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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 East Huron Street Suite 12-160​
    Chicago, IL
STU00010003
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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.

Wei, Jian-JunWei, Jian-Jun
  • 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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A Randomized Open-Label Pilot Trial to Evaluate the Safety and Efficacy of Repetitive Transcranial Magnetic Stimulation in Cancer Patients with Depression and Anxiety

The primary goals of this study are to determine if rTMS is safe and tolerable in depressed cancer patients and to determine how well these two methods of rTMS work in treating cancer-related depression. You are being asked to take part in this study because you are a cancer …
The primary goals of this study are to determine if rTMS is safe and tolerable in depressed cancer patients and to determine how well these two methods of rTMS work in treating cancer-related depression. You are being asked to take part in this study because you are a cancer patient in remission who is depressed currently. In the future, we hope to be able to use rTMS on depressed cancer patients who are actively receiving cancer treatment. However, since this is a preliminary study, we will only include patients in remission. Finally, anxiety often accompanies depression. So, we are also interested in understanding your current level of anxiety and how rTMS affects any anxiety that you might have. Your participation in this study will last for approximately seven weeks and will involve 31 visits.
Dokucu, Mehmet EDokucu, Mehmet E
NCT01701284 STU00063218
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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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A 36 month multi-center, open label, randomized, comparator study to evaluate the efficacy and safety of everolimus immunosuppression treatment in liver transplantation for hepatocellular carcinoma exceeding Milan criteria.

This study is a prospective Phase IV study to determine if the use of Everolimus results in lower liver tumor recurrence and improved patient and graft survival after liver transplant for hepatocellular carcinoma (HCC). The immunosuppressive comparators will be Everolimus and Tacrolimus therapy compared to Tacrolimus and Mycophenolic acid/Mycophenolate Mofetil. Primary outcomes data is disease free survival (the time from randomization to HCC recurrence or death). Secondary outcomes are rate of recurrence of Hepatitis C, problems related to wound healing, hernia repair within the first 12 months, hepatic arterial thrombosis, renal function, acute cellular rejection, post-transplant diabetes, hypertension, and hyperlipidemia.
Kulik, Laura MKulik, Laura M
NCT02081755 STU00083409
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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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NRG HN001: Randomized Phase II And Phase III Studies of Individualized Treatment for Nasopharyngeal Carcinoma Based on Biomarker Epstein Barr Virus (EBV) Deoxyribonucleic Acid (DNA)

There are two study questions the investigators are asking in this randomized phase II/III trial based on a blood biomarker, Epstein Barr virus (EBV) deoxyribonucleic acid (DNA) for locoregionally advanced non-metastatic nasopharyngeal cancer. All patients will first undergo standard concurrent chemotherapy and radiation therapy. When this standard treatment is completed, if there is no detectable EBV DNA in their plasma, then patients are randomized to either standard adjuvant cisplatin and fluorouracil chemotherapy or observation. If there is still detectable levels of plasma EBV DNA, patients will be randomized to standard cisplatin and flurouracil chemotherapy versus gemcitabine and paclitaxel. Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, fluorouracil, gemcitabine hydrochloride, and 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. It is not yet known whether giving cisplatin and fluorouracil is more effective than gemcitabine hydrochloride and paclitaxel after radiation therapy in treating patients with nasopharyngeal cancer.
Gharzai, LailaGharzai, Laila
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02135042 STU00200330
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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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Demo/Test Study

This is a screener for a demo study. Thank you for your interest!
Wehbe, FirasWehbe, Firas
NCT04633018 STUXXXXXXXX
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A large-scale multicenter phase II study evaluating the protective effect of a tissue selective estrogen complex (TSEC) in women with newly diagnosed ductal carcinoma in situ.

The main purpose of this study is to determine if taking the study drug, conjugated estrogens/bazedoxifene (Duavee®) causes any changes in the proliferation markers within the breast tissue of the study subjects. The study drug is approved by the US Food and Drug Administration in healthy postmenopausal women to treat certain symptoms of menopause such as hot flashes. Since it is not approved in women with DCIS, its use in this study is experimental. This study will also look at whether taking the study drug causes any significant or undesirable side effects in women with DCIS. The researchers hope that this study will help them determine if taking the study drug is safe in women taking DCIS and if it can possibly reduce the risk of developing breast cancer in women with DCIS.
Some of the eligibility criteria include:

- Participants must be postmenopausal women with newly diagnosed DCIS scheduled to undergo surgical therapy.
- Patients must be able to swallow the oral medication.
- Patients must be able to understand and the willing to sign a written informed consent document and comply to all procedures.

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.
Kulkarni, SwatiKulkarni, Swati
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02694809 STU00202100
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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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ECOG-ACRIN 6141: Randomized Phase II/III Study of Nivolumab plus Ipilimumab plus Sargramostim versus Nivolumab plus Ipilimumab in Patients with Unresectable Stage III or Stage IV Melanoma

This randomized phase II/III trial studies the side effects and best dose of nivolumab and ipilimumab when given together with or without sargramostim and to see how well they work in treating patients with stage III-IV melanoma that cannot be removed by surgery. Monoclonal antibodies, such as ipilimumab and nivolumab, may kill tumor cells by blocking blood flow to the tumor, by stimulating white blood cells to kill the tumor cells, or by attacking specific tumor cells and stop them from growing or kill them. Colony-stimulating factors, such as sargramostim, may increase the production of white blood cells. It is not yet known whether nivolumab and ipilimumab are more effective with or without sargramostim in treating patients with melanoma.
Chandra, SunandanaChandra, Sunandana
NCT02339571 STU00202372
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Culturally Adapted Cognitive Behavioral Stress and Self-Management (C-CBSM) Intervention for Prostate Cancer

Este estudio está diseñado para ayudar a los hombres a mejorar la calidad de vida y reducir los síntomas del cáncer de próstata. El estudio imparte habilidades de manejo de estrés y promueve la salud. Este programa de salud e intervención para hombres diagnosticados …
Este estudio está diseñado para ayudar a los hombres a mejorar la calidad de vida y reducir los síntomas del cáncer de próstata. El estudio imparte habilidades de manejo de estrés y promueve la salud. Este programa de salud e intervención para hombres diagnosticados con cáncer de próstata, ofrece información sobre cómo reducir el estrés y aprender a relajarse. Este estudio dentro Northwestern University está financiado por el Instituto Nacional del Cáncer. El objetivo del estudio es examinar cómo los programas de salud pueden mejorar la calidad de vida de los hombres tratados por cáncer de próstata.
(a) ≥ 18 years of age;
(b) Hispanic/Latino self-identification;
(c) Spanish speakers (including bilinguals who express interest in a Spanish-based psychosocial intervention); (d) Willingness to be randomized and followed for approximately 12 months.
(d) Primary diagnosis of localized Prostate Cancer (T1-T3, N0, M0);
(e) Surgical or radiation treatment (e.g., external beam, brachytherapy, proton) within the past 48 months prior to participating in the study
Miller, GregMiller, Greg
  • Map it 633 N. St. Clair St.
    Chicago , IL
NCT03344757 STU00203197
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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.

Shah, Ami NShah, Ami N
  • 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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NU 16U05: A Randomized Phase II Trial of Abiraterone, Olaparib, or Abiraterone + Olaparib in Patients with Metastatic Castration-Resistant Prostate Cancer

Purpose The purpose of this research is to study two US FDA approved drugs alone or in combination with each other in people who have metastatic castration-resistant prostate cancer and specific changes in their DNA, to see which one is best at keeping prostate cancer from growing. Metastatic castration-…
Purpose The purpose of this research is to study two US FDA approved drugs alone or in combination with each other in people who have metastatic castration-resistant prostate cancer and specific changes in their DNA, to see which one is best at keeping prostate cancer from growing. Metastatic castration-resistant prostate cancer means the cancer is spreading outside of the prostate and does not stop or go away with hormone therapy or surgery to reduce testosterone. One of the drugs, Olaparib, is not FDA approved for prostate cancer, which means it is experimental or investigational. Overview Once prostate cancer has progressed to metastatic castration-resistant prostate cancer, standard treatment focuses on extending life, delaying disease progression, and improving symptoms and quality of life. The purpose of this research is to study two US FDA approved drugs alone and in combination with each other in people who have metastatic castration-resistant prostate cancer and DNA repair defects. One of the drugs, Olaparib, is not FDA approved for prostate cancer. People who take part in this research study have been diagnosed with metastatic castration-resistant prostate cancer and either their body or the the cancer have a genetic defect (flaw) that causes problems with their body‰Ûªs ability to repair damage to their DNA. Description of Treatment Participants will be placed into one of four groups. The treatment that each group will receive is as follows. Group 1 will receive Abiraterone (1000 mg by mouth once per day) and prednisone (5 mg by mouth twice per day). Group 2 and 4 will receive Olaparib (300 mg by mouth twice per day). Group 3 will receive Olaparib (300 mg by mouth twice per day), Abiraterone (1000 mg by mouth once per day) and prednisone (5 mg by mouth twice per day). Treatment may continue until disease progression, severe or unacceptable side effects, or until the participant or study doctor think the treatment should stop.
Some of the eligibility criteria include:

- participants must have been diagnosed with prostate cancer that is metastatic (has spread outside of the prostate region) and castration-resistant (means the cancer is still growing even when testosterone levels are close to zero)
- participants must be males 18 years of age or above

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.
Hussain, MahaHussain, Maha
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03012321 STU00203960
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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.

Sosman, Jeffrey AlanSosman, Jeffrey Alan
  • Map it 201 E. Huron St.
    Chicago, IL
STU00204151
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(xIRB NCI CIRB) SWOG 1609 DART: Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumors

The purpose of this study is to test any good and bad effects of the combination of study drugs called ipilimumab and nivolumab in treating rare cancers and cancers of unknown primary origin. The combination treatment of ipilimumab and nivolumab could shrink a participant's cancer but it could also …
The purpose of this study is to test any good and bad effects of the combination of study drugs called ipilimumab and nivolumab in treating rare cancers and cancers of unknown primary origin. The combination treatment of ipilimumab and nivolumab could shrink a participant's cancer but it could also cause side effects. Researchers hope to learn if the study drugs will shrink the cancer by at least one-quarter compared to its present size. Both ipilimumab and nivolumab have already been FDA-approved to treat other cancers. However, ipilimumab and nivolumab are investigational and not FDA-approved for use in combination in treating rare cancers or cancers of unknown primary origin.Description of TreatmentAll study participants will get the same study drugs: ipilimumab and nivolumab. Participants will receive both study drugs through a vein on the first day of each cycle (or every 6 weeks), and they will receive nivolumab through a vein every 2 weeks. Participants will continue to receive study drugs until their disease gets worse or they experience bad side effects from the study drugs or their study doctor decides that they are not benefiting from the study drugs.
Some of the eligibility criteria include:

- Participants must be at least 18 years of age or older.

No other prior malignancy is allowed except for the following:

1. Adequately managed Stage I or II cancer from which the participant is currently in complete remission

2. Any other cancer from which the participant has been disease free for one year.

3. Adequately managed Stage I or II follicular thyroid or prostate cancer is also eligible, in which the participant is not required to be in complete remission

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.
Chae, Young KwangChae, Young Kwang
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02834013 STU00205572
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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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PET/MRI using [18F]-DCFPyL for the Staging of Newly Diagnosed Prostate Cancer

This research study involves the use of a scanner that is capable of taking PET and MR images at the same time. A PET scan is a test that uses radioactive glucose (sugar) and a computer to create images of how organs and tissues in the body are functioning. Abnormal …
This research study involves the use of a scanner that is capable of taking PET and MR images at the same time. A PET scan is a test that uses radioactive glucose (sugar) and a computer to create images of how organs and tissues in the body are functioning. Abnormal cells in the body use glucose at a different rate than normal cells and this allows the scanner to create a detailed picture of how your body is working. A MR scan uses strong magnets and computers to created detailed images of the soft tissue in your body. The purpose of this study is to gain understanding how PET-MR (positron emission tomography-magnetic resonance imaging) using the substance 18F-DCFPyL (PyL) may help in diagnosing prostate cancer and in determining the stage of prostate cancer before surgery.
Men with biopsy-proven prostate cancer and a diagnosis of high risk, very high risk or locally advanced prostate cancer per NCCN guidelines.
Schaeffer, Edward MatthewSchaeffer, Edward Matthew
NCT03392181 STU00205957
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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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Mobile – PrOmoting Wellness after cancER Study: M-POWER Feasibility Study

M-POWER is an 8-week weight loss study in the Department of Preventive Medicine at Northwestern University. The participant will be given a smartphone application and have weekly telephone calls with health coaches. Participants will be asked to track their weight, diet, and activity through the smartphone application and …

M-POWER is an 8-week weight loss study in the Department of Preventive Medicine at Northwestern University. The participant will be given a smartphone application and have weekly telephone calls with health coaches. Participants will be asked to track their weight, diet, and activity through the smartphone application and will be asked to recruit a "Buddy" to support them throughout their time in the study. Participants will be compensated for their time in the study. If you are interested in participating, please complete our eligibility here: https://tinyurl.com/2p86cm5a

You are a cancer survivor (breast, melanoma, prostate or colorectal) between the ages of 18 and 84 years old. You own a smartphone; you are living with obesity and willing to participate in a weight-loss research study that focuses on health behavior changes.
Spring, BonnieSpring, Bonnie
  • Map it 680 N. Lake Shore Drive Suite 1410
    Chicago, IL
STU00207968
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NU 18I01: A Phase 2 study of pembrolizumab in combination with pelareorep in patients with advanced pancreatic adenocarcinoma

This study involves the use of an investigational drug called pelareorep (Reolysin®).“Investigational” means that the drug pelareorep has not been approved by the U.S. Food &Drug Administration (FDA) for treating pancreatic adenocarcinoma.The primary goal is to see if a treatment using both pelareorepand pembrolizumab has any …
This study involves the use of an investigational drug called pelareorep (Reolysin®).“Investigational” means that the drug pelareorep has not been approved by the U.S. Food &Drug Administration (FDA) for treating pancreatic adenocarcinoma.The primary goal is to see if a treatment using both pelareorepand pembrolizumab has any effect on pancreatic cancer and also to evaluate the safety ofthis combination of these two drugs. Pelareorep is an investigational product that uses a type ofvirus called reovirus. This virus is commonly found in natural environments throughout the world(such as ponds) and is associated with minor breathing difficulties and stomach upsets inhumans. Infection of cancer cells by this virus is expected to be able to slow cancer lesiongrowth and kill cancer cells.  Pembrolizumab is a drug thatworks on stimulating the immune system to fight the cancer cells and it is currently approvedfor the treatment of other tumors (melanoma and lung). It is not presently known if it will help inthe treatment of pancreatic cancer. The combination of pembrolizumab and pelareorep isexpected to be able to determine if pelareorep will or will not stimulate the immune systemand make it more responsive to therapy with pembrolizumab.
Participants with advancedpancreatic adenocarcinoma.
Mahalingam, DevalingamMahalingam, Devalingam
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03723915 STU00207577
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(xIRB NCI CIRB) CCTG MA.39: TAILOR RT: A Randomized Trial Of Regional Radiotherapy In Biomarker Low Risk Node Positive Breast Cancer

In addition to endocrine therapy and possibly chemotherapy, many women with node positive breast cancer will also receive radiotherapy to the whole breast/chest area and the surrounding lymph glands (called regional radiotherapy). Because no one really knows whether patients with low risk breast cancer need to receive regional radiotherapy, …
In addition to endocrine therapy and possibly chemotherapy, many women with node positive breast cancer will also receive radiotherapy to the whole breast/chest area and the surrounding lymph glands (called regional radiotherapy). Because no one really knows whether patients with low risk breast cancer need to receive regional radiotherapy, it is possible that some women who get it may not actually need it. These women may be exposed to the side effects of their treatment without benefit. The purpose of this study is to learn if not giving regional radiotherapy is just as good as using regional radiotherapy by comparing any good and bad effects of both approaches. The study has two randomly assigned study groups; Group 1 will receive regional radiotherapy and Group 2 will not. 
Patients who are of 40 years of age or older may be able to take part in this study if they have newly diagnosed breast cancer that has been treated with breast-conserving surgery or mastectomy and has not spread to other parts of the body.
Donnelly, Eric DonaldDonnelly, Eric Donald
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03488693 STU00208897
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ECOG-ACRIN 6174: STAMP: Surgically Treated Adjuvant Merkel cell Carcinoma with Pembrolizumab, a Phase III Trial

We are asking you to take part in a research study. We do research studies to try to answer questions about how to prevent, diagnose, andtreat diseases like cancer.This study is being done to answer the following question: Can we lower the chance of your cancer growing back by …

We are asking you to take part in a research study. We do research studies to try to answer questions about how to prevent, diagnose, andtreat diseases like cancer.This study is being done to answer the following question: Can we lower the chance of your cancer growing back by adding a study drug after your 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 Merkel Cell Carcinoma. The usual approach is defined as care most people get after surgery to remove the cancer.

We are asking you to take part in this research study because you have stage I-IIIB Merkel Cell Carcinoma (MCC) that has been removed by surgery.

Chandra, SunandanaChandra, Sunandana
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03712605 STU00208944
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(xIRB NCI CIRB) NRG GY012: A Randomized Phase II Study Comparing Single-Agent Olaparib, Single Agent Cediranib, and the Combinations of Cediranib/Olaparib, Olaparib/Durvalumab (MEDI4736), Cediranib/Durvalumab (MEDI4736), Olaparib/AZD5363 (Capivasertib) in Women with Recurrent, Persistent or Metastatic Endometrial Cancer. A Multi-Arm Trial for Women with Recurrent or Persistent Endometrial Cancer.

This is a study to look at a different approach to treating endometrial cancer. It is being done to answer the following question: Can we lower the chance of your endometrial cancer growing or spreading by giving a combination of two experimental drugs or one experimental drug rather than the …

This is a study to look at a different approach to treating endometrial cancer. It is being done to answer the following question: Can we lower the chance of your endometrial cancer growing or spreading by giving a combination of two experimental drugs or one experimental drug rather than the usual approach?

The purpose of this study is to compare any good and bad effects of using experimental study drugs cediranib alone, olaparib alone, or a combination of cediranib and olaparib. These drugs could shrink your cancer but they could also cause side effects. This study will allow the researchers to know whether one of these approaches is better, the same, or worse than the usual approach. The usual approach is defined as care most people get for endometrial cancer.

You may be eligible for this research study if you have endometrial cancer which has grown or has returned after earlier treatment.

Matei, Daniela ElenaMatei, Daniela Elena
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03660826 STU00208995
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An Open Label, Pilot Study Evaluating the Effect of Low-Dose Oral Minoxidil as Treatment of Permanent Chemotherapy-Induced Alopecia

This study will test if low-dose oral minoxidil has an effect on permanent chemotherapy-induced alopecia (defined as hair loss after the completion of a chemotherapy regimen that persists for over six months). In this study, you will receive the study drug; there is no placebo option. The effectiveness …

This study will test if low-dose oral minoxidil has an effect on permanent chemotherapy-induced alopecia (defined as hair loss after the completion of a chemotherapy regimen that persists for over six months). In this study, you will receive the study drug; there is no placebo option. The effectiveness and safety of the treatment will be determined by a range of assessments, including biopsies, images, and subjective evaluation of perceived hair growth.

Age 18 and above with a diagnosis of permanent chemotherapy-induced alopecia and agree to use contraception for the duration of the study.

Choi, Jennifer NamChoi, Jennifer Nam
  • Map it 676 N. St. Clair St.
    Chicago, IL
NCT03831334 STU00206882
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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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(xIRB NCI) SWOG 1706: A Phase II Randomized Trial of Olaparib (NSC-747856) Administered Concurrently with Radiotherapy versus Radiotherapy Alone for Inflammatory Breast Cancer

The purpose of this study is to determine if including thedrug olaparib taken along with radiation treatment decreases the recurrence of cancerin patients who have inflammatory breast cancer and have already hadchemotherapy and surgery to remove the cancer. The drug olaparib is already approved by the Food and DrugAdministration (FDA) …

The purpose of this study is to determine if including thedrug olaparib taken along with radiation treatment decreases the recurrence of cancerin patients who have inflammatory breast cancer and have already hadchemotherapy and surgery to remove the cancer. The drug olaparib is already approved by the Food and DrugAdministration (FDA) for use in ovarian, fallopian tube, peritoneal cancer, andgBRCA mutated her2-negative metastatic breast cancer, however olaparib is notapproved for inflammatory breast cancer.

inflammatory breast cancer who have already had chemotherapy and surgery to remove the cancer
Donnelly, Eric DonaldDonnelly, Eric Donald
  • Map it 201 East Huron Street Suite 12-160​
    Chicago, IL
NCT03598257 STU00209490
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(xIRB) NRG-BN005 A Phase II Randomized Trial of Proton vs. Photon Therapy (IMRT) for Cognitive Preservation in Patients with IDH Mutant, Low to Intermediate Grade Gliomas.

The purpose of this study is to compare any good and bad effects of using proton therapy to using photontherapy. Photon therapy is the usual treatment approach for brain cancer. Proton therapy uses a beam ofproton particles to send radiation inside the body to the tumor. This study will allow …

The purpose of this study is to compare any good and bad effects of using proton therapy to using photon

therapy. Photon therapy is the usual treatment approach for brain cancer. Proton therapy uses a beam of

proton particles to send radiation inside the body to the tumor. This study will allow the researchers to know

whether proton therapy is better, the same, or worse than the usual approach. Proton therapy may have less

negative effects on brain function than photons because less brain is exposed to radiation when proton therapy

is used. However, proton therapy might also be associated with more frequent tumor recurrences.

-Participants must be 18 years of age or older

-Participants must be diagnosed with a brain tumor

Stupp, RogerStupp, Roger
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03180502 STU00209631
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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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(xIRB NCI CIRB) ETCTN 10183: A Pilot Study of Tazemetostat and MK-3475 (Pembrolizumab) in Advanced Urothelial Carcinoma

The purpose of this study is to see how peoplewith advanced urothelial carcinoma respond to an approved treatment for thistype of cancer (MK-3475) in combination with the study drug tazemetostat(MK-3475 with tazemetostat). Tazemetostat is an investigational drug, whichmeans it is not approved by the FDA. Laboratory research …

The purpose of this study is to see how peoplewith advanced urothelial carcinoma respond to an approved treatment for thistype of cancer (MK-3475) in combination with the study drug tazemetostat(MK-3475 with tazemetostat). Tazemetostat is an investigational drug, whichmeans it is not approved by the FDA. Laboratory research indicates thatcombining the two drugs has the potential to have a better response thanMK-3475 alone.

This study will help the study doctors findout the safest and most effective dose for tazemetostat when combined withMK-3475. It will also help doctors determine if the combination treatment has abetter anticancer effect than treatment with MK-3475 alone. To decide if it isbetter, the study doctors will be looking to see if adding tazemetostatimproves the response rates of patients compared to the usual approach.

Diagnosis ofadvanced urothelial carcinoma

· Age of at least 18 years

Hussain, MahaHussain, Maha
NCT03854474 STU00209918
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NU MTBC 18M02: Melanoma Tissue Bank Consortium Protocol

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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DRUG KRT-232-103: A Phase 1b/2, Open-Label Study Evaluating the Safety and Efficacy of KRT-232 in Patients with p53 Wild-Type (p53WT) Merkel Cell Carcinoma (MCC) Who Have Failed Anti-PD-1 or Anti-PD-L1 Immunotherapy, or in Combination with Avelumab in MCC Patients who are Anti-PD-1 or Anti-PD-L1 Treatment Naïve

We are asking you to take part in this research study because you have been diagnosed with Merkel cell carcinoma (MCC) and your prior treatment with a specific immunotherapy (a type of therapy called anti-PD-1 or anti-PD-L1) was not or is no longer effective for your …

We are asking you to take part in this research study because you have been diagnosed with Merkel cell carcinoma (MCC) and your prior treatment with a specific immunotherapy (a type of therapy called anti-PD-1 or anti-PD-L1) was not or is no longer effective for your disease. The purpose of this study is to evaluate how well tolerated KRT-232 is when given to participants with Merkel cell carcinoma, and whether KRT-232 can improve your MCC.

In order to participate in this study, your Merkel cell carcinoma cells must be a certain type of cell, called “p53 wild type” cells (p53wt).
Chandra, SunandanaChandra, Sunandana
NCT03787602 STU00209401
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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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Phase III Randomized Trial of Concurrent Chemoradiotherapy with or without Atezolizumab in Localized Muscle Invasive Bladder Cancer

Thepurpose of this study is to compare the effects, good and/or bad, ofchemotherapy and radiation therapy with or without the use of atezolizumab,which is used to treat bladder cancer. The combination of chemotherapy,radiation therapy and the immunotherapy atezolizumab is consideredexperimental.…
Thepurpose of this study is to compare the effects, good and/or bad, ofchemotherapy and radiation therapy with or without the use of atezolizumab,which is used to treat bladder cancer. The combination of chemotherapy,radiation therapy and the immunotherapy atezolizumab is consideredexperimental.
  • Participants must be 18 years orolder
  • Participants must be diagnosed with bladder cancer thathas not spread beyond the bladder.
Sachdev, SeanSachdev, Sean
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03775265 STU00210415
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A randomized, controlled, multi-center, safety and efficacy study of FCR001 cell-based therapy relative to a tacrolimus and mycophenolate-based regimen in de novo living donor renal transplant recipients, and safety in FCR001 donors

Research study which involves the use of a combination of an Enriched Hematopoetic Stem Cell Infusion (stem cells, produced by the bone marrow, generate the cells that form the blood elements, help fight infection and assist in clotting) and kidney transplantation from the same donor to try to avoid the …
Research study which involves the use of a combination of an Enriched Hematopoetic Stem Cell Infusion (stem cells, produced by the bone marrow, generate the cells that form the blood elements, help fight infection and assist in clotting) and kidney transplantation from the same donor to try to avoid the need for long-term anti-rejection drug therapy. The desired result of this study is to allow your body to develop "tolerance" to the transplanted kidney. Tolerance means that your body would see the transplanted kidney as part of you and not try to get rid of, or reject it. To prevent rejection, drugs called immunosuppressive agents must be taken on a daily basis. The purpose of this study is to determine if this procedure is safe and to try to substantially reduce or even eliminate the need for anti-rejection medications.
Leventhal, Joseph RLeventhal, Joseph R
NCT03995901 STU00209928
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(XIRB) DRUG IMSA101-101: Phase I/IIA Safety and Efficacy Study of IMSA101 in Patients with Advanced Treatment-Refractory Malignancies

The purpose of this research is to find a safe and tolerable dose of the study drug, IMSA101, for the treatment of your type of cancer and other types of cancer. …

The purpose of this research is to find a safe and tolerable dose of the study drug, IMSA101, for the treatment of your type of cancer and other types of cancer.

All adult subjects ages 18 and above with advanced cancer that is no longer responding to standard of care treatment are eligible to participate.
Mahalingam, DevalingamMahalingam, Devalingam
  • Map it 201 E. Huron St.
    Chicago, IL
NCT04020185 STU00210768
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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.
Boumber, YanisBoumber, Yanis
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03942653 STU00210435
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(xIRB) A Phase III Randomized, Placebo-Controlled Study of Pembrolizumab (MK-3475) in addition to Paclitaxel and Carboplatin for Measurable Stage III or IVA, Stage IVB or Recurrent Endometrial Cancer

This study is being done to answer the following question: Can we lower the chance of your endometrial cancer growing or spreading by adding anew immunotherapy drug called Pembrolizumab to the usual combination of chemotherapy drugs? We want to find out if this approach of using a new immunotherapy drug …

This study is being done to answer the following question: Can we lower the chance of your endometrial cancer growing or spreading by adding anew immunotherapy drug called Pembrolizumab to the usual combination of chemotherapy drugs? We want to find out if this approach of using a new immunotherapy drug called Pembrolizumab is better or worse than the usual approach for your endometrial cancer. The usual approach is defined as care most people get for endometrial cancer, which includes treatment with surgery, radiation, or drugs including: carboplatin, paclitaxel, gemcitabine, pegylated liposomal doxorubicin, and topotecan (all U.S. Food and Drug Administration [FDA] approved agents). Sometimes, combinations of these treatments are used.

Everyone in the study will get paclitaxel and carboplatin with pembrolizumab or paclitaxel and carboplatin with a placebo forfour and a half months, followed by pembrolizumab or a placebo for up to two years. Placebo looks like the study drug but contains no medication.

  • Stage III, IVA, IVB, or recurrent endometrial cancer.
  • No chemotherapy within 12 months and no radiation therapy within 4 weeks.
Matei, Daniela ElenaMatei, Daniela Elena
  • Map it 250 E. Superior St.
    Chicago, IL
NCT03914612 STU00210842
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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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A Phase III, Randomized Study of Nivolumab (Opdivo) Plus AVD or Brentuximab Vedotin (Adcetris) Plus AVD in Patients (Age >/= 12 Years) with Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma

The purpose of this study is to compare nivolumab plus the three chemotherapy drugs: doxorubicin, dacarbazine, and vinblastine sulfate (AVD) to brentuximab vedotin plus the three chemotherapy drugs: doxorubicin, dacarbazine, and vinblastine sulfate (AVD), followed by targeted radiation therapy in some patients with lymphoma that does not completely respond to therapy. The addition of either nivolumab or brentuximab vedotin to the usual treatment could shrink the cancer or extend your time without your disease symptoms coming back.

Nivolumab is an immunotherapy drug (a type of drug that works by boosting your immune system) that attaches to a target protein called PD-1 (found within white blood cells) and helps to increase the immune system’s activity against the cancer. Brentuximab vedotin is an antibody drug conjugate, which means that the drug contains an antibody that attaches to a protein (CD30) that is found on the surface of classical Hodgkin Lymphoma cells and then releases a drug inside those cells that kills the cancer cells.

This study will help the study doctors find out if one of the drug combinations (nivolumab plus the usual chemotherapy or brentuximab vedotin plus the usual chemotherapy) is better, the same, or worse than the other drug combination, followed by radiation therapy in some patients. To decide if it is better, the study doctors will be comparing the drug combinations to see which drug combination allows more patients to have no disease symptoms at 2 years or more after the completion of the study treatment and which drug combination extends the overall survival of patients at 10 years after completion of the study treatment.

  • Participantsmust be 18 years or older
  • Participants must have a confirmed diagnosis newlydiagnosed and previously untreated stage III or IV classical Hodgkin lymphoma
Winter, Jane NormaWinter, Jane Norma
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03907488 STU00210926
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(xIRB Sterling) DRUG 68284528MMY2003: A Phase 2, Multicohort Open-Label Study of JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA in Subjects with Multiple Myeloma (CARTITUDE-2)

The purpose of this study is to see if JNJ-68284528 is safe and useful for treating patients with relapsed or refractory multiple myeloma. In this type of treatment, your white blood cells (which are a part of the immune system) will be genetically modified to become JNJ-68284528 and …
The purpose of this study is to see if JNJ-68284528 is safe and useful for treating patients with relapsed or refractory multiple myeloma. In this type of treatment, your white blood cells (which are a part of the immune system) will be genetically modified to become JNJ-68284528 and used to treat your multiple myeloma.

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
NCT04133636 STU00210994
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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 NRG HN005: A Randomized Phase II/III Trial of De-Intensified Radiation Therapy for Patients with Early-Stage, P16-Positive, Non-Smoking Associated Oropharyngeal Cancer

The purpose of PhaseII this study is to compare the usual treatment of a standard-dose radiationgiven over 6 weeks with cisplatin chemotherapy to a reduced-dose radiationgiven over either 6 weeks with cisplatin or 5 weeks with the immunotherapydrug, nivolumab. A lower dose of radiation as compared to the …

The purpose of PhaseII this study is to compare the usual treatment of a standard-dose radiationgiven over 6 weeks with cisplatin chemotherapy to a reduced-dose radiationgiven over either 6 weeks with cisplatin or 5 weeks with the immunotherapydrug, nivolumab. A lower dose of radiation as compared to the usual radiationtreatment dose could be as effective in lengthening the time without the cancergetting worse.

This study will helpresearchers find out if this different approach is the same or worse than theusual approach. To decide if it is the same, the study doctors will be lookingto see if the study approach maintains the length of time without cancergetting worse compared to the usual approach. If the study approach is the sameas the usual approach, the study will advance to the second part, the phaseIII, and participants may be asked to participate in the second part of thestudy.

The purpose of thesecond part of this study is to compare the usual treatment of a standard-doseradiation given over 6 weeks with cisplatin chemotherapy to a reduced-doseradiation given over either 6 weeks with cisplatin or 5 weeks with theimmunotherapy drug, nivolumab. A lower dose of radiation as compared to theusual radiation treatment dose may or may not be as effective in lengtheningthe time without the cancer getting worse. Another purpose of the second partof this study is to see if a lower dose of radiation as compared to the usualradiation treatment dose could also have a better effect on a participant'swell-being.

We are asking you to take part in this research study because you have low-risk, Human Papillomavirus (HPV) positive oropharyngeal cancer. 
Gharzai, LailaGharzai, Laila
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03952585 STU00211079
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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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NU COH21S03: A Phase II Study of Cabozantinib and Temozolomide in Patients with Unresectable or Metastatic Leiomyosarcoma and Other Soft Tissue Sarcomas

The purpose of this study is to determine if cabozantinib, given together with temozolomide is able to stop or reduce the rate of cancer growth in participants with your kind of cancer better than temozolomide alone. Both drugs are considered investigational. Preclinical and clinical evidence shows that adding antiangiogenic agents (…
The purpose of this study is to determine if cabozantinib, given together with temozolomide is able to stop or reduce the rate of cancer growth in participants with your kind of cancer better than temozolomide alone. Both drugs are considered investigational. Preclinical and clinical evidence shows that adding antiangiogenic agents (substances, drugs, or compounds which get rid of parts of the blood vessels needed by tumors to grow and spread) to chemotherapy, enhances anti-tumor and antiangiogenic effects.  
We are asking you to take part in this research study because you have been diagnosed with leiomyosarcoma (cancer of the smooth muscles) or non leiomyosarcoma (another kind of soft tissue cancer), and your type of cancer cannot be removed through surgery or has spread to a different part of your body. 
Pollack, Seth MichaelsPollack, Seth Michaels
  • Map it 201 E. Huron St.
    Chicago, IL
NCT04200443 STU00210699
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(xIRB) NCI CIRB Alliance A021703: Randomized Double-blind Phase III Trial of Vitamin D3 Supplementation in Patients with Previously Untreated Metastatic Colorectal Cancer (SOLARIS)

Participants with colorectal cancer will beinvited to participant in this study. The purpose of this study is to comparethe usual treatment (usual chemotherapy plus bevacizumab) plus high-dosevitamin D3 to using the usual treatment plus regular-dose vitamin D3. Thisstudy will help the study doctors find out if this different …

Participants with colorectal cancer will beinvited to participant in this study. The purpose of this study is to comparethe usual treatment (usual chemotherapy plus bevacizumab) plus high-dosevitamin D3 to using the usual treatment plus regular-dose vitamin D3. Thisstudy will help the study doctors find out if this different approach isbetter, the same, or worse than the usual approach. To decide if it is better,the study doctors will be looking to see if the addition of high-dose vitaminD3 to usual approach can shrink or stabilize tumors for a longer period of timethan regular-dose vitamin D3 and usual approach.

This study has two groups:

Group 1: Participants in this group will getthe usual drug regimen used to treat this type of cancer, either FOLFOX plusbevacizumab or FOLFIRI plus bevacizumab, plus a study drug called high-dosevitamin D3.

Group 2: Participants in this group you willget the usual drug regimen used to treat this type of cancer, either FOLFOXplus bevacizumab or FOLFIRI plus bevacizumab, plus a study drug calledregular-dose vitamin D3.

Participants who are at least 18 years of age or older who have advanced colorectal cancer. 
Kircher, Sheetal MehtaKircher, Sheetal Mehta
  • Map it 201 E. Huron St.
    Chicago, IL
NCT04094688 STU00211478
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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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ECOG-ACRIN 4181: A Randomized 3-Arm Phase II Study Comparing 1.) Bendamustine, Rituximab and High Dose Cytarabine (BR/CR) 2.) Bendamustine, Rituximab, High Dose Cytarabine and Acalabrutinib (BR/CR-A), and 3.) Bendamustine, Rituximab and Acalabrutinib (BR-A) in Patients = 70 years old with Untreated Mantle Cell Lymphoma

This study isbeing done to answer the following question: Which combinationof cancer drugs most effectively treats your MCL? 1. bendamustine, rituximab, and high dosecytarabine (BR/CR) 2. bendamustine, rituximab, high dosecytarabine, and acalabrutinib (BR/CR-A)3. bendamustine, rituximab andacalabrutinib (BR-A) We are doing this study because we want …

This study isbeing done to answer the following question:

Which combinationof cancer drugs most effectively treats your MCL?

1. bendamustine, rituximab, and high dosecytarabine (BR/CR)

2. bendamustine, rituximab, high dosecytarabine, and acalabrutinib (BR/CR-A)

3. bendamustine, rituximab andacalabrutinib (BR-A)

We are doing this study because we want to findout if one of these drug combinations is better or worse than the usualapproach for your MCL. The usual approach is defined as care most people getfor MCL. Acalabrutinib is investigational for treating newly diagnosed MCL. Itis Food and Drug Administration (FDA) approved for MCL that has not respondedto treatment or relapsed
  • Participants must be 18 years orolder and ≤ 70 years old
  • Participants must have a confirmed diagnosis of MantleCell Lymphoma which has not been treated
Karmali, ReemKarmali, Reem
  • Map it 201 E. Huron St.
    Chicago, IL
NCT04115631 STU00211660
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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
NCT04843566 STU00211699
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DRUG CKAZ954A12101: A Phase I/IB, Open-label, Multi-Center, Study of KAZ954 as a Single Agent and in Combination With Spartalizumab, NZV930 and NIR178 in Patients with Advanced Solid Tumors

The purpose of the study is to identify the best dose and treatment schedule of KAZ954 alone,and with Spartalizumab (PDR001), NIR178 or NZV930 that can be given safely to patients with cancer.…
The purpose of the study is to identify the best dose and treatment schedule of KAZ954 alone,and with Spartalizumab (PDR001), NIR178 or NZV930 that can be given safely to patients with cancer.
All patients age 18 and above who have advanced cancers are eligible to participate.
Mahalingam, DevalingamMahalingam, Devalingam
  • Map it 201 East Huron Street Suite 12-160​
    Chicago, IL
NCT04237649 STU00211372
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SWOG 1827: A Randomized Phase III Trial of MRI Surveillance with or Without Prophylactic Cranial Irradiation (PCI) in Small-Cell Lung Cancer

This study is being done to answer the following question: Does the use of brain scans alone instead of brain scans plus preventive brain radiation affect the lifespan of patients with small cell lung cancer? We are doing this study because we want to find out if this approach is …

This study is being done to answer the following question:

Does the use of brain scans alone instead of brain scans plus preventive brain radiation affect the lifespan of patients with small cell lung cancer?

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

  • Participantsmust be 18 years or older
  • Participants must have a confirmed diagnosis Small-CellLung cancer
Abazeed, MohamedAbazeed, Mohamed
  • Map it 201 E. Huron St.
    Chicago, IL
STU00211982
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(xIRB) DRUG IMGN632-0802: A Phase 1b/2 Study of IMGN632 as Monotherapy or Combination with Venetoclax and/or Azacitidine for Patients with CD123-Positive Acute Myeloid Leukemia

The purposes of this research study are:•To combine IMGN632 (study drug), an experimental drug, with standard therapies (azacitidine and/or venetoclax). •To find out what effects, both good and/or bad, the combination of study drug (IMGN632) and standard therapy (azacitidine and/or venetoclax) may have on you and …

The purposes of this research study are:

•To combine IMGN632 (study drug), an experimental drug, with standard therapies (azacitidine and/or venetoclax).

•To find out what effects, both good and/or bad, the combination of study drug (IMGN632) and standard therapy (azacitidine and/or venetoclax) may have on you and your type of cancer.

•To find a safe dose of IMGN632 to use in combination with azacitidine and/or venetoclax.

•To find out how well IMGN632 works with combination therapies (azacitidine and/or venetoclax) to treat your type of cancer.

•Alternatively, if you are in complete remission but have a very small amount of leukemia detectable (called minimal residual disease positive, MRD+) after the previous treatment, this study will see if IMGN632 can make your disease no longer detectable.

If you meet all the eligibility criteria for being in this study, you will be assigned to one of four different groups:

•Combination A: IMGN632 + azacitidine

•Combination B: IMGN632 + venetoclax

•Combination C: IMGN632 + azacitidine + venetoclax

•Combination D: IMGN632

All prospective participants will undergo screening tests to determine if they are eligible to take part in the study. You will be assigned to one of the four study treatment groups in the study.

•Combination A (IMGN632 + azacitidine): Azacitidine is given daily for 7 days, IMGN632 is given on day 7 after the last azacitidine dose. After day 7, no study drug is given for the rest of the cycle. Each cycle in Regimen A is 28 days.

•Combination B (IMGN632 + venetoclax): Venetoclax is taken daily for 21 days. IMGN632 is given on day 7 after the seventh venetoclax dose. Each cycle in Regimen B is 21 days.

•Combination C (IMGN632 + azacitidine + venetoclax): Venetoclax is taken daily for 28 days. Azacitidine is given daily for 7 days. IMGN632 is given on day 7 after the seventh azacitidine and venetoclax doses. Each cycle in Regimen C is 28 days.

•Combination D (IMGN632): IMGN632 is given every 21 days. Each cycle in Regimen D is 21 days.

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

Some of the eligibility criteria include:

•Diagnosis of Acute Myeloid Leukemia (AML) that has not responded fully to treatment or has come back after treatment or you have untreated AML but a clinical trial may be appropriate

•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.

Altman, Jessica KAltman, Jessica K
  • Map it 201 E. Huron St.
    Chicago, IL
NCT04086264 STU00212068
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(xIRB) DRUG JCAR017-FOL-001: A Phase 2, Open-Label, Single-Arm, Multicohort, Multicenter Trial to Evaluate the Efficacy and Safety of jcar017 in Adult Subjects with Relapsed or Refractory Indolent B-Cell Non-Hodgkin Lymphoma (NHL) (Transcend FL)

The purpose of this research study is to determineif the experimental therapy called JCAR017 is effective and safe to treatFollicular Lymphoma or Marginal Zone Lymphoma.This study will have 4 cohorts or patientgroups. Assignment to one of these patient groups depends on if you haveFollicular Lymphoma or Marginal Zone Lymphoma …

The purpose of this research study is to determineif the experimental therapy called JCAR017 is effective and safe to treatFollicular Lymphoma or Marginal Zone Lymphoma.

This study will have 4 cohorts or patientgroups. Assignment to one of these patient groups depends on if you haveFollicular Lymphoma or Marginal Zone Lymphoma and the number and type oftreatments that you have received in the past, as well as how long it took foryour lymphoma to return after your last treatment. Everyone in all 4 patientgroups will receive the same dose of JCAR017 T cells. JCAR017 is a type oftherapy known as chimeric antigen receptor (CAR) T cell therapy which isco-developed with Juno Therapeutics. The visit schedule will also be the samefor all 4 patient groups. At the time you decide to take part in the study andgo through the screening procedures, it will be determined which patient groupyou will be assigned to.

In this study, your immunecells will be collected from your blood in a procedure called leukapheresis.The T cells will be separated from the collected immune cells and will bemodified in a laboratory. In the laboratory, a new gene will be put into your Tcells using genetic modification techniques. After they have been modified, thecells will be grown in the laboratory to reach the expected dose for thetreatment. Adding in the new gene may enable your T cells (now called JCAR017 Tcells) to bind to the CD19 protein, which your type of cancer cells carry ontheir surface. Binding to these cells activates the JCAR017 T cells, and theyattack the cancer cells. The JCAR017 T cells will persist in your body afterattacking the cancer cells, you will be monitored during the study to evaluatehow long these JCAR017 T cells persist. The JCAR017 T cells will be given backto you via infusion (IV).

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 the trial.

Age of at least 18 years

Diagnosis of Follicular Lymphoma or Marginal Zone Lymphoma, which has either returned or is not responding toyour current treatment. Follicular Lymphoma and Marginal Zone Lymphoma are twotypes of non-Hodgkin lymphoma (NHL).

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
NCT04245839 STU00212069
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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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(xIRB) DRUG TAK-788-3001: A Randomized Phase 3 Multicenter Open-label Study to Compare the Efficacy of TAK-788 as First-line Treatment Versus Platinum-Based Chemotherapy in Patients With Non–Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations

The purpose of this study is to determine how safe and how well TAK-788 works as an initial therapy in patients with a certain kind of lung cancer (NSCLC with EGFR exon 20 insertion mutations). The results in these patients will be compared with results in patients receiving standard …
The purpose of this study is to determine how safe and how well TAK-788 works as an initial therapy in patients with a certain kind of lung cancer (NSCLC with EGFR exon 20 insertion mutations). The results in these patients will be compared with results in patients receiving standard of care chemotherapy (platinum-doublet chemotherapy).

If you meet all the eligibility criteria for being in this study, you will have a 50-50 chance to be assigned to one of two different groups:

- A TAK-788 Group (Takeda Study Drug) who will receive TAK-788; OR

- A chemotherapy Group (Other Study Drugs) who will receive platinum-based (standard) chemotherapy of the investigator's choice of either:

* Combination of premetrexed and cisplatin OR

* Combination of premetrexed and carboplatin

- Diagnosis of non-small cell lung cancer (NSCLC) with epithelial growth factor receptor (EGFR) exon 20 insertion mutations

- Be atleast 18 years old

- Cannot have received prior treatment for locally advanced cancer or cancer that has apread to other oarts of the body.

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
NCT04129502 STU00212504
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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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Wearable sensor to monitor and track COVID-19-like signs and symptoms to develop better care strategies for COVID-19 pandemic

Specific Aims:1. Develop a wearable sensor package to gather data on COVID-19-like signs andsymptoms such as elevated body temperature, respiratory parameters, heart rate ,coughand gait.2. Create algorithms to monitor and track changes to COVID19-like signs and symptomsfor developing a better care and isolation strategies for …
Specific Aims:1. Develop a wearable sensor package to gather data on COVID-19-like signs andsymptoms such as elevated body temperature, respiratory parameters, heart rate ,coughand gait.2. Create algorithms to monitor and track changes to COVID19-like signs and symptomsfor developing a better care and isolation strategies for COVID-19 pandemic

Ages between 18-95 years old

Currently experiencing any COVID-like signs and symptoms such as fever, cough,shortness of breath, trouble breathing, persistent pain or pressure in the chest, confusionor inability to arouse, bluish lips or face
Jayaraman, ArunJayaraman, Arun
  • Map it 201 E. Huron St.
    Chicago, IL
STU00212522
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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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(xIRB) DRUG AVM-003-HC: Phase 3 Multicenter, Double-Blind, Placebo-Controlled Trial of Viralym-M (ALVR-105) for the Treatment of Patients With Virus-Associated Hemorrhagic Cystitis After Allogeneic Hematopoietic Cell Transplant.

The purpose of this study is to determine if the study drug, ALVR-105, is safe and works well in the treatment for HC. The study will compare ALVR-105 to placebo in reducing your bladder pain, reducing the amount of blood in your urine, and seeing if specific viruses …

The purpose of this study is to determine if the study drug, ALVR-105, is safe and works well in the treatment for HC. The study will compare ALVR-105 to placebo in reducing your bladder pain, reducing the amount of blood in your urine, and seeing if specific viruses are lowered in your blood and urine.

This is a randomized double-blind study. “Randomized” means that you will be randomly assigned (like the flip of a coin) to receive either ALVR-105, or placebo (inactive substance). You will have a 60% chance of receiving ALVR-105 and a 40% chance of receiving placebo.

Your participation in this study will last approximately 6 months and include about 10 study visits to the study site. Some of these study visits will occur when you are already in the hospital in which case the study team will visit you to complete the study visit.

In healthy people, T-cells defend the body against viruses. Because of the early stage / premature engraftment and /or immune suppressing therapy given for the HCT, T-cell numbers are low, and it is more difficult for the body to control viruses that are already in your body, but are not active. If you have low T-cell numbers and your body cannot control viruses, some of these viruses can cause HC.

Viralym-M (ALVR-105) is a research study medicine that contains T-cells made from healthy human donors to potentially help defend your body against specific viruses. The research study medicine is “investigational.” It has not been approved by the United States Food and Drug Administration (FDA), the health authority that approves new medicine being prescribed for use in the United States. This means that it is not approved to treat patients with hemorrhagic cystitis or any other disease.

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

If you qualify, the research study medicine (ALVR-105 or placebo) will be given to you by an infusion into a vein (IV injection). You will receive a second dose of research study medicine about two weeks after your first dose.

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 hemorrhagic cystitis (HC) caused by a viral infection after your allogeneic hematopoietic cell transplant (HCT)

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
NCT04390113 STU00213027
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(xIRB) NCI CIRB ECOG-ACRIN 2185: Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs

The purpose of this study is tocompare the two approaches for monitoring pancreatic cysts. The doctors want tosee if less frequent monitoring is better or worse than more frequentmonitoring for patients with pancreatic cysts. This study has 2 study groups: Group 1Participants in this group willget less frequent monitoring. Participants …

The purpose of this study is tocompare the two approaches for monitoring pancreatic cysts. The doctors want tosee if less frequent monitoring is better or worse than more frequentmonitoring for patients with pancreatic cysts.

This study has 2 study groups:

Group 1

Participants in this group willget less frequent monitoring. Participants will receive an MRI or CT imagingscan at the beginning of the study and repeat the scan 1 year after joining thestudy. If the scans show normal results, scans will be repeated every 2 years.If the scans show abnormal results, participants will receive an endoscopicultrasound.

Group 2

Participants in this group willget more frequent monitoring. Participants will receive an MRI or CT imagingscan at the beginning of the study. . The frequency of repeat imaging couldrange from every 6 months to every 2 years, based on the size of theparticipant's pancreatic cyst.

Participants will be enrolled forup to five years.

Participants between the ages of 50and 75 who have pancreatic cysts will be enrolled into this study.

Chawla, AkhilChawla, Akhil
  • Map it 201 E. Huron St.
    Chicago, IL
NCT04239573 STU00213102
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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 goal of this study is to find out if enfortumab vedotin is effective and safe as a treatment for people with breast, lung, head and neck, gastric, gastroesophageal junction, or esophageal cancer. The study will look at how enfortumab vedotin acts in the body. Enfortumab vedotin is expected to …

    The goal of this study is to find out if enfortumab vedotin is effective and safe as a treatment for people with breast, lung, head and neck, gastric, gastroesophageal junction, or esophageal cancer. The study will look at how enfortumab vedotin acts in the body. Enfortumab vedotin is expected to work by attacking cells that have a protein called Nectin-4. Some, but not all, of the risks and benefits of the drug are known.

    You may be eligible to participate in this study if you have breast, lung, head and neck, gastric, gastroesophageal junction, or esophageal cancer; your cancer has spread to nearby tissues (locally advanced) or other areas of the body (metastatic); and you have also received previous anticancer therapy.

    Participants may withdraw at any time.

    Mulcahy, Mary FrancesMulcahy, Mary Frances
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04225117 STU00213246
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    DRUG ARV-110-mCRPC-101: A Phase 1/2, Open-label, Dose Escalation and Cohort Expansion Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ARV-110 in Patients with Metastatic Castration-resistant Prostate Cancer

    The purpose of this research study is to assess the safety and tolerability of the investigational study drug (ARV-110) in men with metastatic cancer of the prostate which has progressed after multiple previous therapies. The study also seeks to evaluate how the drug moves within the body after administration (…
    The purpose of this research study is to assess the safety and tolerability of the investigational study drug (ARV-110) in men with metastatic cancer of the prostate which has progressed after multiple previous therapies. The study also seeks to evaluate how the drug moves within the body after administration (Pharmacokinetics {PK}) and what effects the drug has on your body after administration (Pharmacodynamics {PD}).

    There are two parts to this study, Part A (dose escalation) and Part B (dose expansion). Your doctor will explain to you which part you are being considered for. Part B cannot start until Part A is completed.

    After a screening period of up to 28 days, if you are eligible, you will receive study treatment in cycles of 28 days. You will be asked to take ARV-110 tablet(s) by mouth, once each day, or twice each day, with food. The study doctor will tell you what dose and how many times per day you should take your study medication. The number of treatment cycles depends on how well you will tolerate the study treatment and until you are no longer benefiting from the treatment (disease progression). Average participation in this study is expected to be between 6-9 months or in some cases may be longer.

    After discussing with your study doctor, should you stop taking the study drug for any reason, the study center will continue to contact you every 3 months via phone or an in-office visit from the end of your treatment or follow up visit (which ever comes later) to see how you are doing.

    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 metastatic cancer of the prostate which is resistant to hormone-based treatments, defined as castration-resistant.

    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.

    Hussain, MahaHussain, Maha
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03888612 STU00212897
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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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    Prospective Molecular Profiling To Guide Therapeutic Decision-making in Patients with Advanced Hepatocellular Cancer (HCC): An Insight to Next Generation Sequencing-Matched Systemic Therapy in Liver Cancer (PROTOLIGHT STUDY)

    Hepatocellular carcinoma (HCC) is the most common form of liver cancer, making up approximately 90% of all liver cancers. It is the fourth largest contributor to cancer-related deaths worldwide. HCC is considered to be a complex tumor. Despite recent drug approvals for HCC, it has become clear that only …

    Hepatocellular carcinoma (HCC) is the most common form of liver cancer, making up approximately 90% of all liver cancers. It is the fourth largest contributor to cancer-related deaths worldwide. HCC is considered to be a complex tumor. Despite recent drug approvals for HCC, it has become clear that only some populations of patients benefit from certain drugs. This leads researchers to suspect that treatment for HCC would be more effective if we could match specific characteristics of a patient’s tumor with a drug that targets them best. Genomic analysis using an FDA-approved method called Next Generation Sequencing (NGS) could be used to potentially help physicians make such treatment decisions. The purpose of this study is to see how long patients will benefit if genomic analysis of their tumors is used to recommend more targeted treatments for HCC from a number of FDA-approved drugs.

    Eligible participants are at least 18 years of age and have advanced hepatocellular cancer (HCC) or recurrent HCC for which they have not yet received systemic therapy for, and are are not candidates for resection, transplant or liver-directed therapies.
    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00212975
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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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    (xIRB NCI CIRB) ECOG-ACRIN 1181: Preoperative THP and Postoperative HP in Patients Who Achieve a Pathologic Complete Response Part 1 Component of: The CompassHER2 Trials (COMprehensive Use of Pathologic Response ASSessment to Optimize Therapy in HER2-Positive Breast Cancer) (CompassHER2-pCR)

    This study isbeing done to answer the following question: Can participantswith HER2-positive breast cancer who have no cancer remaining at surgery(either in the breast or underarm lymph nodes) after 12 weeks of chemotherapyand two HER-targeted therapies eliminate further chemotherapy after surgery? This would be adecrease in the …

    This study isbeing done to answer the following question:

    Can participantswith HER2-positive breast cancer who have no cancer remaining at surgery(either in the breast or underarm lymph nodes) after 12 weeks of chemotherapyand two HER-targeted therapies eliminate further chemotherapy after surgery?

    This would be adecrease in the total number of chemotherapy drugs and the amount ofchemotherapy typically received to treat this type of cancer. We are doing thisstudy because we want to find out if this approach can enable you to take fewerchemotherapy drugs than the usual approach for your type of breast cancerwithout compromising your outcome. The usual approach is defined as care mostpeople get for HER2-positive breast cancer. Usual treatment includes additional chemotherapy drugs that might not benecessary, since the HER2-targeted drugs are so effective.

    The names of thestudy drugs involved in this study are:

    • Paclitaxel (also called Taxol). Thisis chemotherapy. [Alternativechemotherapy drugs allowed in the trial include docetaxel (also called Taxotere)or nab-paclitaxel (also called Abraxane)].
    • Trastuzumab (alsocalled Herceptin). This is HER2-therapy.
    • Pertuzumab (also called Perjeta).This is HER2-therapy.

    All chemotherapy drugs will be givenintravenously through vein for 4 cycles. A cycle consists of 3 weeks. Before surgery, paclitaxel will be givenweekly for 12 weeks; pertuzumab will be given once every cycle; and trastuzumabonce every cycle or once weekly for 12 weeks. Alternatives to paclitaxel include docetaxel that will be given once percycle or nab-paclitaxel that would be given weekly for 12 weeks.

    • Participantsmust have a confirmed diagnosis of HER2-positive primary invasive breastcarcinoma

    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.

    Stein, Regina MStein, Regina M
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04266249 STU00213352
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    A Phase 1/2 Study of Oral LOXO-305 in Patients With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Non-Hodgkin's Lymphoma (NHL)

    atientsof Chronic Lymphocytic Leukemia/Small lymphocytic Lymphoma (CLL/SLL) orNon-Hodgkin's Lymphoma (NHL) who did not respond to standard treatment. Bruton’sTyrosine Kinase (BTK) is a molecular enzyme that plays a key role in thesurvival of B cell malignancies like CLL, SLL, and NHL. The drug LOXO -305 isknown …

    atientsof Chronic Lymphocytic Leukemia/Small lymphocytic Lymphoma (CLL/SLL) orNon-Hodgkin's Lymphoma (NHL) who did not respond to standard treatment.

    Bruton’sTyrosine Kinase (BTK) is a molecular enzyme that plays a key role in thesurvival of B cell malignancies like CLL, SLL, and NHL. The drug LOXO -305 isknown to inhibit /block the BTK pathway thus has the potential to treat thesecancers. There are previously approvedBTK inhibitor drugs, which are already in use in treating these cancers; however,they have limitations, due the development of toxicity or drug resistance.

    LOXO -305 is currently not approved by the FDA

    · Participants must be 18 years orolder

    Participants must have a confirmed diagnosis B-cell malignancy(e.g., CLL/SLL, WM, NHL), failed or intolerant to either ≥ 2 prior standard ofcare regimens
    Ma, ShuoMa, Shuo
    • Map it 201 East Huron Street Suite 12-160​
      Chicago, IL
    NCT03740529 STU00211921
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    DRUG CCTL019B2003I: Managed Access Program (MAP) to provide access to CTL019, for acute lymphoblastic leukemia (ALL) or large B-cell lymphoma patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release.

    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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    (xIRB) NCI CIRB NRG CC008: A Non-Randomized Prospective Clinical Trial Comparing the Non-Inferiority of Salpingectomy to Salpingo-oophorectomy to Reduce the Risk of Ovarian Cancer Among BRCA1 Carriers [SOROCk]

    The main purpose of this study is to determine if two surgical procedures, the usual approach of removing the fallopian tubes and ovaries and the other approach of removing the fallopian tubes at this time with the plan to remove the ovaries at a later time, are no different for …

    The main purpose of this study is to determine if two surgical procedures, the usual approach of removing the fallopian tubes and ovaries and the other approach of removing the fallopian tubes at this time with the plan to remove the ovaries at a later time, are no different for ovarian cancer risk reduction in women with BRCA1 mutations who have completed childbearing.

    You may be eligible to participate in this study if you are an adult with a BRCA1 mutation and have elected to undergo a surgical intervention.

    Barber, Emma LongleyBarber, Emma Longley
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04251052 STU00213473
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    DRUG QBGJ398-302: Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial of Infigratinib for the Adjuvant Treatment of Subjects with Invasive Urothelial Carcinoma with Susceptible FGFR3 Genomic Alterations (PROOF 302)

    The PROOF 302 trial is a clinical research study that aims to determine whether patients whohave undergone surgery to remove invasive urothelial cancer that also have a geneticabnormality (changes in the tumor’s DNA) in the Fibroblast Growth Receptor 3 (FGFR3), whoreceive the investigational drug infigratinib for one year remain …

    The PROOF 302 trial is a clinical research study that aims to determine whether patients whohave undergone surgery to remove invasive urothelial cancer that also have a geneticabnormality (changes in the tumor’s DNA) in the Fibroblast Growth Receptor 3 (FGFR3), whoreceive the investigational drug infigratinib for one year remain cancer free compared to thosewho receive placebo for one year.

    1. Are ≥18 years of age of either sex.

    2. Have histologically or cytologically confirmed, invasive urothelial carcinoma with susceptible FGFR3alterations within 120 days following nephroureterectomy, distal ureterectomy, or cystectomy.

    Meeks, Joshua JMeeks, Joshua J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04197986 STU00211963
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    (xIRB) NCI CIRB ETCTN 10300: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 1 (BLAST MRD AML-1): A Randomized Phase 2 Study of the Anti-PD-1 Antibody Pembrolizumab in Combination with Conventional Intensive Chemotherapy as Frontline Therapy in Patients with Acute Myeloid Leukemia

    The purpose of this study is to compare theusual treatment alone to adding immune system activating therapy, Pembrolizumab(MK-3475), to the usual treatment. This study will help the study doctors findout if this different approach is better than the usual approach. To decide if it is better, the study …

    The purpose of this study is to compare theusual treatment alone to adding immune system activating therapy, Pembrolizumab(MK-3475), to the usual treatment. This study will help the study doctors findout if this different approach is better than the usual approach. To decide if it is better, the study doctorswill be looking to see if the addition of pembrolizumab results in fewerdetectable leukemia using new methods.

    Pembrolizumab (MK-3475), is already approvedby the FDA for use in several cancers, including advanced or metastaticsmall-cell and non-small cell lung cancer, melanoma, head and neck cancer,urothelial cancer, hepatocellular carcinoma, gastric cancer, among others. However, Pembrolizumab (MK-3475) is notapproved by the FDA or known to be safe for use in AML either alone or incombination with standard chemotherapy.

    This study has 2 study groups. You will be putinto a group by chance. You will have anequal chance of being in Group 1 or Group 2

    Group 1

    Participants in group 1 will get the usualstudy drugs, cytarabine on Days 1-7 and either daunorubicin or idarubicin onDays 1-3. If you have evidence ofresidual leukemia in the bone marrow at Day 14, you will receive a second roundof the first part of therapy (5+2 chemotherapy), which means cytarabine on Days1-5 and either daunorubicin or idarubicin on Days 1-2. If you have a complete remission after thefirst part of therapy, you will continue with the second part of therapy thatconsists of up to four cycles of high dose cytarabine. If you remain in complete remission aftersecond part of therapy, you will be monitored without further therapy for up to3 years. If you proceed with atransplant, you will forgo any remaining protocol-defined therapy.

    Group 2

    Participants in group 2 will get the usualstudy drugs, cytarabine on Days 1-7 and either daunorubicin or idarubicin onDays 1-3. If you have evidence ofresidual leukemia in the bone marrow at Day 14, you will receive second dose ofthe first part of therapy (5+2 chemotherapy), which means cytarabine on Days1-5 and either daunorubicin or idarubicin on Days 1-2. Regardless of your bone marrow findings onDay 14, you will receive Pembrolizumab (MK-3475) IV on Day 8. If you have a complete remission after thefirst part of therapy, you will continue with the second part of therapy thatconsists of up to four cycles of high dose cytarabine with Pembrolizumab(MK-3475). If you remain in completeremission after the second part of therapy, you will be monitored withoutPembrolizumab (MK-3475) therapy on Day 1 of each 21-day cycle for up to 2years. If you proceed with a transplant,you will forgo any remaining protocol-defined therapy.

    Participants between the ages of 18 and 75 who have newly diagnosed AML willbe enrolled into this study.

    Dinner, Shira NaomiDinner, Shira Naomi
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04214249 STU00213544
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    (xIRB) NCI CIRB ETCTN 10334: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 2 (BLAST MRD AML-2): A Randomized Phase 2 Study of the Venetoclax, Azacitadine, and Pembrolizumab (VAP) Versus Venetoclax and Azacitadine as First Line Therapy in Older Patients with Acute Myeloid Leukemia (AML) Who Are Ineligible or Who Refuse Intensive Chemotherapy

    The purpose of this study is to compare the usual treatment alone to adding MK-3475 (pembrolizumab) to the usual treatment. 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 …

    The purpose of this study is to compare the usual treatment alone to adding MK-3475 (pembrolizumab)

    to the usual treatment. 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 addition of pembrolizumab results in fewer detectable leukemia using new methods.

    MK-3475 (pembrolizumab), is already approved by the FDA for use in several cancers.

    However, MK-3475 (pembrolizumab) is not approved by the FDA or known to be safe for use in AML either alone or in combination with standard chemotherapy.

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

    Group 1

    Participants in this group will get the usual study drugs, azacitidine on Days 1-7 and

    venetoclax on Days 1-28 of the first cycle and on Days 1-21 or Days 1-28 of each cycle thereafter

    depending on the results of your blood count. If you are unable to receive azacitidine over

    the weekend, your doctor may give it to you for 5 days in week 1 and 2 days in week 2.

    If you derive a clinical benefit within the first 6 cycles of therapy, you will continue

    with the second part of therapy that consists of the same combination for up to 3 years

    provided you do not stop responding at any time during the second part of therapy.

    Group 2

    Participants in this group will get the usual study drugs, azacitidine on Days 1-7 and

    venetoclax on Days 1-28 of the first cycle and on Days 1-21 or Days 1-28 of each cycle thereafter

    depending on the results of your blood count. If you are unable to receive azacitidine over

    the weekend, your doctor may give it to you for 5 days in week 1 and 2 days in week 2.

    You will receive MK-3475 (pembrolizumab) on Day 8 of the first cycle and every 3 weeks thereafter.

    If you derive a clinical benefit within the first 6 cycles of therapy,

    you will continue with the second part of therapy that consists of the same combination

    for up to 3 years provided you do not stop responding.

    Participants ages 60 years or older who have newly diagnosed AML will be enrolled in this study. 
    Dinner, Shira NaomiDinner, Shira Naomi
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04284787 STU00213545
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    (xIRB) NCI CIRB SWOG 1823: A Prospective Observational Cohort Study to Assess mRNA 371 for Outcome Prediction in Patients with Newly Diagnosed Germ Cell Tumors

    The purpose of this study is for the study doctors to learn if miRNA 371 is useful for predicting relapse in patients with germ cell cancer. A germ cell tumor is a type of cancer that occurs in the ovaries (for females) or the testes (for males). This tumor may …

    The purpose of this study is for the study doctors to learn if miRNA 371 is useful for predicting relapse

    in patients with germ cell cancer. A germ cell tumor is a type of cancer that occurs in the ovaries (for females) or the testes (for males). This tumor may also be found in the pelvis along the tailbone, the chest, the abdomen and in other structures of the body, generally along the midline of the body.

    A sample of your blood will be collected during regular clinic visits to look for the presence of a tumor marker called miRNA 371. The study doctors do not know if the test is as good as the usual care (tumor scans and bloodwork) in predicting when cancer will return (relapse) in patients with germ cell cancer. If better, this blood test could change the way patients are monitored for relapse in the future.

    If you decide to take part in this study, an extra tube of blood will be collected during your regular clinic visits for miRNA 371

    analysis for up to 3 years from enrollment into the study.

    Participants 18 years of age or older who have germ cell cancer will be enrolled.

    Kundu, Shilajit DKundu, Shilajit D
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00213585
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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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    DRUG AT148002: A Phase 1/2 Study of ALX148 in Combination with Azacitidine in Patients with Higher Risk Myelodysplastic Syndrome (MDS) (ASPEN-02)

    The purpose of this research study is to learn about the effects of the study drug, ALX148, in combination with azacitidine (AZA), a standard treatment for MDS. The study is being done to assess the safety and tolerability of ALX148, to document the levels of ALX148 in the blood, and …
    The purpose of this research study is to learn about the effects of the study drug, ALX148, in combination with azacitidine (AZA), a standard treatment for MDS. The study is being done to assess the safety and tolerability of ALX148, to document the levels of ALX148 in the blood, and to document the effects of ALX148 on your cancer when given together with AZA.

    This Phase 1/2 study includes two parts. In the Phase 1 part of this study, increasing doses of ALX148 will be given together with AZA. In the Phase 2 part of the study, ALX148 will be given at a dose selected from the Phase 1 part in combination with AZA. Depending on the timing, you will participate in either the Phase 1 or Phase 2.

    You will continue to receive treatment in the study as long as: you benefit from study treatment; you do not experience severe side effects; and you are willing to continue to undergo study-specific assessments. There is a 14-day screening period that will begin when you sign the consent form (up to 14 days before your first dose of ALX148), and a follow-up period for up to 3 years after your last dose of ALX148.

    This study will consist of a screening visit(s) and multiple cycles of study treatment and evaluation that will involve multiple visits to the clinic, an end of study visit, and a follow-up visit(s). ALX148 is administered by an intravenous (through a vein) infusion lasting approximately 60-90 minutes in the clinic. AZA will be given once daily either by vein or by injection under the skin for 7 days, every 4 weeks.

    The ALX148 study drug will be administered either every 2 or 4 weeks. AZA will be administered once daily for 7 days, every 4 weeks. A treatment cycle is 28 days both for ALX148 dosing every 2 or 4 weeks. It is possible that your treatment schedule may be changed. For example, your study doctor may start you on an every 4 week schedule and then change the schedule to every 2 weeks based on how well you tolerate the drug.

    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 higher risk myelodysplastic syndrome (MDS) that is either no longer responsive to standard therapies of proven effectiveness and/or for which new safe and effective therapies need to be developed to improve outcomes.

    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.

    Altman, Jessica KAltman, Jessica K
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04417517 STU00213414
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    DRUG ELVCAP-001-01: A Phase 2 Study of Seribantumab in Adult Patients with Neuregulin-1 (NRG1) Fusion Positive Locally Advanced or Metastatic Solid Tumors

    The purpose of this study is to test an experimental drug called seribantumab. This means that seribantumab is still being studied to better understand the potential efficacy and safety of the drug. It also means that the U.S. Food and Drug Administration (FDA) or regulatory authorities from other countries …

    The purpose of this study is to test an experimental drug called seribantumab. This means that seribantumab is still being studied to better understand the potential efficacy and safety of the drug. It also means that the U.S. Food and Drug Administration (FDA) or regulatory authorities from other countries do not allow it to be sold for treating patients. Seribantumab can only be used in research and on a clinical research trial. This study is being done:

    •To determine how well your NRG1 gene fusion positive cancer responds to treatment with seribantumab;

    •To determine how long any benefits from treatment with seribantumab last;

    •To determine the highest and safe dose of seribantumab for NRG1 fusion patients

    •To evaluate how the body absorbs and processes different doses of seribantumab (this is called pharmacokinetic (PK) testing);

    •To see if certain biomarkers from tumor tissue or blood samples are linked with positive or negative response outcomes

    This is an open-label study. This means that you, the study doctor, study staff, and the Sponsor will know the study drug and the doses that you are given.

    The length of the study will vary for each person and will be determined by the number of treatment cycles. Overall, you should expect to be on treatment for at least six months or longer. The number of study-visits you will have will be based on the following schedule:

    •Screening period: One or more visits for up to 28 days

    •Induction Treatment period: Weekly visits for 4 weeks.

    •Consolidation Treatment period: Every other week visits for 12 weeks and a total of 6 visits.

    •Maintenance Treatment period: Visits every three weeks until you end your treatment.

    If you are eligible, after the screening period, you will receive treatment with study drug once every 7-days for a total of four weeks. When you start treatment, you will be given an initial amount of seribantumab during your first visit. For your second, third and fourth visits during treatment, the dose of seribantumab will be adjusted based upon how well you and other patients tolerate the planned induction dose. Your study doctor and study team will let you know what dose you will receive for the second, third and fourth induction treatment visits.

    You will receive an infusion of the study drug directly into your vein. This is done by inserting a small hollow tube into a vein in your arm. The tube is placed into the vein with a needle. When the tube is in place, the needle is withdrawn, and the tube is secured with tape. The infusion will take about 60 minutes. Following the study drug infusion, your study doctor may require you to stay in the study clinic for up to an hour or longer, so that he/she can monitor you.

    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 advanced or metastatic tumor that is believed to be caused by a change in the NRG1 gene called a fusion

    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
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04383210 STU00213426
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    ECOG-ACRIN 6192: A Phase II Study of Biomarker Driven Early Discontinuation of Anti-PD-1 Therapy in Patients with Advanced Melanoma (PET-Stop)

    This study is being done to answer the following question:Can we safely shorten the use of standard of care anti-PD1 therapy for advanced melanoma by using biomarkers seen on PET/CT imaging and tumor biopsy?…
    This study is being done to answer the following question:Can we safely shorten the use of standard of care anti-PD1 therapy for advanced melanoma by using biomarkers seen on PET/CT imaging and tumor biopsy?
    • Participants must be 18 years or older
    • Participants must be actively receiving standard of care anti-PD-1 therapy
    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
    NCT04462406 STU00213767
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    (XIRB) Drug MT5111_001; A Phase 1b open-label, multicenter dose escalation and expansion study of MT-5111 in subjects with previously treated advanced HER2-positive solid tumors

    The investigational drug tested in this study, called MT-5111, is a biologic drug that is an antibody attached to a toxin. An antibody is a protein and in the case of the study drug it is connected to atoxin that has been shown to slow the growth of cancer …

    The investigational drug tested in this study, called MT-5111, is a biologic drug that is an antibody attached to a toxin. An antibody is a protein and in the case of the study drug it is connected to atoxin that has been shown to slow the growth of cancer cells or to kill cancer cells in laboratory experiments and in animals with cancer. The antibody recognizes and binds to the HER2 on the surface of cancer cells and afterwards kills these cells.

    This is the first research study involving MT-5111 (study drug) in humans. The study drug is experimental. It has not been approved for the treatment of cancer by any regulatory authorities and is not commercially available.

    The trial will be divided into two parts: Part A (dose-escalation) and Part B (doseexpansion).

    The objective of Part A is to determine the highest tolerable dose of study drug with the goal of defining the recommended dose to be used in Part B.

    The purpose of Part B is to confirm the safety and tolerability of the recommended dose of study drug that was determined during Part A, and to start to assess whether the study drug is a useful treatment for subjects with certain types of advanced HER2-positive solid tumors.

    Key eligibility criteria include: •Subject must have histologically confirmed, unresectable, locally advanced or metastatic solid cancers. oa. In Part A, all HER2-positive solid cancers are eligible. ob. In Part B, HER2-positive breast, GEA and other HER2- positive solid cancers are eligible for the respective expansion groups.• All subjects in both parts of the study must be HER2-positive in the latest tumor sample tested for HER2 (it is required that testing is done on a metastatic lesion in cases of metastatic cancers for subjects with metastatic disease), according to standard testing procedures. For the purpose of this study, HER2-positivity is defined as: oa. Tumors tested by IHC: must have an IHC status of 2+ or 3+, regardless of ISH result OR ob. BC or GEA tumors tested by ISH only (no IHC available): must be HER2-positive. Note: cancers other than BC and GEA must be tested via IHC and must have a status of 2+ or 3+, regardless of ISH result.•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..

    .

    Gradishar, William JGradishar, William J
    • Map it 201 East Huron Street Suite 12-160​
      Chicago, IL
    NCT04029922 STU00213784
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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) DRUG 20190135: A Phase 1b, Master Protocol Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Sotorasib in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation

    PURPOSE: The purpose of this study isto evaluate the safety and tolerability of sotorasib (AMG 510) in combinationwith other cancer treatments in patients with advanced tumors. Sotorasib is an investigationalanticancer drug that is being developed for tumors with a specific mutationcalled KRAS p.G12C. There are threedifferent sub-studies named …

    PURPOSE: The purpose of this study isto evaluate the safety and tolerability of sotorasib (AMG 510) in combinationwith other cancer treatments in patients with advanced tumors. Sotorasib is an investigationalanticancer drug that is being developed for tumors with a specific mutationcalled KRAS p.G12C. There are threedifferent sub-studies named I, J, and K.

    Sub-study I:This research studyis being done to evaluate the effects of a new combination of sotorasib andpembrolizumab that is being investigated for adult subjects with advancedNon-small Cell Lung Cancer (NSCLC) with a specific mutation called KRAS p.G12C.

    Sub-study J:This study is being done to learn moreaboutsotorasib in combination with palbociclib in participants with advanced solidtumors with KRAS P.G12C mutation.

    Sub-study K:This research study is being done to test theeffects of a new combination of sotorasib with everolimus that is beinginvestigated for adult subjects with certain cancer types with a specificmutation called KRAS p.G12C.

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

    OVERVIEW:

    Sub-study I:If you meet the study requirements and are enrolledyou will be in this study for about 4 years, which includes screening ofup to 28 days, study procedures of approximately 8 months, safetyfollow-up visit 30 (plus 3) days after the last dose of study drugs and up to 3years of long-term follow-up (LTFU). However, this may vary depending on how well you tolerate or respond totherapy.

    Sub-study J:If you meet the study requirements and are enrolledyou will be in this study for about 4 years which will include screeningperiod of up to 28 days, a study procedure period of approximately8 months, a 30 (plus 3) days safety follow‑up (SFU), afterthe last dose of investigational product or protocol mandated therapies. Following SFU, you will enter a long‑termfollow‑up period (LTFU), in which you will be followed up in clinic or viatelephone every 12 weeks (± 2 weeks) for assessment of survival anddocumentation of anti‑cancer treatment for up to 3 years.

    Sub-studyK:If you meet the studyrequirements and are enrolled, you will be in this study for about4 years. This includes up to 28days of screening, approximately 8 months of study procedures (which may varydepending on how well you tolerate or respond to the study drugs), a safetyfollow-up visit about 30 (plus or minus 3) days after your lastdose of study drugs, and up to 3 years of long-term follow-up.

    · · · · Sub-studyK: diagnosis of certain cancer types with a specific mutation called KRASp.G12C.

    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
    NCT04185883 STU00213909
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    ECOG-ACRIN 9181: A Phase III Randomized Trial of Steroids + Tyrosine Kinase Inhibitor Induction with Chemotherapy or Blinatumomab for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults

    This study is being done to answer the following question: This study is being done to determine what effects (good or bad) using the combination of potent TKI, steroids and blinatumomab versus treatment with steroids, TKI and chemotherapy. This investigational therapy will be added to what has traditionally been used …
    This study is being done to answer the following question: This study is being done to determine what effects (good or bad) using the combination of potent TKI, steroids and blinatumomab versus treatment with steroids, TKI and chemotherapy. This investigational therapy will be added to what has traditionally been used to treat your specific sub-type of ALL. Studies are being done in ALL and other blood cancers with blinatumomab. We are doing this study because we want to find out if this approach is better or worse than the usual approach for you. The usual approach is defined as care most people get for ALL.
    • Participants must be 18 years or older
    • Participants must have a confirmed diagnosis of newly diagnosed BCR-ABL-positive Acute Lymphoblastic Leukemia (ALL).
    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
    NCT04530565 STU00213941
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    (xirb) DRUG SGN35-033 : A Phase 2 Study of Brentuximab Vedotin in Combination with Pembrolizumab in Subjects with Metastatic Solid Malignancies After Progression on Prior Pd-1 Inhibitor Treatment

    This is a phase 2 clinical trial designed to evaluate effectiveness and safety of brentuximab vedotin in combination with pembrolizumab (alsocalled KEYTRUDA® ) in patients with lung or skin cancer who had tumorprogression, after they had PD-1 inhibitor treatment.…
    This is a phase 2 clinical trial designed to evaluate effectiveness and safety of brentuximab vedotin in combination with pembrolizumab (alsocalled KEYTRUDA® ) in patients with lung or skin cancer who had tumorprogression, after they had PD-1 inhibitor treatment.

    We’re asking you to take part in a clinical trial (study) because you have lung or skin cancer that has spread to other parts of your body. And your cancer has come back or gotten worse since your last treatment.
    Chandra, SunandanaChandra, Sunandana
    NCT04609566 STU00213974
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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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    NU 20H07: 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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    NU 20H02: Phase II Study of Brentuximab Vedotin in Combination with Pembrolizumab in Patients with Recurrent Systemic Peripheral T-Cell Lymphoma (PTCL)

    The purpose of this study is to assess the antineoplastic efficacy of brentuximab vedotin in combination with pembrolizumab in previously treated patients with PTCL.

    Relapsed and refractory T-cell lymphomas remain an ongoing challenge with repeated courses of cytotoxic chemotherapy often yielding diminishing results. The 5-year overall survival (OS) and progression free survival (PFS) in transplant ineligible patients with T-cell lymphomas was 32% and 20%, respectively. There remains a significant need for more active therapies and combinations.

    Brentuximab vedotin is an FDA approved antibody-drug and is an effective agent in PTCL. Studies have shown this drug has a response rate of upto 40 % in PTCL

    Pembrolizumab is an FDA approved antibody-drug which targets the programmed death-1 (PD-1) immune checkpoint pathway and restores bodies natural antitumor immune responses.

    An early study with nivolumab and a more recent study with pembrolizumab showed that PD1 blockade is associated with antitumor effects in PTCL. A recent report showed significant single agent activity of pembrolizumab in NK-T cell lymphoma. Seven patients who had failed asparaginase-containing regimens were treated with single agent pembrolizumab, and all patients responded, with 5 of the CRs still ongoing at a median follow-up of 6 months. Additionally, in patients with recurrent Hodgkin lymphoma (HL), the combination of nivolumab and brentuximab vedotin was shown to be safe and effective.

    Together, the two agents could yield improved response rates and improved durability of responses, potentially leading to better long-term outcomes.

    · The target population for this study ispatients with CD30-expressing relapsed/refractory peripheral T-cell lymphoma

    Moreira, JonathanMoreira, Jonathan
    • Map it 675 N. St. Clair St.
      Chicago, IL
    NCT04795869 STU00213618
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    DRUG Q702-ONC-P1-US001 A Phase 1 Multicenter, Open-label, Dose-Escalation, Safety, Pharmacodynamic, Pharmacokinetic Study of Q702 with a Cohort Expansion at the RP2D in Patients with Advanced Solid Tumors

    The major purpose of this study is to determine the highest dose of Q702 that does not result in severe side effects, the dose that is tolerated, and once this dose is found, if it has any effect against the cancer in patients with solid cancer tumors. This study is …
    The major purpose of this study is to determine the highest dose of Q702 that does not result in severe side effects, the dose that is tolerated, and once this dose is found, if it has any effect against the cancer in patients with solid cancer tumors. This study is being done:

    • To test the safety of Q702 and see what effects (good and bad) it has on you and your cancer.
    • To find the highest dose of Q702 that can be given without causing serious side effects when treatment is given every day for 7 days, followed by 7 days of no treatment, repeated two times during a 28-day cycle.
    • To find the dose of Q702 that should be used in future studies.
    • To evaluate what the human body does and how the body reacts to Q702.

    This research is being performed because improvements are needed in the treatment of patients with cancer.

    We are asking you to take part in this research study because you have cancer that has continued to grow despite the treatments you have already received. Either the standard drugs and therapies used to treat your disease are no longer working or there are no known treatments which work because your tumor cells may be resistant to available treatments or you are not a candidate for or intolerant of available treatment. Your cancer had been confirmed by a pathologist (a person who studies the causes and effects of diseases).

    This clinical trial tests a study drug, Q702. The study drug, Q702, targets certain molecules present in cancer cells that may help activate your body's immune system to fight the cancer. The study drug, Q702, is not approved for sale by the FDA.

    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04648254 STU00213510
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    NU MDA20L01: An Open-Label Randomized Phase II Study of Combining Osimertinib with and without Ramucirumab in TKI-naïve EGFR-mutant Locally Advanced or Metastatic NSCLC

    The purpose of this study is to compare the usual treatment osimertinib alone to ramucirumabplus the usual treatment (osimertinib). The addition of ramucirumab to the usual treatment could help osimertinib control the abnormal EGFR protein for a longer duration and in turn, for you tohave a longer period of …
    The purpose of this study is to compare the usual treatment osimertinib alone to ramucirumabplus the usual treatment (osimertinib). The addition of ramucirumab to the usual treatment could help osimertinib control the abnormal EGFR protein for a longer duration and in turn, for you tohave a longer period of time that your disease is inactive.We are doing this study because we want to find out if this approach is better or worse than theusual approach for your cancer. The usual approach is defined as care most people get for thetreatment of non-small cell lung cancer. 
    Age ≥ 18 years at the time of consent, Histologically or cytologically confirmed non-squamous, nonsmall cell lung cancer, Locally advanced or metastatic disease, not amenable tocurative surgery or radiotherapy.
    Patel, Jyoti DPatel, Jyoti D
    • Map it 201 East Huron Street Suite 12-160​
      Chicago, IL
    NCT03909334 STU00212727
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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 SGNLVA-005: Open-Label Phase 2 Study of Ladiratuzumab Vedotin (LV) for Unresectable Locally Advanced or Metastatic Solid Tumors

    The purpose of this study is to find out if the experimental drug called ladiratuzumab vedotin (LV) or SGN-LIV1A works for solid tumor cancers and what kind of side effects it causes.LV is a type of drug called an antibody drug conjugate or ADC. ADCs usually have 2 …

    The purpose of this study is to find out if the experimental drug called ladiratuzumab vedotin (LV) or SGN-LIV1A works for solid tumor cancers and what kind of side effects it causes.

    LV is a type of drug called an antibody drug conjugate or ADC. ADCs usually have 2 parts.

    •Antibody: Antibodies are part of your immune system. Usually they help protect you from getting sick. In LV, we are using an antibody designed to find and stick to the solid tumor cancer cells in your body.

    •Drug: The drug is the part of the ADC that kills cells. The cell-killing part of LV is a drug called MMAE.

    In LV, the antibody part is designed to stick to cancer cells so that the drug part can kill them. It may also stick to some non-cancer cells in your body.

    This study has 2 groups in it, part A and part B. Part A is closed to enrollment. If you qualify, you will be enrolled in part B and you will receive LV once every week.

    We will give you LV in 21-day treatment cycles. If your cancer stays the same or gets better, and you don’t have bad side effects, you can keep getting LV treatments until the treatment part of the study is closed, which may be several years after your first cycle.

    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 one of the solid tumor types of cancer in the list below:

    osmall cell lung cancer (SCLC)

    onon-small cell lung cancer-squamous (NSCLC-Sq)

    onon-small cell lung cancer–nonsquamous (NSCLC-non Sq)

    ohead and neck squamous cell carcinoma (HNSCC)

    oesophageal squamous cell carcinoma (ESCC)

    ogastric and gastroesophageal junction adenocarcinoma (G/GEJ-A)

    oprostate cancer

    omelanoma

    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
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04032704 STU00214153
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    (xIRB) NCI CIRB ECOG-ACRIN 2197: Optimal Perioperative Therapy for Incidental Gallbladder Cancer (OPT-IN): A Randomized Phase II/III Trial

    The purpose of this study is to compare the usual treatment(surgery plus chemotherapy after) to using chemotherapy both before and aftersurgery. This study will help the study doctors find out if thisdifferent approach is better than the usual approach. To decide if it isbetter, the study doctors will look …

    The purpose of this study is to compare the usual treatment(surgery plus chemotherapy after) to using chemotherapy both before and aftersurgery.

    This study will help the study doctors find out if thisdifferent approach is better than the usual approach. To decide if it isbetter, the study doctors will look to see if the chemotherapy increases thetime to disease recurrence and if it increases a patient’s overall survivalcompared to the usual approach given both before and after surgery.

    There are two groups in this study.

    Group 1 (Control Arm-Arm A) receives surgery and then 6 monthsof chemotherapy (gemcitabine/ cisplatin) after surgery.

    Group 2 (Treatment Arm-Arm B). In Group 2, participants willreceive 3 months of chemotherapy) prior to undergoing surgery, followed by 3months of chemotherapy after undergoing surgery.

    Participants will be randomly assigned to one group or theother. In Group 2, there will be a waiting period of approximately 4-8 weeksafter completion of chemotherapy before undergoing surgery. Only patients whohave not progressed with disease outside the area of the surgery will proceedto surgery.

    After all the treatment is done, participants will havefollow-up procedures with imaging studies (CT and/or MRI) every 3 months for 2years and every 6 months for year 3 after treatment or until diseaserecurrence, whichever comes first.

    Participants ages 18 years or older who have recently been diagnosedwith gallbladder cancer that was found after their gallbladder was removedduring surgery.
    Chawla, AkhilChawla, Akhil
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00214491
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    (xIRB) NCI CIRB Alliance A091902: A Multicenter Phase II Trial of Paclitaxel with and Without Nivolumab in Taxane Naïve, and Nivolumab and Cabozantinib in Taxane Pretreated Subjects with Angiosarcoma

    The purpose of thisstudy is to compare treatment with chemotherapy (paclitaxel) alone to using acombination of nivolumab plus chemotherapy (paclitaxel) treatment inparticipants with angiosarcoma who have not been treated with paclitaxel chemotherapyalone. Another purpose is to evaluate the effect of nivolumab in combinationwith cabozantinib on angiosarcoma (cancer) in participants who …

    The purpose of thisstudy is to compare treatment with chemotherapy (paclitaxel) alone to using acombination of nivolumab plus chemotherapy (paclitaxel) treatment inparticipants with angiosarcoma who have not been treated with paclitaxel chemotherapyalone. Another purpose is to evaluate the effect of nivolumab in combinationwith cabozantinib on angiosarcoma (cancer) in participants who have eitherreceived paclitaxel or similar chemotherapy previously, or whose cancer hasgrown previously while getting paclitaxel chemotherapy on this study.

    This study has 2 study groups.

    Participants enrolledinto group 1 are those who have not received prior chemotherapy treatment withpaclitaxel or similar “taxane” chemotherapy. In this group, participants willbe assigned to one of two arms. In Arm 1, participants will receive combinationof paclitaxel and nivolumab. Participants assigned to Arm 2, will only receivepaclitaxel.

    You will be put into astudy arm by chance. You will have a 50:50 chance of being in Arm 1 or Arm 2.If you are assigned to Arm 2 and your cancer gets worse you will have thechoice to receive cabozantinib and nivolumab if your doctor feels it wouldbenefit you.

    Participantsenrolled into group 2 are those that have received prior chemotherapy treatmentwith paclitaxel or a similar “taxane” chemotherapy or participants who progresswhile in Group 1. In this group, participants will receive a combination ofcabozantinib and nivolumab.

    After treatment is finished, participants will be followed every3 months for 3 years to be watched for side effects.

    Participants ages 18 years or older who have a type of cancer called angiosarcoma.
    Pollack, Seth MichaelsPollack, Seth Michaels
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04339738 STU00214492
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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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    (xIRB) DRUG VS-6766-202: A Phase 2 Study of VS-6766 (Dual RAF/MEK Inhibitor) as a Single Agent and In Combination with Defactinib (FAK Inhibitor) in Recurrent KRAS-Mutant (KRAS-MT) and BRAF-Mutant (BRAF-MT) Non-Small Cell Lung Cancer (NSCLC)(RAMP 202)

    The main aims of this clinical study are to:•Find out if the best course of cancer treatment is to take either VS-6766 alone (monotherapy) or to take VS-6766 together (in combination) with defactinib.•Understand the safety of VS-6766 taken alone or taken together with defactinib.•Describe …

    The main aims of this clinical study are to:

    •Find out if the best course of cancer treatment is to take either VS-6766 alone (monotherapy) or to take VS-6766 together (in combination) with defactinib.

    •Understand the safety of VS-6766 taken alone or taken together with defactinib.

    •Describe how well and how long the study treatment with VS-6766 alone or in combination with defactinib works.

    •Measure the amount of VS-6766, defactinib and compounds related to the two study drugs in your blood at different times (this is called pharmacokinetics).

    This study will look at a potential treatment for KRAS-mutant or BRAF-mutant NSCLC by comparing VS-6766 taken alone, versus VS-6766 taken in combination with defactinib. The study will be conducted in two parts, Part A and Part B. Participants will only be taking part in one of these two parts, not both. The type of KRAS or BRAF mutation will determine which group participants will be enrolled in.

    Participants could be randomized (like the flip of a coin, with a 50:50 chance) to one of two study treatment groups or could be assigned to a study treatment group.

    The 2 study treatment groups:

    - Monotherapy: VS-6766 4.0 mg by mouth, twice weekly (for example: Monday/Thursday, Tuesday/Friday or Wednesday/Saturday), 3 weeks on and 1 week without study drug (each 4-week period is considered a cycle).

    - Combination Therapy: VS-6766 3.2 mg by mouth, twice weekly (for example: Monday/Thursday, Tuesday/Friday or Wednesday/Saturday) and defactinib 200 mg by mouth, twice a day, 3 weeks on and 1 week without study drug (each 4-

    week period is considered a cycle).

    For participants with BRAF-Mutant NSCLC, study treatment group is:

    - Combination therapy: VS-6766 3.2 mg by mouth, twice weekly (for example: Monday/Thursday, Tuesday/Friday, Wednesday/Saturday) and defactinib 200mg by mouth, twice a day, 3 weeks on and 1 week without study drug (each 4-week period

    is considered a cycle).

    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 have KRAS-mutant non-small cell lung cancer (NSCLC) or BRAF-Mutant NSCLC.

    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
    NCT04620330 STU00214623
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    (xIRB) NCI CIRB 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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    (xIRB) NCI CIRB ECOG-ACRIN 8185: Phase 2 Study of Bladder-SparIng ChemoradiatioN with MEDI4736 (Durvalumab) in Clinical Stage 3, Node PosItive BladdeR CancEr (INSPIRE)

    The purpose of this study is to compare the usual treatment of chemotherapy and radiation to adding MEDI4736 (durvalumab) immunotherapy to the usual treatment. This study will help determine if this different approach is better than the usual approach. To decide if it is better, the study doctors will be …

    The purpose of this study is to compare the usual treatment of chemotherapy and radiation to adding MEDI4736 (durvalumab) immunotherapy to the usual treatment. This study will help determine 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 life of patients compared to the usual approach.

    This immunotherapy drug,MEDI4736 (durvalumab), is already approved by the FDA for use in metastatic bladder cancer.

    Participants who decide to take part in this study will either get chemotherapy and radiation for 6-8weeks, or will get MEDI4736 (durvalumab) immunotherapy in addition to chemotherapy and radiation for 6.5-8 weeks. Participants in the MEDI4736(durvalumab) Group 1 whose bladder cancer has responded (shrunk, gone away or remained stable) to treatment with chemotherapy, radiation and MEDI4736(durvalumab) will be offered more treatments with MEDI4736 (durvalumab) alone for up to 9 months.

    Participants who are in the arm with chemotherapy and radiation, and whose cancer has responded, will be watched closely without any additional chemotherapy and radiation treatments. Participants whose cancer has not responded, may be offered surgery or some other treatment.

    After study treatment is finished, participants will be followed by the study doctor for up to 3 years.

    Participants ages 18 years or older who have bladder cancer that has spread from the bladder to the lymph nodes will be enrolled into this study.

    VanderWeele, David JamesVanderWeele, David James
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04216290 STU00214716
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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.

    Sosman, Jeffrey AlanSosman, Jeffrey Alan
    • 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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    NU UM20I04 : Phase 1/2 Trial to Evaluate Cabozantinib in Patients with Advanced Hepatocellular Carcinoma with Child Pugh Class B Cirrhosis after First-Line Therapy

    Patients with unresectable Hepatocellular carcinoma (HCC) with underlying Child-Pugh classB cirrhosis have no options for systemic therapy based on current guidelines and available evidence.The aim of this study is to determine the safety and efficacy of cabozantinib in the management of HCCin this patient population…

    Patients with unresectable Hepatocellular carcinoma (HCC) with underlying Child-Pugh classB cirrhosis have no options for systemic therapy based on current guidelines and available evidence.The aim of this study is to determine the safety and efficacy of cabozantinib in the management of HCCin this patient population

    Patients must have a radiologically consistent (early enhancement and delayed enhancement washout) or pathologically confirmed diagnosis of hepatocellular carcinoma that is not eligible for curative resection, transplantation, or ablative therapies

    Prior radiation, liver directed therapy (including bland, chemo- or radioembolization, or ablation), orhepatic resection are permitted if >4 weeks from start of therapy.

    Extra-hepatic palliative radiation is permitted if completed >2 weeks prior to first dose of study therapy and the patient has recovered to <grade 1 toxicity.

    Patients must have radiographically measurable disease (RECIST1.1) in at least one site not previously treated or with progression after radiation or liver directed therapy

    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 inthis clinical trial.

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

    Kalyan, AparnaKalyan, Aparna
    NCT04497038 STU00214060
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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
    STU00214918
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    DRUG KN035SAR201: ENVASARC: A Pivotal Trial of Envafolimab, and Envafolimab in Combination with Ipilimumab, in Patients with Advanced or Metastatic Undifferentiated Pleomorphic Sarcoma or Myxofibrosarcoma Who Have Progressed on Prior Chemotherapy

    The purposeof this study is to determine the effectiveness (how well the experimentaldrugs work) and safety of envafolimab, when given alone or in combination withipilimumab to patients with advanced or metastatic undifferentiated pleomorphicsarcoma (UPS) or myxofibrosarcoma (MFS) in order to stimulate the immune systemto attack cancer cells. Undifferentiatedpleomorphic sarcoma (UPS) …

    The purposeof this study is to determine the effectiveness (how well the experimentaldrugs work) and safety of envafolimab, when given alone or in combination withipilimumab to patients with advanced or metastatic undifferentiated pleomorphicsarcoma (UPS) or myxofibrosarcoma (MFS) in order to stimulate the immune systemto attack cancer cells.

    Undifferentiatedpleomorphic sarcoma (UPS) is a rare type of cancer that begins mostly in thesoft tissues of the body and myxofibrosarcoma (MFS) is a type of cancer thattypically appears as a slow-growing, painless lump on one of your legs or arms.

    • Age of at least 18 years
    • Locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS) or ≥ Grade 2 myxofibrosarcoma (MFS) (or Grade 1 MFS with documented metastases) confirmed by histologic analysis
    • Documented progression by radiographic criteria (e.g., RECIST, WHO, Choi) on or following chemotherapy

    Pollack, Seth MichaelsPollack, Seth Michaels
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04480502 STU00214197
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    (xIRB) NCI CIRB SWOG 2007: A Phase II Trial of Sacituzumab Govitecan (IMMU-132) (NSC #820016) for Patients with HER2-Negative Breast Cancer and Brain Metastases

    The purpose of this study is to examine the good and bad effects of taking the study drug sacituzumab govitecan. This study will help the study doctors to find out if taking the study drug, sacituzumab govitecan will help to decrease cancer in the brain more than usual treatment. The …

    The purpose of this study is to examine the good and bad effects of taking the study drug sacituzumab govitecan. This study will help the study doctors to find out if taking the study drug, sacituzumab govitecan will help to decrease cancer in the brain more than usual treatment. The study will also help the study doctors understand if taking the study drug extends the time until the cancer gets worse.

    Sacituzumab govitecan is not approved by the FDA for use in patients with HER2-negative breast cancer that has spread to the brain. It is approved for use in patients with metastatic triple negative breast cancer that was previously treated.

    Participants who are enrolled into this study will get the usual drugs selected by their study doctor that can help to prevent the side-effects that might be caused by the study drug. Participants will also get the study drug, sacituzumab govitecan, during each cycle. Each cycle lasts 21 days. This study has up to 35 cycles (or approximately 2 years).

    As long as the cancer does not get worse and participants do not experience severe side effects, and their study doctor determines that it is beneficial for them to remain on study, they will continue to get the study drug until completion of the study.

    Participants ages 18 years or older who have HER2-negative breast cancer with brain metastases that have spread after initial treatment will be enrolled into this study.
    Shah, Ami NShah, Ami N
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04647916 STU00214939
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    (XIRB) Drug R5668-ONC-1938: Phase 1/2 Study of REGN5668 (MUC16 X CD28, a Costimulatory Bispecfic) Administered in Combination with Cemiplimab OR REGN4018 (MUC16 X CD3)

    The main purposes of this study are to learn about the safety and profile of any side effects from the study drugs and to determine the highest, safe dose that can be given to patients with ovarian cancer and to look for signs that the study drugs can treat ovarian …

    The main purposes of this study are to learn about the safety and profile of any side effects from the study drugs and to determine the highest, safe dose that can be given to patients with ovarian cancer and to look for signs that the study drugs can treat ovarian cancer

    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.

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

    Roque, Dario RRoque, Dario R
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04590326 STU00214950
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    (xirb) Drug BGB-11417-101: A Phase 1/1b Open-Label Dose Escalation and Expansion Study of Bcl-2 Inhibitor BGB-11417 in Patients with Mature B-Cell Malignancies

    This study will look at the safety and tolerability of an investigational anticancer drug currently known as BGB-11417. In addition, this study also aims to look at the safety of BGB-11417 when given in combination with zanubrutinib (also known as BGB-3111). BGB-11417 is made by BeiGene, …

    This study will look at the safety and tolerability of an investigational anticancer drug currently known as BGB-11417. In addition, this study also aims to look at the safety of BGB-11417 when given in combination with zanubrutinib (also known as BGB-3111).

    BGB-11417 is made by BeiGene, Ltd. BGB-11417 is an experimental drug. This means that it has not been approved for treatment by the Food and Drug Administration (FDA) in the United States or other regulatory agencies outside the United States where the Sponsor seeks approval of BGB-11417. As of 04 February 2021, BGB-11417 as a single drug has been given to over 9 participants enrolled in this research study.

    This study aims to determine the range of BGB-11417 doses that can safely be used, the safest dosing schedule to minimize side effects when first taking BGB-11417, what side effects may be experienced when taking this drug, how your body processes this drug, and if this drug is effective against your cancer.

    Key eligibility criteria include:

    ·

    · Age of at least 18 years

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

    Note: This is only a partial list of eligibility criteria. Pleasecontact the Robert H. Lurie Comprehensive Cancer Center of NorthwesternUniversity for complete screening information if you are interested in thisclinical trial.

    Ma, ShuoMa, Shuo
    • Map it 201 East Huron Street Suite 12-160​
      Chicago, IL
    NCT04277637 STU00214957
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    NU NCI 20C06: Phase II Trial of the Immune Checkpoint Inhibitor Nivolumab in Patients with Recurrent Select Rare CNS Cancers

    Background:More than 130 primary tumors of the central nervous system (CNS) have been identified. Most affect less than 1,000 people in the United States each year. Because these tumors are so rare, there are few proven therapies. This study will test whether the immunotherapy drug nivolumab is an …

    Background:

    More than 130 primary tumors of the central nervous system (CNS) have been identified. Most affect less than 1,000 people in the United States each year. Because these tumors are so rare, there are few proven therapies. This study will test whether the immunotherapy drug nivolumab is an effective treatment for people with rare CNS tumors.

    Objectives:

    To learn if stimulating the immune system using the drug nivolumab can shrink tumors in people with rare CNS (brain or spine) tumors or increase the time it takes for these tumors to grow or spread.

    Eligibility:

    Adults whose rare CNS tumor has returned.

    Design:

    Participants will be screened:

    • Heart and blood tests
    • Physical and neurological exam
    • Hepatitis tests
    • Pregnancy test
    • MRI. They will lay in a machine that takes pictures.
    • Tumor tissue sample. This can be from a previous procedure.

    At the start of the study, participants will have blood tests. They will answer questions about their symptoms and their quality of life.

    Participants will get nivolumab in a vein every 2 weeks for up to 64 weeks.

    Participants will have monthly blood tests. Every other month they will have an MRI and a neurologic function test. They will also answer questions about their quality of life.

    Genetic tests will be done on participants' tumor tissue. Participants will be contacted if any clinically important results are found.

    After treatment ends, participants will be monitored for up to 5 years. They will have a series of MRIs and neurological function tests. They will be asked to report any symptoms they experience....

    • INCLUSION CRITERIA:

    • Histopathologically proven diagnosis of Ependymoma, Medulloblastoma, Parenchymal Pineal Region Tumors (Pineoblastoma, Pineocytoma, Pineal Tumor of Intermediate Differentiation, Papillary Tumor of the Pineal Region), Choroid Plexus Tumors (Carcinoma, Papilloma, Atypical Papilloma), Histone Mutated Gliomas, Gliomatosis Cerebri, ATRT, Malignant/Atypical Meningioma*, Gliosarcoma or Primary CNS Sarcoma, Pleomorphic Xanthoastrocytoma (PXA) and Anaplastic Pleomorphic Xanthoastrocytoma (APXA), and tumors formerly known as Primitive Neuro-Ectodermal Tumors (Embryonal Tumor with Multilayered Rosettes, Medulloepithelioma, CNS Neuroblastoma, CNS Ganglioneuroblastoma, CNS Embryonal Tumor NOS; and tumor entities emerging from methylation profiling of CNS-PNETs: CNS neuroblastoma with FOXR2 activation, CNS Ewing sarcoma family tumor with CIC alteration, CNS high-grade neuroepithelial tumor with MN1 alterations, and CNS high-grade neuroepithelial tumor with BCOR alteration) prior to registration.

      *Patient with extra CNS metastases from meningioma will be eligible even if pathology review fails to demonstrate high grade features on available tumor samples.

    • The tumor tissue (e.g. block or 20 unstained slides) must be available to be sent for immunophenotyping.
    • Participants must have progressive tumor growth after having received established standard of care and/or other experimental treatments for their newly diagnosed or recurrent disease. Participants will be enrolled into 2 different cohorts (cohort 1 or heavily pretreated; cohort 2 or not heavily pretreated
    • Age greater than or equal to 18;
    • Karnofsky performance status (Bullet) 70 within 14 days prior to Step 2 registration; Participants with severe paraparesis/paraplegia who need minimal assistance for selfcare due to their motor deficit but are otherwise functionally independent will be considered eligible.
    • Adequate hematologic function based on CBC/differential within 14 days prior to Step 2 registration defined as follows:

      • Absolute neutrophil count greater than or equal to 1,500 cells/mm3;
      • Platelet count greater than or equal to 100,000 cells/mm3
      • Hemoglobin > 9.0 g/dl (may be transfused to achieve this level)
    • Adequate renal function within 14 days prior to Step 2 registration defined as follows:

      • BUN less than or equal to 30 mg/dl and
      • Serum creatinine less than or equal to 1.7 mg/dl

      Note: If the serum creatinine is greater than 1.7 mg/dl, a 24-hour urine creatinine clearance will be obtained and if the result of this study is within normal limits*, the patient would be eligible to enroll onto study. (*Normal Creatinine Clearance Range: Male: 90 - 130 ml/min; Female: 80 - 125 ml/min)

    • Adequate hepatic function within 14 days prior to Step 2 registration defined as follows:

      • Total bilirubin (except patients with Gilbert s Syndrome, who are eligible for the study but exempt from the total bilirubin eligibility criterion) less than or equal to 2.0 mg/dl and
      • ALT and AST less than or equal to 2.5x ULN
      • No active or chronic hepatitis infection. HCV antibody (for Hepatitis C) and Hepatitis B Surface antigen and Hepatitis B core antibody must be negative. This has been routinely incorporated into immunotherapy trials with checkpoint inhibitors because of concerns that the risk of treatment-induced hepatic injury is increased in the setting of active viral hepatitis.
    • The patient must not be on a corticosteroid dose greater than physiologic replacement dosing defined as 30 mg of cortisone per day or its equivalent.
    • The patient must provide study-specific informed consent prior to study entry. No Durable Power of Attorney or Next of Kin can provide initial consent.

      2.1.1.10 Participants must meet the below requirements regarding COVID-19 Status:

      2.1.1.10.1 Participants must be fully vaccinated for coronavirus disease 2019 (COVID-19) as defined by the Center for Disease Control guidance for patients who are immunocompromised. Participants must have received required vaccination(s) by the time of Step 2 registration and be considered fully immunized (typically 2 weeks after final vaccination) by the time of the initiation of treatment.

      2.1.1.10.2 Participants must have a negative COVID-19 test within 72 hours of the first dose of study drug. Patients who had documented COVID-19 infection within 90 days of treatment but are more than 20 days from infection do not need to be tested and are eligible if they fulfill the eligibility requirement regarding adequate vaccination.

      2.1.1.10.3 Vaccinated participants must agree to follow current guidance to protect themselves from exposure to COVID-19, such as wearing masks, social distancing, and maintaining good hand hygiene even after vaccination.

    • The effects of nivolumab on the developing human fetus are unknown. For this reason, women of childbearing potential (WOCBP) must use appropriate method(s) of contraception. WOCBP should use an adequate method to avoid pregnancy for 5 months (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug.

    NOTE: Based on the evidence cited in Nivolumab IB ver. 20, given that nivolumab is not a genotoxic agent, and that relevant systemic concentrations sufficient to produce a risk of fetal toxicity are not expected in WOCBP partners from exposure to a male participant s seminal fluid, male study participants will not be required to use contraceptive measures and/or a latex or other synthetic condom during sexual activity with a WOCBP partner.

    EXCLUSION CRITERIA:

  • Patients who are receiving any other investigational agents.
  • Prior use of an immunotherapy such as (but not limited to) a vaccine therapy, dendritic cell vaccine, other checkpoint inhibitors, or intracavitary or convectional enhanced delivery of chemotherapy.
  • Prior or concurrent malignancy unless its natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen
  • Severe, active co-morbidity defined as follows:

    Unstable angina within the last 6 months prior to Step 2 registration.

    Transmural myocardial infarction within the last 6 months prior to Step 2 registration

    Evidence of recent myocardial infarction or ischemia by the findings of S-T elevations of (Bullet) 2 mm using the analysis of an EKG performed within 14 days prior to Step 2 registration.

    New York Heart Association grade II or greater congestive heart failure requiring hospitalization within 12 months prior to Step 2 registration.

    History of stroke, cerebral vascular accident (CVA) or transient ischemic attack within 6 months prior to Step 2 registration, with the exception of pericavitary ischemia due to tumor resection.

    Serious and inadequately controlled cardiac arrhythmia.

    Significant vascular disease (e.g., aortic aneurysm, history of aortic dissection) or clinically significant peripheral vascular disease.

    Evidence of bleeding diathesis or coagulopathy.

    Serious or non-healing wound, ulcer, or bone fracture or history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Step 2 registration, with the exception of the craniotomy for tumor resection.

    Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.

    Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration.

    Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects.

    Known acquired immune deficiency syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude participants with AIDS is based on the lack of information regarding the safety of nivolumab in patients with active HIV infection.

    Active connective tissue disorders, such as lupus or scleroderma, which in the opinion of the treating physician may put the patient at high risk for immunologic toxicity.

  • Participants with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded. These include but are not limited to participants with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome or CIDP, myasthenia gravis; systemic autoimmune disease such as SLE, connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn s, ulcerative colitis, hepatitis; and participants with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease.

    --Of note, participants with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible. Participants with rheumatoid arthritis and other arthropathies, Sj(SqrRoot)(Delta)gren s syndrome and

    psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible. However, patients with vitiligo, diabetes mellitus, and Hashimoto thyroiditis on appropriate replacement therapy may be enrolled.

  • Any other major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy.
  • Allergies and Adverse Drug Reaction: History of allergy to study drug components
  • Pregnancy or lactating females due to possible adverse effects on the developing fetus or infant due to study drug. Women of childbearing potential must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to Step 2 registration.
  • History of severe hypersensitivity reaction to any monoclonal antibody.
  • 10. Participants with contraindications to COVID-19 vaccination will not be eligible.

    11. Participants unable to have MRIs.

    Kumthekar, Priya UKumthekar, Priya U
    • Map it 420 E. Superior St.
      Chicago, IL
    NCT03173950 STU00214301
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    DRUG AN2025H0301: The BURAN Study of Buparlisib (AN2025) In Combination with Paclitaxel Compared to Paclitaxel Alone, in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

    The purpose of this open-label research study is to assess the effectiveness and safety of once-daily buparlisib in combination with weekly paclitaxel compared to weekly paclitaxel alone in subjects with refractory, (a disease or condition which does not respond to previous forms of treatment) recurrent, or metastatic (disease …

    The purpose of this open-label research study is to assess the effectiveness and safety of once-daily buparlisib in combination with weekly paclitaxel compared to weekly paclitaxel alone in subjects with refractory, (a disease or condition which does not respond to previous forms of treatment) recurrent, or metastatic (disease that has returned or spread) head and neck cancer that has progressed after prior immunotherapy (treatment that uses the immune system to attack cancer, such as antiPD1/antiPDL1 treatments) with or without prior platinum-based chemotherapy.

    The study will consist of the following parts:

    •A preliminary (screening) period of up to 4 weeks (28 days) to determine eligibility

    •A treatment period of up to 15 cycles (1 cycle is 21 days)

    •End-of-treatment visit

    •A follow-up visits 30 days after the end-of-treatment visit

    •Continued follow-up to monitor health status every 3 months for up to 5 years

    Participants will continue to receive the study drug until they are no longer benefiting, or experience unacceptable side effects or withdraw from the study.

    Participants will be assigned into one of two study treatment groups:

    •80 mg/m2/week paclitaxel intravenous infusion in combination with 100 mg/day buparlisib given orally in 21-day cycles

    •80 mg/m2/week paclitaxel intravenous infusion

    Study treatment assignment will be random. Participants will be assigned to the study treatment groups in a 2:1 ratio, which means 2 out of 3 subjects will be in the buparlisib group and 1 out of 3 subjects placed in the paclitaxel only study treatment group.

    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 Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

    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.

    Boumber, YanisBoumber, Yanis
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04338399 STU00214841
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    (xIRB) NU MC21B04: Genetic Risk Estimation of Breast Cancer Prior to Decisions on Preventive Therapy Uptake, Risk Reducing Surgery or Intensive Imaging Surveillance: A Study to Determine if a Polygenic Risk Score Influences the Decision Making Options Amongst High Risk Women

    The purpose of this research is to determine whether providing an individual polygenic risk score (PRS), in addition to the Breast Cancer Risk Assessment Tool (BCRAT) or Tyrer-Cuzick (IBIS) score, to women at high risk of breast cancer will improve their ability to make a better informed decision to …

    The purpose of this research is to determine whether providing an individual polygenic risk score (PRS), in addition to the Breast Cancer Risk Assessment Tool (BCRAT) or Tyrer-Cuzick (IBIS) score, to women at high risk of breast cancer will improve their ability to make a better informed decision to accept preventive therapy and/or supplemental breast cancer screening.

    Study participation involves: 2 separate visits at which you will be asked to complete surveys and blood draws; and 8 annual visits of which you will be asked to complete surveys remotely.

    Some of the eligibility criteria include:

    •Adult woman of at least 18 years of age

    •Have been determined to be at risk of developing 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.

    Khan, Seema AhsanKhan, Seema Ahsan
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00215127
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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 oropharyngeal 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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    DRUG BB2121-MM-007: An Exploratory Phase 1/2 Trial to Determine Recommended Phase 2 Dose (RP2D), Safety and Preliminary Efficacy of bb2121 (Ide-cel) Combinations in Subjects with Relapsed/Refractory Multiple Myeloma (KarMMa-7)

    The purpose of this research study is to testthe safety and effectiveness of an investigational drug (bb2121) in combinationwith other treatments for patients diagnosed with multiple myeloma, a cancer ofthe plasma cells (a type of immune cell that produces antibodies), which hasreturned after a recent treatment regimen (relapsed), or has …

    The purpose of this research study is to testthe safety and effectiveness of an investigational drug (bb2121) in combinationwith other treatments for patients diagnosed with multiple myeloma, a cancer ofthe plasma cells (a type of immune cell that produces antibodies), which hasreturned after a recent treatment regimen (relapsed), or has not responded to arecent treatment regimen (refractory).

    Screening: the study doctor will perform tests foreligibility purposes. This may take up 28 days.

    Treatment: If eligible,participants will be assigned to one of the following Treatment Arms.

    Treatment Arm

    Treatment

    A

    bb2121 + CC-220 (± dexamethasone)

    B

    bb2121 + BMS-986405 (JSMD194)

    C Cohort 1

    bb2121 + Daratumumab, Pomalidomide and Dexamethasone

    C Cohort 2

    bb2121 + Pomalidomide, Bortezomib, and Dexamethasone

    The maximum time spent in the research study will depend on theparticipant’s response to treatment. Participants will be required to returnfor a visit at the time of study treatment discontinuation (End of TreatmentVisit) (except for Treatment Arm B). Participants may be followed up for up to15 years.

    In this research study, T cells will be collected from theparticipant’s blood in a procedure called leukapheresis. The collected cellswill then be modified in a laboratory. In the laboratory, a new gene will beinserted into your T cells using a genetically modified virus. Afterapproximately 4 to 6 weeks the modified T cells, now called bb2121 T cells,will be infused back into the participant’s blood.

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

    · · Diagnosis of multiplemyeloma, a cancer of the plasma cells (a type of immune cell that producesantibodies), which has returned after your most recent treatment regimen(relapsed), or has not responded to your most recent treatment regimen(refractory).

    Note: This is only a partial list of eligibilitycriteria. Please contact the Robert H. Lurie Comprehensive Cancer Center ofNorthwestern University for complete screening information if you areinterested in this clinical trial.

    Singhal, SeemaSinghal, Seema
    NCT04855136 STU00214619
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    DRUG CPI 0610-04: A Phase 3, Randomized, Double-blind, Active-Control Study of CPI-0610 and Ruxolitinib vs. Placebo and Ruxolitinib in JAKi Treatment Naive MF Patients

    This study (also known as MANIFEST-2) is being done to find out if a study drug called pelabresib (CPI-0610) can help decrease spleen size and make participants with MF feel better. Myelofibrosis is commonly treated with a drug called ruxolitinib; which is an FDA (Food and Drug Administration) …

    This study (also known as MANIFEST-2) is being done to find out if a study drug called pelabresib (CPI-0610) can help decrease spleen size and make participants with MF feel better.

    Myelofibrosis is commonly treated with a drug called ruxolitinib; which is an FDA (Food and Drug Administration) approved drug to treat patients with myelofibrosis in the US. Since ruxolitinib is approved, it is usually a doctor’s first choice of treatment. This study will see if taking ruxolitinib and the study drug pelabresib together works better than taking only ruxolitinib. The study drug (pelabresib) is also called an investigational drug. An investigational drug is a drug that is not yet approved for sale in the US by the FDA.

    There are two different treatment groups or arms in this study. One arm is called the ‘Experimental Arm’, those getting pelabresib and ruxolitinib. The second arm is the ‘Control Arm’, those getting ruxolitinib and placebo. The placebo is a harmless pill that looks like pelabresib but has no medication in it. Participants will have an equal chance (50:50), like flipping a coin, of being randomly assigned to either the Experimental Arm or the Control Arm.

    The screening period is up to 4 weeks – this is the time prior to receiving any drug. Each study treatment cycle is 3 weeks. Participants will see the study doctor for a study visit after each cycle. The study doctor will decide if participants will continue to another cycle. If the study doctor decides to continue to another cycle, participants will receive another cycle of study treatment. Average time on study is expected to be about 18 months. The amount of time on study depends on how well the study treatment works against the progression of a participant’s disease. Participants may decide to stop at any time.

    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 myelofibrosis

    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 study.

    Stein, Brady LeeStein, Brady Lee
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04603495 STU00214989
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    (xirb) Drug BA3011-001: DRUG BA3011-001: A PHASE 1/2 DOSE ESCALATION AND DOSE EXPANSION STUDY OF MECBOTAMAB VEDOTIN (BA3011) ALONE AND IN COMBINATION WITH NIVOLUMAB IN ADULT AND ADOLESCENT PATIENTS 12 YEARS AND OLDER WITH ADVANCED SOLID TUMORS

    The purpose of this research study includes the following:To test the safety of different doses of BA3011and to find out what effects, good and/or bad, it has on cancer.To choose which dose amount should be studied in future studies. (Part A only)To test greater numbers of …

    The purpose of this research study includes the following:

    • To test the safety of different doses of BA3011and to find out what effects, good and/or bad, it has on cancer.
    • To choose which dose amount should be studied in future studies. (Part A only)
    • To test greater numbers of patients with the dose level selected during Part A. (Part B only)
    • To identify the highest dose of the study drug to be used in this study that patients can receive without having severe symptoms.
    • To understand how the body absorbs and processes different doses of BA3011 by measuring the amount of the study drug in the blood before, during and after receiving BA3011. This is called pharmacokinetics (PK) testing.
    • To understand whether BA3011 causes a response by the immune system that leads to the development of antibodies (proteins made in the body that respond to a substance that is foreign to the body) which may prevent the study drug from working and/or increase risk of side effects. These antibodies are called anti-drug antibodies (ADA)

    Phase 1:Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumor and have failed available standard of care therapy and for whom no curative therapy is available or who are not eligible, intolerant to or refuse standard therapy.

    Phase 2: Patients must:

    • Have histologically or cytologically confirmed locally advanced unresectable or metastatic sarcoma.

    • Have documented progression according to Response Evaluation Criteria in Solid Tumors (RECIST)Version 1.1 criteria within the 6 months prior to enrollment.

    • Be ineligible for chemotherapy or have received at least 1 regimen containing anthracycline and a maximum of 3 previous lines of approved systemic therapy for metastatic disease (no more than 2 lines of combination regimens),including pazopanib, trabectedin, eribulin mesylate, or tazemetostat, if applicable per regional prescribing information. The requirements for prior treatments do not apply to sarcoma subtypes for which no treatment is approved
    • Age of at least 18years

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

    Pollack, Seth MichaelsPollack, Seth Michaels
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03425279 STU00215527
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    Drug 42756493BLC2003: A Randomized Phase 2 Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Subjects Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) and FGFR Mutations or Fusions

    The purpose of this study is to see if erdafitinibis safe and useful for treating patients with high risk non-muscle invasivebladder cancer (NMIBC) that recurred (came back) after BCG therapy and has agene mutation or fusion called FGFR.…

    The purpose of this study is to see if erdafitinibis safe and useful for treating patients with high risk non-muscle invasivebladder cancer (NMIBC) that recurred (came back) after BCG therapy and has agene mutation or fusion called FGFR.

    1) Histologically confirmed, recurrent, non-muscle invasive urothelial carcinoma of the bladder

    2) Age of at least 18 years

    3) There are other tests required to confirm if you are eligible. All prospective patient will undergo these tests to determine if they are eligible to take part in the study.

    Note: This is only a partial list of eligibility criteria. Pleasecontact the Robert H. Lurie Comprehensive Cancer Center of NorthwesternUniversity for complete screening information if you are interested in thisclinical trial.

    Meeks, Joshua JMeeks, Joshua J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04172675 STU00215238
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    Drug C4471001: A TWO-PART, PHASE 1A/B, OPEN-LABEL, MULTICENTER TRIAL EVALUATING PHARMACOKINETICS, SAFETY AND EFFICACY OF PF-07284890 (ARRY-461) IN PARTICIPANTS WITH BRAF V600-MUTANT SOLID TUMORS WITH AND WITHOUT BRAIN INVOLVEMENT

    The purpose of this study is to learn about the safety and the effects of study drug PF-07284890 and to find the best dose for treating certain cancer(s) when it is given alone or with binimetinib. Binimetinib, alsoknown as Mektovi®, is a cancer medicine that is approved by …

    The purpose of this study is to learn about the safety and the effects of study drug PF-07284890 and to find the best dose for treating certain cancer(s) when it is given alone or with binimetinib. Binimetinib, alsoknown as Mektovi®, is a cancer medicine that is approved by the FDA to be given together with a different drug that, like PF-07284890, also blocks the BRAF enzyme and makes that combination drug work better against certain cancers. The study drug PF-07284890 is an investigational drug because it is not approved for use in this country. In this study, the study drug binimetinib is considered investigational as well because, although it is approved for use in patients already, it is not approved for use in combination withPF-07284890.

    We expect that you will be in this research study for 10-14 months. The time could be longer or shorter than this, depending on how your body is affected by the study drug(s). You will be assigned to receive the study drug PF-07284890 with or without binimetinib.

    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:

    -We are asking you to take part in this research study because you have a type of cancer that has a specific change in the BRAF gene (BRAFV600 mutation) and is advanced (cancer that has grown or spread outside the organ it started in) and available treatment(s) are no longer effective in controlling your cancer.

    -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.

    Chandra, SunandanaChandra, Sunandana
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04543188 STU00215417
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    NU 21S02: Pilot Study to Investigate Tumor Infiltrating Lymphocytes (TILs) in Tumor Samples

    Patients will be asked to give a blood sample during blood draw for routine laboratory testing(before surgery). Fresh tissue will be collected during scheduled surgery, which is a part of standard of care. Tumor draining lymph nodes removed duringsurgery may also be collected, if appropriate and available. After fresh …

    Patients will be asked to give a blood sample during blood draw for routine laboratory testing(before surgery).

    Fresh tissue will be collected during scheduled surgery, which is a part of standard of care.

    Tumor draining lymph nodes removed duringsurgery may also be collected, if appropriate and available.

    After fresh tissue collection, if available, archival tissuemay be obtained if the study doctor feels it is necessary.

    The study team will access patient medical records after your surgery until death, patient withdrawal from data collection,patient being lost to follow up, data collection for the study is considered complete or at PIdecision (whichever comes first).

    Patients who are 18 years or older, havebeen diagnosed with sarcoma OR other cancers, and are scheduled or will be schedule for a standard of care surgery to remove the tumor.
    Pollack, Seth MichaelsPollack, Seth Michaels
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00215595
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    (xIRB) DRUG CAAA617C12301:An International Prospective Open-label, Randomized, Phase III Study comparing 177Lu-PSMA-617 in combination with Standard of Care, versus Standard of Care alone, in adult male patients with Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

    This study is being conducted to determine if a new experimental Radioligandtherapeutic agent drug named [177Lu]Lu-PSMA-617 given with androgen deprivation therapy(also called ADT) and androgen receptor targeted therapy (called ARDT) is safe and effectiveas a treatment for men with metastatic hormone-sensitive prostate cancer (mHSPC). …
    This study is being conducted to determine if a new experimental Radioligandtherapeutic agent drug named [177Lu]Lu-PSMA-617 given with androgen deprivation therapy(also called ADT) and androgen receptor targeted therapy (called ARDT) is safe and effectiveas a treatment for men with metastatic hormone-sensitive prostate cancer (mHSPC). 
    Patients must be adults ≥18 years of age.

    Patients must have metastatic prostate cancer with histologically or cytologicallyconfirmed adenocarcinoma (current or prior biopsy of the prostate and/or metastatic site).

    VanderWeele, David JamesVanderWeele, David James
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04720157 STU00215972
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    Drug 0739-CL-0101: A Phase 1/2 Open-label Study Investigating the Safety, Tolerability and Efficacy of ASP0739 as a Single Agent and in Combination with Pembrolizumab in Patients with Advanced Solid Tumors known to Express NY-ESO-1

    The purpose of this study is to see ifASP0739 is both safe and effective as a treatment for patients who have been diagnosed with a solid tumor that isknown to express NY-ESO-1. Anotherpurpose is to find a suitable dose for ASP0739. In this study, ASP0739 will begiven either …

    The purpose of this study is to see ifASP0739 is both safe and effective as a treatment for patients who have been diagnosed with a solid tumor that isknown to express NY-ESO-1. Anotherpurpose is to find a suitable dose for ASP0739. In this study, ASP0739 will begiven either by itself or together with another drug called pembrolizumab inorder to compare the effects this might have on your cancer.

    The United States Food and DrugAdministration (U.S. FDA) has not approved ASP0739 for sale or for treatment ofcancer.

    •The patient has been diagnosed with a solid tumor that is known to express NY-ESO-1 (New York Esophageal Squamous Cell Carcinoma 1). NY-ESO-1 is a group of proteins seen in numerous cancer types. Patient has also been treated with all standard therapies and their disease has progressed or they no longer qualify for standard therapy in the opinion of their study doctor.

    •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

    Pollack, Seth MichaelsPollack, Seth Michaels
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04939701 STU00215634
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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: Phase 3 Randomized Double-Blind Study of Abemaciclib versus Placebo in Patients with Advanced Dedifferentiated Liposarcoma

    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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    DRUG ALLO-605-201: A Single-Arm, Open-Label, Phase 1/2 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-647 and ALLO-605, an Anti-BCMA Allogeneic CAR T Cell Therapy in Patients with Relapsed/Refractory Multiple Myeloma

    The purpose of this research study is to test the safety of ALLO-605 and ALLO-647, and how effective ALLO-605 is in treating multiple myeloma, along with ALLO-647. Treatment with ALLO-647 and ALLO-605 is experimental and is not approved in the United States by the …

    The purpose of this research study is to test the safety of ALLO-605 and ALLO-647, and how effective ALLO-605 is in treating multiple myeloma, along with ALLO-647. Treatment with ALLO-647 and ALLO-605 is experimental and is not approved in the United States by the Food and Drug Administration (FDA) for use in the general public, although both treatments have been cleared for testing in clinical trials.

    Pre-screening: Participants will have a blood test to determine eligibility for the main study.

    Main study: Participants who qualify and agree to participate are expected to be in the study for approximately 36 months.

    The screening period will last up to 28 days. Once screening is complete and participants are determined to be eligible, they will enter the treatment phase of the study.

    While in the trial, participants will be asked to come to the clinic for approximately 27 study visits. At six of these visits participants will receive study treatment (i.e., lymphodepletion with fludarabine, cyclophosphamide, and ALLO-647, or treatment with ALLO-605). The remaining visits will involve procedures to monitor safety, and to evaluate any effect on the participant’s multiple myeloma.

    The study is made up of two parts. The first part is called dose escalation (Phase 1) and the second part is called dose expansion (Phase 2). In the dose escalation phase, the study will test different doses of ALLO-605, following lymphodepletion with a combination of medicines that includes different doses of ALLO-647, to determine safety and which is most effective. In the dose expansion phase of the study, one ALLO-605 dose level and a lymphodepleting regimen will be chosen for further evaluation, and additional patients treated with those doses.

    Some of the eligibility criteria include:

    •Age of at least 18 years

    •Diagnosis of multiple myeloma

    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
    NCT05000450 STU00215605
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    DRUG DT2216-001: A Phase 1, Open-Label, Dose Escalation, and Cohort Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Clinical Activity of DT2216, an Antiapoptotic Protein Targeted Degradation Compound, in Subjects with Relapsed or Refractory Malignancies

    The main purpose of this study is to determine if the investigational drug, called DT2216, is safe, and to determine the anti-cancer activity. This is the first time that the study drug has been used in people.The study will consist of the following parts: •A preliminary (screening) period …

    The main purpose of this study is to determine if the investigational drug, called DT2216, is safe, and to determine the anti-cancer activity. This is the first time that the study drug has been used in people.

    The study will consist of the following parts:

    •A preliminary (screening) period of up to 28 days to determine eligibility

    •A treatment period of up to 1 year

    •A follow-up visit 28 days after the last dose of drug

    •Continued follow-up to monitor health status every 3 months for up to 2 years

    Participants will continue to receive the study drug until they are no longer benefiting, or experience unacceptable side effects or withdraw from the study.

    On the first day of the study treatment period (Day 1), the study doctor will perform some tests before participants receive the first dose of study drug. After these are completed, participants will receive a single dose of study drug by intravenous (IV) line on Day 1 and again on Day 4 each week for at least 4 weeks (this is known as 1 cycle of study treatment). During each cycle clinic visits, the study doctor will perform some tests to check for health status.

    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 advanced cancer, which has returned after your most recent treatment regimen (relapsed) or has not responded to your most recent treatment regimen (refractory).

    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
    NCT04886622 STU00215654
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    Drug RP-3500-01: Phase 1/2a Study of the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Activity of RP-3500 Alone or in Combination with Talazoparib or Gemcitabine in Advanced Solid Tumors with ATR inhibitor Sensitizing Mutations (TRESR Study)

    The purpose of this research study is to:- Test how safe RP-3500 is at different doses and dosing schedules- Test how well RP-3500 alone works to shrink tumors in 3 different groups ofpatients, each group having different tumor types and/or tumors with different,specific gene changes (mutations)- …

    The purpose of this research study is to:

    - Test how safe RP-3500 is at different doses and dosing schedules

    - Test how well RP-3500 alone works to shrink tumors in 3 different groups of

    patients, each group having different tumor types and/or tumors with different,

    specific gene changes (mutations)

    - Test how safe RP-3500 and talazoparib or gemcitabine are when given together

    at different doses

    - Test how well RP-3500 alone works to shrink cancer tumors in the body

    - Test how well RP-3500 and talazoparib or gemcitabine work together to shrink

    cancer tumors in the body

    •Histologically confirmed solid tumors resistant or refractory to standard treatment and/or patients who are intolerant to standard therapy.

    •Measurable disease as per RECIST v1.1.

    •Existing biomarker profile (tumor tissue or plasma) reported from a local test obtained in a CAP/CLIA, ISO or equivalent laboratory per institutional guidelines:

    •Documented ATRi sensitizing biomarkers or and other genes decided upon between the Sponsor and Investigators.

    •Age of at least 18 years

    Mahalingam, DevalingamMahalingam, Devalingam
    NCT04497116 STU00216015
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    (xIRB) DRUG TAK-007-2001: A Phase 2, Open-label, Multicenter Study of the Safety and Efficacy of TAK-007 in Adult Patients With Relapsed or Refractory Non-Hodgkin Lymphoma

    The purpose of this study is to determine how safe, at what dose and how well TAK-007 works as a therapy in participants with worsened or refractory B-cell Non Hodgkin Lymphoma. If you meet all the eligibility criteria for being in this study, the study consists of two …

    The purpose of this study is to determine how safe, at what dose and how well TAK-007 works as a therapy in participants with worsened or refractory B-cell Non Hodgkin Lymphoma.

    If you meet all the eligibility criteria for being in this study, the study consists of two parts:

    Part 1: You will be given one of two dose levels to determine the safety and tolerability of TAK-007. The information from this part of the study will help the Sponsor determine what dose level to explore in a larger number of participants. Both doses expected to be safe.

    Part 2: You will be given the recommended phase 2 dose, determined in part 1 of the study, to further evaluate the safety and effectiveness of TAK-007.

    Some of the eligibility criteria include:

    • Diagnosed with relapsed/refractory histologically proven CD19 expressing Non-Hodgkin Lymphoma, after at least being treated 2 lines of systemic therapy (except Anti-CD19 therapy, like CAR-T cells)
    • Be at least 18 years old
    Karmali, ReemKarmali, Reem
    NCT05020015 STU00216463
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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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    Site for (xIRB) BMT ACCESS: A Multi-Center, Phase II Trial of HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation (HCT) with Post-Transplantation Cyclophosphamide for Patients with Hematologic Malignancies

    The purpose of this study is to see how well transplant works in adults with a mismatched unrelated donor using stem cells from a donor’s blood. We’ll look at how well the transplant treats your disease, what the side effects may be, and what your life looks like …

    The purpose of this study is to see how well transplant works in adults with a mismatched unrelated donor using stem cells from a donor’s blood. We’ll look at how well the transplant treats your disease, what the side effects may be, and what your life looks like after your transplant. The study will also help us give better care to future patients. This study treatment does not include any investigational drugs.

    Before you begin the study, your doctor will review your test results to decide if it’s safe for you to be in the study. If you join the study, you will have tests and evaluations to closely watch your health and safety. Most of these tests and evaluations are considered part of the standard care you would get if you receive a transplant and weren’t in this study. You may have had some of them done already. Your study doctor will determine if any of these tests or procedures will need to be repeated for you to participate in the study. There are some surveys we will ask you to fill out before and after the transplant that are not part of routine care.

    The medicines and procedures in this study are also standard for transplant. You may still receive these medicines and procedures if you are not part of the study and receive a transplant.

    Transplant day

    On your transplant day (Day 0), the donor cells will be given to you through your central line, like a blood transfusion. The cells will travel to your bone marrow where they will start to make healthy, new blood cells after several weeks.

    After your transplant

    Graft-versus-host disease (GVHD) is a common complication of transplant. It happens because of differences between the donated cells (graft) and your body’s cells (host). Your new cells from your donor might see your body’s cells as different and attack them. You’ll get standard medicines to lower your risk of getting graft versus host disease (GVHD). You’ll start these medicines around the time of your transplant, and continue taking them for many months afterwards. They may not completely prevent GVHD and you may need more medicines to treat GVHD if you develop it.

    The Survey Research Group (SRG) team of the Center for Blood and Marrow Transplant Research (CIBMTR) will contact you to do the surveys 4 times during the 1 year you’re in the study. Each survey will take between 15 and 25 minutes to complete.

    oBefore transplant

    oAbout 3 months after transplant

    oAbout 6 months after transplant

    oAbout 1 year after transplant

    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 (Donor and Recipient)

    •Normal liver function

    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
    NCT04904588 STU00216689
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    DRUG 20200439: A Phase 1b Study Evaluating the Safety and Efficacy of AMG 757 in Combination with AMG 404 in Subjects with Small Cell Lung Cancer (SCLC)

    This study is being done to find out about the safety and efficacy (effects good or bad) of AMG757 in combination with AMG 404 for the treatment of SCLC. AMG 757 and AMG 404 are thestudy drugs in this study. AMG 757 and AMG 404 are being developed by Amgen …
    This study is being done to find out about the safety and efficacy (effects good or bad) of AMG757 in combination with AMG 404 for the treatment of SCLC. AMG 757 and AMG 404 are thestudy drugs in this study. AMG 757 and AMG 404 are being developed by Amgen Inc., a for-profit biopharmaceutical company. AMG 757, AMG 404, or the treatment in combination of AMG757 and AMG 404 are still experimental (investigational) and are not approved by anyregulatory health agency, such as the U.S. Food and Drug Administration (FDA).The study will consist of 2 phases, "dose exploration" and "dose expansion". During the doseexploration phase, the purpose is to find out which dose is safe and tolerable to patients.During the dose expansion phase, the purpose is to assess the dose determined in the doseexploration phase is safe and to understand its effects on the tumor.

    • At least 18 years of age
    • Small Cell Lung Cancer
    • Progressed or recurred following at least 1 platinum-based treatment
    • Having adequate organ function (Heart and Lung)

    Patel, Jyoti DPatel, Jyoti D
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04885998 STU00215229
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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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    NU UM21I01: A Multi-Center Randomized Phase IB/II Study of Gemcitabine and Cisplatin With or Without CPI-613 as First Line Therapy for Patients with Advanced Unresectable Biliary Tract Cancer (BilT-04)

    The goals of this study are to see if the combination of CPI-613, gemcitabine and cisplatin is safe as well as whether it is effective in improving outcomes. The first part of the study will try to find out what effects, good and/or bad, this drug combination has …

    The goals of this study are to see if the combination of CPI-613, gemcitabine and cisplatin is safe as well as whether it is effective in improving outcomes. The first part of the study will try to find out what effects, good and/or bad, this drug combination has on cancer, and to find a dose to use in the second part of the trial. CPI-613 is an experimental drug which is not approved by any Health Authorities anywhere in the world for the treatment of advanced biliary tract cancer. Platinum-based combination chemotherapy, including gemcitabine and cisplatin is considered the standard of care treatment since it has demonstrated a survival benefit for patients with advanced biliary tract cancer.

    Key eligibility criteria include:

    · Patients must have a pathologically or cytologically confirmed carcinoma

    (except neuroendocrine) of the biliary tract (intra-hepatic, extra-hepatic (hilar,

    distal) or gallbladder) that is not eligible for curative resection, transplantation, or ablative therapies. Tumors of mixed cholangiocarcinoma/hepatocellular carcinoma histology are excluded.

    · Patients may not have received prior systemic treatment (chemotherapy or targeted therapy) for advanced BTC. Prior peri-operative chemotherapy is

    permitted provided it was completed > 6 months from enrollment

    · Patients may have received prior radiation, chemoembolization, radioembolization or other local ablative therapies or hepatic resection if completed ≥ 4 weeks prior to enrollment AND if patient has recovered to ≤ grade 1 toxicity. Extrahepatic palliative radiation is permitted if completed ≥ 2 weeks prior to enrollment AND if patient has recovered to ≤ grade 1 toxicity

    · Patients must have radiographically measurable disease (as per RECISTv1.1) in at least one site not previously treated with radiation or liver directed therapy (including bland, chemo- or radio-embolization, or ablation) either within the liver

    or in a metastatic site.

    · 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.

    Mahalingam, DevalingamMahalingam, Devalingam
    NCT04203160 STU00216540
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    (xIRB) DRUG BST005: A Phase I/II Dose Escalation and Expansion Study of BST-236 plus Venetoclax in Patients with Newly Diagnosed Acute Myeloid Leukemia Unfit for Intensive Induction Chemotherapy

    The main purpose of this study is to determine the safety of BST-236 at different dose levels when administered in combination with venetoclax and to find out what effects, good and/or bad, the study drug (BST-236) in combination with venetoclax has. The first part of this study …

    The main purpose of this study is to determine the safety of BST-236 at different dose levels when administered in combination with venetoclax and to find out what effects, good and/or bad, the study drug (BST-236) in combination with venetoclax has. The first part of this study will have up to 6 groups (cohorts) of subjects who will receive different doses of the study drug, BST-236, with different doses of venetoclax. In the second part of the study subjects will receive the selected dose of BST-236 and venetoclax that were found most appropriate according to the data from the first part of the study.

    The study will consist of the following parts:

    •A preliminary (screening) period of up to 28 days to determine eligibility

    •Up to 5 courses of treatment depending on your response study

    •follow-up visits every month after the last dose of study drug, for up to 1 year

    •Post study follow-up by remote (phone ) visits for an additional 1 year

    Participation in the study may last up to two years. This will involve visits to the study doctor, which will include inpatient stays for study treatment and monthly follow-ups. Participants will receive study treatment for 7 days (Cohorts 1, 2, 3, 4) or 14 days (Cohort 5) for each of the 2 initial study treatment cycles. If participants respond to the initial study treatment, they will also receive up to 3 additional cycles of 6 days study treatment with BST-236 alone. At the end of study , the study doctor will continue to monitor participants for one year.

    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 acute myeloid leukemia (AML)

    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
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT05503355 STU00216910
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    DRUG CYTB323A12101: Phase I, open label, multicenter, dose escalation study of YTB323 in adult patients with CLL/SLL and DLBCL

    This is a first-in-human study to evaluate the feasibility, safety and preliminary antitumor efficacy of autologous T cells genetically engineered with a CD19-specific chimeric antigen receptor (CAR) and manufactured with a new process. CAR-T cells will be investigated in combination with ibrutinib in chronic lymphocytic leukemia (…

    This is a first-in-human study to evaluate the feasibility, safety and preliminary antitumor efficacy of autologous T cells genetically engineered with a CD19-specific chimeric antigen receptor (CAR) and manufactured with a new process. CAR-T cells will be investigated in combination with ibrutinib in chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and as single agent in diffuse large B-cell lymphoma (DLBCL) and in adult acute lymphoblastic leukemia (ALL).

    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:

    •Age of at least 18 years

    •Diagnosis of DLBCL, or ALL

    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
    NCT03960840 STU00215546
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    DRUG PRT811-01: A Phase 1, Open-Label, Multicenter, Dose Escalation and Expansion Study of PRT811 in Subjects with Advanced Solid Tumors, CNS Lymphoma, and Recurrent High-Grade Gliomas

    Participants will be asked to take the study drug once a day on Days 1-21 of a 21-day cycle. 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.…

    Participants will be asked to take the study drug once a day on Days 1-21 of a 21-day cycle.

    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 advanced cancer without any approved or available treatment option including select solid tumors, or recurrent glioma, lymphoma with CNS (central nervous system) involvement, uveal melanoma or a select solid tumor which has metastasized (spread) to the brain.

    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
    NCT04089449 STU00215859
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    (xIRB NCI CIRB) NRG GU010: Parallel Phase III Randomized Trials of Genomic-Risk 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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    TELLOMAK: T-cell Lymphoma anti-KIR3DL2 therapy An open label, multi-cohort, multi-center phase II study evaluating the efficacy and safety of IPH4102 alone or in combination with chemotherapy in patients with Advanced T-cell lymphoma

    The purpose of this study is to evaluate the effectiveness and safety of a new experimental drug named lacutamab (IPH4102). …

    The purpose of this study is to evaluate the effectiveness and safety of a new experimental drug named lacutamab (IPH4102).

    • Be at least 18 years of age
    • Be diagnosed with one of the following types of cancer: Sezary Syndrome (SS), or mycosis fungoides (MF)
    • Have received at least two prior systemic therapies (treatments that use substances that travel through the bloodstream, reaching and affecting cells all over the body)
    • Prior treatment with mogamulizumab
    Zhou, AlanZhou, Alan
    • Map it 676 N. St. Clair St.
      Chicago, IL
    NCT03902184 STU00215713
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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
    NCT02974647 STU00216438
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    DRUG ADCT-901-101: A Phase 1, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ADCT-901 as Monotherapy in Patients With Selected Advanced Solid Tumors

    The primary objectives of this study are to identify the recommended dose for expansion (RDE) (and recommended schedule) and/or maximum tolerated dose (MTD), and to characterize the safety and the tolerability of ADCT-901. Note: This is only a partial description of the study. Please contact the Robert H. …

    The primary objectives of this study are to identify the recommended dose for expansion (RDE) (and recommended schedule) and/or maximum tolerated dose (MTD), and to characterize the safety and the tolerability of ADCT-901.

    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:

    Pathologic diagnosis of selected solid tumor malignancy that is locally advanced or metastatic at time of Screening: cholangiocarcinoma, ovarian/fallopian tube cancers, prostate cancer, renal cell carcinoma, and triple negative breast cancer (TNBC).

    Note: Histologic variants of prostate cancer, including neuroendocrine features and small cell carcinoma of the prostate are permitted.

    Participants who are refractory to or intolerant to existing therapy(ies) known to provide clinical benefit for their condition per Investigator judgment.

    Participants with measurable disease as determined by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1:

    Note 1: Lytic bone lesions or mixed lytic-blastic lesions, with identifiable soft tissue components, that can be evaluated by cross sectional imaging techniques such as computed tomography (CT) or magnetic resonance imaging (MRI) can be considered as measurable lesions only if the soft tissue component meets the definition of measurability per RECIST v1.1.

    Note 2: Prostate cancer participants without measurable lesions will be accepted, with evidence of bone metastatic disease on radiographic examination, whether from bone scan or other imaging modality, and prostate specific antigen (PSA) ≥2.0 ng/mL.

    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
    NCT04972981 STU00216671
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    NU 21N05: A Phase II, Multicenter Study of XmAb20717 in Patients with Metastatic Anaplastic Thyroid Cancer with an Exploratory Cohort in Aggressive Hurthle Cell Thyroid Cancer

    The purpose of this study is to test any good and bad effects of the study drug, XmAb20717, and test how well it works on your type of cancer, anaplastic thyroid cancer (ATC) or Hurthle cell thyroid cancer (HCC). ATC is the most advanced and aggressive thyroid cancer. It is …

    The purpose of this study is to test any good and bad effects of the study drug, XmAb20717, and test how well it works on your type of cancer, anaplastic thyroid cancer (ATC) or Hurthle cell thyroid cancer (HCC). ATC is the most advanced and aggressive thyroid cancer. It is very rare and is found in less than 2% of patients with thyroid cancer. HCC is another aggressive form of thyroid cancer found in 5% of patients with thyroid cancer.

    If the study requirements are met, the enrolled patient will be given the study drug, XmAb20717, as treatment. There will be 2 cohorts receiving treatment—patients with ATC and patients with HCC.

    Each cycle of treatment will be 28 days (4 weeks), and the study drug will be administered on days 1 and 15 of each 28-day cycle. The treatment cycles may repeat until the patient has received treatment for 24 months (2 years).

    After the last dose of the study drug, the study doctor will continue to watch the patient for side effects and follow the patient’s condition for up to 5 years.

    · Age of at least 18 years

    · Subject ATC or HCC must be metastatic or incurable

    · Subjects whose ATC carries a known BRAF V600E mutation must previously have received and failed, or be intolerant to, a BRAF/MEK inhibitor (e.g., dabrafenib or trametinib).

    · Subjects with HCC must previously have received and failed, or be intolerant to, one line of primarily anti-VEGFR tyrosine kinase inhibitor therapy (e.g., levantibib)

    Lorch, Jochen Hanns-MartinLorch, Jochen Hanns-Martin
    NCT05453799 STU00216441
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    (xIRB) NCI CIRB ETCTN 10405: Phase I Trial of BAY 1895344 ATR Inhibitor Combined with Stereotactic Body Radiation Therapy and Pembrolizumab for Recurrent Head and Neck Squamous Cell Carcinoma

    The purpose of this study is to test the safety and tolerability of a drug called BAY 1895344 given with pembrolizumab and radiation. This study tests different doses of the drug and radiation to see which dose is safest for people as part of the combination treatment. There will be up to 37 people taking part in this study.

    Pembrolizumab has already been approved by the FDA to treat your cancer. The combination of BAY 1895344, pembrolizumab, and radiation is not FDA-approved to treat your cancer. BAY 1895344 is not FDA-approved to treat your cancer or any cancer.

    If the study requirements are met, the enrolled patient will be enrolled into one of the two parts of this study below:

    · Dose escalation part: different patients will get different doses of the study drug BAY 1895344 and different doses of radiation, as well as the same doses of pembrolizumab

    OR

    · Dose expansion part: patients will receive the highest dose of BAY 1895344 with manageable side effects, along with pembrolizumab and radiation

    The doctor and the study team will watch for side effects during the trial. Patients will also be followed for 5 years after starting the study.

    Some of the eligibility criteria include:

    · At least 18 years of age.

    · Patients must have histologically confirmed recurrent, unresectable head and neck squamous cell carcinoma, including oral cavity, oropharynx, larynx, hypopharynx, or cervical lymphadenopathy.

    · Patients must have recurrent disease within a previously irradiated area (radiotherapy to dose ≥40 Gy, i.e., in-field recurrence).

    · Patients must have competed prior radiotherapy ≥6 months prior to enrollment.

    · Patients must have received prior cisplatin chemotherapy

    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
    NCT04576091 STU00217166
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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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    DRUG CA224-098: A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy with Relatlimab and Nivolumab Fixed-dose Combination versus Nivolumab Monotherapy after Complete Resection of Stage III-IV Melanoma

    The purpose of this research study is to compare the efficacy and safety of relatlimab-nivolumab in combination with nivolumab alone among patients with fully resected stage III-IV melanoma. The study treatment consists of two immunotherapy drugs, relatlimab and nivolumab. We call these drugs immunotherapies because they work by …

    The purpose of this research study is to compare the efficacy and safety of relatlimab-nivolumab in combination with nivolumab alone among patients with fully resected stage III-IV melanoma. The study treatment consists of two immunotherapy drugs, relatlimab and nivolumab. We call these drugs immunotherapies because they work by stimulating the immune system to destroy cancer cells and potentially generate an anti-tumor effect.

    This study is comprised of 4 periods: screening, treatment,follow-up and Long Term Follow-up. If you join this study, you will receive one of the study treatments for up to 1 year from first dose or maximum of 13 doses and return for follow-up visits for a minimum of 6 years.

    All prospective patients will undergo screening tests to determine if they are eligible to take part in the study. All study participants will receive one of the study treatments which will be given in cycles. A cycle lasts 28 days. Study treatment will be given to you on Day 1 of each cycle, beginning with Cycle 1, for up to 1 year. 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:

    · Diagnosis of a stage III-IV melanoma

    · Adjuvant treatment after complete resection

    · 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.

    Chandra, SunandanaChandra, Sunandana
    NCT05002569 STU00217142
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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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    (xIRB NCI CIRB) NRG GI008: Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease (CIRCULATE-US)

    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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