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Hematology-Oncology Clinical Trials

The following searchable list includes all the Division of Hematology-Oncology - Department of Medicine clinical trials currently looking for participants. Please feel free to contact us with inquiries about any of our ongoing research.

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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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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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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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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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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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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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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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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PET/MRI using [18F]-DCFPyL for the Staging of Newly Diagnosed Prostate Cancer
This research study involves the use of a scanner that is capable of taking PET and MR images at the same time. A PET scan is a test that uses radioactive glucose (sugar) and a computer to create images of how organs and ti…
This research study involves the use of a scanner that is capable of taking PET and MR images at the same time. A PET scan is a test that uses radioactive glucose (sugar) and a computer to create images of how organs and tissues in the body are functioning. Abnormal cells in the body use glucose at a different rate than normal cells and this allows the scanner to create a detailed picture of how your body is working. A MR scan uses strong magnets and computers to created detailed images of the soft tissue in your body. The purpose of this study is to gain understanding how PET-MR (positron emission tomography-magnetic resonance imaging) using the substance 18F-DCFPyL (PyL) may help in diagnosing prostate cancer and in determining the stage of prostate cancer before surgery.
Men with biopsy-proven prostate cancer and a diagnosis of high risk, very high risk or locally advanced prostate cancer per NCCN guidelines.
Schaeffer, Edward MatthewSchaeffer, Edward Matthew
NCT03392181 STU00205957
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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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    (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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    (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 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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    (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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    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) 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 Sterling) DRUG 68284528MMY2003: A Phase 2, Multicohort Open-Label Study of JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA in Subjects with Multiple Myeloma (CARTITUDE-2)
    The purpose of this study is to see if JNJ-68284528 is safe and useful for treating p…
    The purpose of this study is to see if JNJ-68284528 is safe and useful for treating patients with relapsed or refractory multiple myeloma. In this type of treatment, your white blood cells (which are a part of the immune system) will be genetically modified to become JNJ-68284528 and used to treat your multiple myeloma.

    Some of the eligibility criteria include:

    • Participants must have a diagnosis of multiple myeloma
    • Participants must be 18 or older.
    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.
    Singhal, SeemaSinghal, Seema
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04133636 STU00210994
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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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    (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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    (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 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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    (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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    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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    (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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    (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) 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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    (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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    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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    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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    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) 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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    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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    (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 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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    (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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    (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
    More Info
    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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    (xIRB) NCI CIRB ETCTN 10285: Phase 1/2 Study of an EZH2 Inhibitor (Tazemetostat) in Combination with Dual BRAF/MEK Inhibition in Patients with BRAF- Mutated Metastatic Melanoma Who Progressed on Prior BRAF/MEK Inhibitor Therapy

    This study hastwo phases. Phase 1 and Phase 2.

    The purpo…

    This study hastwo phases. Phase 1 and Phase 2.

    The purpose ofPhase 1 is to test the safety of the study drug, tazemetostat, in combinationwith the usual treatment, dabrafenib and trametinib. This study tests differentdoses of tazemetostat with the usual dose of dabrafenib and trametinib to seewhich dose of tazemetostat is safest for people. Tazmetostatis not approved bythe FDA for treatment of this type of cancer.

    Allpeople taking part in this study will get the same dose of the usualintervention, dabrafenib and trametinib. However, people in this study will getdifferent doses of the study drug, tazemetostat. Once the highest safe dose isfound, phase 1 of the study is stopped.

    Thepurpose of Phase II is to compare the combination of tazemetostat, dabrafenib,and trametinib to tazemetostat alone. This study will help the study doctors findout if this different approach is better, the same, or worse than the usualapproach. Another purpose of this study is for the study doctors to learn if agenetic test is helpful to decide if tazemetostat is more effective in patientswhose cancer has an abnormal EZH2 gene. The combination of tazemetostat, trametinib, and dabrafenib, has notbeen administered together in patients and the combination of these agents arenot FDA approved for the treatment of this type of cancer.

    Participants whotake part in this study will either get a combination of usual approach ofdabrafenib and trametinib, and the study drug, tazemetostat or will get thestudy drug, tazemetostat alone, until their disease gets worse or the sideeffects become too severe.

    Participants18 years or older who have metastatic melanoma, and the cancer has a change inthe gene called the BRAF, and is not responsive to treatment with MEK and BRAFinhibitors will be enrolled.

    Chandra, SunandanaChandra, Sunandana
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00214795
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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
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    (xIRB) NCI CIRB SWOG 2007: A Phase II Trial of Sacituzumab Govitecan (IMMU-132) (NSC #820016) for Patients with HER2-Negative Breast Cancer and Brain Metastases

    The purpose of this study is to examine the good and bad effects of taking the study drug sacituzumab govitecan. This study will help the…

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

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

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

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

    Participants ages 18 years or older who have HER2-negative breast cancer with brain metastases that have spread after initial treatment will be enrolled into this study.
    Shah, Ami NShah, Ami N
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04647916 STU00214939
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    (xIRB) NCI CIRB ETCTN 10402: BAY 1895344 Plus Topoisomerase-1 (Top1) Inhibitors in Patients with Advanced Solid Tumors, Phase I Studies with Expansion Cohorts in Small Cell Lung Carcinoma (SCLC), Poorly Differentiated Neuroendocrine Carcinoma (PD-NEC) and Pancreatic Adenocarcinoma (PDA)

    The purpos…

    The purpose of this study is to test the safety and tolerability of a drug called BAY 1895344 in combination with irinotecan liposome or topotecan at different doses. The combination of the experimental drug BAY 1895344 and topotecan or irinotecan liposome is not approved by the Food and Drug Administration (FDA)for your cancer or any cancer.

    There are two parts in this study, a dose escalation (or dose-finding) part and a dose expansion part (further testing the safety and tolerability of the established dose found in the first part).

    Thedose escalation part of this study involves two different drug combinations. Different people will get different doses of either BAY 1895344 and irinotecan liposome or BAY 1895344and topotecan. Participants will be told which combination and dose they will be receiving.

    In the dose expansion parts of this study, the highest dose of BAY 1895344 and irinotecan liposome or BAY 1895344 and topotecan, with manageable side effects will be given to participants. This will help study doctors better understand the side effects that may happen with these drug combinations.

    After treatment is completed, participants will be watched for side effects for 6months. This follow up could occur by visiting their doctor or over the phone.

    Participants ages 18 years or older who have an advanced solid tumor or small cell lung cancer, poorly differentiated neuroendocrine cancer or pancreatic cancer will be enrolled into this study.

    Kalyan, AparnaKalyan, Aparna
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00215008
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