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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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A Phase III Randomized Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Observation for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein

This randomized phase III trial studies how well the study drug (crizotinib, also known …

This randomized phase III trial studies how well the study drug (crizotinib, also known as XALKORI®) works, and compares it to placebo in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called ALK. Mutations, or changes, in ALK can make it very active and important for tumor cell growth and progression. Tumors with this mutation may respond to treatments that target the mutation, such as crizotinib. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working.

It is not yet known if crizotinib may be an effective treatment for treating non-small cell lung cancer with an ALK mutation. The addition of crizotinib may help prevent your cancer from returning, but it could also cause side effects. This research study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach. To be better, the study drug should improve how long you are able to live by 2 years and 9 months (33 months total) or more compared to the usual approach.

The study drug, crizotinib, is already FDA-approved for use in ALK-positive locally advanced or metastatic (spread to other areas of the body) non-small lung cancer. The use of crizotinib in this study is investigational (not approved by the FDA) because crizotinib will be prescribed for earlier stage disease after the cancer has been surgically removed.

You are being asked to take part in this research study because you have ALK-positive non-small cell lung cancer, which has been removed by a surgeon. 
Mohindra, Nisha AnjaliMohindra, Nisha Anjali
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02201992 STU00102000
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Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)

This research trial is trying to see if tumor genetic testing would be helpful at guiding treatment in patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying…

This research trial is trying to see if tumor genetic testing would be helpful at guiding treatment in patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in a patient's tumor cells may help doctors select the best treatment for patients that have certain genetic changes. The purpose of the study is to examine lung cancer patients’ surgically removed tumors for certain genetic changes, and to possibly refer these patients to a treatment study with drugs that may specifically target tumors that have these genetic changes.

Genetic testing will be done to learn if your tumor has any of these genetic changes. This test will look at the genetic material of the tumor cells. All tissues in the body are made up of cells. Those cells contain DNA, which is your unique genetic material that carries the instructions for your body’s development and function. Cancer can develop when changes in certain genes cause those cells to divide in an uncontrolled way and, sometimes, to travel to other organs.

Another purpose of this research study is to learn more about cancer and why treatments may be more effective or even stop working with some tumors or in certain patients. After your tumor tissue is screened, if there is any tissue left, the remainder of your coded tissue samples will be sent to a National Cancer Institute (NCI)-sponsored storage facility, currently known as the Biospecimen Core Resource (BCR).

You may be eligible for this research study if you have lung cancer that has either been removed or will be removed by a surgeon. As part of your normal treatment, you may receive chemotherapy or radiation therapy to reduce the chance of the cancer coming back.

Mohindra, Nisha AnjaliMohindra, Nisha Anjali
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02194738 STU00200150
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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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Alliance A071401: Phase II Trial Of SMO/AKT/NF2 Inhibitors in Progressive Meningiomas with SMO/AKT/NF2 Mutations

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

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

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

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

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

Kumthekar, Priya UKumthekar, Priya U
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02523014 STU00202953
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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 CC-90009-AML-001: A PHASE 1, OPEN-LABEL, DOSE-FINDING STUDY OF CC-90009, A NOVEL CEREBLON E3 LIGASE MODULATING DRUG, IN SUBJECTS WITH RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA OR RELAPSED OR REFRACTORY HIGHER-RISK MYELODYSPLASTIC SYNDROMES

The purpose of this study is to test the safety (…

The purpose of this study is to test the safety (any good or bad effects) of the new experimental drug, CC-90009 (study treatment), in subjects with relapsed or refractory acute myeloid leukemia (AML). The purpose is also to see if CC-90009 can control the disease and to explore how long CC-90009 stays in the body.

CC-90009 has not been approved by the Food and Drug Administration (FDA) for the treatment of acute myeloid leukemia or any other cancer or disease and its use in this study is investigational. This study is the first time CC-90009 is being given to humans.

Laboratory and animal studies showed that CC-90009 can slow down the growth or kill cancer cells. CC-90009 binds to a protein called cereblon inside cells in your body, including the AML cells. Upon binding with CC-90009, cereblon causes the destruction of other proteins that the AML cells need for survival.

This study also includes testing of blood and bone marrow aspirate samples for biomarkers. Biomarkers are substances such as proteins and genes that tell us how the drug is working in the body. These studies may help to better understand the genetic profile of AML as well as determine whether CC-90009 is having an effect on the cancer or in the blood.

You may be eligible for this research study if you have been diagnosed with acute myeloid leukemia (AML) that has come back after treatment or cannot be cured or treated by any other known therapies.

Altman, Jessica KAltman, Jessica K
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02848001 STU00203119
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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
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    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
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    Chicago, IL
NCT03213041 STU00205013
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BTCRC-GI15-015: A Phase II Study of FOLFOX combined with Nab-Paclitaxel (FOLFOX-A) in the Treatment of Metastatic or Advanced Unresectable Gastric, Gastro-Esophageal Junction Adenocarcinoma

This study is being done to find out if a drug called nab-paclitaxel plus a combination chemotherapy regimen…

This study is being done to find out if a drug called nab-paclitaxel plus a combination chemotherapy regimen called FOLFOX have any effect on stomach cancer or cancer where the esophagus and the stomach meet. The study drugs could shrink your cancer but it could also cause side effects.

Nab-paclitaxel is a new formulation of a chemotherapy called paclitaxel. Regular paclitaxel is made with stabilizers that cause allergic reactions in many patients. Nab-paclitaxel does not use these stabilizers which means more of the drug can be given with fewer allergic reactions. Nab-paclitaxel (Abraxane®) is approved by the U.S. Food and Drug Administration (FDA) to treat breast, lung, and pancreas cancers.

FOLFOX stands for a combination of three drugs: oxaliplatin, leucovorin, and 5-fluorouracil. Oxaliplatin is a chemotherapy approved by the FDA to treat colon and rectal cancer. Leucovorin is not a chemotherapy. It is form of folic acid and it is given with 5-fluorouracil to help increase the anti-cancer effects of 5-fluorouracil. It is approved by the FDA to be given with fluorouracil in patients with advanced colorectal cancer. 5-fluorouracil is approved by the FDA to treat cancers of the breast, stomach, colon, rectum, and pancreas.

Combining nab-paclitaxel with FOLFOX should be considered investigational. Investigational means that the FDA has not approved this combination of drugs for stomach cancer or cancer where the esophagus and the stomach meet.

Benson III, Al BBenson III, Al B
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03283761 STU00205558
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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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A Phase II Randomized, Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 Compared with Investigator’s Choice in HLA-A*0201 Positive Patients with Previously Untreated Advanced Uveal Melanoma
This research study is investigating a drug (that is called IMCgp100) in patients with a…
This research study is investigating a drug (that is called IMCgp100) in patients with advanced uveal melanoma. Uveal melanoma is generally treated with either chemotherapy or drugs that work by activating the immune system, known as immunotherapies. In this research study, IMCgp100 will be compared to three representative standard treatments: dacarbazine (a chemotherapy drug), ipilimumab (an immunotherapy drug targeting a protein called CTLA-4), or pembrolizumab (an immunotherapy drug targeting a protein called PD-1). This research study is being done to assess the efficacy and safety of the IMCgp100 in patients with uveal melanoma in comparison to these standard treatments.
Chandra, SunandanaChandra, Sunandana
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    Chicago, IL
NCT00000418 STU00205550
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A Phase 1b/2 Open-Label, Dose Escalation and Expansion Study of Orally Administered VRx-3996 and Valganciclovir in Subjects with Epstein-Barr Virus-Associated Lymphoid Malignancies

This study tests the combination of an investigational drug, called VRx-3996, along with an antiviral (fights viruses…

This study tests the combination of an investigational drug, called VRx-3996, along with an antiviral (fights viruses) drug called valganciclovir. “Investigational” means the drug being tested (VRx-3996) has not been approved by the United States Food and Drug Administration (FDA). The antiviral drug, valganciclovir, has been FDA-approved to prevent and treat certain types of viral infections. Some people may already have received or are currently taking the antiviral drug, valganciclovir, for their disease.

The primary purpose of this study is to determine how safe is it to take the investigational drug (VRx-3996) along with valgaciclovir and find the maximal dose that can be taken safely. The study will also determine if the cancer responds to treatment with the drug combination. The study will also evaluate how much of the study drug is present in your blood at different time points.

You may be eligible for this research study if you have a cancer, called lymphoma, that tested positive for Epstein-Barr Virus (EBV).

Karmali, ReemKarmali, Reem
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NCT03397706 STU00206699
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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
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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
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NCT03211416 STU00207399
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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
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NCT03150693 STU00208162
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An Open-Label, Expanded Access Program of Ruxolitinib for the Treatment of Graft-Versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplant

This research study is a type of treatment program called an Expanded Access Program sponsored by Incyte Corporation. The purpose of the Prog…

This research study is a type of treatment program called an Expanded Access Program sponsored by Incyte Corporation. The purpose of the Program is to give access to the investigational drug, ruxolitinib, to graft-versus-host disease (GVHD) patients in the United States who are not eligible or able to participate in clinical trials.

A second objective is to monitor the safety of ruxolitinib in GVHD patients.

Ruxolitinib is an investigational drug that is being studied for use in the treatment of GVHD. “Investigational” means that ruxolitinib has not been approved by the FDA (Food and Drug Administration) for use as a prescription or over-the-counter medication.

You may be eligible for this research study if you have acute or chronic graft-versus-host disease (GVHD) but are not eligible or able to obtain ruxolitinib by participating in clinical trials.

Frankfurt, OlgaFrankfurt, Olga
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NCT03147742 STU00208471
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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
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NCT03488693 STU00208897
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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
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NCT03838367 STU00209594
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A Phase II, Open-Label, Multicenter, Randomized Study Of The Efficacy And Safety Of RO7198457 In Combination With Pembrolizumab Versus Pembrolizumab In Patients With Previously Untreated Advanced Melanoma
The purpose of this study is to compare the effects, good or bad, of PCV plus pembrolizumab vers…
The purpose of this study is to compare the effects, good or bad, of PCV plus pembrolizumab versus pembrolizumab alone on patients with melanoma. In this study, particpants will get either PCV plus pembrolizumab or pembrolizumab alone.The goal of a PCV is to help train the immune system to recognize and attack cancer cells. And because the immune system has memory, it is hoped that once the immune cells have been trained, they will continue to work long after the vaccine is given. This treatment is a type of immunotherapy. To make PCV, samples of tumor tissue and blood will be collected and tested to see if a vaccine can be made for participants.Pembrolizumab is approved in the United States and the European Union, as well as other countries, for the treatment of unresectable or metastatic melanoma, and several other indications.PCV is an experimental drug, which means health authorities have not approved PCV in combination with pembrolizumab for the treatment of melanoma, and it has not been tested in people with untreated melanoma prior to this study.
Participants must be age 18 years or older. Metastatic or unresectable locally advanced melanoma. 
Chandra, SunandanaChandra, Sunandana
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NCT03815058 STU00209868
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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
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NCT03504644 STU00210605
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DRUG DCC-2036-01-003: An Open-Label, Multicenter, Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination with Paclitaxel to Assess Safety, Tolerability, and Pharmacokinetics in Patients with Advanced or Metastatic Solid Tumors
This study will evaluate the safety and tolerability of rebastinib when …
This study will evaluate the safety and tolerability of rebastinib when taken in combination with the anti-cancer chemotherapy paclitaxel (also known as Taxol or Onxal). 
You may be eligible to take part in this research study if you have been diagnosed withtriple-negative breast cancer, inflammatory breast cancer, ovarian cancer or endometrial cancer.
Cristofanilli, MassimoCristofanilli, Massimo
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NCT03601897 STU00210178
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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
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NCT03016819 STU00210420
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RTK inhibitor
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BTCRC HN17-111: Phase II trial of androgen deprivation therapy (ADT) and pembrolizumab for advanced stage androgen receptor-positive salivary gland carcinoma
This study is being done to study two investigational drugs called pembrolizumab and goserelin to see if they shrink your cancer or stop it fro…
This study is being done to study two investigational drugs called pembrolizumab and goserelin to see if they shrink your cancer or stop it from growing. 
You may be eligible for this research study if you have salivary gland carcinoma that has grown or has come back after treatment.
Boumber, YanisBoumber, Yanis
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NCT03942653 STU00210435
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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
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NCT04001829 STU00210984
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(xIRB) DRUG KRT-232-104: An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 Combined with Low-Dose Cytarabine (LDAC) or Decitabine in Patients with Acute Myeloid Leukemia (AML)

Thisstudy will test an investigational drug called KRT-232 that has not be…

Thisstudy will test an investigational drug called KRT-232 that has not beenapproved for the potential treatment of AML. This study will determine if thisdrug is able to reduce the growth of unhealthy or tumor cells, and help restorethe function of your bone marrow. The study drug will be given along withanother therapy for AML assigned by the study doctor. This other therapy will be either cytarabine(injected under the skin) or decitabine (injected into a vein).

Thereare 2 parts planned for this study, Part A (Phase 1b) will test different dosesof KRT-232 given with either cytarabine or decitabine to identify therecommended dose for Part B. Part B (Phase 2) will continue to test thisKRT-232 recommended dose with either cytarabine or decitabine to determine ifit is a tolerable and effective treatment for AML.

Participantsat our site will currently participate in only Part A.

Participantswill take the study drug until their cancer becomes worse, have severe sideeffects, or the research study ends.

  • Participants must have been diagnosed with Acute Myeloid Leukemia (AML)
  • Participants must be 18 years of age or older
Altman, Jessica KAltman, Jessica K
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NCT04113616 STU00211193
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(xIRB) NCI CIRB ETCTN 10170: A Phase 2 Study of AZD1775 in SETD2-Deficient Advanced Solid Tumor Malignancies

Participants who have a cancer which has grown or has recurred will be asked to participate in this study. The purpose of this study is to test any good and bad effects of the study drug ca…

Participants who have a cancer which has grown or has recurred will be asked to participate in this study. The purpose of this study is to test any good and bad effects of the study drug called AZD1775 in tumors that have a mutation called SETD2. Researchers hope to learn if the study drug will shrink the cancer by at least one-quarter compared to its present size.

All study participants will get the same study drug called AZD1775 until their disease gets worse, or the study drug causes side effects that cannot be managed with medications, or by changing the dose or schedule of the study drug.

Participants ages 18 years of age or older who have a cancer that has grown or has recurred will be asked to participate in this study. 
Mahalingam, DevalingamMahalingam, Devalingam
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NCT03284385 STU00211328
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DRUG R2810-ONC-1788: A Randomized, Placebo-Controlled, Double-Blind Study of Adjuvant Cemiplimab Versus Placebo after Surgery and Radiation Therapy in Patients with High Risk CSCC

This study is being conducted to determine the safety and effectiveness of a study drug called cemiplimab. The main pu…

This study is being conducted to determine the safety and effectiveness of a study drug called cemiplimab. The main purpose of this study is to determine if cemiplimab will prevent cutaneous squamous cell carcinoma from returning after surgery and radiation.

You may be eligible to take part in this research study if you have had surgery and radiation therapy for a type of skin cancer called cutaneous squamous cell carcinoma, and there is a risk that this cancer may come back.
Chandra, SunandanaChandra, Sunandana
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NCT03969004 STU00210740
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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
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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
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NCT04164901 STU00211620
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(xirb) DRUG RMC-4630-02 A Phase 1b/2, Open Label, Multicenter, Dose Escalation and Dose-Expansion Study of the Combination of RMC 4630 with Cobimetinib in Adult Participants with Relapsed/Refractory Solid Tumors and a Phase 1b Study of RMC-4630 with Osimertinib in Participants with Epidermal Growth Factor Receptor Mutation Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer
This study contains two different study arms. The purpose of one arm (called cobimetinib arm) is to test a new drug called RMC-4630 in combination with cobimetinib (COTELLIC®). The purpose of the second arm (called osimertinib arm) is to test a new drug called RMC-4630 in combination with osimertinib (TAGRISSO®).

The study will test different doses of RMC-4630 in combination with cobimetinib and RMC-4630 in combination with osimertinib to determine which combination of doses is safe and tolerated. This study will also test how your body processes RMC-4630 and cobimetinib or RMC-4630 and osimertinib when given together.

You may be eligible to participate in this study if your cancer has returned after treatment or did not respond to treatment. 
Chae, Young KwangChae, Young Kwang
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NCT03989115 STU00211907
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(xirb) Drug EZH-1201: A Phase I, Open-label Multi-dose Pharmacokinetic and Safety Study of Oral Tazemetostat in Subjects with Moderate and Severe Hepatic Impairment with Advanced Malignancies
Tazemetostat (EPZ-6438) is an experimental study drug that has not yet been approved. This study intends to f…
Tazemetostat (EPZ-6438) is an experimental study drug that has not yet been approved. This study intends to find out what effects, good and/or bad, it has on you and in the treatment of your cancer. 
You may be eligible to take part in this study if you have advanced cancer that has spread to different parts of your body after receiving certain types of therapy. 
Mahalingam, DevalingamMahalingam, Devalingam
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NCT04241835 STU00212081
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EPZ-6438
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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
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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
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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
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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
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NCT04387656 STU00213072
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(xIRB) NCI CIRB ECOG-ACRIN 1183: FDG PET to Assess Therapeutic Response in Patients with Bone-Dominant Metastatic Breast Cancer, FEATURE

The purpose of this study is to test if animaging test, FDG-PET/CT is useful for detecting changes in breast cancer bonemetastases with treatment. The study doct…

The purpose of this study is to test if animaging test, FDG-PET/CT is useful for detecting changes in breast cancer bonemetastases with treatment. The study doctors want to see if FDG-PET/CT scansare better than the other imaging options (ie, bone scan, CT, and MRI) mostoften used to monitor breast cancer bone metastases over time.

All participants will complete two FDG-PET/CTscans. One scan will take place prior to starting initial or new treatment formetastatic breast cancer. The second scan will take place approximately 12weeks after starting treatment. After the 12 week FDG-PET/CT scan, participantswill continue to be monitored with exams, labs and imaging which may includestandard of care CT, bone scan, MRI or FDG-PET/CT. These evaluations will occurevery 3 months for 1 year and then every 6 months for as long as needed basedon the response of the breast cancer to treatment.

Participants who are 18 years of age or olderwho have metastatic breast cancer involving bones in your skeleton.

Shah, Ami NShah, Ami N
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NCT04316117 STU00213217
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(xirb) DRUG 7465-CL-202 : An Open-label, Multicenter, Multicohort, Phase 2 Study to Evaluate Enfortumab Vedotin in Subjects with Previously Treated Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)

The goal of this study is to find out if enfortumab vedotin is effective and safe as a …

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

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

Participants may withdraw at any time.

Mulcahy, Mary FrancesMulcahy, Mary Frances
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NCT04225117 STU00213246
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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
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NCT04233866 STU00213326
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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
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STU00212975
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(xIRB) DRUG 1951-CL-0101: A Phase 1b Study of ASP1951, a GITR Agonistic Antibody, as a Single Agent and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors

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

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

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

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

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

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

Some of the eligibility criteria include:

•Age of at least 18 years

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

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

Mulcahy, Mary FrancesMulcahy, Mary Frances
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NCT03799003 STU00213423
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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
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NCT04421378 STU00213433
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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
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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
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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)
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 s…
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
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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
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NCT04383210 STU00213426
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(xIRB) NCI CIRB ETCTN 10367: A Phase 1b Study with Expansion Cohort of Escalating Doses of KRT-232 (AMG 232) Administered in Combination with Standard Induction Chemotherapy (Cytarabine and Idarubicin) in Newly Diagnosed Acute Myelogenous Leukemia (AML)

The purpose of this study is to test the saf…

The purpose of this study is to test the safety and tolerability (side effects) of adding a

study drug called KRT-232 (AMG 232) at different doses to standard treatment with cytarabine

and idarubicin. This study tests different doses of the drug to see which dose is safer and

more tolerable for people. Another purpose of the study is to check the level of the study drugs

in the blood (pharmacokinetics). In addition, another objective of the study is genetic testing

using tumor tissue to see if the combination of drugs may work in treating this type of cancer.

This is the first time these drugs will be tested together in humans and therefore this is not

approved by the FDA for treatment of AML.

There are two parts in this study, a dose escalation part and a dose expansion part.

You will only be enrolled into one part of the study. In the dose escalation part of this study,

different people will get different doses of the study drug KRT-232 (AMG 232) along with cytarabine

and idarubicin. The doses will continue to increase for every new group until people have serious

side effects that require the dose to be lower. Once this dose is found, the dose escalation is

stopped. In the dose expansion part of this study, the highest dose with manageable side effects

will be given along with cytarabine and idarubicin. The dose of the study drug might be decreased

or kept the same depending on the side effects. This will help study doctors better understand the

side effects that may happen with this drug.

Participants will only receive the study drug, KRT-232 (AMG 232), along with cytarabine and idarubicin

during the first cycle and second cycle of treatment. Participants will receive the study drug until

their disease progresses, or the side effects become too severe. If you stop the study but your

disease has not gotten worse, you will have a bone marrow aspirate/biopsy assessment of your AML every

3 months for 2 years until your disease gets worse or you begin a different treatment.

After that, the doctor or study team will follow up every six months (either in person or by phone call).

Participants 18 years of age or older who have newly diagnosed acute myeloid leukemia (AML).

Altman, Jessica KAltman, Jessica K
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NCT04190550 STU00213763
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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
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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
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STU00212971
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(xIRB) NCI CIRB SWOG 2000: A Randomized Phase 2 Trial of Encorafenib + Binimetinib + Nivolumab Vs Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma with Brain Metastases

The purpose of this study is to compare a triplet regimen of encorafenib + binimetinib + nivolumab

to doublet regimen o…

The purpose of this study is to compare a triplet regimen of encorafenib + binimetinib + nivolumab

to doublet regimen of ipilimumab + nivolumab in melanoma with brain metastases. The triplet regimen

may potentially be more effective in shrinking and controlling brain metastases than the doublet

regimen, particularly in patients who require corticosteroids or have symptoms from their brain

metastases. This study will help the study doctors find out if this triplet approach is more

beneficial for melanoma brain metastases than the doublet approach. To decide if it is better,

the study doctors will be looking to see if encorafenib + binimetinib + nivolumab increases time

before progression of melanoma, and overall life span of patients compared to ipilimumab + nivolumab.

The drugs, encorafenib, binimetinib, nivolumab and ipilimumab are all already approved by the FDA

for use in metastatic melanoma.

This study has 2 study groups. Participants will be told which group they are in.

Group 1

Participants in this group will get the study drugs called encorafenib, binimetinib and nivolumab.

Treatment will be given in cycles, with each cycle lasting 28 days.

Group 2

Participants in this group will receive nivolumab and ipilimumab once every three weeks for up to

four times. After four treatments of this drug combination, participants will receive nivolumab by

itself once every four weeks.

After you finish your study treatment, your doctor will continue to follow your condition for up to

3 years after you register to the study. Your doctor will watch you for side effects and to see

how your cancer affects you. You will have clinic visits periodically from the time you stop taking

treatment until 3 years after you register to the study.

Participants 18 years or older who have melanoma that has spread to the brain, and the cancer has a

change in the gene called the BRAFV600 gene.

Chandra, SunandanaChandra, Sunandana
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NCT04511013 STU00213853
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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
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NCT04396860 STU00213865
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(xIRB) NCI CIRB ETCTN 10389: A Phase 1 Trial Combining WEE1 Inhibitor Adavosertib (AZD1775) with Radiation Therapy for Metastatic or Inoperable and Ineligible for Definitive Chemoradiation Esophageal and Gastroesophageal Junction Cancer

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

The purpose of this study is to test the safety and tolerability (side effects) of adding a

study drug called AZD1775 at different doses along with standard radiation treatment.

This study tests different doses of the study drug when given with radiation at various times to see

which dose is safer and more tolerable for people. Researchers want to find out what effects

(good or bad) the drug has on people, if any. In addition, another objective of the study is to

perform genetic testing on tumor tissue to determine if certain genetic changes in the tumor help

predict who will respond to the drug. This drug, either alone or in combination with radiation,

is not approved by the FDA for treatment of this type of cancer.

There are two parts in this study, a dose escalation part and a dose expansion part.

Participants will only enroll into one part of the study.

In the dose escalation part of this study, different people will get different doses of the study drug

AZD1775. The doses will continue to increase for every new group until reaching the highest planned

dose.

In the dose expansion part of this study, the highest dose with manageable side effects will be given

to participants who are enrolled. This will help study doctors better understand the side effects

that may happen with this drug.

Participants will get the study drug, AZD1775, alone for one week, and then in combination with

standard radiation therapy for up to three weeks (one cycle) of treatment, or until the side effects

become too severe for those enrolled in the dose escalation part of this study.

Participants in the dose expansion part of this study will get the study drug, AZD1775, for one week

followed by 3 weeks of combination study drug and radiation therapy.

Participants will be checked for side effects three weeks after completing treatment with a

clinic visit and then clinic visits will occur every 3 months for 2 years after treatment.

After that, participants will be checked for side effects with clinic visits every 6 months

for 3 years, for a total of 5 years after treatment.

Participants 18 years of age or older who have esophageal cancer and gastroesophageal junction

cancer that is not able to be treated with surgery or with chemotherapy and radiation therapy given

at the same time or that has spread to other parts of the body.

Mulcahy, Mary FrancesMulcahy, Mary Frances
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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
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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.

Morgans, Alicia KatherineMorgans, Alicia Katherine
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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
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    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
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NCT04145115 STU00214358
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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
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NCT04484818 STU00214490
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(xIRB) NCI CIRB ECOG-ACRIN 2197: Optimal Perioperative Therapy for Incidental Gallbladder Cancer (OPT-IN): A Randomized Phase II/III Trial

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

This st…

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

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

There are two groups in this study.

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

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

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

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

Participants ages 18 years or older who have recently been diagnosedwith gallbladder cancer that was found after their gallbladder was removedduring surgery.
Chawla, AkhilChawla, Akhil
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STU00214491
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(xIRB) NCI CIRB ETCTN 10330: A Phase 2 Study of Belinostat and SGI-110 (Guadecitabine) for the Treatment of Unresectable and Metastatic Conventional Chondrosarcoma

The purposeof this study is to test the good and bad effects of the drugs calledbelinostat and SGI-110 (guadecitabine), and to determi…

The purposeof this study is to test the good and bad effects of the drugs calledbelinostat and SGI-110 (guadecitabine), and to determine if the combination ofdrugs belinostat and SGI-110 are effective at lowering the chance ofchondrosarcoma growing or spreading compared to the usual care forchondrosarcoma cancer.

If enrolledin this study, patients will receive the study drugs belinostat and SGI-110(guadecitabine). Patients will receive bilinostat and SGI-110 (guadecitabine)on days 1 through 5 of each cycle. Some procedures involved in this studyinclude blood draws, biopsies, imaging tests and genetic testing.

Each patient will receive twodrugs, belinostat and SGI-110 (guadecitabine). Belinostat is administered through a vein in the arm (IV) overapproximately 30 minutes, and SGI-110 (guadecitabine) is administered bysubcutaneous injection (i.e., under the skin). Both drugs will be given together, once daily for 5 consecutive days inthe doctor’s office. This 5-daytreatment is repeated every 28 days. Thetreatment will continue for as long as the disease remains controlled, nounacceptable side-effects are developed, and the patient still wants tocontinue participating in the study.

The status of the cancer willbe evaluated by imaging tests (e.g., by a CT scan or an MRI scan) every 8 weekswhile patients are receiving the treatment. After treatment is completed forthe study, the study team will follow up with patients in the clinic or bytelephone approximately once every 3 months for information related to thestatus of the cancer and any new treatments patients might be receiving, for aperiod of up to 24 months.

•Age ≥18 years.

•Patients must have biopsy-proven conventional chondrosarcoma (CS) which is:

-either metastatic or locally advanced and unresectable, and

-measurable at study entry according to RECIST version 1.1 criteria, and

-amenable to biopsy with imaging guidance at no or acceptable risk to the patient as

defined by institutional guidelines for research-related biopsies or the treating investigator’s assessment.

•Patients must have at least one lesion measurable by RECIST version 1.1 criteria

which has not been previously irradiated.

Pollack, Seth MichaelsPollack, Seth Michaels
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NCT04340843 STU00214562
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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
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NCT04510597 STU00214655
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