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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 prod…

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) ti…

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 import…

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 r…

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, pacli…
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 …
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…

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
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 i…
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 …

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 …
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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The Genetics of Prostate Cancer in Active Surveillance
Our study uses saliva samples to detect whether or not active surveillance is the best option for the subject, based on their their genetic makeup and susceptibility to aggressive prostate cancer.
1. Patients diagnosed with prostate cancer
2. Patients with Gleason ≤ 3+3 prostate cancer
3. Patients with fewer than 3 cores involved with cancer. If a patient has 3 or more cores involved with cancer but still meets all pathologic criteria and after discussing risks and benefits does not want definitive treatment, he may still be eligible for active surveillance.
4. Patients with no more than 50% of any 1 core involved with prostate cancer. If a patient has more than 50% of any 1 core involved with prostate cancer but still meets all pathologic criteria and after discussing risks and benefits does not want definitive treatment, he may still be eligible for active surveillance.
5. Patients age > 18. Patients are typically offered AS if they are ≥ 60 years of age. However, if a man meets pathologic criteria and is < 60, he can be entered in AS if, after discussing risks and benefits, does not want definitive treatment.
6. Most patients will have PSA value ≤ 10 ng/ml. However, since PSA is prostate specific and not prostate cancer specific, many patients with elevated PSA levels > 10 ng/ml will not have prostate cancer, and PSA is elevated due to conditions such as BPH or inflammation. If a patient has a PSA value > 10 ng/ml, but still meets all pathologic criteria, he may still be eligible for active surveillance
Kundu, Shilajit DKundu, Shilajit D
  • Map it 201 E. Huron St.
    Chicago, IL
STU00059221
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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 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 add…

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 …
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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B-WELL-Mom (Breathe-Wellbeing, Environment, Lifestyle, and Lung Function)
This NIH funded research study is to better understand how the lungs function during pregnancy and how the immune system responds to pregnancy. This study will help us to better understand why some women with asthma experience…
This NIH funded research study is to better understand how the lungs function during pregnancy and how the immune system responds to pregnancy. This study will help us to better understand why some women with asthma experience worsening of their symptoms while others improve. Because pregnancy affects lung function and immune response of all women, we are looking for both women with and without asthma to participate. The study consists of 4 clinic visits (1st, 2nd, and 3rd trimesters of pregnancy and 4 months postpartum), and an at-home diary.
-Pregnant women at least 18 years old.
-Less than 15 weeks pregnant with a single baby.
-Women with and without asthma are eligible to participate. -No diagnosis of Multiple Sclerosis, Lupus, Rheumatoid Arthritis, HIV, or Mixed Connective Tissue Disease.
Grobman, William AGrobman, William A
STU00093038
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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 …
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 b…
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.
Mittal, Bharat BMittal, Bharat B
  • 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. Pr…
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 proble…

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

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

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

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

Eklund, Elizabeth AEklund, Elizabeth A
  • Map it 201 E. Huron St.
    Chicago, IL
STU00200435
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NU 15B01: A Single Arm Phase II Study Evaluating the Efficacy and Safety of Durvalumab (MEDI4736) in Combination with Tremelimumab in Patients with Metastatic HER2 Negative Breast Cancer: TNBC Expansion Cohort

The main purpose of this study is to determine the anti-tumor activity of durvalumab (ME…

The main purpose of this study is to determine the anti-tumor activity of durvalumab (MEDI4736) in combination with tremelimumab in patients with metastatic HER2-negative breast cancer.

Both durvalumab and tremelimumab are antibodies (proteins used by the immune system to fight infections and cancers). Durvalumab attaches to a protein in tumors called PD-L1. It may prevent cancer growth by helping certain blood cells of the immune system get rid of the tumor. Tremelimumab stimulates (wakes up) the immune system to attack the tumor by binding to a protein molecule called CTLA-4 on immune cells. Combining the actions of these drugs may result in better treatment options for patients with breast cancer.

Both durvalumab and tremelimumab are “investigational” drugs, which means that the drugs are not approved by the Food and Drug Administration. The idea behind developing these types of experimental drugs is that stimulating the immune system could be a different way of killing cancer cells.

We will be investigating primarily the ability of this drug combination to shrink tumors, or prevent them from growing larger. We will also investigate if this drug combination can increase survival. Finally, we will explore how these drugs affect your immune system and tumor cells by conducting tests on tumor samples before and after the first two months of treatment. This will help us learn if certain types of tumor or immune system features are associated with better responses. The information learned in this study may be helpful in the further development of durvalumab and tremelimumab for the treatment of women with advanced breast cancer.

You may be eligible for this research study if you have metastatic breast cancer that has not responded to or stopped responding to at least one line of standard-of-care chemotherapy.

Cristofanilli, MassimoCristofanilli, Massimo
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02536794 STU00200984
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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/bazedoxife…
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 a…

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…

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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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 prom…
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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Alliance A071401: Phase II Trial Of SMO/AKT/NF2 Inhibitors in Progressive Meningiomas with SMO/AKT/NF2 Mutations

This phase II trial studies how well two drugs, vismodegib and GSK2256098, work in treating patients with meningiomas that may have gotten bigger or grew back after treatment. Vismodegi…

This phase II trial studies how well two drugs, vismodegib and GSK2256098, work in treating patients with meningiomas that may have gotten bigger or grew back after treatment. Vismodegib and GSK2256098 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

The purpose of this study is to test good and bad effects of these two different drugs against meningioma tumors with altered (or mutated) genes. Altered genes can cause a tumor to grow. The study drugs, vismodegib and GSK2256098, target these genes. The study drugs could shrink the cancer, or the cancer could stay the same size or grow. They may cause side effects. Researchers hope to learn if the study drugs will shrink the cancer by at least one-half compared to its present size.

Today, therapy for meningioma is the same for all patients, and is not based on tumor genetic testing. This trial is trying to see if tumor genetic testing would be helpful at guiding treatment in meningioma patients.

You may be eligible for this research study if you have a meningioma which has gotten bigger or grew back after treatment.

Kumthekar, Priya UKumthekar, Priya U
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02523014 STU00202953
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NU 15U06: A Phase 1 Dose-Escalation Study of Intravesical Pembrolizumab and Bacillus Calmette-Guerin (BCG) in Subjects with High Risk and BCG-Refractory Non-Muscle-Invasive Bladder Cancer
Purpose The purpose of this study is to evaluate the efficacy (the effect of drug on tumor) and the tolerabili…
Purpose The purpose of this study is to evaluate the efficacy (the effect of drug on tumor) and the tolerability (the effect of drug on the body) of Pembrolizumab, when given as a single agent in patients with bladder tumors. Another purpose of the study is to see what tumor characteristics are associated with increased efficacy of the Pembrolizumab. Overview Pembrolizumab (MK-3475) is an antibody (a human protein that sticks to a part of the tumor and/or immune cells) designed to allow the body‰Ûªs immune system to work against tumor cells. Pembrolizumab is FDA approved for the treatment of advanced melanoma (a type of skin cancer) and some types of lung cancer. It is not yet approved by the USFDA for bladder cancer, hence it is considered an investigational agent for this disease. Description of Treatment All study participants will take the same study drug, Pembrolizumab. Pembrolizumab will be given intravesically through urethra. With intravesical therapy, doctor administers the drug directly into the bladder (through a catheter), rather than giving it by mouth or injecting it into a vein. During the first six weeks of therapy, one will also receive treatment with BCG as a standard of care. We expect that one will receive treatment for up to 1 year or until your disease gets worse (whichever occurs first). After completing treatment, the study team will continue to watch you for side effects for at least 30 days. The study team will also continue to check periodically to see how you are doing until your disease returns.
Some of the eligibility criteria include:

- Participants must have a recurrent, high or low risk non-muscle-invasive bladder carcinoma.
- Participants must (be BCG refractory) have received at least one 6-week course of BCG induction plus 1 maintenance dose, OR 2 full 6-week courses of induction BCG treatment.
- 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.
Meeks, Joshua JMeeks, Joshua J
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02808143 STU00202754
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A Double Blind, Randomized, Vehicle Controlled, Crossover Study to Evaluate the Safety and Efficacy of Topical Naloxone Hydrochloride Lotion 0.5% for the Relief of Pruritus in Patients with the Mycosis Fungoides (MF) or Sézary Syndrome (SS) Forms of Cutaneous T-Cell Lymphoma (CTCL)
The main goal of …
The main goal of this study is to test the efficacy and safety of topical Naloxone for itching in patients with MF.
21 years of age or older with a diagnosis of mycosis fungoides (MF) with itching present on a daily basis for more than one month and willing to fill out a diary for 7 days to provide severity of itch before enrollment.
Guitart, JoanGuitart, Joan
  • Map it 676 N. St. Clair St.
    Chicago, IL
NCT02811783 STU00203078
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Phase II Multicenter Study of Natalizumab Plus Standard Steroid Treatment for High Risk Acute Graft-Versus-Host Disease

This research trial is designed to study the safety and effectiveness of adding the drug, Natalizumab (Tysabri®) to the standard treatment (which consist in the use of steroids …

This research trial is designed to study the safety and effectiveness of adding the drug, Natalizumab (Tysabri®) to the standard treatment (which consist in the use of steroids such as prednisone i.e., a corticosteroid), as a new treatment for acute graft versus host disease (GVHD).

GVHD is the most common serious complication after bone marrow transplant. GVHD occurs when the donor cells (the graft) treat the recipient’s body as “foreign” and attack the cells in the recipient’s body. During this immune system response, donor cells damage body tissues, such as the skin, liver, stomach, and/or intestines. GVHD can be severe and potentially fatal to the transplant recipient. The only proven effective treatment for patients with acute GVHD is steroids. Patients who do not respond to steroid treatment are at high risk for death.

We want to test whether we can improve steroid response and prevent death from GVHD by blocking the donor cells from getting to the intestine and causing damage.

The study drug, Natalizumab (Tysabri®), is a drug that works by blocking the signals that cause donor cells to travel to the intestine or brain. Natalizumab is FDA-approved in adults to treat Crohn’s disease, a chronic condition where immune cells cause damage to the digestive system (such as the stomach, intestines). It is also used to treat multiple sclerosis where immune cells cause damage to the nervous system in the brain. Its intended use is for patients whose disease has not responded to the standard treatment or if they cannot tolerate the side effects from standard treatments. Natalizumab has never been used for treating GVHD. It is an experimental drug for this study, because we are investigating a new use for the drug as a GVHD treatment.

The goal of this research is to develop safer and more effective treatments for GVHD, with the ultimate goal being safer and more effective transplant therapies for blood cancers such as leukemia, lymphoma, and multiple myeloma.

You may be eligible for this research study if you have been diagnosed with acute graft-versus-host disease (GVHD) of the GI tract.

Adekola, KehindeAdekola, Kehinde
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02133924 STU00203346
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DRUG AG-221-AML-005: A phase 1B/2 open-label, randomized study of 2 combinations of isocitrate dehydrogenase (IDH) mutant targeted therapies plus azacitidine: oral AG-120 plus subcutaneous azacitidine and oral AG-221 plus SC azacitidine in subjects with newly diagnosed acute myeloid leukemia harboring an IDH1 or an IDH2 mutation, respectively, who are not candidates to receive intensive induction chemotherapy

The purpose of this study, which involves research, is to determine a safe and tolerable dose of the investigational combination of AG-120 plus azacitidine or AG-221 plus azacitidine (Phase 1b) as well as the effectiveness of AG-221 plus azacitidine in treating this disease, when compared to azacitidine alone (Phase 2). AG-120 is not currently approved for the treatment of any type of AML and its use in this study is investigational. Recently AG-221, also known as

enasidenib (IDHIFA®), was approved in the United States (US) for the treatment of adult patients with relapsed or refractory AML with an Isocitrate dehydragenase 2 (IDH2) mutation as detected by an FDA-approved test. The use of enasidenib in this study is investigational. Enasidenib is not currently approved in other countries for the treatment of any type of AML. Azacitidine (Vidaza®) is approved in Canada for the treatment of AML for patients with 20 - 30% bone marrow blast and multi lineage dysplasia, according to WHO classification, who are not candidates to receive hematopoietic stem cell transplantation.

- Adults at least 18 years of age

- Newly diagnosed, primary (i.e., de novo) or secondary (Progression of MDS or myeloproliferative neoplasms [MPN], or therapy-related) AML according to WHO classification with at least 20% leukemic blasts in the bone marrow

- Have an IDH1 or IDH2 gene mutation

- Not candidates to receive intensive IC.

Frankfurt, OlgaFrankfurt, Olga
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02677922 STU00203231
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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 t…

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.

Cristofanilli, MassimoCristofanilli, Massimo
  • Map it 201 E. Huron St.
    Chicago, IL
STU00203944
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OT-15-001: A Phase 3, Randomized, Open-Label Study To Evaluate the Efficacy and Safety of Eflornithine with Lomustine Compared to Lomustine Alone in Patients with Anaplastic Astrocytoma That Progress/Recur After Irradiation and Adjuvant Temozolomide Chemotherapy
Purpose The purpose of this study i…
Purpose The purpose of this study is to measure how well and how safe eflornithine is in combination with lomustine, compared to lomustine taken alone, in treating patients whose anaplastic astrocytoma has come back after radiation and chemotherapy. Overview Elfornithine is an experimental drug. An experimental drug means that the United States Food and Drug Administration (FDA) has not approved it for use. This drug will be used with another drug called Lomustine that is approved by the FDA in the United States for patients with anaplastic astrocytoma. Description of Treatment This study has two study groups. Patients will be randomly placed in one of the 2 groups.
Some of the eligibility criteria include:

- Participants must be 18 years of age or older.

- Patients must have surgical or biopsy proven diagnosis of WHO grade 3 Anaplastic Astrocytoma

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
NCT02796261 STU00203957
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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 with DNA Repair Defects
Purpose The purpose of this research is to study two US FDA approved drugs alone or in combination with each other in p…
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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The Molecular Markers of Bladder Cancer
Genetic research may discover genes, find out how genes function, or help researchers learn how to use what we know about genes to treat or prevent and treat disease. The purpose is to study whether the results of genetic testing can predict if bladder cancer i…
Genetic research may discover genes, find out how genes function, or help researchers learn how to use what we know about genes to treat or prevent and treat disease. The purpose is to study whether the results of genetic testing can predict if bladder cancer is going to recur, progress (get worse), or respond to chemotherapy.
Male or female patients ages 40-89 with high-grade T1 bladder cancer or patients with muscle invasive (>T2) bladder cancer undergoing neoadjuvant chemotherapy and radical cystectomy.
Meeks, Joshua JMeeks, Joshua J
STU00204352
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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 p…
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…

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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NU 16B14: I-CURE-1: A Phase II, single arm study of Pembroluzimab combined with carboplatin in patients with circulating tumor cells (CTCs) positive Her-2 negative metastatic breast cancer (MBC)

Previous studies have indicated that in triple negative breast cancer patients with tumor recurrence, t…

Previous studies have indicated that in triple negative breast cancer patients with tumor recurrence, those tumors are more resistant to chemotherapy and may be associated with a weak immune system. This study is investigating the use of an immune therapy drug, pembrolizumab, that has the ability to restore the capacity of controlling and killing cancer cells of an important component of your immune system called T-cells.

This drug has been found effective in other type of cancer and already approved by FDA for those indications, but the efficacy in breast cancer is still unknown. Pembrolizumab will be combined with chemotherapy, a drug called carboplatin, to increase the cancer cell killing. There is no control or placebo treatment in this study. Use of Pembrolizumab in this study is considered investigational, meaning that the drug is not approved for the indication under investigation.

You may be eligible for this research study if you have advanced breast cancerthat is triple negative and you have been found to have more than 5 circulating cancer cellsdetected by the FDA-approved test, CellSearch™, in one tube of blood.
Cristofanilli, MassimoCristofanilli, Massimo
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03213041 STU00205013
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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 Y9…
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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DRUG CA209-914: A Phase 3 Randomized Double Blind Study of Nivolumab Monotherapy or Nivolumab Combined with Ipilimumab Combination vs Placebo in Participants with Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse

The purpose of this stu…

The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of an investigational drug combination of nivolumab (also known as BMS-936558) and ipilimumab (also known as BMS-734016) in subjects with localized kidney cancer that have had their tumors completely removed but are at risk of having their cancer return.

Nivolumab and ipilimumab are types of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack the cancer cells.

OPDIVO® (nivolumab) is approved for the treatment of certain types of cancer, including skin, kidney, blood, and lung, in multiple countries including the United States, the European Union, and Japan. Ipilimumab (Yervoy™) is approved by the FDA, EMA and other health authorities for the treatment of metastatic melanoma. The combination of nivolumab (Opdivo™) and ipilimumab (Yervoy™) is also approved by the US FDA for the treatment of advanced kidney cancer that has spread to other parts of the body and by the US FDA and the EMA for the treatment of metastatic melanoma.

You may be eligible for this research study if you have kidney cancer and have had your tumors completely removed but are at risk of having your cancer return.

Sosman, Jeffrey AlanSosman, Jeffrey Alan
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03138512 STU00205491
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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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(xIRB) DRUG 201973: A phase I/II dose escalation and expansion study to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of GSK525762 in combination with fulvestrant in subjects with ER+ breast cancer
The purpose of this study is to evaluate the safety of the investiga…
The purpose of this study is to evaluate the safety of the investigational drug, GSK525762, and how well it works when taken with fulvestrant, a drug that is a standard treatment for estrogen receptor positive breast cancer. Researchers will test 2 dose levels of GSK525762 and fulvestrant. There will be 2 groups of subjects at each dose level. If dose level 1 is shown to be tolerated without serious side effects, a small number of consenting participants will be enrolled and start a second, higher dose level (dose level 2) of GSK252762. If DL1 is not safe, a lower dose will be given. If the small number of subjects completes DL2 and it is shown to be safe, additional subjects will be randomly assigned to receive either DL1 or DL2.
• Diagnosis of advanced or metastatic estrogen receptor-positive breast cancer (ER+BC) that hasn’t responded to previous endocrine treatment.
• Age of at least 18 years
Gradishar, William JGradishar, William J
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02964507 STU00206335
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Palbociclib after CDK and Endocrine Therapy (PACE): A Randomized Phase II study of Fulvestrant, Palbociclib, and Avelumab for Endocrine Pre-treated ER+/HER2- Metastatic Breast Cancer

This research study is studying three combinations of drugs as treatments for this type of cancer:

  • Ar…

This research study is studying three combinations of drugs as treatments for this type of cancer:

  • Arm A: fulvestrant
  • Arm B: fulvestrant with palbociclib
  • Arm C: fulvestrant with palbociclib and avelumab

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. “Investigational” means that the intervention is being studied and the researchers are trying to find out more about it— for example, the side effects it may cause, and the activity of a drug, or combination of drugs, against a cancer.

In this research study, we are evaluating the activity of fulvestrant alone, fulvestrant and palbociclib, or fulvestrant, palbociclib, and avelumab in participants with metastatic hormone receptor positive breast cancer that has previously stopped responding to prior palbociclib therapy, or another medication in the class of therapy called CDK 4/6 inhibitors.

You may be eligible for this research study if you have breast cancer that has spread to other parts of your body (metastatic cancer) and your cancer is hormone receptor positive. This study is designed for patients who have previously had exposure to the medication palbociclib, or another medication in the class of therapy called CDK 4/6 inhibitors.

Shah, Ami NShah, Ami N
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03147287 STU00207256
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A Phase Ib/ II Study of Sorafenib and Pembrolizumab in Advanced Hepatocellular Cancer (HCC)

The standard therapy for advanced hepatocellular carcinoma (HCC) that cannot be treated with surgery is sorafenib (Nexavar®). Sorafenib works by interfering with signaling pathways in the body that cause n…

The standard therapy for advanced hepatocellular carcinoma (HCC) that cannot be treated with surgery is sorafenib (Nexavar®). Sorafenib works by interfering with signaling pathways in the body that cause normal and cancerous cells to grow and multiply. While sorafenib is an effective drug for treating HCC, there is evidence suggesting that combining sorafenib therapy with pembrolizumab may be more effective than sorafenib by itself.

Pembrolizumab, which is approved in the USA and some other countries, is available by prescription to treat several different cancers, but is not approved to treat HCC. Pembrolizumab works by helping the immune system to fight cancer. However, pembrolizumab can also cause the immune system to attack normal organs and tissues in the body and can affect the way they work, which can result in side effects that may become serious or life-threatening, and in some cases, may lead to death.

The purpose of this study is to test the safety of giving pembrolizumab in combination with sorafenib, and to look at the effect that this combination has on HCC and how it responds to this treatment.

You may be eligible for this research study if you have hepatocellular carcinoma (HCC), which is the most common type of liver cancer and usually occurs with chronic liver disease.

Mahalingam, DevalingamMahalingam, Devalingam
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03211416 STU00207399
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Phase I/II Study to Evaluate the Safety and Efficacy of Nivolumab in Combination with R-CHOP in a Cohort of Patients with DLBCL/tFL/ high grade B-NHL

The purpose of this research study is to evaluate a new drug, nivolumab, given in combination with standard chemotherapy, for the treatment of diffu…

The purpose of this research study is to evaluate a new drug, nivolumab, given in combination with standard chemotherapy, for the treatment of diffuse large B-cell lymphoma (DLBCL).

The standard chemotherapy regimen for DLBCL and many other aggressive B-cell non-Hodgkin lymphomas is called “R-CHOP” and includes the drugs: Rituximab (R), Cyclophosphamide (C), Doxorubicin (H), Vincristine (O) and Prednisone (P). The new drug, nivolumab, works by targeting the immune system and increasing the effect of immune cells against the cancer cells.

The purpose of the study is to determine if the combination of nivolumab with R-CHOP is safe and will not cause significant or dangerous side effects. We also want to see how well the combination works in controlling the cancer growth, and whether or not it improves symptoms and quality of life in those who participate in the study.

Nivolumab is investigational, which means that it has not been approved by the FDA for the treatment of this kind of cancer. However, it has been studied and approved by the FDA for other types of cancer.

    You may be eligible for this research study if you have been diagnosed with aggressive diffuse large B-cell lymphoma (DLBCL) or another form of aggressive B-cell non-Hodgkin lymphoma, and you have not been treated for this type of cancer.

    Karmali, ReemKarmali, Reem
    • Map it 201 East Huron Street Suite 12-160​
      Chicago, IL
    NCT03704714 STU00207793
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    (xIRB NCI CIRB) ALLIANCE A041501: A PHASE III TRIAL TO EVALUATE THE EFFICACY OF THE ADDITION OF INOTUZUMAB OZOGAMICIN (A CONJUGATED ANTI-CD22 MONOCLONAL ANTIBODY) TO FRONTLINE THERAPY IN YOUNG ADULTS (AGES 18-39 YEARS) WITH NEWLY DIAGNOSED PRECURSOR B-CELL ALL
    The first purpose of this study is to te…
    The first purpose of this study is to test the safety of adding a new drug called inotuzumab to the usual chemotherapy drugs. The second purpose of this study is to compare any good and bad effects of using inotuzumab along with the usual chemotherapy treatment to using the usual treatment alone. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach. Inotuzumab is investigational and is not FDA-approved.
    You may be able to take part in this study if you have acute lymphoblastic leukemia (ALL) and are 18 to 39 years old.
    Dinner, Shira NaomiDinner, Shira Naomi
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03150693 STU00208162
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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). S…
    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. Partic…

    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.

    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. Fo…
    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) DRUG 017004: An Open-Label, Phase 1 Safety and Phase 2 Randomized Study of JCAR017 in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (017004)
    JCAR017 is an investigational treatment. Investigational means that it is an experimental therapy that …
    JCAR017 is an investigational treatment. Investigational means that it is an experimental therapy that has not yet been approved for sale or use to the public by the United States Food and Drug Administration (FDA). This study is designed to test the safety and effectiveness of a new approach to treating Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma. This study has many parts and you will be asked to participate in one portion of the study. The Phase 1 portion of the study will evaluate whether the treatment works in treating your cancer. In the Phase 1 portion, you may be required to be on another cancer treatment called ibrutinib (IMBRUVICA®). Your study doctor will tell you which group you are eligible to be treated on. The Phase 2 is designed to assess JCAR017 as treatment versus standard of care. The approach involves modifying the patient's own immune cells, called T cells, to enable them to kill their cancer cells. T cells fight infections and can also kill cancer cells in some cases. In most cases, a patient's T cells are not able to kill their own cancer cells. In this study, some of the patient's T cells are removed from their blood, modified in a laboratory, and then given back to them by intravenous (IV) injection. While in the laboratory, researchers will put a new gene into the T cells that allows the patient's T cells to then recognize and kill the lymphoma cells. The method of putting the gene into the T cells uses a weakened virus that cannot multiply or spread. T cells that have genes added in the laboratory are called “genetically modified T cells” or “chimeric antigen receptor T cells (CAR T cells)”. When the genetically modified T cells recognize and attach to cancer cells, they have the ability to become activated and kill them. The modified T cells do not appear to recognize other normal cells in the body, with the exception of normal B cells. However, studies have shown that normal B cells will return after being treated with the modified T cells.
    • Participants must have any of the following types of lymphoma: Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
    • You must have received 2 or 3 prior treatments for your CLL or SLL
    • Participants must have cancer that has returned or has not responded to other treatment.
    • Participants must be 18 or older
    Ma, ShuoMa, Shuo
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT03331198 STU00208648
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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 an…
    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 do…

    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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    NU 18I03: Pilot study of nivolumab in combination with Therasphere (yttrium-90) for treatment of hepatocellular carcinoma (HCC) with intent for resection
    The purpose of this study is to evaluate the feasibility of using nivolumab in combination with Y90(Therasphere) to decrease the occurrence of your…
    The purpose of this study is to evaluate the feasibility of using nivolumab in combination with Y90(Therasphere) to decrease the occurrence of your HCC from coming back. Also another purposeis to evaluate the efficacy (the effect on the tumor) of nivolumab, when given with standard ofcare Y-90 (Therasphere) in patients. Another purpose of the study is to see what tumor characteristics are different among patientswho undergo resection versus those who do not undergo resection. 
    Participants who have advancedhepatocellular carcinoma (HCC). 
    Kulik, Laura MKulik, Laura M
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03812562 STU00208542
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    Technology-Supported Physical Activity Intervention for Metastatic Breast Cancer Survivors:Fit2ThriveMB

    The Fit2ThriveMB study is designed to study the effectiveness of a 3 month technology-supported physical activity intervention in metastatic breast cancer patients. This program primarily focuse…

    The Fit2ThriveMB study is designed to study the effectiveness of a 3 month technology-supported physical activity intervention in metastatic breast cancer patients. This program primarily focuses on increasing steps and is designed with progressions so that individuals of varying abilities will be able to engage in physical activity safely. All participants in the study will have access to a Fitbit and smartphone app specifically designed for this study, with half of participants obtaining immediate access and half obtaining access at a later time.

    Females 18 years of age or older

    Diagnosis of metastatic breast cancer

    Fluent in spoken and written Englsh

    Own a smartphone and have access to the internet

    Engage in less than 150 minutes of moderate to vigorous physical activity

    Phillips, Siobhan MPhillips, Siobhan M
    STU00208930
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    Hood, Susan
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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 aneffect on permanent chemotherapy-induced alopecia (defined as hair loss afterthe completion of a chemotherapy re…

    This study will test if low-dose oral minoxidil has aneffect on permanent chemotherapy-induced alopecia (defined as hair loss afterthe completion of a chemotherapy regimen that persists for over six months). Inthis study, you will receive the study drug; there is no placebo option. Theeffectiveness 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 permanentchemotherapy-induced alopecia and agree to use contraception for the durationof 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. …
    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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    A Phase II Randomized Study of Adjuvant Versus Neoadjuvant MK-3475 (Pembrolizumab) for Clinically Detectable Stage III-IV High Risk Melanoma

    This study is being done to answer the following question: How does treating melanoma with the study drug pembrolizumab, before versus after surgery affect t…

    This study is being done to answer the following question: How does treating melanoma with the study drug pembrolizumab, before versus after surgery affect the disease?

    We are doing this study because we want to find out which approach is better for treating high-risk melanoma. If you decide to take part in this study, you will eitherget treatment with pembrolizumab after your surgery, or you will be treated withpembrolizumab for a few weeks before surgery, then undergo surgery, and getmore pembrolizumab after your surgery.After you finish your study treatment, your doctor willcontinue to follow your condition for up to 10 years after you register to thestudy. Your doctor will watch you forside effects and to see how your cancer affects you. You will have clinic visits periodically fromthe time you stop taking treatment until 10 years after you register to the study.

    We are asking you to take part in this research study because you have melanoma which is ready for removal by surgery.

    Chandra, SunandanaChandra, Sunandana
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03698019 STU00209408
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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…

    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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    DRUG U31402-A-J101: Phase 1/2, Multicenter, Open-label, Multiple Dose First-In-Human Study of U3-1402, in Subjects with HER3 Positive Metastatic Breast Cancer
    In this study we are looking to see whether U3-1402 has any effect on slowing tumor growth inbreast cancer that progressed after previous trea…
    In this study we are looking to see whether U3-1402 has any effect on slowing tumor growth inbreast cancer that progressed after previous treatments. The purpose of the study is tounderstand U3-1402 for its safety, how well it works, and how well it is tolerated.U3-1402 is an investigational drug being developed to be given in breast cancer. Aninvestigational drug is a medication that has not been approved by the United States (US) Foodand Drug Administration (FDA). The FDA allows U3-1402 to be used only in research.U3-1402 is a monoclonal antibody that has chemotherapy attached to it. A monoclonal antibody isa molecule that is made to target a specific cancer cells and may affect normal cells.Chemotherapy is a type of cancer treatment that kills cells that grow and divide quickly. This caninclude cancer cells or normal cells. U3-1402 is designed to bring chemotherapy inside HER3-positive cancer cells and kill them. HER3 is one of a number of proteins that are thought to beelevated in breast cancer. A protein is a large molecule that is important for many of the processesthat happen in and around cells in the body. 
    You may be eligible for this research study if you have breast cancer and your cancer has grown after prior treatments. Along with that your tumor tissue tested should have showed your cancer to be HER3 positive.
    Gradishar, William JGradishar, William J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02980341 STU00208625
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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 photon

    therapy. Photon…

    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 mut…

    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 251 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 d…

    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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    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:

  • Is adding a new anti-cancer …
  • This study is being done to answer the following questions:

  • Is adding a new anti-cancer drug (venetoclax) to the usual treatment (ibrutinib plus obinutuzumab) better, the same as, or worse than the usual treatment alone for untreated older patients with CLL?
  • Can patients who have no detectable CLL after a year of receiving the usual treatment plus the new anti-cancer drug discontinue therapy?
  • We are doing this study because we want to find out if thisapproach is better or worse than the usual approach for your chroniclymphocytic leukemia. The usual approachis defined as care most people get for chronic lymphocytic leukemia.

    • Participants must be 70 years orolder
    • Participants must be diagnosed with Chronic LymphocyticLeukemia (CLL), a type of blood cancer.
    Ma, ShuoMa, Shuo
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT03737981 STU00210099
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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 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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    DRUG CD07_TNBC: A Phase Ib/II Study of Leronlimab (PRO 140) Combined with Carboplatin in Patients with CCR5+ Metastatic Triple-Negative Breast Cancer (mTNBC)
    The purpose of this study to find out if the study drug, leronlimab (PRO 140), when given incombination with another chemotherapy drug, carbopl…
    The purpose of this study to find out if the study drug, leronlimab (PRO 140), when given incombination with another chemotherapy drug, carboplatin, is safe and effective for the treatmentof patients with metastatic Triple Negative Breast Cancer (mTNBC).

    You may be eligible to take part in this research study if you have Triple Negative Breast Cancer that has come back, i.e. spread to other areas of your body (metastatic), after you have previously received chemotherapies at the time when your cancer was first detected.

    Cristofanilli, MassimoCristofanilli, Massimo
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03838367 STU00209594
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    Alliance A041703: A Phase II Study of Inotuzumab Ozogamicin Followed by Blinatumomab for Ph-negative CD22-positive B-lineage Acute Lymphoblastic Leukemia in Newly Diagnosed Older Adults or Adults with Relapsed or Refractory Disease

    Thepurpose of this study is to test the good and bad effects of th…

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

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

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

    Diagnosed with Acute Lymphoblastic Leukemia (ALL) that is untreated or has come back. Participants with untreated ALL must be 60 years of age or older. Participants with ALL that has relapsed or come back must be at least 18 years of age or older. 
    Dinner, Shira NaomiDinner, Shira Naomi
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03739814 STU00210163
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    A041702: A Randomized Phase III Study of Ibrutinib Plus Obinutuzumab Versus Ibrutinib Plus Venetoclax and Obinutuzumab in Untreated Older Patients (= 70 Years of Age) with Chronic Lymphocytic Leukemia (CLL)
    This study is being done to answer the following questions:1. Is adding a new anti-cancer drug…
    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 …

    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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    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 Enriche…
    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 NCI CIRB) ECOG-ACRIN 9152: A Phase Ib/II Study of Venetoclax (ABT-199) in Combination with Liposomal Vincristine in Patients with Relapsed or Refractory T-cell or Bcell Acute Lymphoblastic Leukemia
    This study is being done to determine what effects (good and bad) the therapy venetoclax has on y…
    This study is being done to determine what effects (good and bad) the therapy venetoclax has on your type of cancer (acute lymphoblastic leukemia, also known as ALL). This investigational therapy will be added to what is a standard, liposomal vincristine, to treat relapsed acute lymphoblastic leukemia.
    You may be eligible for this research study if you have acute lymphoblastic leukemia, which has grown after your first treatment regimen or has recurred.
    Dinner, Shira NaomiDinner, Shira Naomi
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03504644 STU00210605
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    A Phase 2 Study of pembrolizumab in patients with histiocyte/dendritic cell neoplasms and biologically selected subtypes of relapsed/refractory aggressive lymphomas. (Protocol #17-448)

    This is a clinical research study to test the safety and effectiveness of the study drug, pembrolizumab, in treat…

    This is a clinical research study to test the safety and effectiveness of the study drug, pembrolizumab, in treating patients with an aggressive lymphoma or a histiocyte or dendritic cell neoplasm (tumor) that hasnot responded to or has come back after other treatments. The effectiveness and safety of the treatment will be determined by a range of assessments including biopsies, scans (or imaging tests), as well as general health and performance status.

    Age 18 and above with a diagnosis of a histiocyte/dendritic cell neoplasm or relapsed/refractory aggressive lymphoma. Must be willing to provide tissue from a newly obtained biopsy, have normal organ and marrow function and not a candidate for potentially curative therapy at the time of enrollment.

    Choi, JaehyukChoi, Jaehyuk
    • Map it 676 N. St. Clair St.
      Chicago, IL
    NCT03316573 STU00209675
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    lymphoma
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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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    DRUG AL3818-US-004: A Phase III Study of AL3818 (Catequentinib, Anlotinib) Hydrochloride Monotherapy in Subjects with Metastatic or Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma and Synovial Sarcoma

    If you have ASPS, the main purpose of the study is to learn if you respond to treatment with …

    If you have ASPS, the main purpose of the study is to learn if you respond to treatment with a drug called AL3818. If you have either LMS or SS, the main purpose is to learn if AL3818 delays the time until your cancer worsens when compared to another drug called dacarbazine.

    You may be eligible for this research study if you have a soft tissue sarcoma (STS) - specifically alveolar soft part sarcoma (ASPS), leiomyosarcoma (LMS), or synovial sarcoma (SS) - and you either need new treatment or your prior treatments have not been effective.
    Pollack, Seth MichaelsPollack, Seth Michaels
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03016819 STU00210420
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    RTK inhibitor
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    (XIRB) DRUG CPI-006-001: A Phase 1/1b Multicenter Study To Evaluate The Humanized Anti-CD73 Antibody, CPI-006, As A Single Agent or In Combination With Ciforadenant, with Pembrolizumab, And With Ciforadenant Plus Pembrolizumab In Adult Subjects With Advanced Cancers
    The purpose of this research is to…
    The purpose of this research is to evaluate the safety of the study drug called CPI-006 when administered alone, or in combination with another drug called Ciforadenant, or in combination with another drug called Pembrolizumab, or when given with Ciforadenant plus Pembrolizumab.
    All adults subjects 18 years of age or over with advanced or metastatic cancer that has grown, spread, and/or has not responded to previous treatments are eligible to participate.
    Sosman, Jeffrey AlanSosman, Jeffrey Alan
    • Map it 201 East Huron Street Suite 12-160​
      Chicago, IL
    NCT03454451 STU00210900
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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: doxorubic…

    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 251 E. Huron St.
      Chicago, IL
    NCT03907488 STU00210926
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    (xIRB) NCI CIRB: ECOG-ACRIN Z171: Prospective validation trial of taxane therapy (docetaxel or weekly paclitaxel) and risk of chemotherapy-induced peripheral neuropathy in African American women

    This study isbeing done to determine which routine course of treatment (docetaxel orpaclitaxel) will re…

    This study isbeing done to determine which routine course of treatment (docetaxel orpaclitaxel) will result in less nerve damage (known as peripheral neuropathy)in African-American women.

    You may beeligible to participate in this study if you are an adult with breast cancerand if you self-identify as black, African American, or of African descent.

    Shah, Ami NShah, Ami N
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04001829 STU00210984
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    (xIRB) DRUG 18-0402: A Phase 1/2 Dose-Finding Study Followed by Expansion Cohorts of NGM120, A GFRAL Antagonist Monoclonal Antibody Blocking GDF15 Signaling, In Subjects With Advanced Solid Tumors And Pancreatic Cancer Using Combination Therapy
    find out what effects, both good and/or bad, ofthe study…
    find out what effects, both good and/or bad, ofthe study drug “NGM120”, as well as the combination of NGM120 and standardtherapy (gemcitabine and Abraxane) may have on you and your type of cancer andyour cancer associated loss of appetite, weight loss and loss of muscle.

    • Participants must be 18 years or older

    •Participants must have a confirmed diagnosis of advanced solid cancers

    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04068896 STU00211037
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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 carbopl…

    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…

    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. 
    Mittal, Bharat BMittal, Bharat B
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03952585 STU00211079
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    (xIRB) NCI CIRB NRG LU005: Limited Stage Small Cell Lung Cancer (LS-SCLC): A Phase II/III Randomized Study of Chemoradiation Versus Chemoradiation Plus Atezolizumab

    Thepurpose of this study is to compare the usual treatment to atezolizumab plusthe usual treatment. This study will help the study do…

    Thepurpose of this study is to compare the usual treatment to atezolizumab plusthe usual treatment. This study will help the study doctors find out if thisdifferent approach is better, the same or worse than the usual approach. To decide if it is better, the study doctorswill be looking to see if the study drug increases the average lifespan ofpatients by 6 months or more compared to the usual approach.

    Thisimmunotherapy drug, atezolizumab, is approved by the FDA for use in metastaticnon-small cell lung cancer for patients whose cancer progresses. But, it is notapproved for use in small cell lung cancer.

    Thisstudy has 2 study groups. Allparticipants will have received one cycle of chemotherapy before entering thestudy. On the study all participants will receive 3 cycles of chemotherapy (fora total of 4 cycles including the one cycle of chemotherapy received beforeentering the entry), plus radiation.

    • Group 1

    Participants in group 1will get the usual chemotherapy used to treat this type of cancer (etoposideand either cisplatin or carboplatin) 3 weeks for 3 cycles; each cycle equals 21days. In addition, you will receive the usual radiation to your tumor.Radiation will be given either twice a day for approximately 3 weeks or once aday for approximately 6-7 weeks.

    • Group 2

    Participants in group 2will get the same chemotherapy and radiation as noted above, plus the studydrug called atezolizumab. The atezolizumab will be given on days 1 or 2 of eachchemotherapy cycle and will continue every 3 weeks for up to one year or until thedisease gets worse or the side effects become too severe.

    Participants ages 18 years or older who have been diagnosed with limited state small cell lung cancer. 
    Mohindra, Nisha AnjaliMohindra, Nisha Anjali
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03811002 STU00211222
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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 a…

    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 251 E. Huron St.
      Chicago, IL
    NCT03994796 STU00211229
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    (xIRB) NCI CIRB: ETCTN 10089: A Randomized Phase 2 Study of CDX-1127 (Varlilumab) in Combination with Nivolumab in Patients with Relapsed or Refractory Aggressive B-cell Lymphomas

    The purpose of this study is to compare any good and bad effects of using CDX-1127 (varlilumab) along with anot…

    The purpose of this study is to compare any good and bad effects of using CDX-1127 (varlilumab) along with another immunotherapy drug, nivolumab. CDX-1127 (varlilumab) is an antibody that can stimulate the immune system to attack cancer tumor cells. Nivolumab is an antibody that can block signals that some types of tumors may use to suppress the immune system.

    The addition of CDX-1127 (varlilumab) to nivolumab could shrink your cancer but it could also cause side effects. This study will allow researchers to know whether the study approach is better, the same, or worse than nivolumab alone. To be better, the study drug combination should increase the proportion of the patients who have at least partial shrinkage of the tumors by 20 percent compared to the nivolumab only approach.

    • Participantsmust be 18 years or older
    • Participants must have a confirmed diagnosis of B-celllymphomas that have come back after standard treatment or did not respond tothe standard treatment
    Karmali, ReemKarmali, Reem
    • Map it 251 E. Huron St. Seventh Floor
      Chicago, IL
    NCT03038672 STU00211260
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    (xIRB) NCI CIRB Alliance A071801: Phase III Trial of Post-Surgical Single Fraction Stereotactic Radiosurgery (SRS) Compared with Fractionated SRS (FSRS) for Resected Metastatic Brain Disease

    The purpose ofthis study is to compare the usual treatment of single fraction radiosurgery tousing fraction…

    The purpose ofthis study is to compare the usual treatment of single fraction radiosurgery tousing fractionated radiosurgery.This study will help the study doctors find outif this different approach is better than the usual approach. To decide if it is better, the study doctorswill be looking to see if fractionated radiosurgery decreases the chances ofcancer coming back in the area where you had your brain surgery by 17.4% at oneyear compared to the usual approach of single fraction radiosurgery.

    This study has two groups. All study participants in each group will get radiosurgery.

    Group 1:Participants in this group will get the usual approach to treat the surgicalcavity with single fraction radiosurgery delivered in a single treatment.

    Group 2: Participants in this group will get fractionatedradiosurgery to the surgical cavity in three or five daily treatments, withsmaller cavities treated with 3 daily fractions and larger cavities treatedwith 5 daily treatments.

    After participants finish radiosurgery, they will befollowed for side effects for 2 years after treatment.

    Participants 18 years or older who have resected metastatic brain disease. 
    Sachdev, SeanSachdev, Sean
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04114981 STU00211282
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    DRUG PRELUDEDX : A Prospective Registry Study to Evaluate the Effect of the DCISionRT Test on Treatment Decisions in Patients with DCIS Following Breast Conserving Therapy
    This is a registry study that is keeping track of people who are undergoing therapy for ductal carcinomain situ (DCIS) and who ar…
    This is a registry study that is keeping track of people who are undergoing therapy for ductal carcinomain situ (DCIS) and who are having genomic testing. This type of genomic testing looks athow certain genes are used by your tumor cells.
    The use of the DCISionRT DCIS test results in recommending treatment for your DCIS
    Strauss, Jonathan BStrauss, Jonathan B
    • Map it 250 E. Superior St.
      Chicago, IL
    NCT03448926 STU00210952
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    DCIS DCISionRT
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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 comp…

    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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    Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP II TR): A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter tricuspid valve repair with the Edwards PASCAL Transcatheter Valve Repair System and optimal medical therapy (OMT) compared to OMT alone in patients with tricuspid regurgitation
    This study is enrolling patients with severe Tricuspid Regurgitation (TR), a condition in the heart’s tricuspid valve does not close tightly which causes the blood to flow in the wrong direction. The standard medical treatments generally available to patients with tricuspid regurgitation who do not undergo surgery, may temporarily alleviate some symptoms, but will not permanently alleviate or cure tricuspid regurgitation.  The goal of this trial is to evaluate the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System (hereinafter referred to as the PASCAL System) with optimal medical therapy (OMT) compared to OMT alone in the treatment of participants with symptomatic severe tricuspid regurgitation who may not be ideal candidates for tricuspid valve surgery (performed via open-heart surgery) and may be eligible for transcatheter tricuspid valve repair (minimally invasive procedure that repairs the valve). Optimal Medical Therapy (OMT) refers to standard of care treatment using recommended medications
    Davidson, Charles JDavidson, Charles J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04097145 STU00211052
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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 stud…

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

    This study has 2 studygroups.

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

    · Group 2 (Arm B)

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

    Participants who are 18 years of age or older with anal cancer will beinvited to participant in this study.
    Kircher, Sheetal MehtaKircher, Sheetal Mehta
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04166318 STU00211554
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    DRUG KO-MEN-001: A Phase 1/2A First in Human Study of the Menin-MLL(KMT2A) Inhibitor KO-539 in Patients with Relapsed or Refractory Acute Myeloid Leukemia
    The main purpose of this study is to determine the tolerability and the potential safety of a new drug called KO-539 in treating your cancer. …
    The main purpose of this study is to determine the tolerability and the potential safety of a new drug called KO-539 in treating your cancer. 
    You may be eligible to take part in this research study if you have a type of cancer called acute myeloid leukemia (AML) that has not responded to standard therapy.
    Altman, Jessica KAltman, Jessica K
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04067336 STU00211062
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    (xIRB) DRUG AG881-C-004: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of AG-881 in Subjects with Residual or Recurrent Grade 2 Glioma with an IDH1 or IDH2 Mutation
    The main purpose of this research study is to investigate the safety and efficacy (usefulness) of AG-881 as…
    The main purpose of this research study is to investigate the safety and efficacy (usefulness) of AG-881 as compared to placebo (a medically inactive substance) in subjects with residual or recurrent Grade 2 glioma that have an IDH1 or IDH2 mutation.

    Some of the eligibility criteria include:

    • Participants must be 18 or older.
    • Be able to understand and willing to sign informed consent and willing to comply with scheduled visits, treatment plans, procedures, and laboratory tests, including serial peripheral blood sampling and urine sampling, during 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
    NCT04164901 STU00211620
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    A randomized double-blind phase III study of ibrutinib during and following autologous stem cell transplant versus placebo in patients with relapsed or refractory diffuse large B-cell lymphoma of the activated B-cell subtype

    Diffuse Large B-cell Lymphoma (DLBCL) is the most commonlymphoma worldwid…

    Diffuse Large B-cell Lymphoma (DLBCL) is the most commonlymphoma worldwide. Even though rituximab/anthracycline-containing chemotherapy(e.g. R-CHOP) can cure a significant proportion of patients, about 60 % casesrelapse . Patients with relapsed ABC DLBCL have poor outcomes with salvage chemotherapy,followed by stem cell transplant.

    The study hypothesizes if addition of anticancer drug ibrutinib,which is known to have selective activity against ABC DLBCL , as a single agent will augment transplant effectivenessand target residual burden of disease .

    This study isbeing done to answer the following question:

    Can we improveefficacy of stem cell transplant regime in relapsed ABC DLBCL

    We are doing this study because we want to findout if this approach is better or worse than the usual approach in relapsed ABC DLBCL

    Patients have relapsed or refractory diffuse largeB-cell lymphoma (DLBCL )of the activatedB-cell subtype ( ABC)

    Moreira, JonathanMoreira, Jonathan
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02443077 STU00211652
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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 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 251 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). …
    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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    DRUG AST-008-102: Merkel Cell Carcinoma, Cutaneous Squamous Cell Carcinoma, or Other Advanced Solid Tumors: A Phase 1b/2 Study of Cavrotolimod Combined with Pembrolizumab or Cemiplimab
    The purpose of this study is to examine the safety and tolerability of the study drug, AST-008, alone and in combina…
    The purpose of this study is to examine the safety and tolerability of the study drug, AST-008, alone and in combination with pembrolizumab in adult patients with advanced solid tumors. The study is a classical 3+3 design, ascending dose, phase 1b study of AST-008 combined with pembrolizumab in cancer patients. Patients will be dosed twice with the study drug as a monotherapy before adding pembrolizumab, which will be added starting at the second cycle. The study is specifically looking to determine whether the combination of the AST-008 and pembrolizumab is better than pembrolizumab alone. There will be two DLT periods for each patient: a monotherapy DLT period of 15 days (Cycle 1) and a combination DLT period of 22 days (Cycle 2). Participants who consent will be assigned to either phase 1b (dose escalation phase) or Phase 2 (dose expansion phase). You will participate in either Phase 1b or Phase 2 of the study (not both), and your study doctor will tell you which phase you are being asked to participate in. The total amount of treatment that participants may receive is 2 years of treatment on trial.

    You are being asked to participate in this study, because you have been diagnosed with an advanced stage of cancer. The purpose of this study is to determine a safe and tolerated dose of the study drug, AST-008, when given with pembrolizumab or cemiplimab and to measure how the human body processes the study drug at different dose levels. We want to find out what effects, good and/or bad, the study drug has on you and your cancer.

    Chandra, SunandanaChandra, Sunandana
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03684785 STU00211083
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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 Spartaliz…
    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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    (xIRB) DRUG BNT411-01: Phase 1/2a, First-In-Human, Open-label, Dose-escalation Trial With Expansion Cohorts To Evaluate Safety, Pharmacokinetics, Pharmacodynamics, And Preliminary Efficacy Of Bnt411 As A Monotherapy In Patients With Solid Tumors And In Combination With Atezolizumab, Carboplatin And Etoposide In Patients With Chemotherapy-Naïve Extensive-stage Small Cell Lung Cancer (ES-SCLC)
    The purpose of this research study is to establish a safe dose of the research study drug called BNT411. This study has two parts: 1A and 1B. Part 1A will include participants with various types of solid tumors that have either spread in the body (metastatic) or that cannot be removed by surgery (unresectable). Part 1B will include participants who have extensive–stage small cell lung cancer (EC-SCLC) that has not been treated by chemotherapy before. If you meet all the criteria for being in the study, BNT411 will be given as an intravenous (IV) infusion.

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

    Treatment regimen for part 1A:

    Participants will receive BNT411 alone (monotherapy) as an infusion (a drip) into the vein (so called i.v. infusion). This will last about 30 minutes. The infusion will be given on days 1, 8 and 15 of each 3-week cycle for the first four cycles. From the 5th cycle onwards, participants will receive BNT411 only on day 1 of each 3-week treatment cycle.

    Treatment regimen for part 1B:

    Participants will receive BNT411 in combination with other anti-cancer medicines (atezolizumab, carboplatin and etoposide).

    Participants will get BNT4111 via i.v. infusion lasting about 30 minutes on days 2, 8 and 15 of each 3-week treatment cycle for the first four cycles. From the 5th cycle onward, participants will get BNT411 only on day 2 of each 3-week treatment cycle.

    The order of administration will be as follows:

    Day 1: atezolizumab -> carboplatin -> etoposide

    Day 2: BNT411 -> etoposide

    Day 3: etoposide

    Atezolizumab, carboplatin, and etoposide will be also given via i.v. infusion. The first atezolizumab infusion will last about 60 minutes and subsequent infusions may be shortened to 30 minutes if the first one was well tolerated. Carboplatin infusions may last between 30 – 60 minutes. Etoposide infusions will last over 60 minutes. The doses of these medicines will be as per standard of care.

    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

    •Either:

    oDiagnosis solid tumors that have either spread in the body (metastatic) or that cannot be removed by surgery (unresectable) or

    oDiagnosis of extensive–stage small cell lung cancer (EC-SCLC) that has not been treated by chemotherapy before

    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04101357 STU00211880
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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 a…

    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 251 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 th…

    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 251 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 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 251 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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    NRG GY020: A Phase III Randomized Trial of Radiation +/- MK-3475 (Pembrolizumab) for Newly Diagnosed Early Stage High Intermediate Risk Mismatch Repair Deficient (dMMR) Endometrioid Endometrial Cancer

    The purpose of this study is to compare the usual treatment alone (radiation) to using the us…

    The purpose of this study is to compare the usual treatment alone (radiation) to using the usual treatment plus pembrolizumab (immunotherapy). The addition of pembrolizumab to the usual treatment could reduce the risk of cancer coming back.This study will help the study doctors find out if this different approach is better, 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 pembrolizumab to radiation treatment reduces the risk of cancer coming back from approximately 20% to approximately 5% at 3 years.This immunotherapy drug, pembrolizumab (Keytruda®), is already approved by the FDA for use in several other types of cancer (e.g. melanoma, lung cancer, kidney cancer, bladder cancer, head and neck cancers, and also in cervical cancer and endometrial cancer that has come back after treatment with chemotherapy). This study has 2 study groups. Participants will either get radiation for 2-6 weeks or radiation for 2-6 weeks and immunotherapy every 3 weeks for up to one year, unless cancer returns sooner or the side effects become too severe.After participants finish treatment on the study, study doctor will continue to follow one's condition and watch for side effects. They will evaluate participants' health at clinic visits every 3 months for 2 years after finishing treatment. After that, they will continue to check participants' health with clinic visits every 6 months for 3 years.

    • Diagnosis of Stage I endometrioid endometrial cancer OR Stage II endometrioid endometrial cancer
    • At least 18 years old.
    Barber, Emma LongleyBarber, Emma Longley
    • Map it 250 E. Superior St.
      Chicago, IL
    NCT04214067 STU00212389
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    COVID-19 Convalescent Blood BioBank (SeroCore)
    Individuals will have blood drawn on enrollment as well as 6, 12 and 24 months later.  Blood will be used for genetic testing to identify factors associated with disease severity and immunologic responses.  Blood will be used to interrogate imm…
    Individuals will have blood drawn on enrollment as well as 6, 12 and 24 months later.  Blood will be used for genetic testing to identify factors associated with disease severity and immunologic responses.  Blood will be used to interrogate immunologic responses over time.  Blood will be shared with other investigators to validate serologic testing assays and to facilitate vaccine development.  
    Individuals who have recovered from COVID-19 are eligible for enrollment.  Patients will need to be confirmed to have had COVID-19 either through PCR testing or a positive antibody test prior to enrollment.  
    Ison, Michael GIson, Michael G
    • Map it 676 N. Saint Clair St. Suite 940
      Chicago, IL
    STU00212371
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    (xIRB) DRUG HPN424-1001: A Phase 1 Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmacokinetics of HPN424 in Patients with Advanced Prostate Cancer Refractory to Androgen Therapy

    The purpose of this study is to test the safety and clinical eff…

    The purpose of this study is to test the safety and clinical effects of an investigational drug known as HPN424 in patients with advanced prostate cancer. This drug has been tested in animals and this is the first study in which it is being tested in people. This study tests different doses of HPN424. We want to find out what effects, good and/or bad, it has on you and your cancer.

    This study is comprised of a 28-day screening period, 21-day cycles of treatment, the End of Treatment/Safety Follow-Up and the Long-Term Follow-up. All patients enrolled in this study will receive the study drug (HPN424) once weekly for approximately 28 weeks. However, the length of your participation in the study may be shorter if you experience unacceptable side effects to the study drug, your cancer gets worse, you withdraw consent, or the sponsor ends the study early.

    All prospective patients will undergo screening tests to determine if they are eligible to take part in the study. HPN424 is an intravenous drug, meaning that it is given through a needle placed in your vein. HPN424 is intended to stimulate your own immune system to attack your body’s prostate cancer cells. The Treatment Period is divided into two parts:

    Dose Escalation (Part 1): If you participate in Part 1, different doses of HPN424 will be given to study participants. The first patient in the first group will receive the lowest dose of the study drug. If the drug does not cause serious side effects, it will be given to other patients at a higher dose. The doses will continue to increase for every group of study participants until side effects occur that require the dose to be lowered.

    All patients at each dose level will remain in the hospital for 48 hours following the first and second dose of the study drug so your study doctor can watch for any serious side effects.

    Dose Expansion (Part 2): If you participate in Part 2, the same dose of HPN424 will be given to all study participants. Because the most well-tolerated dose will be determined in Part 1, the 48 hour- hospitalization following the first study drug dose is not required for any patients participating in Part 2.

    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 prostate cancer that recurred after treatment with standard therapy, or prostate cancer that worsened while on treatment with standard therapy.

    • 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.

    VanderWeele, David JamesVanderWeele, David James
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT03577028 STU00212475
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    (xIRB) DRUG CO-338-100: LODESTAR: A Phase 2 MuLticenter, Open-label Study of Rucaparib as Treatment for SoliD Tumors Associated with DEleteriouS MuTations in Homologous RecombinAtion Repair Genes
    The goal of this study is to find biomarkers in subjects with different types of cancers with specific HR…
    The goal of this study is to find biomarkers in subjects with different types of cancers with specific HRR gene mutations to help doctors decide if rucaparib is a good study treatment option. One of the main goals of biomarker research is to develop a diagnostic test that might help show which subjects are most likely to benefit from study treatment with rucaparib.

    - Aged at least 18 years old

    - Have an unresectable, locally advanced (primary or recurrent) or metastatic solid tumor and have relapsed/progressive disease confirmed by radiologic assessment

    - Have one of several specific mutations that is confirmed by lab testing

    - Have received at least 1 line of available therapy

    Kalyan, AparnaKalyan, Aparna
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04171700 STU00212482
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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 s…
    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 251 E. Huron St.
      Chicago, IL
    NCT04129502 STU00212504
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    (xIRB) First-In-Human Dose Escalation Study of STP1002 in Patients with Advanced-Stage Solid Tumors

    This is a research study to test a new investigational drug called STP1002. An investigational drug is one that is not approved by the United States Food and Drug Administration (FDA). The main pur…

    This is a research study to test a new investigational drug called STP1002. An investigational drug is one that is not approved by the United States Food and Drug Administration (FDA). The main purpose of this study is to find the best dose of STP1002and to evaluatethe safety and tolerability of STP1002.

    This study tests different doses of STP1002 to see which doses are safe in people with advanced-stage solid tumors, such as, colorectal cancer, non-small cell lung cancer, gastric cancer, renal cell carcinoma, or hepatocellular carcinoma. The study will also observe the anti-tumor effects of STP1002 and evaluate the way one's body absorbs,distributes, break downs, and gets rid of STP1002 and look at special cancer markers in blood and tissue.

    Atotal of approximately 30 subjects will participate in this study and 3 to 6subjects will be enrolled in each dose group. At Northwestern University, wewill enroll about 4 participants.

    Some of the eligibility criteria include:

    •Diagnosis of a advanced stage solid tumor, including, colorectal cancer, non-small cell lung cancer, gastric cancer, renal cell carcinoma, or hepatocellular carcinoma.

    •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.
    Benson III, Al BBenson III, Al B
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04505839 STU00212555
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    (xirb) Drug ACE1702-001 : A Phase I, Open Label, Dose Escalation Study of ACE1702 Cell Immunotherapy in Subjects with Advanced or Metastatic HER2-expressing Solid Tumors

    The purpose of this study is to determine if the study drug ACE1702 is safe when given as a cancer treatment and how your cancer…

    The purpose of this study is to determine if the study drug ACE1702 is safe when given as a cancer treatment and how your cancer responds.

    Although laboratory studies have shown that ACE1702 can kill some cancer cells in a laboratory culture plate or test tube and shrink tumors in animals, we do not know if ACE1702 will work in subjects with cancer.

    All subjects 18 and above with HER 2 positive advanced cancers that cannot be removed by surgery or has spread to other parts of the body are eligible to participate.

    This is only a partial list. Please contact the research team for a full list.

    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04319757 STU00212562
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    NU COVID-19 INT20L02 - International registry on thoracic cancer patients with COVID 19 - TERAVOLT (Thoracic cancERs international coVid 19 cOLlaboraTion)
    An early report of COVID-19 cases indicated that cancer patients had an increased risk of developing severe COVID-19-related symptoms compared to …
    An early report of COVID-19 cases indicated that cancer patients had an increased risk of developing severe COVID-19-related symptoms compared to COVID-19 patients without cancer. The purpose of this registry is to collect clinical information like symptoms, treatments, and outcomes of thoracic cancer patients (NSCLC, SCLS, MPM, and TETs) with COVID-19 to help develop risk assessment strategies and treatment recommendations for thoracic cancer patients.

    Participants 18 years or older who have a type of thoracic cancer; (Non-Small Cell Lung Carcinoma [NSCLC], Small CellLung Carcinoma [SCLC], Malignant Pleural Mesothelioma [MPM], or thymicepithelial tumor [TET]) and have also been diagnosed with COVID-19

    Patel, Jyoti DPatel, Jyoti D
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00212311
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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 …
    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 251 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 ,cou…
    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 carboplati…
    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 251 E. Huron St.
      Chicago, IL
    NCT03786692 STU00211923
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    (xIRB) DRUG 5F9009: ENHANCE: A Randomized, Double-blind, Multicenter Study Comparing Magrolimab in Combination with Azacitidine versus Azacitidine Plus Placebo in Treatment-naïve Patients with Higher Risk Myelodysplastic Syndrome

    The purpose of this study is to compare the effects, both good and …

    The purpose of this study is to compare the effects, both good and bad, of magrolimab in combination with azacitidine, to those of azacitidine in combination with placebo, to find out which is better for treating patients with Myelodysplastic Syndrome (MDS).

    Other purposes of this study include determining the quantity of magrolimab in the blood, aspects of your disease management (e.g. if you can have less frequent blood transfusions), your quality of life and the side effects magrolimab has on the body.

    This is a randomized double-blind study. “Randomized” means that you will be randomly assigned (like the flip of a coin) to receive either magrolimab in combination with azacitidine, or placebo in combination with azacitidine. There is an equal chance (1 in 2, or 50%) that you will be assigned to the magrolimab with azacitidine treatment or to the placebo with azacitidine treatment. Using a placebo is important so that the effects of magrolimab can be well understood and to determine whether magrolimab in combination with azacitidine is better than receiving azacitidine alone.

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

    If you qualify, each day for the first 7 days of each cycle, you will receive a dose of azacitidine.

    You will receive azacitidine by intravenous (IV) infusion, given directly into the blood by inserting a needle into a vein in your arm; or by or subcutaneous (SC) injection, given under the skin. If you are receiving magrolimab or placebo on the same day, you must will wait at least an hour after the azacitidine to start the magrolimab or placebo infusion that day.

    On Days 1, 4, 8, 11, 15, and 22 of Cycle 1 and then weekly (Day 1, 8, 15, 22) for Cycle 2, you will receive a dose of magrolimab or placebo. The dose of magrolimab will be increased during the first weeks of the study until reaching a final dose of 30 mg/kg from Cycle 2 onwards. You will receive magrolimab or placebo by infusion (IV injection), given directly into the blood, by inserting a needle into a vein in your arm and allowing magrolimab or placebo to slowly enter your body. During the first two weeks of magrolimab or placebo administration, you will receive pre-medication with acetaminophen (Tylenol ®) and diphenhydramine (Benadryl ®). For the first 4 weeks of treatment, the dose of magrolimab or placebo will be administered over approximately 3 hours. After the 4th week, the doses of magrolimab or placebo will be administered over approximately 2 hours. If you have a central line port, the port may be used for this infusion. You will be monitored for 1 hour post-infusion for the first four weeks.

    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 Myelodysplastic Syndrome (MDS)

    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.

    Additional information can be found by visiting the NIH website:

    https://clinicaltrials.gov/ct2/show/NCT04313881

    Dinner, Shira NaomiDinner, Shira Naomi
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04313881 STU00212732
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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 trea…
    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) NCI CIRB ECOG-ACRIN 5181: Randomized Phase III Trial of MEDI4736 (durvalumab) as Concurrent and Consolidative Therapy or Consolidative Therapy Alone for Unresectable Stage 3 NSCLC

    The purpose of this study is to compare the usual approach of chemo/radiationfollowed by one year of MEDI4736 (…

    The purpose of this study is to compare the usual approach of chemo/radiationfollowed by one year of MEDI4736 (durvalumab) to chemo/radiation with MEDI4736(durvalumab) followed by one year of MEDI4736 (durvalumab) for participants whohave locally advanced non-small cell lung cancer that cannot be removed. This study will help researchers find out ifthis different approach is better, the same, or worse than the usual approach.To decide if it is better, the study doctors will be looking to see if thestudy drug extends the life of patients and/or prevents the tumor from comingback as compared to the usual approach.

    This study has two groups:

    • Group 1 (Arm A,Arm C)

    Participants in this group will get the study drug, MEDI4736(durvalumab), once every other week during the first, third, and fifth weeks ofchemo/radiation (Arm A). One year of MEDI4736 (durvalumab) (Arm C)

    • Group 2 (Arm B,Arm C)

    Participants in this group will receive only standardchemo/radiation (Arm B). One year of MEDI4736 (durvalumab) (Arm C).

    For this study, all patients, including those who discontinueprotocol therapy early, will be followed for response until progression, evenif non-protocol therapy is initiated and after consolidation has ended, and forsurvival for 10 years from the date of registration. During this follow-upperiod, participants will have clinic visits every 3 months until the end oftheir 2nd year on the study, and then every 6 months until the end of their10th year on study.

    Participants 18 years of age or older who have locally advanced non-small cell lung cancer that cannot be removed.
    Mohindra, Nisha AnjaliMohindra, Nisha Anjali
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04092283 STU00212961
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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…

    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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    NCICOVID: NCI COVID-19 in Cancer Patients Study (N-CCaPS): A Longitudinal Natural History Study

    Thepurpose of this study is to collect blood samples, medical information, andcopies of medical images from patients who are being treated for cancer and haveCOVID-19. Researchers will use thesesampl…

    Thepurpose of this study is to collect blood samples, medical information, andcopies of medical images from patients who are being treated for cancer and haveCOVID-19. Researchers will use thesesamples, information, and images to answer questions about how cancer affectsCOVID-19 and how COVID-19 affects cancer treatment outcomes.

    Oneof the future research studies we expect to do with these blood samples isgenomic or genetic sequencing. Thesesequencing studies will be done to try to find genetic traits that might mean aperson with cancer has a better or worse outcome when they are infected withCOVID-19. They will also look at whetherthere are genetic traits that might mean being infected with COVID-19 affectscancer treatment outcomes.

    Participantswho have already tested positive or if a coronavirus test result comes back andis positive, researchers will collect blood samples, COVID-19 and cancertreatment and outcome information, and copies of medical images such ascomputerized tomography (CT) scans to use for future research on COVID-19 incancer patients. For participants who are waiting for the results of theircoronavirus test, researchers will collect information about your medicalhistory and cancer history, but will not collect any blood samples or medicalimages yet. If the test result comesback and is negative, you will stop being in the study and no furtherinformation will be collected, but we will do research using the information wehave already collected.

    Participants 18 years or older who are being treated for cancer and have COVID-19 will be enrolled.
    Wehbe, FirasWehbe, Firas
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04387656 STU00213072
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    COVID-19
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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 …

    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.

    Yang, Anthony DYang, Anthony D
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04239573 STU00213102
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    DRUG CX-839-012: A Phase 1b/2, Open label, Dose Escalation and Expansion Study of the Glutaminase Inhibitor Telaglenastat (CB-839) in Combination with the CDK4/6 Inhibitor Palbociclib in Patients with Advanced or Metastatic Solid Tumors
    The purpose of this study is to determine a safe and tolerable d…
    The purpose of this study is to determine a safe and tolerable dose of telaglenastat (an “investigational” drug), given together with palbociclib (an “approved” drug),  
    All participants in Part 2 of the study must be 18 years of-age or older and be diagnosed with advanced or metastatic CRC or NSCLC.
    Chae, Young KwangChae, Young Kwang
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03965845 STU00212083
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    (xIRB) DRUG EZH-108: A Phase 1, Open-Label Multi-Dose Two-Part Study to Characterize the Effects of a Strong CYP3A4 Inhibitor on the Steady-State Pharmacokinetics of Tazemetostat (EPZ-6438), And The Effects Of A Strong CYP3A4 Inducer on the Steady- State Pharmacokinetics of Tazemetostat in Subjects with Advanced Malignancies

    The purpose of this study is to:

    •determine how tazemetostat is processed by your body, known as pharmacokinetics or PK, both alone and in combination with another drug (itraconazole or rifampin) by measuring the amount of tazemetostat in your blood over time

    •determine what happens to tazemetostat when it is taken with drugs like itraconazole or rifampin

    •to find out how safe tazemetostat is both alone and when taken with itraconazole or rifampin

    Itraconazole is approved by the FDA for the treatment of different types of fungal infections. Rifampin is approved by the FDA for the treatment of different types of bacterial infections, including tuberculosis (TB). However, itraconazole and rifampin are not approved by the FDA for the treatment of cancer. Therefore, both itraconazole and rifampin are considered experimental in this study.

    This study has 2 parts. Subjects will complete either Part 1 or Part 2, but not both.

    •During the first cycle (called Cycle 1) of Part 1: Participants will be given tazemetostat and itraconazole.

    •During the first cycle (called Cycle 1) of Part 2: Participants will be given tazemetostat and rifampin.

    After Cycle 1 (for Part 1 or Part 2), you may continue to receive tazemetostat alone as long as your cancer is not getting worse and your study doctor believes it is in your best interest to continue receiving study drug, you can tolerate any side effects, or until you no longer wish to take part in the study.

    There are 3 periods for Cycle 1 of the study: Screening, Study Dosing and PK Blood Samples, and the End of Study Safety Follow-up Visit.

    1)Screening will last up to 30 days.

    2)Study Dosing and PK Blood Samples will be divided into cycles.

    •Cycle 1 will last 39 days for Part 1 participants or 26 days for Part 2 participants.

    3)The End of Study Safety Follow-up Visit will happen about 30 days after you receive the last dose of the study drug.

    How long you stay in this study depends on how well you tolerate the study drugs and how long you are willing to take part in this study.

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

    This is an open-label study. This means that you, the study doctor, study staff, and the Sponsor of the study will know the name of the study drugs and the doses you will be given.

    Participants in Part 1 will take 400 mg tazemetostat by mouth as a single dose during some periods of Cycle 1 and twice daily during other periods of Cycle 1. Participants in Part 1 will also take 200 mg itraconazole by mouth during certain periods of Cycle 1 of the study. The Tazemetostat dose will be increased to 800 mg twice per day for Cycle 2 onwards.

    Participants in Part 2 will take 800 mg tazemetostat by mouth as a single dose during some periods of the study and twice daily during other periods. Participants in Part 2 will also take 600 mg rifampin by mouth during certain periods of Cycle 1of the study.

    If you decide to continue participation after Cycle 1 of the study (for both Part 1 or Part 2), you will be given a supply of 800 mg tazemetostat to take by mouth twice daily for repeated 28-day cycles as long as your cancer is not getting worse, your study doctor believes it is in your best interest to continue receiving study drug, you are tolerating any side effects, or until you withdraw consent.

    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 a type of cancer that has spread in the body and you have previously received standard treatment for your disease. Your cancer has either failed to

    respond to that treatment or your cancer has spread and there is no other standard treatment available.

    •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.

    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04537715 STU00213166
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    (xIRB) DRUG M15-954: A Randomized, Double-Blind, Phase 3 Study Evaluating the Safety and Efficacy of Venetoclax in Combination with Azacitidine in Patients Newly Diagnosed with Higher-Risk Myelodysplastic Syndrome (Higher-Risk MDS)

    The purpose of this research study is to test a new investigationa…

    The purpose of this research study is to test a new investigational drug called venetoclax that is not approved by the Food and Drug Administration (FDA) to treat Higher-Risk Myelodysplastic Syndrome.

    Venetoclax has been approved by the regulatory authorities to treat specific medical conditions but is not approved to treat Myelodysplastic Syndrome (MDS). Therefore, the use of the study drug is investigational (experimental) for the purposes of this study. Azacitidine is approved for the treatment of certain forms of MDS in the United States and in Europe but is currently not approved to treat MDS in combination with venetoclax.

    This study will compare subjects randomly assigned to receive venetoclax and azacitidine versus placebo and azacitidine in subjects newly diagnosed with MDS. A placebo is a dummy study drug that looks like the real study drug but has no active ingredients. Azacitidine in combination with venetoclax may or may not work better than azacitidine alone.

    Subjects will be randomly assigned to receive:

    •Venetoclax and azacitidine

    OR

    •Placebo and azacitidine.

    If you decide to be in the study, you will be randomly assigned (like flipping a coin) to one of two groups above. You will have a 1:1 chance of receiving venetoclax and azacitidine, or placebo and azacitidine. This study is blinded which means you and your study doctor will not know to which study group you were assigned.

    As an estimate, study treatment will last approximately 3 to 14 months and include approximately 18 study visits to the research center. You will be asked to provide post-study treatment information, such as starting new therapies, for up to 5 years.

    If eligible, you will take venetoclax/placebo tablets by mouth with a meal and water in the morning at approximately the same time each day. Venetoclax/placebo is to be taken every day on days 1-14 of each 28-day cycle.

    Azacitidine will be administered intravenously (through a needle in your arm) or subcutaneously (an injection under the skin) based on your study center’s guidelines. The dosage will be calculated based on your body size. It will be administered for 7 days within the first 9 calendar days starting with Day 1 of each 28-day cycle.

    In addition to these study drugs, you will be given the best supportive care medications as needed according to your study doctor’s local practices.

    You will receive study drug treatment until your study doctor confirms that the cancer is no longer responding to the study treatment or until you meet any of the other criteria for study treatment discontinuation.

    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 if you are interested in this clinical trial.

    Some of the eligibility criteria include:

    •18 years of age or older

    •Have been diagnosed with Higher Risk Myelodysplastic Syndrome

    •Have not received prior treatment for Myelodysplastic Syndrome

    •Are eligible for a stem cell transplant, but have not yet identified a donor or arranged for the transplant, ORare ineligible for a stem cell transplant

    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.

    Frankfurt, OlgaFrankfurt, Olga
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04401748 STU00213254
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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 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 251 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 …

    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 251 E. Huron St.
      Chicago, IL
    NCT04333537 STU00213298
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    (xIRB) NCI CIRB ECOG-ACRIN 2186: A Randomized Phase II Study of Gemcitabine and Nab-Paclitaxel Compared with 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan in Older Patients with Treatment Naïve Metastatic Pancreatic Cancer (GIANT)

    The purpose of this study is to determine whether Gemcitabi…

    The purpose of this study is to determine whether Gemcitabine and Nab-paclitaxel or 5-Fluorouracil,

    Leucovorin, and Liposomal Irinotecan are more effective treatments for vulnerable patients

    over the age of 70 with newly diagnosed metastatic pancreatic cancer (mPCA).

    These drugs are already approved by the FDA for use in pancreatic cancer. But, it is unknown

    which combination is the most effective for vulnerable mPCA patients over the age of 70.

    This study will help the study doctors find out which approach is better at prolonging the life

    of patients over 70 with mPCA. To determine this, the study doctors will be looking to see which

    of the two approaches shows better results.

    Participants who participate will be randomized to either get Gemcitabine and Nab-paclitaxel

    every other week or 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan every other week.

    This study has 2 study groups.

    Group 1 (Arm A)

    Participants in this group will get the combination treatment of Gemcitabine and Nab-paclitaxel.

    Group 2 (Arm B)

    Participants in this group will get the combination treatment of 5-Fluorouracil, Leucovorin,

    and Liposomal Irinotecan.

    Your doctor will continue to follow your condition for up to 2 years after you start the study,

    and watch you for side effects and monitor your cancer.

    Vulnerable patients over the age of 70 with newly diagnosed metastaticpancreatic cancer (mPCA).
    Kalyan, AparnaKalyan, Aparna
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04233866 STU00213326
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    mPCA
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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, m…

    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…

    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.

    Cristofanilli, MassimoCristofanilli, Massimo
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04266249 STU00213352
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    (xIRB) DRUG ARC-6: A Phase 1b/2, Open-Label, Randomized Platform Study Evaluating the Efficacy and Safety of AB928-Based Treatment Combinations in Patients with Metastatic Castrate Resistant Prostate Cancer
    The purpose of this study is to understand whether an experimental treatment, AB928, is safe a…
    The purpose of this study is to understand whether an experimental treatment, AB928, is safe and effective when given in combination with other treatments to patients with metastatic castrate resistant prostate cancer (mCRPC). AB928 may be combined with other experimental drugs, known as AB680 and zimberelimab (AB122), or may be combined with drugs that are approved by the US Food and Drug Administration (FDA) and other government agencies to treat mCRPC.

    This is an open-label, randomized study. If you are eligible to participate in the study, you will be assigned to one of the following treatment arms based on your prior cancer treatment(s):

    •AB928 + zimberelimab + enzalutamide (Stage 1 and Stage 2)

    •Enzalutamide (Stage 2 only)

    •AB928 + zimberelimab + docetaxel (Stage 1 and Stage 2)

    •Docetaxel (Stage 2 only)

    •AB928 + zimberelimab (Stage 1 and Stage 2)

    •AB928 + zimberelimab + AB680 (Stage 1 and Stage 2)

    •AB928 + AB680 (Stage 1 and Stage 2)

    Depending on your past treatment history, the study doctor will help to decide which study treatment is best for you. You may be eligible for more than one study treatment. If this is the case, study treatment may be assigned randomly (by chance, like rolling dice). The study doctor can provide more detail on which study treatment(s) you may qualify for.

    This study is made up of two stages. Regardless of which stage you are enrolled into, you will follow the same procedures as outlined below.

    This research study is made up of the following parts:

    •Screening

    •Treatment

    •End of Study and Long-Term Safety Follow Up

    You will receive treatment depending upon the arm for which you qualify. The study drugs AB928 and enzalutamide are administered orally. The study drugs zimberelimab, AB680, and docetaxel are administered intravenously (IV) over approximately 1 hour.

    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 castrate resistant prostate 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.

    VanderWeele, David JamesVanderWeele, David James
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04381832 STU00213357
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    (xirb) Drug APTO-CG-806-03 : A Phase 1a/b Trial of CG-806 in Patients with Relapsed/Refractory Acute Myeloid Leukemia

    This research study is being done to evaluate the safety and effectiveness of the study drug called CG-806, for the treatment of your disease. CG-806 is classified as an experiment…

    This research study is being done to evaluate the safety and effectiveness of the study drug called CG-806, for the treatment of your disease. CG-806 is classified as an experimental drug, which means that it has not yet been approved for sale by the Food and Drug Administration (FDA).

    • Diagnosis of acute myeloid leukemia (AML) or chronic myeloid leukemia in blast crisis, for which either the standard treatment for disease has failed, is no longer effective, has not been tolerable or it has been determined to be ineligible for intensive chemotherapy.

    ·

    • 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
    NCT04477291 STU00213396
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    (xIRB) DRUG 1951-CL-0101: A Phase 1b Study of ASP1951, a GITR Agonistic Antibody, as a Single Agent and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors

    The purpose of this study is to determine at what dose the study drug (ASP1951 alone or ASP1951 plus pembrolizumab) is sa…

    The purpose of this study is to determine at what dose the study drug (ASP1951 alone or ASP1951 plus pembrolizumab) is safe and tolerated and how it is processed in the blood of subjects with tumors that cannot be removed (unresectable) or has spread (metastasized) to a different part of the body. During this period, the study drug will be continuously assessed to determine if it is safe and tolerated by subjects taking it.

    This is an open-label study, which means both you and your study doctor will know what study drug you will be receiving. Many dose levels will be tested in the study. It is not known which dose, if any, will work the best. Y Your study doctor will inform you which study drug dose you will be assigned to at the time of screening and if you qualify to enroll in the study.

    The study consists of up to 3 periods: Screening; Study Treatment; Follow-up; and if you qualify and are willing to continue, a Re-treatment period.

    The study drug will be given directly into your veins through an intravenous (IV) infusion.

    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 a tumor that cannot be removed through surgery (unresectable) or may have spread (metastasized) to other parts of your 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.

    Mulcahy, Mary FrancesMulcahy, Mary Frances
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT03799003 STU00213423
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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…

    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 th…

    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 251 E. Huron St.
      Chicago, IL
    NCT03601442 STU00213101
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    (xIRB) DRUG XPORT-GBM-029: A Phase 1/2 Study of Selinexor in Combination with Standard of Care (SoC) Therapy for Newly Diagnosed or Recurrent Glioblastoma
    The purpose of this research study is to see if the combination of approved Glioblastoma (GBM) medications, together with the study drug, selinexo…
    The purpose of this research study is to see if the combination of approved Glioblastoma (GBM) medications, together with the study drug, selinexor (also known as XPOVIO), has any effects on your cancer. Selinexor is approved by the U.S. Food and Drug Administration (FDA) for the use in certain patients with multiple myeloma but is considered to be investigational for the use in GBM. Investigational means that it has not been approved by the FDA, Health Canada, or any other regulatory agencies for the treatment of GBM.

    This is an open-label study, which means that both you and your study doctor will know how much selinexor and the names of the other medications you are taking. This study includes the following different treatment combination arms:

    •Arm A – Selinexor plus radiation treatment in patients with newly diagnosed, unmethylated GBM

    •Arm B – Selinexor plus temozolomide (TMZ) and radiation treatment in patients with newly diagnosed, methylated GBM

    •Arm C – Selinexor plus lomustine in patients with recurrent GBM

    All prospective patients will undergo screening tests to determine if they are eligible to take part in the study. Your study doctor will decide which combination is right for you, based on what therapies are available in your location and based on your diagnosis and treatments you have had in the past.

    There are two parts of this study. The first part is a “dose-escalation phase,” where the purpose is to find the best dose and the best treatment schedule of the above combinations, based on how well the medications work together and how safe they are when they are given together. The second part, the “dose-expansion phase,” will be used to see how well the best dose and treatment schedule from part 1 works when given to a larger group of patients.

    If you are assigned to Arm A or B for the dose-expansion phase and are assigned to the control treatment, you will receive a maximum of 7 cycles of treatment which is consistent with what the FDA or other regulatory agency has approved. If you are a part of the dose-escalation phase of Arm A or B, the dose-expansion phase for Arm A or B and are assigned to the treatment arm, or if you are assigned to Arm C, you can continue to receive study treatment as long as your doctor thinks you are benefitting from therapy, until the study ends, your disease progresses, you have side effects that makes you want to not continue, you decide to withdraw from the study, your study doctor decides you should not continue, or you become pregnant (if applicable).

    For each visit, your study doctor will review your data and perform some tests to see if it is appropriate for you to continue in this study. Selinexor, the study drug, comes in tablet form and should be swallowed whole with about one-half of a cup of water. Selinexor can be taken with or without food.

    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

    •Newly Diagnosed or Recurrent Glioblastoma

    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 251 E. Huron St.
      Chicago, IL
    NCT04421378 STU00213433
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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 app…

    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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    (xIRB) DRUG 209627: A Phase I Study to Evaluate the Pharmacokinetics and Safety of Belantamab Mafodotin Monotherapy in Participants with Relapsed or Refractory Multiple Myeloma Who Have Normal and Varying Degrees of Impaired Hepatic Function (DREAMM 13)

    The purpose of this study is to find out the…

    The purpose of this study is to find out the relationship between liver function and safety and pharmacokinetics of study drug. Pharmacokinetics means study of the movement of drug through the body, and this study will be looking to see if liver disease affects that movement.

    This is a study in people with relapsed (returning) and/or refractory (not responding to treatment) multiple myeloma (RRMM) with various grades of impaired liver function to test how the study drug belantamab mafodotin (a drug being tested to treat people with RRMM) behaves in people with liver disease. There are 2-parts to the study. Participants with RRMM from 3 groups based on how well your liver functions can take part in the study.

    Part Group Hepatic function group Number of participants

    1 1 Normal liver function 8-12

    1 2 Moderate liver impairment Up to 8

    2 3 Severe liver impairment Up to 8

    The study will include three phases. A Screening phase, a Study Treatment phase, and a Follow-up phase.

    The screening assessment will be performed within 21 days before the first dose. After your screening period, if you are eligible, you will need to visit the study site at least every 3 weeks to receive the study treatment and take part in additional exams, tests, or procedures. Study drug will be infused through a vein over approximately 30 minutes starting at a 2.5 mg/kg dose in Part 1 (Groups 1 and 2) and potentially at a lower dose in Part 2 (Group 3) with doses calculated on your body weight at the time of dosing. Study visits will take as little as 3 hours or as much as 12 hours of your 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 RRMM

    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 251 E. Huron St.
      Chicago, IL
    NCT04398680 STU00213494
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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 …

    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 251 E. Huron St.
      Chicago, IL
    NCT04197986 STU00211963
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    NU MSK19H03 : Combination Therapy with Entinostat and Pembrolizumab in Relapsed and Refractory Lymphomas

    Almost allpatients with relapsed and refractory Hodgkin lymphoma require additionaltreatment. Typical treatments for relapsed or refractory Hodgkin lymphoma inthe United States can include addi…

    Almost allpatients with relapsed and refractory Hodgkin lymphoma require additionaltreatment. Typical treatments for relapsed or refractory Hodgkin lymphoma inthe United States can include additional chemotherapy regimens such asbrentuximab vedotin, or nivolumab. Webelieve that the addition of entinostat to pembrolizumab may provide benefit tothese patients and without having the need to undergo a stemcell transplant ( SCT)

    Pembrolizumab has already been approved by theUS Food and Drug Administration (FDA) to treat relapsed or refractory classicalHodgkin lymphoma and other cancers. The combination of Entinostat andPembrolizumab has been tested in patients with lung cancer and has been foundto be safe.

    · Participantsmust be 18 years or older

    The target populationfor this study is patients relapsed and refractory Hodgkin lymphoma
    Pro, BarbaraPro, Barbara
    • Map it 201 East Huron Street Suite 12-160​
      Chicago, IL
    NCT03179930 STU00212107
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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 cel…

    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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    DRUG ME-522-001: A Phase 1, Open-Label, Study of Voruciclib in Subjects with Relapsed and/or Refractory B Cell Malignancies or Acute Myeloid Leukemia After Failure of Prior Standard Therapies
    This study has been designed to look at the safety of voruciclib (also known as the study drug), how your bod…
    This study has been designed to look at the safety of voruciclib (also known as the study drug), how your body tolerates the drug, how effective the drug may be, and how the drug is taken up by your body when administered orally after multiple doses over the course of the study. This study is being conducted to determine the highest safely tolerated dose of voruciclib in patients that have relapsed and/or refractory B cell type cancers or acute myeloid leukemia.
    Must be diagnosed with a certain type of B cell cancer or acute myeloidleukemia (AML) that has relapsed (come back) or is refractory (did not respondto previous treatment). The types of B cell cancers in this study includefollicular lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphoma(MZL), small lymphocytic lymphoma (SLL), chronic lymphocytic leukemia (CLL), ordiffuse large B-cell lymphoma (DLBCL).
    Frankfurt, OlgaFrankfurt, Olga
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03547115 STU00213009
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    (xIRB) DRUG CA209-7FL: A Randomized, Multicenter, Double-blind, Placebo-controlled Phase 3 Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Patients With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer (CheckMate 7FL)

    The purpose of this study is to test the effectiveness (how well the experimental drugs work), safety and tolerability of nivolumab (Opdivo) given in combination with chemotherapy (neoadjuvant treatment, i.e. treatment given before surgery) prior to definitive breast cancer surgery, followed by nivolumab with endocrine treatment (adjuvant treatment, i.e. treatment given after surgery) in newly diagnosed, treatment naive participants with high-risk, estrogen-receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-) breast cancer.

    As part of this study, we will collect samples of your tumor tissue and blood to look for biomarkers. Biomarkers are substances such as genetic material (DNA) and proteins found in blood and tumor tissue that might show if a subject with cancer will respond or not respond to a particular type of treatment.

    If you meet all of the eligibility criteria, you will be randomized (assigned by chance) to one of the two treatment arms below:

    There is a 50% chance that you will receive either:

    •Treatment Arm A: Nivolumab combined with chemotherapy before surgery (maximum 8 treatment cycles) followed by nivolumab combined with endocrine treatment after surgery (maximum 7 treatment cycles).

    OR

    •Treatment Arm B: Placebo combined with chemotherapy before surgery (maximum 8 treatment cycles) followed by placebo combined with endocrine treatment after surgery (maximum 7 treatment cycles).

    The study treatments are double blind, which means that neither you nor your study doctor will know which treatment you are receiving, except in an emergency.

    The placebo is a dummy treatment, one that looks like the real one but contains no active study drug.

    There are 4 periods to the study:

    oScreening Period

    oPre-surgery (Neoadjuvant) Treatment Period

    oPost-surgery (Adjuvant) Treatment Period

    oFollow-up Period

    Blood samples will be collected during each period of the study.

    You will receive treatment depending upon the arm for which you qualify. The study drug, Nivolumab is administered intravenously (IV) over approximately 30 minutes.

    Paclitaxel followed by an anthracycline and cyclophosphamide is a standard chemotherapy treatment regimen for your type of breast cancer. Treatments are administered by intravenous (IV) infusion, meaning the drug is given through a vein. The anthracycline drug (either doxorubicin or epirubicin) and its administration schedule (given once every 3 weeks or once every 2 weeks) will be chosen by your doctor.

    Endocrine therapy (in combination with nivolumab or nivolumab placebo) will be taken daily for a maximum of 7 treatment cycles. Your doctor will provide you further details on how to take this endocrine treatment.

    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

    •Newly diagnosed with high-risk, estrogen-receptor positive (ER+) and human

    epidermal growth factor receptor 2 negative (HER2-) 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.

    Gradishar, William JGradishar, William J
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04109066 STU00213659
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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…

    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 251 E. Huron St.
      Chicago, IL
    NCT04340141 STU00213664
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    DRUG RPM-CART-001 : An Observational Study to Evaluate a Wearable Temperature Monitoring Device in Subjects Receiving Car-T Therapy
    The study participant will participate in thestudy by wearing a patch and keeping an android phone within range of the patch24-hours a day for 42 days. Patientswill als…
    The study participant will participate in thestudy by wearing a patch and keeping an android phone within range of the patch24-hours a day for 42 days. Patientswill also take their own oral temperature in a place of their choosing 3-4 timesa day.

    Patients who are taking CART-T treatment will berecruited for this observational study.

    Karmali, ReemKarmali, Reem
    • Map it 675 N. St. Clair St.
      Chicago, IL
    STU00213145
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    CART-T RPM Patch
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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…
    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 251 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 un…

    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 251 E. Huron St.
      Chicago, IL
    NCT04383210 STU00213426
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    (xIRB) NCI CIRB SWOG 1929: Phase II Randomized Study of Maintenance Atezolizumab Versus Atezolizumab in Combination with Talazoparib in Patients with SLFN11 Positive Extensive Stage Small Cell Lung Cancer (ES-SCLC)

    The purpose of the study is to determine if researchers can lower the

    The purpose of the study is to determine if researchers can lower the

    chance of small cell lung cancer growing or spreading by adding talazoparib to the usual atezolizumab

    treatment. Researchers want to find out if this approach is better or worse than the usual approach

    for small cell lung cancer.

    This study has two parts: a screening part and a treatment part. The purpose of the screening

    part is to test your tumor to find out if it has a protein, SLFN11.

    If it does and you meet all the study requirements, then you will be randomized to a study group

    for treatment. The purpose of the treatment part of the study is to compare the usual

    treatment (atezolizumab) alone to using talazoparib plus the usual treatment. This immunotherapy drug,

    atezolizumab, is already approved by the FDA for use in ES-SCLC cancer.

    The treatment part of the study has two groups:

    Group 1

    Participants in group 1 will be given atezolizumab.

    Group 2

    Participants in group 2 will get talazoparib plus atezolizumab.

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

    They will check you every 6 months for 2 years and at the end of year 3 from the start of treatment.

    This means you will keep seeing your doctor for up to 3 years from the time you start treatment.

    Participants aged 18 years or older who have extensive stage small cell lung cancer (ES-SCLC) will

    participate in this study.

    Chae, Young KwangChae, Young Kwang
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04334941 STU00213765
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    ETCTN 10388: A Phase I Trial of Triapine and Lutetium Lu 177 Dotatate in Combination for Well-Differentiated Somatostatin Receptor-Positive Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)
    This study is being done to answer the following question: What is the highest dose of triapine in combin…
    This study is being done to answer the following question: What is the highest dose of triapine in combination with Lutetium Lu 177 Dotatate that is safe and tolerable in patients with neuroendocrine tumors? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your neuroendocrine tumor. The usual approach is defined as care most people get for neuroendocrine tumors. There is evidence that the study drug, triapine, can make cancer more sensitive to the usual treatment, Lutetium Lu 177 Dotatate. The combination of triapine and Lutetium Lu 177 Dotatate is not approved by the Food and Drug Administration (FDA) for any cancer.This is the first time these drugs will be tested together in humans.
    • Participants must be 18 years or older
    • Participants must have had a confirmed diagnosis of gastroeneteropancreatic neuroendocrine tumors (GEP-NETs)
    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 251 E. Huron St.
      Chicago, IL
    NCT04234568 STU00213770
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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 circulati…

    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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    NRG BN007: A Randomized Phase II/III Open-Label Study of Ipilimumab and Nivolumab Versus Temozolomide in Patients with Newly Diagnosed MGMT (Tumor O-6-Methylguanine DNA Methyltransferase) Unmethylated Glioblastoma
    This study is being done to answer the following question: Can we lengthen time without…
    This study is being done to answer the following question: Can we lengthen time without your brain tumor returning or growing and can we extend your life by replacing the usual chemotherapy with immune therapy? We are doing this study because we want to find out if this approach is better, the same, or worse than the usual approach for your brain tumor. The usual approach is defined as care most people get for glioblastoma brain tumors.
    • Participants must be 18 years or older
    • Participants must have a confirmed diagnosis of newly diagnosed Glioblastoma with a specific biomarker known as unmethylated MGMT.
    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.
    Dixit, Karan SinghDixit, Karan Singh
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04396860 STU00213865
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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…

    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 251 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 determin…
    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 251 E. Huron St.
      Chicago, IL
    NCT04530565 STU00213941
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    (xirb) DRUG 7051-ONC-101: A Phase 1 Study of FT-7051 in Men with Metastatic Castration-Resistant Prostate Cancer
    This research is being performed because improvements are needed in the management ofpatients with cancer. FT-7051 may help treat prostate cancer by blocking a receptor in the tumor c…
    This research is being performed because improvements are needed in the management ofpatients with cancer. FT-7051 may help treat prostate cancer by blocking a receptor in the tumor cell, called theandrogen receptor. The major purpose of this study is to To test the safety of FT-7051 and see what effects (good and bad) it has on cancer, and to find the highest dose of FT-7051 that can be given alone without causing serious side effects. 

    Some of the eligibility criteria include:

    1. ≥ 18 years of age

    2. Life expectancy of ≥ 3 months

    3. Diagnosis of mCRPC with either adenocarcinoma or mixed histology

    VanderWeele, David JamesVanderWeele, David James
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04575766 STU00213972
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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 …
    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 …

    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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    (xIRB) NCI CIRB ETCTN 10220: A Phase II Basket Trial of Glutaminase Inhibitor (BeGIN) CB-839 HCl in Patients with NF1 Aberrations, NF1 Mutant Malignant Peripheral Nerve Sheath Tumors (MPNST), KEAP1/NRF2 and LKB1 Aberrant Tumors

    The purpose of this study is to test the good and bad effects of the d…

    The purpose of this study is to test the good and bad effects of the drug called

    CB-839 HCl (telaglenastat). The study doctors hope to learn if the study drug will help control the

    disease in patients with advanced cancer with changes in specific genes.

    In this study, you will get the study drug CB-839 HCl for as long as your disease does not worsen

    and you do not experience unacceptable side effects. This could be for a period of weeks or months.

    Participants will get CB-839 HCl starting on Day 1 of each cycle. Each cycle lasts 28 days (4 weeks).

    This drug is not approved by the FDA for treatment of your disease.

    Participants 18 years of age or older who have advanced cancer that has spread and your cancer has a

    change in the gene called the NF1 (Neurofibromatosis type 1) gene

    (ex. NF1 mutant malignant peripheral nerve sheath tumor [MPNST] or other tumors),

    KEAP1 (Kelch-like ECH-associated protein 1)/NRF2 (nuclear factor [erythroid-derived 2]-like 2) gene

    or STK11/LKB1 (Serine/Threonine Kinase 11/Liver Kinase B1) gene.

    Chae, Young KwangChae, Young Kwang
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00214026
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    BTCRC GI15-067: A phase II study to evaluate the efficacy of liposomal irinotecan in combination with oxaliplatin, leucovorin, and 5-fluorouracil for patients with locally advanced pancreatic carcinoma: Big Ten Cancer Research Consortium BTCRC-GI15-067

    The purpose of this voluntary research study …

    The purpose of this voluntary research study is to see if using four drugs called liposomal irinotecan, 5-fluorouracil (5FU), leucovorin and oxaliplatin as a first line treatment can improve outcomes. The combination of 5FU, leucovorin and oxaliplatin is also called FOLFOX.

    This study will see if the drugs:

    1.are tolerable as a combination therapy

    2.keep the cancer away for a longer period of time

    3.increase the number of people that can have the tumor removed by surgery after treatment

    4.improves quality of life for patients undergoing chemotherapy for this disease.

    If you are eligible and agree to participate, you will receive the study drugs: liposomal irinotecan, 5FU, leucovorin and oxaliplatin.

    During the study you will need to attend visits, follow the instructions provided by the study staff and tell the study doctor or study staff about any changes in your health or the way you feel.

    All prospective patients will undergo screening tests to determine if they are eligible to take part in the study. Each drug will be given as an intravenous (IV) infusion through a vein. The dose of the drugs will depend on how much you weigh.

    The drugs will be given in units of time called cycles. One cycle equals 14 days (2 weeks). The cycles will repeat until your cancer can be removed by surgery, your cancer gets worse or you have severe side effects.

    Each drug will be given as an intravenous (IV) infusion through a vein. The dose of the drugs will depend on how much you weigh. On the first day of each cycle (Day 1) you will receive the study drugs in a certain order. There will be a 15 to 30 minute break between each drug.

    After you have stopped the study drugs, your doctor will continue to watch you for side effects and follow your condition. This may happen with a clinic visit, phone call, email, or other form of communication.

    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:

    •cancer of the pancreas which has not been treated and you cannot undergo surgery to remove the 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.

    Benson III, Al BBenson III, Al B
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT03861702 STU00213639
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    NU 20G02: A Phase II Trial of Irinotecan Liposome and Bevacizumab in Women with Platinum Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

    Adult patients with a diagnosis of platinum-resistant ovarian, fallopian or primary peritoneal cancer.
    Matei, Daniela ElenaMatei, Daniela Elena
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04753216 STU00213582
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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 t…

    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

    Pro, BarbaraPro, Barbara
    • Map it 675 N. St. Clair St.
      Chicago, IL
    NCT04795869 STU00213618
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    (xIRB) DRUG U31402-A-U201: HERTHENA-Lung01: A Phase 2 Randomized Open-Label Study of Patritumab Deruxtecan (U3-1402) in Subjects with Previously Treated Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer (NSCLC)

    The purpose of this study is to understand patritumab deruxtecan f…

    The purpose of this study is to understand patritumab deruxtecan for its safety, how well it is tolerated, and how well it works.

    As part of this study, tissue will be collected as part of Screening process in order to participate in the Main research study.

    Study participation will be divided into three periods: Screening, Treatment and Follow-up.

    Screening - maximum duration of 28 days.

    Treatment - may continue until documented disease progression, clinical progression, unacceptable toxicity, withdrawal of consent by the subject, physician’s decision, protocol deviation, pregnancy, lost to follow-up, study termination by the Sponsor, death, or other reasons.

    Follow-up - starts upon permanent discontinuation of patritumab deruxtecan. Participants will be followed every 3 months for survival.

    Participants will be randomly assigned by chance to 1 of 2 study Arms in equal numbers and randomly (like flipping a coin):

    •Arm 1: fixed dose of patritumab deruxtecan every three weeks

    •Arm 2: Up-titration (going from a lower to a higher dose for the first three cycles) dose of patritumab deruxtecan every three weeks

    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 lung cancer that is unable to be surgically removed or has spread

    from the lung(s) to other parts 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 251 E. Huron St.
      Chicago, IL
    NCT04619004 STU00214135
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    (xIRB) DRUG LOXO-IDH-20001: A Phase 1 Study of Oral LY3410738 in Patients with Advanced Hematologic Malignancies with IDH1 or IDH2 Mutations

    The main purpose of this study is to test the safety of an investigational treatment called LY3410738. LY3410738 is an investigational (or experimental) drug…

    The main purpose of this study is to test the safety of an investigational treatment called LY3410738. LY3410738 is an investigational (or experimental) drug, taken by mouth that may treat certain cancers. It was designed to target particular abnormalities that can occur in some types of cancer cells. These abnormalities (called an IDH1 or IDH2 mutation) are tested in advance and if the participant’s cancer has one or both of these abnormalities, he or she may be considered for enrollment in this study.

    This study will be conducted in two parts: dose escalation and dose expansion.

    •The Dose Escalation part is to determine what dose of LY3410738 is safe and well tolerated.

    •The Dose Expansion cohort is to determine if the dose level chosen in the Dose Escalation part is effective

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

    Dose Escalation

    During dose escalation, patients will be enrolled into one of two groups (i.e. dose escalation arms) depending on whether certain medicines are taken to help prevent from getting an infection (called antifungal medicines). These medicines may change how LY3401738 works.

    For each dose escalation arm, LY3410738 participants be studied at different total daily dose levels in groups called cohorts, where each different cohort may be assigned to a different dose and/or dose schedule. About 3 to 6 participants will be enrolled in each cohort. Once a cohort has completed dosing and safety has been assessed, the next cohort will be enrolled. Participants will be assigned to the cohort that is open.

    Dose Expansion

    Following dose escalation, a dose of LY3410738 will be chosen for the dose expansion portion of the study. The dose may be different for participants that take certain medicines to help prevent infections (called antifungal medicines). If participating at the time dose expansion is ongoing, participants will be enrolled into one of four groups (i.e. expansion cohorts) depending on the type of cancer, the type of abnormality their cancer cells have (called an IDH1 and / or IDH2 mutation) and what cancer treatments they have received.

    The study doctor will inform participants if the study is currently in dose escalation or dose expansion. The group assignment will depend on when the participant joins. Enough LY3410738 will be given so that it can be taken for up to 28 days each cycle.

    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.

    Some of the eligibility criteria include:

    •Diagnosis of cancer and have previously received standard treatment and either the

    cancer did not respond to that treatment, the cancer progressed, the participant did not tolerate the treatment; or the participant’s physician does not think standard treatment will be effective or tolerated.

    •Cancer cells with IDH1 and/or IDH2 mutation that LY3410738 is designed to treat

    •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 251 E. Huron St.
      Chicago, IL
    NCT04603001 STU00214167
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    DRUG CG2003C: A Phase 2, Single Arm Study of CG0070 Combined with Pembrolizumab in Patients with Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG)

    The main purpose of this study is to find out whether CG0070, DDM, and pembrolizumab are safe when given togeth…

    The main purpose of this study is to find out whether CG0070, DDM, and pembrolizumab are safe when given together, whether your tumor disappears after treatment (called a complete response), and if you have a complete response, to monitor how long the response lasts.

    This study consists of 3 distinct phases: Screening Phase, Treatment Phase, and Follow-Up Phase. The Screening Phase will last up to 8 weeks. The Treatment Phase can continue for up to 24 months from the start of study treatment unless your cancer gets worse or recurs. The Follow-Up Phase will last for up to 4 years from the start of study. You will not be scheduled to return to the clinic/hospital for the study during the Follow-Up Phase, but you will be contacted every ~12 weeks.

    Intravesical Procedure

    CG0070 and DDM will be given by intravesical treatment, meaning that these agents will be put into your bladder using a catheter.

    CG0070 and DDM Administration

    CG0070 and DDM will first be given as part of an induction period. After 3 months, your study doctor will look to see if you have any cancer remaining. If you have cancer remaining that has not spread, you can receive a second induction.

    Pembrolizumab Administration

    Pembrolizumab will be given by intravenous infusion (directly into your vein via intravenous drip).

    CG0070, DDM, and pembrolizumab may be given occasionally on the same day. If this happens, pembrolizumab will be given first and then CG0070 and DDM will be given at least 2 hours later.

    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.

    Some of the eligibility criteria include:

    •Diagnosis of bladder cancer that has not invaded the muscular wall

    •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.

    Meeks, Joshua JMeeks, Joshua J
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04387461 STU00213631
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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…
    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 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 Alliance A071702: A Phase II Study of Checkpoint Blockade Immunotherapy in Patients with Somatically Hypermutated Recurrent Glioblastoma

    The purpose of this study is to test the good and bad effects of the combination of immunotherapy drugs

    called nivolumab and ipilimumab. T…

    The purpose of this study is to test the good and bad effects of the combination of immunotherapy drugs

    called nivolumab and ipilimumab. The study doctors hope to learn if the study drugs will lead to a

    stability or reduction in the size of your tumor.

    Nivolumab and Ipilimumab have already been approved by the FDA to treat other cancers.

    In this study, if your tumor has a higher number of mutations, you will receive a combination of

    nivolumab and ipilimumab every three weeks for four cycles and then you will receive nivolumab alone

    every four weeks as long as you keep responding to it and do not experience any serious side effects.

    If your tumor starts to grow while receiving the medication, we will stop treating you with it.

    After you finish your study treatment, your doctor will continue to follow your condition every 3

    months for 3 years and watch you for side effects.

    Participants age 18 years or older who have a glioblastomawhich has recurred (come back) or gotten bigger after initial treatment will beenrolled into this study.

    Kumthekar, Priya UKumthekar, Priya U
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04145115 STU00214358
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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…

    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 …

    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 251 E. Huron St.
      Chicago, IL
    NCT04032704 STU00214153
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    DRUG ITM-LET-01 : A prospective, randomised, Controlled, Open-label, Multicentre phase III study to evaluate efficacy and safety of Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-Edotreotide compared to targeted molecular therapy with Everolimus in patients with inoperable, progressive, somato-statin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin (GEP-NET).
    This study aims to compare two different treatment options: the current routine treatment with orally administered everolimus on the one hand and on the other hand, a new treatment option called Peptide Receptor Radionuclide Therapy (shortly PRRT). The PRRT that is being studied is based on the administration of the radioactive pharmaceutical 177Lu-edotreotide. The aim of both treatment arms is to slow or stop tumor progression or even to reduce tumor sizes. By inclusion of both, 1st line (patients having had no disease treatment before) and 2nd line (patients having been treated before) GEP-NET patients, the issue of optimum timing of PRRT during the disease course will also be addressed by the present trial.
    Patients who are of 18 years of age or older may be able to take part in this study is they have inoperable, progressive, somato-statin receptor-positive (SSTR+), neuroendocrine tumors of gastroenteric or pancreatic origin (GEP-NET).
    Benson III, Al BBenson III, Al B
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03049189 STU00213444
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    (xIRB) NCI CIRB ECOG-ACRIN 8183: A Phase III Double Blinded Study of Early Intervention After RADICAl ProstaTEctomy with Androgen Deprivation Therapy with Darolutamide vs. Placebo in Men at Highest Risk of Prostate Cancer Metastasis by Genomic Stratification (ERADICATE)

    The purpose of thisstudy is…

    The purpose of thisstudy is to compare Androgen Deprivation Therapy (ADT) alone to ADT plusdarolutamide for participants who have had surgery for prostate cancer. Thisstudy will help the study doctors find out if this different approach worksbetter than the approach of ADT alone. To decide if it is better, the studydoctors will be looking to see if the darolutamide increases the life of patientsby 6 months or more compared to the usual approach.

    This study has 2groups. Participants will not be told which group they are in.

    Group 1: Participantsin group 1 will get ADT plus a placebo pill for up to 12 months. A placebo is apill that looks like the study drug but contains no medication.

    Group 2: Participants ingroup 2 will get ADT plus darolutamide. Darolutamide is not approved by the FDAfor treatment of this type of disease.

    After study treatmentis finished, participants will be followed for 3-month intervals for 36 months towatch for side effects and disease progression.

    Male participants ages 18 years or older who have had surgery forprostate cancer will be enrolled in this study.
    Ross, Ashley EvanRoss, Ashley Evan
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04484818 STU00214490
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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 ac…

    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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    angiosarcoma
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    (xIRB) NCI CIRB ECOG-ACRIN 3161: A Phase III Randomized Study of Maintenance Nivolumab versus Observation in Patients with Locally Advanced, Intermediate Risk HPV Positive OPCA

    The purposeof this study is to compare the usual treatment alone, radiation andchemotherapy (cisplatin), to adding mainte…

    The purposeof this study is to compare the usual treatment alone, radiation andchemotherapy (cisplatin), to adding maintenance nivolumab to the usualtreatment. The addition of nivolumab to the usual treatment could shrinkintermediate risk HPV positive oropharynx cancer or prevent it from returning. Thisstudy will help determine if maintenance nivolumab following definitive therapywith radiation and chemotherapy (cisplatin) result in significant improvementin overall survival (time being alive) and progression-free survival (timebeing alive without cancer) for patients with intermediate risk HPV positiveoropharynx cancer.

    Each patient will receivetreatment based on the group by which they are assigned. In Group 1, patientswill receive chemotherapy weekly for up to 7 weeks and radiation dailyexcluding weekends, for up to 7 weeks. Then the patient will either getnivolumab by vein (intravenously) every 4 weeks for up to 12 months and bemonitored and observed. In Group 2, patients will receive chemotherapy andradiation in the same way as in Group 1 but will be monitored and observedwithout getting nivolumab. However, if the cancer grows during observation, thenGroup 2 patients will be offered nivolumab by vein (intravenously) every 4weeks for up to 12 months.

    After treatment is complete, thedoctor and study team will watch patients for side effects. They will check patients every 3-6 months for3 years after treatment. After that,they may check patients every year. This means patients may keep seeing thedoctor for 10 years after treatment.

    •Age of at least 18 years

    •For Step 1 – Patients must have oropharynx cancer (AJCC 8) that is p16-positive by immunohistochemistry with smoking status: ≥10 pack-years, stage T1-2N2-N3 or T3-4N0-3 (less than 10 packyears is considered a non-smoker)

    OR

    <10 pack-years, stage T4N0-N3 or T1-3N2-3.

    •For Step 2 – Patients must have progression per RECIST criteria AND tissueproven progression on Arm B treatment within 12 months after completion of radiation therapy

    Boumber, YanisBoumber, Yanis
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03811015 STU00214496
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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 …

    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 251 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) Non-Small Cell Lung Cancer (NSCLC)

    The main aims of this clinical study are to:

    •Find out if the best course …

    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-mutated 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 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 are:

    •Monotherapy: VS-6766 4.0 mg by mouth, twice weekly (Monday/Thursday or Tuesday/Friday), 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 (Monday/Thursday or Tuesday/Friday) 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).

    If participants are in the randomized group, the study doctor will not know what study treatment will participants be assigned to in advance. If participants are assigned to a study treatment group, the study doctor will know in advance what study treatment participants will be taking.

    VS-6766 is given as a capsule(s) that will be taken by mouth twice a week on a Monday and Thursday or on a Tuesday and Friday. The study doctor will inform participants which days to take the capsules. VS-6766 capsules should be taken on an empty stomach. Participants should not eat any food at least 2 hours before or one hour after taking VS-6766. VS-6766 capsules must be stored in the refrigerator.

    Defactinib is given as a tablet that will be taken twice a day and must be taken within 30 minutes after a meal. Defactinib tablets can be stored at room temperature.

    The number of capsules/tablets participants will take will depend on the dose of the study drugs that will be assigned to the. Participants should swallow the capsules/tablets whole with approximately 8 ounces or 240 mL of water and should not chew, crush, divide or dissolve them.

    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).

    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 251 E. Huron St.
      Chicago, IL
    NCT04620330 STU00214623
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    (xIRB) NCI CIRB ECOG-ACRIN 2176: A Randomized Phase III Study of Immune Checkpoint Inhibition with Chemotherapy in Treatment-Naïve Metastatic Anal Cancer Patients

    The purpose of this study is to compare the usual treatment (chemotherapy) alone to using nivolumab

    plus the usual treatment. T…

    The purpose of this study is to compare the usual treatment (chemotherapy) alone to using nivolumab

    plus the usual treatment. This study will help the study doctors find out if this different

    treatment (chemotherapy plus nivolumab) is better, the same, or worse than the usual approach of

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

    when given with the usual treatment will slow the progression of cancer.

    The study drug nivolumab, is already approved by the FDA for use in different types of cancer,

    including lung, skin (melanoma), kidney, bladder, colorectal, and some types of liver cancers.

    Participants who decide to take part in this study will either get chemotherapy for up to 6 months

    or get chemotherapy plus a drug called nivolumab for 6 months. After the 6 months of chemotherapy,

    participants will continue to receive nivolumab until their cancer gets worse or up to 2 years.

    All of these treatments have been approved by the Food and Drug Administration (FDA),

    but the use of nivolumab with chemotherapy to treat this type of cancer is considered investigational.

    After treatment, participants will be followed for up to 2 years to check for side effects.

    Participants will visit the clinic once every 3 months for the first year, then every 6 months

    for the second year.

    Participants ages 18 years or olderwho have anal canal cancer that has spread to some other areas in the body willbe enrolled into this study.

    Kalyan, AparnaKalyan, Aparna
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04444921 STU00214628
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    (xIRB) NCI CIRB SWOG 1931: Phase III Trial of Immunotherapy-Based Combination Therapy with or Without Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma (PROBE Trial)

    The purpose of this study isto compare Standard Systemic Therapy (SST) alone to SST plus surgery to removeall or part of…

    The purpose of this study isto compare Standard Systemic Therapy (SST) alone to SST plus surgery to removeall or part of the kidney with tumor. All patients receive SST to shrink the tumor and stimulate the immunesystem. Participants who are benefiting from this treatment will be selected bychance to have surgery and then continue SST or continue SST without surgery. Thisstudy will help the study doctors find out which approach is better, the same,or worse.

    Participantswho decide to take part in this study will get either only standard drugcombination therapy or will get the standard drug combination therapy andsurgery to remove part or all of their kidney. Participants will get treatment until their disease gets worse.

    After study treatmentis completed, participants will be followed for up to 7 years to watch for sideeffects.

    All of the drugs that are usedas part of treatment on this study are commercially available, FDA approved,and considered standard treatment for this type of kidney cancer.

    Participants ages 18 years or older who havekidney cancer that has spread outside of the kidney will participate in this study.
    Sosman, Jeffrey AlanSosman, Jeffrey Alan
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04510597 STU00214655
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    kidney SST
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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) immunoth…

    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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    NU UC20L05: A Randomized Phase I Trial to Evaluate Concurrent Or Sequential Ipilimumab, Nivolumab, and Stereotactic Body Radiotherapy in Patients with Stage IV Non-Small Cell Lung Cancer (COSINR Study)
    This purpose of this study is to find the dose of radiation therapy which can be optimally given to…
    This purpose of this study is to find the dose of radiation therapy which can be optimally given to tumors in specific areas of the body (such as the lung or liver) after nivolumab and ipilimumab has already begun.

    Participants are expect to be in this research study for up to 5 years. Participants may receive nivolumab and ipilimumab for up to 2 years. After participants stop taking the study drug, they will be followed up for at least 1 year.

    The study will consist of the following parts:

    •A preliminary (screening) to determine whether you are eligible for the study

    •A treatment period of up to 2 years

    •End-of-treatment visit

    •A follow-up period of visits every 2 months for at least 1 year

    Participants will receive radiation therapy (RT) directed to tumor(s) over the course of 1-2 weeks. The dose and schedule of the radiation therapy received will be based on where the tumors are located.

    The study drugs will be given before radiation therapy by intravenous (IV) infusion. The infusion of nivolumab and ipilimumab usually takes about a half hour (30 minutes) for each drug. A pump will be used to ensure the correct amount of drug is given over the proper amount of time. Participants will receive nivolumab every 2 weeks and ipilimumab every 6 weeks for up to 2 years.

    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.

    Some of the eligibility criteria include:

    •Age of at least 18 years

    •Diagnosis of advanced non-small cell lung 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.

    Patel, Jyoti DPatel, Jyoti D
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT03223155 STU00214288
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    (xIRB) NCI CIRB ETCTN 10411: Phase 2 Study of Rogaratinib (BAY 1163877) in the Treatment of Patients with Sarcoma Harboring Alterations in Fibroblast Growth Factor Receptor (FGFR) 1-4 and SDH-Deficient Gastrointestinal Stromal Tumor (GIST)

    The purpose of this study is to test the good and bad effe…

    The purpose of this study is to test the good and bad effects of the investigational study drug called rogaratinib (BAY 1163877). The study drug, Rogaratinib (BAY 1163877), is not approved by the FDA for this type of cancer.

    Participants who agree to take part in this study will receive rogaratinib (BAY 1163877) for as long as this treatment is helping not causing side effects that are too severe. Treatment will last for up to 24 months.

    Participants 18 years of age or older who have sarcoma that has a change in a group of proteins called the FGFRs (fibroblast growth factor receptors), or a type of sarcoma called SDH-deficient GIST (succinate dehydrogenase deficient gastrointestinal stromal tumor) will be enrolled into this study.

    Pollack, Seth MichaelsPollack, Seth Michaels
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04595747 STU00214810
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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 …

    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
    STU00213944
    More Info
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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 effect…

    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 251 E. Huron St.
      Chicago, IL
    NCT04480502 STU00214197
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    (xIRB) DRUG 2020-01: Detection by circulating RNA with OPtimized machine LEarning Technology for Breast Cancer: DROPLET-BC Study

    The goal of this research study is to learn if a new type of test called Droplet-BC screening test can detect circulating RNA (a type of genetic information) in the bloo…

    The goal of this research study is to learn if a new type of test called Droplet-BC screening test can detect circulating RNA (a type of genetic information) in the blood of breast cancer patients. Researchers want to learn if this test can show the difference among different stages and groups of breast cancer.

    The Droplet-BC screening test is not FDA approved or commercial available. It is currently being used for research purposes only.

    Both healthy volunteers and patients with breast cancer will be enrolled in this study. Participants in Group A will be healthy volunteers. Participants in Group B will be patients with breast cancer. The study staff who test the blood samples will not know if you are a healthy volunteer or a patient.

    If eligible, at the same visit as screening visit, blood (about 2 tablespoons) will be drawn for the Droplet-BC test. This blood draw may take up to about 30 minutes to complete.

    Participants will not receive any individual results from the research testing that is done using your blood. Your participation in this study will be over after the blood draw.

    Some of the eligibility criteria include:

    •Age of at least 18 years

    •Diagnosis of breast cancer or healthy volunteer

    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 251 E. Huron St.
      Chicago, IL
    NCT04671498 STU00215020
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    UWI2015-05-01 Phase Ib 9cUAB30 in Early Stage Breast Cancer to Evaluate Biologic Effect
    This phase 1b trial studies the biologic effect of 9cUAB30 on early stage breast cancer. 9cUAB30 is a retinoid X receptor (RXR)-selective retinoid that acts in a tissue selective manner with the goal of minimizing…
    This phase 1b trial studies the biologic effect of 9cUAB30 on early stage breast cancer. 9cUAB30 is a retinoid X receptor (RXR)-selective retinoid that acts in a tissue selective manner with the goal of minimizing side effects, a necessary feature of agents under development for cancer prevention.
    Khan, Seema AhsanKhan, Seema Ahsan
    NCT02876640 STU00215041
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    DRUG SGNTV-003: A Randomized, Open-Label, Phase 3 Trial of Tisotumab Vedotin vs Investigator’s Choice Chemotherapy in Second- or Third-Line Recurrent or Metastatic Cervical Cancer

    This purpose of this study is to evaluate the safety and efficacy of tisotumab vedotin compared to investigator’s …

    This purpose of this study is to evaluate the safety and efficacy of tisotumab vedotin compared to investigator’s choice of chemotherapy in patients with recurrent or metastatic cervical cancer. We want to know if patients with cervical cancer respond to tisotumab vedotin and how long the response lasts. We would also like to learn more about the side effects of tisotumab vedotin in patients with cervical cancer. Learning about the side effects of tisotumab vedotin and how it works will help us understand if it’s better or worse than other treatments.

    Tisotumab vedotin is an experimental drug which means the Food and Drug Administration (FDA) hasn’t approved it for sale in the United States.

    If the participant meets the study requirements and agrees to participate, they will be randomly assigned to one of two groups. The study doctor will inform participants to which group they have been assigned. Group 1 will receive tisotumab vedotin. Group 2 will receive standard chemotherapy. The standard chemotherapy will be chosen by the study doctor.

    Tisotumab vedotin or standard chemotherapy will be given in 21-day cycles (28-day for irinotecan). After the participant has stopped getting tisotumab vedotin or chemotherapy, they will be followed up by phone every 2 months until they are no longer in the study or until the study is closed.

    Group 1 (tisotumab vedotin):

    oThe study drug will be given intravenously (IV, into a vein) once every 3 weeks.

    oAn eye exam on Day 1 of each cycle will take place.

    oBlood samples for research will be collected on Day 3 of the first cycle.

    Group 2 (standard chemotherapy), the study doctor will choose one of these:

    oTopotecan as an IV on Days 1 through 5 every 3 weeks

    oVinorelbine as an IV on Days 1 and 8 every 3 weeks

    oGemcitabine as an IV on Days 1 and 8 every 3 weeks

    oIrinotecan as an IV weekly for about the first 4 weeks and 2 weeks off

    oPemetrexed as an IV on Day 1 every 3 weeks

    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.

    Some of the eligibility criteria include:

    •Age of at least 18 years

    •Diagnosis of advanced cervical cancer that has come back or gotten worse

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

    Roque, Dario RRoque, Dario R
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04697628 STU00214318
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    DRUG DZ2019J0005: A Phase I/II, Open-Label, Multicentre Study to Investigate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AZD4205 in Patients with Peripheral T Cell Lymphoma (PTCL)

    The purpose of this study is to test the:

    •Safety and tolerability: side effects of…

    The purpose of this study is to test the:

    •Safety and tolerability: side effects of the study medication,

    •Pharmacokinetics: how your body processes the study medication, and

    •Anti-tumor activity: what effect the study medication brings to your cancer.

    The study will consist of the following parts:

    •A preliminary (screening) period to determine eligibility

    •A treatment period composed of cycles (1 cycle is 21 days)

    •End-of-treatment visit and telephone follow up

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

    This research has two parts, including part A (conducted outside United States) and part B. You will participate in part B study.

    •In Part B, approximately 100 participants will be enrolled in this study. All participants in this part will take the study medication AZD4205 at the selected dose from Part A. Every participant in this study will be given instructions about how to take the study medication.

    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 peripheral T cell lymphoma (PTCL), and able to provide 12 archived or fresh tumor slides

    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.

    Pro, BarbaraPro, Barbara
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04105010 STU00214958
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    DRUG MK-3475-B21-00: A Phase 3, Randomized, Double-Blind Study of Pembrolizumab versus Placebo in Combination With Adjuvant Chemotherapy With or Without Radiotherapy for the Treatment of Newly Diagnosed High-Risk Endometrial Cancer After Surgery With Curative Intent (KEYNOTE-B21 / ENGOT-en11 / GOG-3053)

    The purpose of this study is to test pembrolizumab in combination with chemotherapy with or without radiation therapy in women with endometrial cancer who have no cancer remaining after surgery. This study will compare pembrolizumab given with chemotherapy (with or without radiation therapy) to placebo given with chemotherapy (with or without radiation therapy). The chemotherapy combination of carboplatin and paclitaxel is a standard treatment for women with your type of endometrial cancer.

    Pembrolizumab has been approved for use for certain types of endometrial cancer. In this study, Pembrolizumab is being considered an investigational drug because the Food and Drug Administration (FDA) hasn’t approved it for your type of endometrial cancer.

    Screening: The Screening Phase and will last about 1 month. During this time, participants will visit the site one or more times.

    Treatment: If eligible to participate in the trial, participants will be in the Treatment Phase about 1 year and will visit the trial site about 12 times.

    Follow-up: After participants stop getting the trial drug, they will enter the Follow-up Phase and will visit the trial site about every 6 months (until 2 years after starting treatment) and every 1 year after that.

    If the study requirements are met, the enrolled patient will be randomized (assigned by chance) to one of the two treatment groups:

    There is a 50% chance that a patient will receive either:

    •Group 1: Pembrolizumab

    oStage 1: Pembrolizumab 200 mg once every 3 weeks (6 times)

    oStage 2: Pembrolizumab 400 mg once every 6 weeks (6 times)

    •Group 2: Placebo (this is a look alike with no active ingredients)

    oStage 1: Placebo 0 mg once every 3 weeks (6 times)

    oStage 2: Placebo 0 mg once every 6 weeks (6 times)

    Participants will get a combination of chemotherapy (carboplatin and paclitaxel) every 3 weeks (4 6 times) and either pembrolizumab or placebo with or without radiation therapy.

    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 high-risk endometrial cancer and have no cancer remaining after having 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.

    Barber, Emma LongleyBarber, Emma Longley
    STU00214464
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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 effectivene…

    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 spl…

    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 251 E. Huron St.
      Chicago, IL
    NCT04603495 STU00214989
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