ESCC, TNBC, HR+/HER2-BC, and HNSCC will receive intravenous (IV) ABBV-400 monotherapy for up to 2 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.

    There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have a documented diagnosis of locally advanced or metastatic hepatocellular carcinoma (HCC), pancreatic ductal adenocarcinoma (PDAC), biliary tract cancers (BTC), squamous cell carcinoma of the esophagus, (ESCC), triple negative breast cancer (TNBC), hormone receptor+/HER2-breast cancer (HR+/HER2-BC), or head and neck squamous-cell-carcinoma (HNSCC) (by World Health Organization [WHO] criteria).

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT06084481 STU00220894
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    DRUG C1763102: A Phase 1b Study of Oral AS-1763 in Patients with Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Non-Hodgkin Lymphoma

    This is an open-label, multi-center Phase 1b clinical study of oral AS-1763 in patients with CLL/SLL or B-cell NHL who have failed or are intolerant to ≥2 lines of systemic therapy.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    • Participants must have a diagnosis of histologically confirmed B-cell malignancy, including CLL/SLL, WM, MCL, MZL, or FL. Patients must have failed or are intolerant to ≥2 prior lines of systemic therapy

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial

    Ma, ShuoMa, Shuo
    NCT05602363 STU00220996
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    (xIRB) DRUG REC-4881-221: A Phase 2, Open Label Study of REC-4881 in Participants with Unresectable Locally Advanced or Metastatic Cancer with AXIN1 or APC Mutation

    This is a multi-center, open-label study to investigate the safety, efficacy and pharmacokinetics of REC-4881 (12 mg PO daily doses) for participants with unresectable locally advanced or metastatic solid tumors with AXIN1 or APC mutation.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    1. Participants must be 55 years of age or older with histologically-confirmed unresectable, locally advanced, or metastatic solid tumor with AXIN1 or APC mutation. If a participant has colorectal cancer, then they must be RAS / RAF wild type to enroll into the APC mutant cohort

    2. Have experienced progressive disease, relapsed disease, or be intolerant to at least one established standard systemic anti-cancer treatment, or in

    Public Recruitment Abstract

    Version Date: v.02.23.2023

    the opinion of the Investigator have been considered ineligible for standard therapy

    • Participants must be 55 or older

    Kalyan, AparnaKalyan, Aparna
    NCT06005974 STU00221007
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    Testing the role of DNA released from tumor cells into the blood in guiding the use of immunotherapy after surgical removal of the bladder for bladder cancer treatment.

    This phase II/III trial tests the role of DNA released from tumor cells into the blood in guiding the use of immunotherapy (nivolumab alone or with relatlimab) after surgical removal of the bladder for bladder cancer treatment. DNA is material found inside all of our cells that acts as …

    This phase II/III trial tests the role of DNA released from tumor cells into the blood in guiding the use of immunotherapy (nivolumab alone or with relatlimab) after surgical removal of the bladder for bladder cancer treatment. DNA is material found inside all of our cells that acts as a blueprint for how cells function. Tumor cells often have abnormal DNA that looks different than DNA in normal cells. A new test called Signatera has been developed that can detect bladder cancer DNA in the blood which might indicate the presence of bladder tumor cells somewhere in the body. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Relatlimab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. This trial may help doctors determine if the Signatera test can better identify which patients need an additional treatment with immunotherapy to help prevent bladder cancer from coming back after surgery.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of bladder cancer

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    VanderWeele, David JamesVanderWeele, David James
    • Map it 675 N. Saint Clair St. Twenty-First Floor, Suite 100
      Chicago, IL
    NCT05987241 STU00221015
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    DRUG TNG908-C101: A Phase 1/2, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Anti-tumor Activity of TNG908 in Patients with MTAP-deleted Advanced or Metastatic Solid Tumors

    This is a first in human study in patients with advanced or metastatic solid tumors known to have an MTAP deletion. The first part of the study is an open-label, dose escalation and the second part is an open label dose expansion in specific MTAP-deleted tumor types. The …

    This is a first in human study in patients with advanced or metastatic solid tumors known to have an MTAP deletion. The first part of the study is an open-label, dose escalation and the second part is an open label dose expansion in specific MTAP-deleted tumor types. The study drug, TNG908, is a selective PRMT5 inhibitor administered orally. The study is planned to treat up to 192 participants.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of advanced or metastatic solid tumor known to have an MTAP deletion

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Stupp, RogerStupp, Roger
    • Map it 675 N. Saint Clair St. Twenty-First Floor, Suite 100
      Chicago, IL
    NCT05275478 STU00220170
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    ETCTN 10601

    This phase I trial studies the side effects and best dose of mosunetuzumab when given together with polatuzumab vedotin and lenalidomide in treating patients with diffuse large B-cell lymphoma (DLBCL) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). …

    This phase I trial studies the side effects and best dose of mosunetuzumab when given together with polatuzumab vedotin and lenalidomide in treating patients with diffuse large B-cell lymphoma (DLBCL) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Mosunetuzumab and polatuzumab vedotin are monoclonal antibodies that may interfere with the ability of cancer cells to grow and spread. Polatuzumab, linked to a toxic agent called vedotin, attaches to CD79B positive cancer cells in a targeted way and delivers vedotin to kill them. Lenalidomide may stimulate or suppress the immune system in different ways and stop cancer cells from growing and by preventing the growth of new blood vessels that cancer cells need to grow. Giving mosunetuzumab with polatuzumab vedotin and lenalidomide may work better in treating patients with relapsed/refractory DLBCL.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of diffuse large B-cell lymphoma.

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Karmali, ReemKarmali, Reem
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT06015880 STU00221037
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    (xIRB) NCI CIRB COG ACCL1931: A Randomized Trial of Levocarnitine Prophylaxis to Prevent Asparaginase-Associated Hepatotoxicity in Adolescents and Young Adults Receiving Acute Lymphoblastic Leukemia Therapy

    This phase III trial compares the effect of adding levocarnitine to standard chemotherapy vs. standard chemotherapy alone in protecting the liver in patients with leukemia or lymphoma. Asparaginase is part of the standard of care chemotherapy for the treatment of acute lymphoblastic leukemia (ALL), lymphoblastic lymphoma (LL), and mixed phenotype …

    This phase III trial compares the effect of adding levocarnitine to standard chemotherapy vs. standard chemotherapy alone in protecting the liver in patients with leukemia or lymphoma. Asparaginase is part of the standard of care chemotherapy for the treatment of acute lymphoblastic leukemia (ALL), lymphoblastic lymphoma (LL), and mixed phenotype acute leukemia (MPAL). However, in adolescent and young adults (AYA) ages 15-39 years, liver toxicity from asparaginase is common and often prevents delivery of planned chemotherapy, thereby potentially compromising outcomes. Some groups of people may also be at higher risk for liver damage due to the presence of fat in the liver even before starting chemotherapy. Patients who are of Japanese descent, Native Hawaiian, Hispanic or Latinx may be at greater risk for liver damage from chemotherapy for this reason. Carnitine is a naturally occurring nutrient that is part of a typical diet and is also made by the body. Carnitine is necessary for metabolism and its deficiency or absence is associated with liver and other organ damage. Levocarnitine is a drug used to provide extra carnitine. Laboratory and real-world usage of the dietary supplement levocarnitine suggests its potential to prevent or reduce liver toxicity from asparaginase. The overall goal of this study is to determine whether adding levocarnitine to standard of care chemotherapy will reduce the chance of developing severe liver damage from asparaginase chemotherapy in ALL, LL and/or MPAL patients.

    · Participants must have a diagnosis of acute lymphoblastic leukemia (ALL), lymphoblastic lymphoma (LL), and mixed phenotype acute leukemia (MPAL).

    · Participants must be 18 or older

    Dinner, Shira NaomiDinner, Shira Naomi
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT05602194 STU00221048
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    (xIRB) DRUG ORIC-114-01: An Open-Label, Phase 1/1b, Study of ORIC-114 in Patients with Advanced Solid Tumors Harboring an EGFR or HER2 Alteration

    The purpose of this study is to establish the recommended Phase 2 dose (RP2D) and/or maximum tolerated dose (MTD), safety, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of ORIC-114 as a Single Agent or in Combination with Chemotherapy when administered to patients with advanced solid tumors harboring an …

    The purpose of this study is to establish the recommended Phase 2 dose (RP2D) and/or maximum tolerated dose (MTD), safety, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of ORIC-114 as a Single Agent or in Combination with Chemotherapy when administered to patients with advanced solid tumors harboring an EGFR or HER2 alteration.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    • Participants must have a diagnosis of advanced or metastatic lung cancer that is no longer responding to standard available treatment and you have been shown to have a mutation in either your EGFR gene or HER2 gene.
    • Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Patel, Jyoti DPatel, Jyoti D
    • Map it 675 N. Saint Clair St. Twenty-First Floor, Suite 100
      Chicago, IL
    NCT05315700 STU00221053
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    DRUG 2138-CL-0101: A Phase 1/1b Study of ASP2138 in Participants with Metastatic or Locally Advanced Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma or Metastatic Pancreatic Adenocarcinoma Whose Tumors Have Claudin (CLDN) 18.2 Expression

    Claudin 18.2 protein, or CLDN18.2 is a protein found on cells in the digestive system. It is also found on some tumors. Researchers are looking at ways to attack CLDN18.2 to help control tumors. ASP2138 is thought to bind to 2 targets at the same time: CLDN18.…

    Claudin 18.2 protein, or CLDN18.2 is a protein found on cells in the digestive system. It is also found on some tumors. Researchers are looking at ways to attack CLDN18.2 to help control tumors. ASP2138 is thought to bind to 2 targets at the same time: CLDN18.2 and a protein called CD3 found on immune cells, called T-cells. ASP2138 works by binding to both the tumor cell and CD3 which "tells" the immune system to attack the tumor.

    ASP2138 is a potential new treatment for people with stomach cancer, gastroesophageal junction cancer, (cancer where the tube that carries food (esophagus) joins the stomach) or pancreatic cancer. Before ASP2138 is available as a treatment, the researchers need to understand how it is processed by and acts upon the body. This information will help to find a suitable dose and to check for potential medical problems from the treatment.

    Adults 18 years or older with stomach cancer, gastroesophageal junction cancer, or pancreatic cancer can take part. Their cancer is locally advanced unresectable or metastatic. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body.

    The main aims of the study are to check the safety of ASP2138, how well it is tolerated, and to find a suitable dose of ASP2138 to be used later in this study.

    This is an open-label study. This means that people who take part in this study and clinic staff will know that people will receive ASP2138.

    The study will have 2 phases. In phase 1, different small groups of people will receive lower to higher doses of ASP2138. Any medical problems will be recorded at each dose. This is done to find suitable doses of ASP2138 to use later in the study. The first group will receive the lowest dose of ASP2138. A medical expert panel will check the results from this group and decide if the next group can receive a higher dose of ASP2138. The panel will do this for each group until all groups have received ASP2138, or until suitable doses have been selected for later in the study. Doctors will also check how each type of cancer is responding to ASP2138.

    In phase 1b, other different small groups will receive suitable doses of ASP2138 found from phase 1. Phase 1b will check how each type of cancer responds to ASP2138. The response to ASP2138 is measured using scans and blood tests. Doctors will continue to check for all medical problems throughout the study.

    ASP2138 will be given either through a vein in the arm (intravenous infusion) or just below the skin (subcutaneous injection). Treatment will be in cycles of either 7 or 14 days (1 or 2 weeks). In each treatment cycle, intravenous infusions or subcutaneous injections will either be given once a week or once every 2 weeks.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Disease Specific Criteria: Gastric/GEJ Cancer

    • Participant has histologically confirmed gastric or gastroesophageal junction (GEJ) adenocarcinoma.
    • Escalation: Participant with gastric or GEJ adenocarcinoma who has progressed, is intolerant, has refused, or for whom there is no standard approved therapies that impart significant clinical benefit (no limit to the number of prior treatment regimens).
    • Unique to South Korea: Participant with gastric or GEJ adenocarcinoma who has refused standard approved therapies is not allowed.
    • Expansion: Participant gastric or GEJ adenocarcinoma must have received no more than 3 prior lines of systemic chemotherapy treatment.

    Disease Specific Criteria: Pancreatic Cancer

    • Participant has histologically or cytologically confirmed pancreatic adenocarcinoma.
    • Escalation: Participant with pancreatic adenocarcinoma who has progressed, is intolerant, has refused, or for whom there is no standard approved therapies that impart significant clinical benefit (no limit to the number of prior treatment regimens).
    • Unique to South Korea: Participant with pancreatic adenocarcinoma who has refused standard approved therapies is not allowed.
    • Expansion: Participants with pancreatic adenocarcinoma must have received no more than 2 prior lines of systemic chemotherapy treatment.

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Mahalingam, DevalingamMahalingam, Devalingam
    NCT05365581 STU00220381
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    A Randomized Phase III Trial of Olanzapine Versus Megestrol Acetate for Cancer-Associated Anorexia

    This phase III trial compares the effects of olanzapine versus megestrol acetate in treating loss of appetite in patients with cancer that has spread to other places in the body (advanced). Olanzapine may stimulate and increase appetite. This study aims to find out if olanzapine is better than the usual …

    This phase III trial compares the effects of olanzapine versus megestrol acetate in treating loss of appetite in patients with cancer that has spread to other places in the body (advanced). Olanzapine may stimulate and increase appetite. This study aims to find out if olanzapine is better than the usual approach (megestrol acetate) for stimulating appetite and preventing weight loss.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of advanced cancer and their cancer and treatments for cancer can cause side effects such as loss of appetite.

    · Participants must be 18 or older.

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Smith, Melanie MeghanSmith, Melanie Meghan
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04939090 STU00221063
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    A Randomized Open label Phase II Trial of FDG-PETguided Metastasis Directed Therapy in Patients With Metastatic Hormone Sensitive Prostate Cancer: PRTY trial: PET- Guided RadioTherapY consolidation

    This study aims to examine the use of radiotherapy and its ability to keep cancer controlled for longer than with just standard medications on their own. Patients will undergo standard systemic therapy (treatment that is widely used by healthcare professionals for your cancer), and then imaging (fluorodeoxyglucose (FDG)-positron emission …

    This study aims to examine the use of radiotherapy and its ability to keep cancer controlled for longer than with just standard medications on their own. Patients will undergo standard systemic therapy (treatment that is widely used by healthcare professionals for your cancer), and then imaging (fluorodeoxyglucose (FDG)-positron emission tomography or FDG-PET) to identify cancer sites that remain active despite the treatment.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of prostate cancer

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    VanderWeele, David JamesVanderWeele, David James
    • Map it 676 N. Saint Clair St.
      Chicago, IL
    • Map it 675 N. Saint Clair St.
      Chicago, IL
    • Map it 675 N. Saint Clair St. Eleventh Floor, Suite 105
      Chicago, IL
    NCT06244004 STU00220350
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    (xIRB) DRUG CT7001_003: A Phase 1b/2 Open-label Study of Samuraciclib in Combination with Elacestrant in Participants with Metastatic or Locally Advanced Hormone Receptor-positive and Human Epidermal Growth Factor Receptor 2-negative Breast Cancer

    This is an international, multisite, open-label, Phase 1b/2 study, to confirm safety and efficacy of samuraciclib in combination with elacestrant in adult participants with metastatic or locally advanced Hormone Receptor (HR) positive and Human Epidermal Growth Factor Receptor (HER)2-negative breast cancer.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    Participants must have:

    • Histologically confirmed diagnosis of ER-positive, HER2-negative locally advanced or metastatic breast cancer.
    • Documented objective disease progression while on or within 6 months after the end of the most recent therapy.
    • Received prior AI in combination with a CDK4/6i as the last therapy
    • Known TP53 and ESR1 mutation status.

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Gradishar, William JGradishar, William J
    NCT05963997 STU00221171
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    ECOG-ACRIN Y191-A3 A COMBOMATCH TREATMENT TRIAL: PALBOCICLIB AND BINIMETINIB IN RAS-MUTANT CANCERS

    This phase II clinical trial evaluates the effectiveness of palbociclib and binimetinib in treating patients with RAS-mutated cancers. Palbociclib and binimetinib are both in a class of medications called kinase inhibitors. They work by blocking the action of abnormal proteins that signals cancer cells to multiply. This trial may help researchers understand if giving the combination of palbociclib and binimetinib can help improve the amount of time before the cancer grows in patients with patients with low grade serous ovarian cancer who have certain changes in the tumor DNA. This trial may also help researchers understand if giving the combination of palbociclib and binimetinib can help improve outcomes among patients with low grade serous ovarian cancer who have previously received a MEK inhibitor. For patients with other tumors, with the exception of lung cancer, colon cancer, melanoma and low grade serous ovarian cancers, this trial may help researchers understand if giving the combination of palbociclib and binimetinib can improve the clinical outcome of survival without progression in patients who have certain changes in their tumor's DNA.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of RAS-mutated cancers

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT05554367 STU00221213
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    (xIRB NCI CIRB) NRG HN011: A Randomized Phase II Study of Nivolumab Versus Nivolumab and BMS-986016 (Relatlimab) as Maintenance Treatment After First-Line Treatment with Platinum-Gemcitabine-Nivolumab for Patients with Epstein-Barr Virus-Associated Recurrent/Metastatic Nasopharyngeal Carcinoma (REMAIN)

    The purpose of this study is to determine the safety of making and giving Epstein-Barr virus (EBV) immunotherapy products to subjects with nasopharyngeal carcinoma (NPC) associated with EBV that has come back or spread to other parts of the body. EBV immunotherapy product is made with white blood cells …

    The purpose of this study is to determine the safety of making and giving Epstein-Barr virus (EBV) immunotherapy products to subjects with nasopharyngeal carcinoma (NPC) associated with EBV that has come back or spread to other parts of the body. EBV immunotherapy product is made with white blood cells from the participants body that are collected intravenously. This EBV immunotherapy product may stop cancer cells from growing abnormally. EBV immunotherapy products have been used in several research studies for NPC. Information from these studies suggests the EBV immunotherapy products may stop the growth of NPC in some subjects.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Lorch, Jochen Hanns-MartinLorch, Jochen Hanns-Martin
    • Map it 251 E. Huron St. Fifth Floor, Suite 704
      Chicago, IL
    NCT06029270 STU00221221
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    A Randomized Phase 2 Study of ATR Inhibition in Advanced PD-(L)1-Refractory Merkel Cell Carcinoma: The MATRiX Trial

    This phase II trial compares tuvusertib in combination with avelumab to tuvusertib alone to determine whether the combination therapy will lengthen the time before the cancer starts getting worse in patients with Merkel cell cancer that has not responded to previous treatment (refractory). Tuvusertib is a drug that inhibits an …

    This phase II trial compares tuvusertib in combination with avelumab to tuvusertib alone to determine whether the combination therapy will lengthen the time before the cancer starts getting worse in patients with Merkel cell cancer that has not responded to previous treatment (refractory). Tuvusertib is a drug that inhibits an enzyme called ataxia telangiectasia and Rad3 related (ATR) kinase, which is an enzyme that plays a role in repair of damaged deoxyribonucleic acid (DNA) as well as tumor cell replication and survival. It may lead to tumor cell death by inhibiting ATR kinase activity. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving tuvusertib in combination with avelumab may lengthen the time before Merkel cell cancer starts getting worse compared to giving avelumab alone.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of pathologically confirmed locally advanced/unresectable Merkel cell carcinoma or metastatic Merkel cell carcinoma.

    · Participants must be 18 or older.

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Chandra, SunandanaChandra, Sunandana
    • Map it 251 E. Huron St. Fifth Floor, Suite 704
      Chicago, IL
    NCT05947500 STU00221246
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    DRUG M23-647: First-in-Human Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of the BTK Degrader, ABBV-101, in Participants with B-cell Malignancies

    Non-Hodgkin's lymphoma (NHL) is a cancer that arises from the transformation of normal B and T lymphocytes (white blood cells). The purpose of this study is to assess the safety, pharmacokinetics, and preliminary efficacy of ABBV-101 in adult participants in relapsed or refractory (R/R) non-Hodgkin'…

    Non-Hodgkin's lymphoma (NHL) is a cancer that arises from the transformation of normal B and T lymphocytes (white blood cells). The purpose of this study is to assess the safety, pharmacokinetics, and preliminary efficacy of ABBV-101 in adult participants in relapsed or refractory (R/R) non-Hodgkin's lymphomas: third line or later of treatment (3L) + chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), diffuse large b-cell lymphoma (DLBCL), non-germinal center B cell (GCB) DLBCL, mantle cell lymphoma (MCL), follicular lymphoma (FL), marginal zone lymphoma (MZL), Waldenström macroglobulinemia (WM), or transformed indolent NHL. Adverse events will be assessed.

    ABBV-101 is an investigational drug being developed for the treatment of NHL. This study will include a dose escalation phase to determine the maximum administered dose (MAD)/Maximum tolerated dose (MTD) of ABBV-101 and a dose expansion phase to determine the change in disease activity in participants with CLL or non-GCB DLBCL. Approximately 128 adult participants with multiple NHL subtypes will be enrolled in the study in sites worldwide.

    In the Dose Escalation phase of the study participants will receive escalating oral doses of ABBV-101, until the MAD/MTD is determined, as part of the approximately 60 month study duration. In the dose expansion phase of the study participants receive oral ABBV-101, as part of the approximately 60 month study duration.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of Non-Hodgkin's lymphoma (NHL)

    · Participants must be 18 or older.

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Ma, ShuoMa, Shuo
    NCT05753501 STU00221253
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    (xIRB NCI CIRB) NRG CC011: Cognitive Training For Cancer Related Cognitive Impairment In Breast Cancer Survivors: A Multi-Center Randomized Double-Blinded Controlled Trial

    This Phase III trial will examine the efficacy of computerized cognitive training methods on perceived cognitive impairment in breast cancer survivors.…

    This Phase III trial will examine the efficacy of computerized cognitive training methods on perceived cognitive impairment in breast cancer survivors.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of breast cancer survivor with cancer-related cognitive impairment (CRCI).

    · Participants must be 18 or older

    Stein, Regina MStein, Regina M
    • Map it 251 E. Huron St. Fifth Floor, Suite 704
      Chicago, IL
    NCT05896189 STU00221319
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    DRUG XL092-305: A Phase 2/3, Randomized, Double-Blind, Controlled Study of Zanzalintinib (XL092) in Combination With Pembrolizumab vs Pembrolizumab in the First-Line Treatment of Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

    This is a multicenter, randomized, double-blind, controlled Phase 2/3 trial of zanzalintinib in combination with pembrolizumab versus zanzalintinib-matched placebo in combination with pembrolizumab in subjects with PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) incurable by local therapies who have …

    This is a multicenter, randomized, double-blind, controlled Phase 2/3 trial of zanzalintinib in combination with pembrolizumab versus zanzalintinib-matched placebo in combination with pembrolizumab in subjects with PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) incurable by local therapies who have not received prior systemic therapy for recurrent or metastatic disease.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    • Histologically or cytologically-confirmed R/M HNSCC that is considered incurable by local therapy.
    • Subjects should not have had prior systemic therapy administered in the recurrent or metastatic setting. Systemic therapy which was completed more than 6 months prior to randomization if given as part of multimodal treatment for locally advanced disease is allowed.
    • The eligible primary tumor locations are the oropharynx, oral cavity, hypopharynx, and larynx.
    • PD-L1 expression level Combined Positive Score (CPS) ≥ 1 by immunohistochemistry (IHC) testing.
    • Have human papilloma virus (HPV) testing result for oropharyngeal cancer defined as p16 IHC testing.

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Lorch, Jochen Hanns-MartinLorch, Jochen Hanns-Martin
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT06082167 STU00221392
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    (xIRB) NCI CIRB CCTG CO32: The NEO-RT Trial: A Phase 3 Randomized Trial of Neoadjuvant Chemotherapy, Excision and Observation Versus ChemoRadioTherapy for Early Rectal Cancer

    This study is being done to answer the following questions: Is the chance of rectal cancer responding the same if chemotherapy alone is given before limited surgery compared to chemotherapy and radiation therapy given together before limited surgery? If radiation therapy is not given, is quality of life better? Note: …

    This study is being done to answer the following questions: Is the chance of rectal cancer responding the same if chemotherapy alone is given before limited surgery compared to chemotherapy and radiation therapy given together before limited surgery? If radiation therapy is not given, is quality of life better?

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of rectal cancer

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Kalyan, AparnaKalyan, Aparna
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT06205485 STU00221394
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    An Open-label, Multicenter Phase 2 Study Evaluating the Efficacy and Safety of CRG-022, a CD22-Directed Autologous Chimeric Antigen Receptor (CAR) T-cell Therapy in Patients With Relapsed/Refractory Large B-Cell Lymphoma After CD19-Directed CAR T-cell Therapy

    This is a prospective, open-label, multi-center clinical study designed to evaluate the safety, tolerability, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of CRG-022, a CD22-directed autologous Chimeric Antigen Receptor (CAR) T-cell therapy for the treatment of relapsed or refractory large B-cell lymphoma (LBCL).CRG-022 is …

    This is a prospective, open-label, multi-center clinical study designed to evaluate the safety, tolerability, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of CRG-022, a CD22-directed autologous Chimeric Antigen Receptor (CAR) T-cell therapy for the treatment of relapsed or refractory large B-cell lymphoma (LBCL).

    CRG-022 is an autologous CAR T-cell therapy targeting CD22, a common B-cell antigen widely expressed in LBCL. This Phase 2 study is designed to evaluate the safety and the efficacy of CRG-022 in patients with R/R LBCL that has progressed after CD19-directed CAR T-cell therapy. The study is designed to treat up to 123 patients with a single infusion of CRG-022.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of Relapsed/Refractory Large B-Cell Lymphoma

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Karmali, ReemKarmali, Reem
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT05972720 STU00221437
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    DRUG BGB-11417-301: A Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared with Venetoclax Plus Obinutuzumab in Patients with Previously Untreated Chronic Lymphocytic Leukemia

    The main objective of this study is to compare the efficacy of sonrotoclax plus zanubrutinib versus venetoclax plus obinutuzumab in participants with chronic lymphocytic leukemia (CLL)

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    • Participants must have a diagnosis of Treatment-naïve (TN) adults with confirmed diagnosis of CLL which requires treatment

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Ma, ShuoMa, Shuo
    NCT06073821 STU00221440
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    (xIRB NCI CIRB) SWOG 2206: Phase III Trial of Neoadjuvant Durvalumab (NSC 778709) Plus Chemotherapy Versus Chemotherapy Alone for Adults with MammaPrint Ultrahigh (MP2) Hormone Receptor (HR) Positive / Human Epidermal Growth Factor Receptor (HER2) Negative Stage II-III Breast Cancer

    This phase III trial compares the addition of an immunotherapy drug (durvalumab) to usual chemotherapy versus usual chemotherapy alone in treating patients with MammaPrint Ultrahigh (MP2) stage II-III hormone receptor positive, HER2 negative breast cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system …

    This phase III trial compares the addition of an immunotherapy drug (durvalumab) to usual chemotherapy versus usual chemotherapy alone in treating patients with MammaPrint Ultrahigh (MP2) stage II-III hormone receptor positive, HER2 negative breast cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as paclitaxel, doxorubicin, and cyclophosphamide work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. There is some evidence from previous clinical trials that people who have a MammaPrint Ultrahigh Risk result may be more likely to respond to chemotherapy and immunotherapy. Adding durvalumab to usual chemotherapy may be able to prevent the cancer from returning for patients with MP2 stage II-III hormone receptor positive, HER2 negative breast cancer.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of stage II-III hormone receptor positive, HER2 negative breast cancer

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Tellez, ClaudiaTellez, Claudia
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT06058377 STU00221518
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    BTCRC LYM20-463: A Single Arm Phase I/II Study of Tazemetostat with Rituximab and Abbreviated Bendamustine in the Frontline Treatment of High Tumor Burden Follicular Lymphoma Big Ten Cancer Research Consortium BTCRC-LYM20-463

    This study is planned as a single arm clinical trial of tazemetostat in combination with bendamustine and rituximab with both a phase I and phase II component. All patients will receive tazemetostat twice daily on days 1-28 in combination with bendamustine 90 mg/m2 IV on days 1 and 2 and rituximab 375 mg/m2 IV on day 1 of a 28-day cycle for up to three cycles. Following this, patients will receive tazemetostat twice daily on days 1-28 and rituximab 375 mg/m2 IV on day 1 of a 28-day cycle for up to three cycles.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    • Participants must have a diagnosis of:
    • Low grade follicular lymphoma (grade 1-2 or 3A by WHO-HAEM4R and/or cFL by WHO-HAEM5). Specifically, grade 3B or FLBL will not be allowed. Must not have evidence of transformed lymphoma at the time of study enrollment.
    • Stage II, III, or IV by Ann Arbor staging system.
    • Meet the definition of high tumor burden follicular lymphoma as defined by Groupe d'Etude des Lymphomes Follicularies (GELF) Criteria or be defined as high risk by the follicular lymphoma international prognostic index (FLIPI) 1 or FLIPI 2.
    • In addition to meeting GELF criteria, must have at least one FDG-avid site on PET that measures 1.5 cm in at least one dimension of a nodal site or 1cm in at least one dimension for extranodal sites.

    · Participants must be 18 or older

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Karmali, ReemKarmali, Reem
    NCT05551936 STU00221360
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    (xIRB) NCI CIRB SWOG 1900K: A Randomized Phase II Study of Tepotinib with or Without Ramucirumab in Participants with MET Exon 14 Skipping Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (LUNG-MAP SUB-STUDY)

    This phase II Expanded Lung-MAP treatment trial tests tepotinib with or without ramucirumab for the treatment of patients with advanced non-small cell lung cancer that has spread from where it first started (primary site) to other places in the body (stage IV) or that has come back after …

    This phase II Expanded Lung-MAP treatment trial tests tepotinib with or without ramucirumab for the treatment of patients with advanced non-small cell lung cancer that has spread from where it first started (primary site) to other places in the body (stage IV) or that has come back after a period of improvement (recurrent). Tepotinib is used in patients whose cancer has a mutated (changed) form of a gene called MET. It is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal MET protein that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving tepotinib with ramucirumab may lower the chance of the cancer from growing or spreading in patients with stage IV or recurrent non-small cell lung cancer.

    · Participants must have a diagnosis of Stage IV or recurrent advanced non-small cell lung cancer

    · Participants must be 18 or older

    Chae, Young KwangChae, Young Kwang
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT06031688 STU00221605
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    (xIRB NCI CIRB) NRG GY028: A Phase IB and Randomized Phase II Trial of Megestrol Acetate with or Without Ipatasertib in Recurrent or Metastatic Endometrioid Endometrial Cancer

    This phase Ib/II trial tests the safety, side effects, best dose, and effectiveness of the combination of ipatasertib with megestrol acetate to megestrol acetate alone in patients with endometrial cancer that has come back (recurrent) or has spread to other places in the body (metastatic). Ipatasertib may stop the …

    This phase Ib/II trial tests the safety, side effects, best dose, and effectiveness of the combination of ipatasertib with megestrol acetate to megestrol acetate alone in patients with endometrial cancer that has come back (recurrent) or has spread to other places in the body (metastatic). Ipatasertib may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for cell growth. Megestrol acetate lowers the amount of estrogen and also blocks the use of estrogen made by the body. This may help stop the growth of tumor cells that need estrogen to grow. The combination of ipatasertib and megestrol acetate may be more effective in treating endometrial cancer than megestrol acetate alone.

    · Participants must have a diagnosis of grade 1 or 2 recurrent or metastatic endometrioid endometrial cancer

    · Participants must be 18 or older

    Barber, Emma LongleyBarber, Emma Longley
    • Map it 201 E. Huron St.
      Chicago, IL
    • Map it 1000 N. Westmoreland Road Main Entrance
      Lake Forest, IL
    • Map it 304 Randall Road
      Geneva, IL
    • Map it 4405 Weaver Pkwy
      Warrenville, IL
    • Map it 1475 E. Belvidere Road
      Grayslake, IL
    • Map it 10 Health Services Drive
      DeKalb, IL
    NCT05538897 STU00222006
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