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Trials
NU 05H6: Acute Leukemias and Map Kinase

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

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

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

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

Platanias, Leonidas CPlatanias, Leonidas C
  • Map it 201 E. Huron St.
    Chicago, IL
STU00004841
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Study Coordinator 312 695 1102
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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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Study Coordinator 312 695 1102
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NUGene: Gene-Disease Associations and Treatment Outcomes

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

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

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

Must be a patient at Northwestern or one of its affiliates.
Chisholm, Rex LChisholm, Rex L
  • Map it 201 East Huron Street Suite 12-160​
    Chicago, IL
STU00010003
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Study Coordinator 1 312 503 6200
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NU 1365-001: A Humanitarian Device Exemption Use Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma
Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be…
Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be effective treatment for liver cancer that cannot be removed by surgery.

This phase II trial is studying how well radiolabeled glass beads work in treating patients with liver cancer that cannot be removed by surgery.

You may be eligible for this research study if you have unresectable cancer primarily in the liver (with the liver being the only site of disease or the dominant site of disease).
Salem, RiadSalem, Riad
  • Map it 201 E. Huron St.
    Chicago, IL
NCT00530010 STU00011036
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Study Coordinator 1 312 695 1102
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A Humanitarian Device Exemption Compassionate Use Protocol of TheraSphere for Treatment of Unresectable Metastatic Cancer to the Liver

Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells m…

Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be effective treatment for liver cancer that cannot be removed by surgery.

This phase II trial is studying how well radiolabeled glass beads work in treating patients with metastatic liver cancer that cannot be removed by surgery.

You may be eligible for this research study if you have been diagnosed with metastatic disease to the liver. This means your cancer originated from somewhere else in your body and spread to your liver.

You cannot be eligible to have surgery to remove the cancerous tissue from your liver.

Salem, RiadSalem, Riad
  • Map it 201 E. Huron St.
    Chicago, IL
NCT00532740 STU00011037
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Study Coordinator 312 695 1102
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NU 00X3: Pathology Core Facility

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

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

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

Wei, Jian-JunWei, Jian-Jun
  • Map it 201 E. Huron St.
    Chicago, IL
STU00020989
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Study Coordinator 1 312 695 1102
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RTOG 0724 - A Phase III Randomized Study of Concurrent Chemotherapy and Pelvic Radiation Therapy with or without Adjuvant Chemotherapy in High-Risk Patients with Early-Stage Cervical Carcinoma Following Radical Hysterecotmy
RATIONALE: Drugs used in chemotherapy, such as cisplatin, pacli…
RATIONALE: Drugs used in chemotherapy, such as cisplatin, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether chemotherapy and radiation therapy are more effective when given with or without additional chemotherapy in treating cervical cancer. PURPOSE: This randomized phase III trial is studying chemotherapy and pelvic radiation therapy to see how well they work when given with or without additional chemotherapy in treating patients with high-risk early-stage cervical cancer after radical hysterectomy.
Some of the eligibility criteria include:

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

Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Donnelly, EricDonnelly, Eric
  • Map it 201 E. Huron St.
    Chicago, IL
NCT00980954 STU00021457
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Study Coordinator 312 695 1102
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NU 99G8: Northwestern Ovarian Cancer Early Detection and Prevention Program: A Specimen and Data Study
RATIONALE: To improve strategies for detection and prevention of early-stage disease. PURPOSE: This research study is collecting specimens and data to develop better methods …
RATIONALE: To improve strategies for detection and prevention of early-stage disease. PURPOSE: This research study is collecting specimens and data to develop better methods for early detection and prevention of ovarian cancer among the high risk population and those who have the disease.
Shulman, Lee PShulman, Lee P
NCT00005095 STU00005421
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1-855-NU-STUDY
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NCI 01X1: Breast Cancer Program: Tissue and Specimen Collection Facility

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

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

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

You may be eligible for this research study if you are a woman with breast cancer undergoing biopsy or surgical procedures for the diagnosis, treatment, or prevention of your cancer. 
Wei, Jian-JunWei, Jian-Jun
  • Map it 201 E. Huron St.
    Chicago, IL
STU00023488
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Study Coordinator 1 312 695 1102
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Peripheral Neuropathy Research Registry (PNRR)
National Peripheral Neuropathy Research Registry, a collection of different types of information, such as patient medical, family, and social histories and blood samples. The information is carefully maintained so that it can be studied repeatedly in t…
National Peripheral Neuropathy Research Registry, a collection of different types of information, such as patient medical, family, and social histories and blood samples. The information is carefully maintained so that it can be studied repeatedly in the future. The registry aims to help researchers’ access large amounts of information about people with PN. By using this registry, researchers will facilitate both basic and clinical research studies that will bring improved understandings of the etiology (origination) and pathogenesis (development) of PN. They will specifically ask why some patients with peripheral neuropathy develop neuropathic pain and others do not, and what the characteristics of patients with painful peripheral neuropathy are in terms of their symptoms, examination findings, and blood tests. Ultimately this research may result in improved diagnosis, more effective treatments, and possibly prevention.
Inclusion criteria: 1. Diabetic Peripheral Neuropathy 2. Chemo-therapy Induced Peripheral Neuropathy 3. HIV-induced Peripheral Neuropathy 4. Idiopathic Peripheral Neuropathy; Exclusion criteria: Any other type of Peripheral Neuropathy
Ajroud-Driss, SendaAjroud-Driss, Senda
  • Map it 675 N. St. Clair St. Suite 20-100
    Chicago, IL
STU00048864
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Joslin, Benjamin 312 503 7504
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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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Study Coordinator 312 695 1102
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A Randomized Open-Label Pilot Trial to Evaluate the Safety and Efficacy of Repetitive Transcranial Magnetic Stimulation in Cancer Patients with Depression and Anxiety
The primary goals of this study are to determine if rTMS is safe and tolerable in depressed cancer patients and to determine how well …
The primary goals of this study are to determine if rTMS is safe and tolerable in depressed cancer patients and to determine how well these two methods of rTMS work in treating cancer-related depression. You are being asked to take part in this study because you are a cancer patient in remission who is depressed currently. In the future, we hope to be able to use rTMS on depressed cancer patients who are actively receiving cancer treatment. However, since this is a preliminary study, we will only include patients in remission. Finally, anxiety often accompanies depression. So, we are also interested in understanding your current level of anxiety and how rTMS affects any anxiety that you might have. Your participation in this study will last for approximately seven weeks and will involve 31 visits.
Dokucu, Mehmet EDokucu, Mehmet E
NCT01701284 STU00063218
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Jain, Ankit +1 312 503 9092
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The Genetics of Prostate Cancer in Active Surveillance
Our study uses saliva samples to detect whether or not active surveillance is the best option for the subject, based on their their genetic makeup and susceptibility to aggressive prostate cancer.
1. Patients diagnosed with prostate cancer
2. Patients with Gleason ≤ 3+3 prostate cancer
3. Patients with fewer than 3 cores involved with cancer. If a patient has 3 or more cores involved with cancer but still meets all pathologic criteria and after discussing risks and benefits does not want definitive treatment, he may still be eligible for active surveillance.
4. Patients with no more than 50% of any 1 core involved with prostate cancer. If a patient has more than 50% of any 1 core involved with prostate cancer but still meets all pathologic criteria and after discussing risks and benefits does not want definitive treatment, he may still be eligible for active surveillance.
5. Patients age > 18. Patients are typically offered AS if they are ≥ 60 years of age. However, if a man meets pathologic criteria and is < 60, he can be entered in AS if, after discussing risks and benefits, does not want definitive treatment.
6. Most patients will have PSA value ≤ 10 ng/ml. However, since PSA is prostate specific and not prostate cancer specific, many patients with elevated PSA levels > 10 ng/ml will not have prostate cancer, and PSA is elevated due to conditions such as BPH or inflammation. If a patient has a PSA value > 10 ng/ml, but still meets all pathologic criteria, he may still be eligible for active surveillance
Kundu, Shilajit DKundu, Shilajit D
  • Map it 201 E. Huron St.
    Chicago, IL
STU00059221
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Stockdale, Jazmine +1 312 694 2417
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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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Study Coordinator 312 695 1102
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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, PriyaKumthekar, Priya
  • Map it 201 E. Huron St.
    Chicago, IL
STU00087359
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Study Coordinator 1 312 695 1102
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A 36 month multi-center, open label, randomized, comparator study to evaluate the efficacy and safety of everolimus immunosuppression treatment in liver transplantation for hepatocellular carcinoma exceeding Milan criteria.
This study is a prospective Phase IV study to determine if the …
This study is a prospective Phase IV study to determine if the use of Everolimus results in lower liver tumor recurrence and improved patient and graft survival after liver transplant for hepatocellular carcinoma (HCC). The immunosuppressive comparators will be Everolimus and Tacrolimus therapy compared to Tacrolimus and Mycophenolic acid/Mycophenolate Mofetil. Primary outcomes data is disease free survival (the time from randomization to HCC recurrence or death). Secondary outcomes are rate of recurrence of Hepatitis C, problems related to wound healing, hernia repair within the first 12 months, hepatic arterial thrombosis, renal function, acute cellular rejection, post-transplant diabetes, hypertension, and hyperlipidemia.
Kulik, Laura MKulik, Laura M
NCT02081755 STU00083409
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Bezler, Laura 312 694 0260
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B-WELL-Mom (Breathe-Wellbeing, Environment, Lifestyle, and Lung Function)
This NIH funded research study is to better understand how the lungs function during pregnancy and how the immune system responds to pregnancy. This study will help us to better understand why some women with asthma experience…
This NIH funded research study is to better understand how the lungs function during pregnancy and how the immune system responds to pregnancy. This study will help us to better understand why some women with asthma experience worsening of their symptoms while others improve. Because pregnancy affects lung function and immune response of all women, we are looking for both women with and without asthma to participate. The study consists of 4 clinic visits (1st, 2nd, and 3rd trimesters of pregnancy and 4 months postpartum), and an at-home diary.
-Pregnant women at least 18 years old.
-Less than 15 weeks pregnant with a single baby.
-Women with and without asthma are eligible to participate. -No diagnosis of Multiple Sclerosis, Lupus, Rheumatoid Arthritis, HIV, or Mixed Connective Tissue Disease.
Grobman, William AGrobman, William A
STU00093038
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Wolfe, Kaitlin A 312 503 3248
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DRUG ATI001-102: A Phase I Study of Ad-RTS-hIL-12, an Inducible Adenoviral Vector Engineered to Express hIL-12 in the Presence of the Activator Ligand Veledimex in Subjects with Recurrent or Progressive Glioblastoma or Grade III Malignant Glioma
This research study involves two investigational drugs…
This research study involves two investigational drugs, veledimex, an activator ligand (INXN-1001) in combination with an Adenovirus Vector Engineered to Express hIL-12 (INXN-2001). IL-12 is a protein that may improve the body's natural response to disease by enhancing the ability of the immune system to kill tumor cells and may interfere with blood flow to the tumor. The main purpose of this study is to evaluate the safety and tolerability of a single tumor injection of INXN-2001 given in combination with oral veledimex.
Inclusion Criteria: 1. Male or female subjects ≥ 18 and ≤ 75 years of age. 2. Histologically confirmed supratentorial glioblastoma or other WHO grade III or IV malignant glioma from archival tissue. 3. Evidence of tumor recurrence/progression by MRI (RANO criteria) post standard initial therapy. 4. Previous standard of care anti-tumor treatment including surgery and/or biopsy and chemoradiation. 5. Able to undergo standard MRI scans with contrast agent. 6. Karnofsky Performance Status ≥ 70. 7. Adequate bone marrow reserves and liver and kidney function. 8.Male and female subjects must agree to use a highly reliable method of birth control. Exclusion Criteria: 1. Radiotherapy within 4 weeks or less prior to starting first veledimex dose. 2. Subjects with clinically significant increased intracranial pressure or uncontrolled seizures. 3. Known immunosuppressive disease, autoimmune conditions, and /or chronic viral infections. 4. Use of systemic antibacterials, antifungals or antivirals for the treatment of acute clinically significant infection. 5. Use of enzyme-inducing anti-epileptic drugs (EIAED) within 7 days prior to the first dose of study drug. 6. Other concurrent clinically active malignant disease requiring treatment. 7. Nursing or pregnant females. 8. Prior exposure to veledimex. 9. Presence of any contra-indication for a neurosurgical procedure.
Lesniak, MaciejLesniak, Maciej
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02026271 STU00094296
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Amidei, Christina 312 695 9124
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Development of a Kidney Cancer Patient Outcomes Database
Purpose This study is evaluating an on-line registry for kidney cancer patients called ‰ÛÏMyQOL,‰Û which stands for My Quality of Life. Overview A registry is a repository (database) of information about a group of people who …
Purpose This study is evaluating an on-line registry for kidney cancer patients called ‰ÛÏMyQOL,‰Û which stands for My Quality of Life. Overview A registry is a repository (database) of information about a group of people who share a common characteristic - in this case, kidney cancer. MYQOL registry participants enter information about their disease, treatment, symptoms, health status, and quality of life into an on-line, password-protected database on a regularly scheduled basis. Participants can use the registry to track many of their symptoms and their health status over time and to compare themselves (anonymously) with other groups of people (for example, how their level of fatigue compares with the average level of fatigue reported by other participants in the registry). Participants can also choose to share relevant information about themselves (from the registry) with their health care provider(s), by printing copies of their completed forms. Registry participants will be offered opportunities to join in other research studies when available. Description of Treatment Participants in this study will be asked to do the following for a 1-year trial period: 1) enroll in the on-line registry; 2) complete questionnaires about their health and treatment every 3 months ; and 3) be willing to have MYQOL researchers contact them confidentially about participating in other research studies. This does not mean that participants are obligated to participate in future research studies; only that they agree to be contacted.
Some of the eligibility criteria include:

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

Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Cella, DavidCella, David
  • Map it 201 E. Huron St.
    Chicago, IL
STU00070200
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Study Coordinator 312 695 1102
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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, NishaMohindra, Nisha
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02201992 STU00102000
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Study Coordinator 312 695 1102
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Behavioral activation and varenicline for smoking cessation in depressed smokers
The goal of this study is to develop a new combined treatment to help individuals with clinical depression to quit smoking. Participants will receive one of four treatments: 1) Standard behavior therapy + placebo; 2) Beh…
The goal of this study is to develop a new combined treatment to help individuals with clinical depression to quit smoking. Participants will receive one of four treatments: 1) Standard behavior therapy + placebo; 2) Behavioral activation for smoking cessation + placebo; 3) Standard behavior therapy + varenicline (Chantix); or 4) Behavioral activation for smoking cessation + varenicline (Chantix).
1. Adult (18 years of age or older) daily cigarette smokers (1+ cigarettes per day)
2. Lifetime history of clinical depression (Major Depressive Disorder)
Hitsman, Brian LHitsman, Brian L
NCT02378714 STU00100303
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Reyes, Celine 1 877 236 7487
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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, NishaMohindra, Nisha
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02194738 STU00200150
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Study Coordinator 312 695 1102
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NRG HN001: Randomized Phase II And Phase III Studies of Individualized Treatment for Nasopharyngeal Carcinoma Based on Biomarker Epstein Barr Virus (EBV) Deoxyribonucleic Acid (DNA)
There are two study questions the investigators are asking in this randomized phase II/III trial b…
There are two study questions the investigators are asking in this randomized phase II/III trial based on a blood biomarker, Epstein Barr virus (EBV) deoxyribonucleic acid (DNA) for locoregionally advanced non-metastatic nasopharyngeal cancer. All patients will first undergo standard concurrent chemotherapy and radiation therapy. When this standard treatment is completed, if there is no detectable EBV DNA in their plasma, then patients are randomized to either standard adjuvant cisplatin and fluorouracil chemotherapy or observation. If there is still detectable levels of plasma EBV DNA, patients will be randomized to standard cisplatin and flurouracil chemotherapy versus gemcitabine and paclitaxel. Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, fluorouracil, gemcitabine hydrochloride, and paclitaxel work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving cisplatin and fluorouracil is more effective than gemcitabine hydrochloride and paclitaxel after radiation therapy in treating patients with nasopharyngeal cancer.
Mittal, Bharat BMittal, Bharat B
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02135042 STU00200330
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Study Coordinator 312 695 1102
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Ex vivo interactions between high-density-like nanoparticles and human blood
This research is significant because the high-density lipoprotein like nanoparticles (HDL-NPs) being investigated have been shown to have tremendous therapeutic properties when evaluated in in vitro and in vivo settings. Pr…
This research is significant because the high-density lipoprotein like nanoparticles (HDL-NPs) being investigated have been shown to have tremendous therapeutic properties when evaluated in in vitro and in vivo settings. Prior to initiating large-scale in vivo animal and human studies it is imperative that we obtain an in-depth knowledge of the interaction of the HDL-NPs with human blood cells using safe ex vivo experiments.
Healthy, non-pregnant adult (age >18-75 years) volunteers.
Thaxton, Colby SThaxton, Colby S
  • Map it 201 E. Huron St.
    Chicago, IL
STU00200368
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Thaxton, Colby S 312 503 1826
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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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A Prospective Study of Early Stage Breast Cancer Patients with Abnormal Myocardial Deformation treated with Anthracycline and/or Trastuzumab and Pertuzumab-based cancer therapy.
This study will help us to determine if prophylactic beta-blocker therapy, in patients with preclinical changes in LV funct…
This study will help us to determine if prophylactic beta-blocker therapy, in patients with preclinical changes in LV function, will prevent a worsening of strain, allowing patients to stay on their chemotherapy treatment.

Main Inclusion:

  • Patients > 18 years of age with HER2-overexpressing early stage breast cancer (Stages I – III)
  • Pathology report must include HER2 expression, estrogen and progesterone receptor status
  • Normal LV function (EF > 53%) on baseline echocardiogram
  • NYHA functional class I-II
  • Scheduled to receive treatment with anthracycline and/or trastuzumab and pertuzumab-based regimens

Main Exclusion:

  • Pre-existing cardiac disease (moderate-severe coronary artery disease, moderate-severe valvular heart disease, constrictive/restrictive cardiomyopathies)
  • Metastatic breast cancer
  • Prior use of BB/ACE therapy
  • 2nd and 3rd degree AV block, Sick Sinus Syndrome, severe bradycardia (<50 BPM), or severe hypotension (SBP < 85 mmHg)
  • Severe liver dysfunction or moderate-severe asthma
Akhter, NausheenAkhter, Nausheen
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02993198 STU00200675
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Ramirez, Haydee +1 312 695 2928
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ECOG-ACRIN 1131: A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy Vs. Capecitabine in Patients with Residual Triple-Negative Breast Cancer following Neoadjuvant Chemotherapy

The main purpose of this study is to compare getting more treatment with capecitabine (i.e. on…

The main purpose of this study is to compare getting more treatment with capecitabine (i.e. one of the usual approaches), to getting more treatment with a platinum-based chemotherapy (using the drug cisplatin or carboplatin), after surgery.

Platinum agents (cisplatin or carboplatin) are already FDA-approved to be used in patients with stage IV (i.e., metastatic) breast cancers, but are usually not used in patients with early forms of breast cancer. Getting a platinum-based chemotherapy after surgery could reduce the risk of cancer returning (metastatic recurrence) in the breast or at other distant organs, but it could also cause side effects. This study will allow the researchers to know whether this different approach is better, the same, or worse than using capecitabine chemotherapy.

You may be eligible for this research study if you:

  • Have early stage breast cancer.
  • Have a breast cancer that does not have the estrogen, progesterone or HER2 receptor, and is called triple-negative breast cancer.
  • Have completed all your chemotherapy prior to your surgery.
  • Had ≥ 1 cm worth of cancer in the breast at the time of your surgery.

Flaum, LisaFlaum, Lisa
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02445391 STU00201173
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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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Study Coordinator 312 695 1102
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Sense2Stop: Mobile Sensor Data to Knowledge
Sense2Stop is a 15-day smokingcessation research study that involves answering surveys on a study-providedsmartphone, smoking cessation counseling, 3 in-person lab sessions, andwearable sensors to detect smoking, eating, and stress. The aim of this research…
Sense2Stop is a 15-day smokingcessation research study that involves answering surveys on a study-providedsmartphone, smoking cessation counseling, 3 in-person lab sessions, andwearable sensors to detect smoking, eating, and stress. The aim of this research is to build systems that can recognize when peopleare stressed and then provide them with relaxation prompts in the moment toreduce their likelihood of being stressed, smoking, or overeating in the nearfuture. Using these systems should help smokers be more effective in theirattempts to quit by reducing their tendency to lapse when they are stressed orexperiencing other negative moods or behaviors.
-Age: 18 to 65 years old ; Smokes 1+ cigarettes/day for past year. ; Willing to try to quit smoking for at least 48 hours during a 15-day quit trial. ; Will not use non-cigarette tobacco products or nicotine replacement
therapy during the study period ; Not taking or intending to take pharmacological smoking cessation aids
(e.g., nicotine replacement, bupropion, venlafaxene) during the study
period
Spring, BonnieSpring, Bonnie
  • Map it 680 N. Lake Shore Dr.
    Chicago, IL
NCT03184389 STU00201566
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Daly, Elyse 312 503 1317
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A large-scale multicenter phase II study evaluating the protective effect of a tissue selective estrogen complex (TSEC) in women with newly diagnosed ductal carcinoma in situ.
The main purpose of this study is to determine if taking the study drug, conjugated estrogens/bazedoxife…
The main purpose of this study is to determine if taking the study drug, conjugated estrogens/bazedoxifene (Duavee®) causes any changes in the proliferation markers within the breast tissue of the study subjects. The study drug is approved by the US Food and Drug Administration in healthy postmenopausal women to treat certain symptoms of menopause such as hot flashes. Since it is not approved in women with DCIS, its use in this study is experimental. This study will also look at whether taking the study drug causes any significant or undesirable side effects in women with DCIS. The researchers hope that this study will help them determine if taking the study drug is safe in women taking DCIS and if it can possibly reduce the risk of developing breast cancer in women with DCIS.
Some of the eligibility criteria include:

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

Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Kulkarni, SwatiKulkarni, Swati
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02694809 STU00202100
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Study Coordinator 312 695 1102
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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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ECOG-ACRIN 6141: Randomized Phase II/III Study of Nivolumab plus Ipilimumab plus Sargramostim versus Nivolumab plus Ipilimumab in Patients with Unresectable Stage III or Stage IV Melanoma
This randomized phase II/III trial studies the side effects and best dose of nivolumab and i…
This randomized phase II/III trial studies the side effects and best dose of nivolumab and ipilimumab when given together with or without sargramostim and to see how well they work in treating patients with stage III-IV melanoma that cannot be removed by surgery. Monoclonal antibodies, such as ipilimumab and nivolumab, may kill tumor cells by blocking blood flow to the tumor, by stimulating white blood cells to kill the tumor cells, or by attacking specific tumor cells and stop them from growing or kill them. Colony-stimulating factors, such as sargramostim, may increase the production of white blood cells. It is not yet known whether nivolumab and ipilimumab are more effective with or without sargramostim in treating patients with melanoma.
Chandra, SunandanaChandra, Sunandana
NCT02339571 STU00202372
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1-855-NU-STUDY
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Culturally Adapted Cognitive Behavioral Stress and Self-Management (C-CBSM) Intervention for Prostate Cancer
Este estudio está diseñado para ayudar a los hombres a mejorar la calidad de vida y reducir los síntomas del cáncer de próstata. El estudio imparte habilidades de manejo de estrés y prom…
Este estudio está diseñado para ayudar a los hombres a mejorar la calidad de vida y reducir los síntomas del cáncer de próstata. El estudio imparte habilidades de manejo de estrés y promueve la salud. Este programa de salud e intervención para hombres diagnosticados con cáncer de próstata, ofrece información sobre cómo reducir el estrés y aprender a relajarse. Este estudio dentro Northwestern University está financiado por el Instituto Nacional del Cáncer. El objetivo del estudio es examinar cómo los programas de salud pueden mejorar la calidad de vida de los hombres tratados por cáncer de próstata.
(a) ≥ 18 years of age;
(b) Hispanic/Latino self-identification;
(c) Spanish speakers (including bilinguals who express interest in a Spanish-based psychosocial intervention); (d) Willingness to be randomized and followed for approximately 12 months.
(d) Primary diagnosis of localized Prostate Cancer (T1-T3, N0, M0);
(e) Surgical or radiation treatment (e.g., external beam, brachytherapy, proton) within the past 48 months prior to participating in the study
Miller, GregMiller, Greg
  • Map it 633 N. St. Clair St.
    Chicago , IL
NCT03344757 STU00203197
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Pizarro, Edgar 312 503 3949
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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, PriyaKumthekar, Priya
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02523014 STU00202953
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Study Coordinator 312 695 1102
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NU 15U06: A Phase 1 Dose-Escalation Study of Intravesical Pembrolizumab and Bacillus Calmette-Guerin (BCG) in Subjects with High Risk and BCG-Refractory Non-Muscle-Invasive Bladder Cancer
Purpose The purpose of this study is to evaluate the efficacy (the effect of drug on tumor) and the tolerabili…
Purpose The purpose of this study is to evaluate the efficacy (the effect of drug on tumor) and the tolerability (the effect of drug on the body) of Pembrolizumab, when given as a single agent in patients with bladder tumors. Another purpose of the study is to see what tumor characteristics are associated with increased efficacy of the Pembrolizumab. Overview Pembrolizumab (MK-3475) is an antibody (a human protein that sticks to a part of the tumor and/or immune cells) designed to allow the body‰Ûªs immune system to work against tumor cells. Pembrolizumab is FDA approved for the treatment of advanced melanoma (a type of skin cancer) and some types of lung cancer. It is not yet approved by the USFDA for bladder cancer, hence it is considered an investigational agent for this disease. Description of Treatment All study participants will take the same study drug, Pembrolizumab. Pembrolizumab will be given intravesically through urethra. With intravesical therapy, doctor administers the drug directly into the bladder (through a catheter), rather than giving it by mouth or injecting it into a vein. During the first six weeks of therapy, one will also receive treatment with BCG as a standard of care. We expect that one will receive treatment for up to 1 year or until your disease gets worse (whichever occurs first). After completing treatment, the study team will continue to watch you for side effects for at least 30 days. The study team will also continue to check periodically to see how you are doing until your disease returns.
Some of the eligibility criteria include:

- Participants must have a recurrent, high or low risk non-muscle-invasive bladder carcinoma.
- Participants must (be BCG refractory) have received at least one 6-week course of BCG induction plus 1 maintenance dose, OR 2 full 6-week courses of induction BCG treatment.
- Participants must be 18 or older.

Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Meeks, Joshua JMeeks, Joshua J
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02808143 STU00202754
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Study Coordinator 312 695 1102
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A Phase 2, single arm, multi-center, open label trial Combining Optune with concurrent Bevacizumab in the setting of Recurrent or Progressive Meningioma
Purpose The purpose of this research study is to determine the effects (good and bad) bevacizumab (the study drug) combined with Optune (the stud…
Purpose The purpose of this research study is to determine the effects (good and bad) bevacizumab (the study drug) combined with Optune (the study device) tumor treatment field therapy has on meningiomas. Overview Bevacizumab (the study drug) is considered investigational because the US Food and Drug Administration (FDA) has not approved its use for the treatment of meningiomas. The study drug is a medication that blocks the growth of new blood vessels. In order for tumors to grow they need to have a blood supply. Tumor cells have been shown to produce substances that stimulate the abnormal growth of new blood vessels that allow the tumor to grow. It is thought that the study drug may interfere with the growth of new blood vessels and therefore might stop tumor growth, and possibly shrink the tumor by keeping it from receiving nutrients and oxygen supplied by the blood vessels. Optune (the study device) is also considered investigational because the US Food and Drug Administration (FDA) has not approved its use for the treatment of meningiomas. The study device, Optune is a device that the patient will wear and use for at least 18 hours of each day. It delivers alternating electrical current to the patient‰Ûªs brain tumor and by doing so interrupts a process called mitosis. Mitosis needs to occur in order for cell division to occur and allows tumors to grow. By slowing this process, we hypothesize that meningioma growth may also be slowed. Description of Treatment Tumor treatment field therapy with Optune will be initiated at the same time as bevacizumab, with both treatments to start within a one-week period of each other. Bevacizumab will be given at current standard central nervous system (CNS) dosing of 10mg/kg q2 weeks in an outpatient setting. After 4 cycles (1 cycle=28days) of therapy (Cycle 5 day 1) patients may choose to switch to bevacizumab at a dose of 15 mg/kg q3 weeks. For patients who chose to make this switch, they have to do it on Day1 of a new cycle. Tumor treatment fields with Optune will be delivered for at least 18 hours a day at a frequency of 200 KHz and intensity of 1-3V/cm. Treatment will be continued until disease progression or up to 1 year.
"Some of the eligibility criteria include:

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

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

Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial."
Kumthekar, PriyaKumthekar, Priya
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02847559 STU00203030
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Study Coordinator 312 695 1102
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NRG-GY006: A Randomized phase III trial of radiation therapy and cisplatin alone or in combination with intravenous triapine in women with newly diagnosed bulky stage IB2, or stage II, IIIB, or IVA cancer of the uterine cervix or stage II-IVA vaginal cancer.

The purpose of this study is to compare…

The purpose of this study is to compare the effects of adding triapine to the usual cisplatin chemotherapy and radiation therapy, as compared to using cisplatin chemotherapy and radiation therapy alone. Triapine is an experimental drug being tested in the treatment of cervical cancer to improve the effects of standard radiotherapy with concurrent chemotherapy. The addition of triapine to the usual chemotherapy and radiation therapy could shrink your tumor and increase the length of time till the cancer returns, but it could also cause side effects. This study will allow the researchers to know whether this new approach is better, the same, or worse than the usual approach.

You may be eligible for this research study if you have newly diagnosed cervical or vaginal cancer for which surgical treatment is not possible.

Donnelly, EricDonnelly, Eric
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02466971 STU00203105
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Study Coordinator 312 695 1102
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A Double Blind, Randomized, Vehicle Controlled, Crossover Study to Evaluate the Safety and Efficacy of Topical Naloxone Hydrochloride Lotion 0.5% for the Relief of Pruritus in Patients with the Mycosis Fungoides (MF) or Sézary Syndrome (SS) Forms of Cutaneous T-Cell Lymphoma (CTCL)
The main goal of …
The main goal of this study is to test the efficacy and safety of topical Naloxone for itching in patients with MF.
21 years of age or older with a diagnosis of mycosis fungoides (MF) with itching present on a daily basis for more than one month and willing to fill out a diary for 7 days to provide severity of itch before enrollment.
Guitart, JoanGuitart, Joan
  • Map it 676 N. St. Clair St.
    Chicago, IL
NCT02811783 STU00203078
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Bagnowski, Katherine +1 312 503 3788
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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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Study Coordinator 312 695 1102
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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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Study Coordinator 312 695 1102
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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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Study Coordinator 312 695 1102
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NUDB 16Z01: The OncoSET Program Database and Biobank - Combining Clinical Outcomes with Next Generation Sequencing and other Advanced Molecular Testing for Genetic Aberrations in Patients with Advanced Solid Malignancies

The purpose of the study is to gather information about your cancer and the t…

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

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

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

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

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

Cristofanilli, MassimoCristofanilli, Massimo
  • Map it 201 E. Huron St.
    Chicago, IL
STU00203944
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Study Coordinator 1 312 695 1102
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OT-15-001: A Phase 3, Randomized, Open-Label Study To Evaluate the Efficacy and Safety of Eflornithine with Lomustine Compared to Lomustine Alone in Patients with Anaplastic Astrocytoma That Progress/Recur After Irradiation and Adjuvant Temozolomide Chemotherapy
Purpose The purpose of this study i…
Purpose The purpose of this study is to measure how well and how safe eflornithine is in combination with lomustine, compared to lomustine taken alone, in treating patients whose anaplastic astrocytoma has come back after radiation and chemotherapy. Overview Elfornithine is an experimental drug. An experimental drug means that the United States Food and Drug Administration (FDA) has not approved it for use. This drug will be used with another drug called Lomustine that is approved by the FDA in the United States for patients with anaplastic astrocytoma. Description of Treatment This study has two study groups. Patients will be randomly placed in one of the 2 groups.
Some of the eligibility criteria include:

- Participants must be 18 years of age or older.

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

Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.
Kumthekar, PriyaKumthekar, Priya
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02796261 STU00203957
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NU 16U05: A Randomized Phase II Trial of Abiraterone, Olaparib, or Abiraterone + Olaparib in Patients with Metastatic Castration-Resistant Prostate Cancer with DNA Repair Defects
Purpose The purpose of this research is to study two US FDA approved drugs alone or in combination with each other in p…
Purpose The purpose of this research is to study two US FDA approved drugs alone or in combination with each other in people who have metastatic castration-resistant prostate cancer and specific changes in their DNA, to see which one is best at keeping prostate cancer from growing. Metastatic castration-resistant prostate cancer means the cancer is spreading outside of the prostate and does not stop or go away with hormone therapy or surgery to reduce testosterone. One of the drugs, Olaparib, is not FDA approved for prostate cancer, which means it is experimental or investigational. Overview Once prostate cancer has progressed to metastatic castration-resistant prostate cancer, standard treatment focuses on extending life, delaying disease progression, and improving symptoms and quality of life. The purpose of this research is to study two US FDA approved drugs alone and in combination with each other in people who have metastatic castration-resistant prostate cancer and DNA repair defects. One of the drugs, Olaparib, is not FDA approved for prostate cancer. People who take part in this research study have been diagnosed with metastatic castration-resistant prostate cancer and either their body or the the cancer have a genetic defect (flaw) that causes problems with their body‰Ûªs ability to repair damage to their DNA. Description of Treatment Participants will be placed into one of four groups. The treatment that each group will receive is as follows. Group 1 will receive Abiraterone (1000 mg by mouth once per day) and prednisone (5 mg by mouth twice per day). Group 2 and 4 will receive Olaparib (300 mg by mouth twice per day). Group 3 will receive Olaparib (300 mg by mouth twice per day), Abiraterone (1000 mg by mouth once per day) and prednisone (5 mg by mouth twice per day). Treatment may continue until disease progression, severe or unacceptable side effects, or until the participant or study doctor think the treatment should stop.
Some of the eligibility criteria include:

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

Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Hussain, MahaHussain, Maha
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03012321 STU00203960
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Study Coordinator 312 695 1102
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The Molecular Markers of Bladder Cancer
Genetic research may discover genes, find out how genes function, or help researchers learn how to use what we know about genes to treat or prevent and treat disease. The purpose is to study whether the results of genetic testing can predict if bladder cancer i…
Genetic research may discover genes, find out how genes function, or help researchers learn how to use what we know about genes to treat or prevent and treat disease. The purpose is to study whether the results of genetic testing can predict if bladder cancer is going to recur, progress (get worse), or respond to chemotherapy.
Male or female patients ages 40-89 with high-grade T1 bladder cancer or patients with muscle invasive (>T2) bladder cancer undergoing neoadjuvant chemotherapy and radical cystectomy.
Meeks, Joshua JMeeks, Joshua J
STU00204352
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312 695 8146
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Physical activity and DNA methylation among women with high breast density
The purpose of this study is to learn more about how physical activity may influence your genes through a mechanism called DNA methylation. Our goal is to determine if being physically active may be associated with a healthy p…
The purpose of this study is to learn more about how physical activity may influence your genes through a mechanism called DNA methylation. Our goal is to determine if being physically active may be associated with a healthy pattern of DNA methylation in your immune system cells. Exercising and being physically active are believed to be important for preventing cancer. It may be particularly important for women with high breast density, and may help reduce risk for breast cancer. However, we do not understand what physical activity changes within the body to alter risk of breast cancer. DNA methylation is a biological process that may help explain the relationship between physical activity and cancer risk.
Generally healthy women with a history of heterogeneously or extremely dense breasts, aged 40-74 with no history of cancer (other than non-melanoma skin cancer), diabetes, and cardiovascular disease.
Hibler, ElizabethHibler, Elizabeth
  • Map it 680 N. Lake Shore Drive Suite 1410
    Chicago, IL
STU00204639
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Hibler, Elizabeth 312 503 1178
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NCI 2015-06-04 Phase IIB trial of neoadjuvant oral tamoxifen versus transdermal 4-hydroxytamoxifen in women with DCIS of the breast
Phase IIB trial of neoadjuvant oral tamoxifen versus transdermal 4-hydroxytamoxifen in women with DCIS of the breast
  • Have been diagnosed with ER positive DCIS
  • Are not pregnant or breastfeeding
  • Have no history of uterine caner or blood clots
  • Have not taken tamoxifen or a similar drug within 5 years
Khan, Seema Ahsan AhsanKhan, Seema Ahsan Ahsan
  • Map it 250 E. Superior St.
    Chicago, IL
NCT02993159 STU00204804
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Pulliam, Natalie +1 312 472 4767
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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, JeffreySosman, Jeffrey
  • Map it 201 E. Huron St.
    Chicago, IL
STU00204151
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Study Coordinator 1 312 695 1102
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(xIRB NCI CIRB) SWOG 1602: A Phase III Randomized Trial to Evaluate the Influence of BCG Strain Differences and T Cell Priming with Intradermal BCG Before Intravesical Therapy for BCG-Naïve High-Grade Non-Muscle Invasive Bladder Cancer
The purpose of this study is to test two things:• Compare any …
The purpose of this study is to test two things:• Compare any good and bad effects of using the Tokyo-172 version of BCG with thecurrently used BCG LIVE (TICE® BCG) version of BCG on people with bladdercancer receiving BCG in the bladder. The study will be considered successful ifapproximately the same number of patients who receive the different treatments arefree from high grade recurrence of their bladder cancer after one year of treatment.• Using the Tokyo-172 version of BCG, compare any good and bad effects of adding aBCG vaccination (given under the skin) in addition to placing BCG in only thebladder. The study will be considered successful if the vaccination results in an 8%improvement in the number of patients who are free from high grade recurrence oftheir bladder cancer after one year of treatment.
Some of the eligibility criteria include: - Participants must have high grade bladder cancer thathas not entered the muscle - Participants must be 18 or older - Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Meeks, Joshua JMeeks, Joshua J
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03091660 STU00205010
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Study Coordinator 312 695 1102
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(xIRB) S1418/BR006 A Randomized Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer with ≥ 1 cm Residual Invasive Cancer or Positive Lymph Nodes (ypN+) After Neoadjuvant Chemotherapy.
The purpose of this study…
The purpose of this study is to compare the usual approach (i.e. no moretreatment or additional post-operative chemotherapy), to any effects, goodand/or bad, of the experimental drug MK-3475 (also called pembrolizumab)after surgery. This study will allow the researchers to know whether treatmentwith MK-3475 (pembrolizumab) is better, the same, or worse than the usualapproach.

This study has two study groups (also called study “arms”). A computer willby chance assign you to one of the two study arms. This is calledrandomization. This is done by chance because no one knows if one studyarm is better, the same, or worse than the other arm. Once you are put on onearm, you cannot switch to the other arm. Neither you nor your doctor canchoose which arm you will be in.

 Some of the eligibility criteria include: Participants must be 18 years of age or older; Participants must have “triple-negative” breast cancer. This is the typeof breast cancer that doesn’t have receptors for estrogen, progesterone,or the protein HER2, that are found in some other types of breastcancer
Gradishar, William JGradishar, William J
  • Map it 250 E. Superior St.
    Chicago, IL
NCT02954874 STU00205340
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Study Coordinator 1 312 695 1102
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NU 16B14: I-CURE-1: A Phase II, single arm study of Pembroluzimab combined with carboplatin in patients with circulating tumor cells (CTCs) positive Her-2 negative metastatic breast cancer (MBC)

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

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

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

You may be eligible for this research study if you have advanced breast cancerthat is triple negative and you have been found to have more than 5 circulating cancer cellsdetected by the FDA-approved test, CellSearch™, in one tube of blood.
Cristofanilli, MassimoCristofanilli, Massimo
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03213041 STU00205013
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Study Coordinator 312 695 1102
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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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Study Coordinator 1 312 695 1102
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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, JeffreySosman, Jeffrey
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03138512 STU00205491
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Study Coordinator 312 695 1102
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(xIRB NCI-CIRB) SWOG 1512: A Phase II and Pilot Trial of PD-1 Blockade with MK-3475 (Pembrolizumab) in Patients with Resectable or Unsectable Desmoplastic Melanoma (DM)
The purpose of this study is to test any good and bad effects of the study drug MK-3475 (also called pembrolizumab). MK-3475 (pembr…
The purpose of this study is to test any good and bad effects of the study drug MK-3475 (also called pembrolizumab). MK-3475 (pembrolizumab) could shrink your cancer but it could also cause side effects. Researchers hope to learn if the study drug will cause the cancer to at least temporarily disappear in more than twenty percent of patients with melanoma that is not surgically removable. In patients with melanoma that is surgically removable, researchers also hope to learn if the study drug will cause the surgery to be more effective and avoid repeated surgery.
Chandra, SunandanaChandra, Sunandana
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02775851 STU00205551
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Study Coordinator 312 695 1102
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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
  • Map it 201 E. Huron St.
    Chicago, IL
NCT00000418 STU00205550
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Study Coordinator 312 695 1102
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Phase II study of front line therapy with nivolumab and salvage nivolumab + ipilimumab in patients with advanced renal cell carcinoma
This research study is a phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational treatment to learn whether the inter…
This research study is a phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational treatment to learn whether the intervention works in treating a specific disease. “Investigational” means that the intervention is being studied. The Food and Drug Administration (FDA) has approved Nivolumab as treatment for advanced renal cell carcinoma, however discontinuation of nivolumab and the combination with Ipilimumab are investigational. Nivolumab is an antibody (type of human protein) drug that may stimulate your body’s immune system to fight tumor cells. Ipilimumab is also an antibody that may stimulate your body’s immune system to fight tumor cells. Ipilimumab is FDA approved for the treatment of melanoma (skin cancer) and has been previously studied in renal cell cancer. Specifically, this study will look at the use of these treatments based on how your disease responds to the treatment. Both of these study drugs are given by IV (intravenous) through a vein. About 12 people are expected to participate in this research study here at Northwestern University out of 160 people in the entire study nationally.
Some of the eligibility criteria include:
• Participants must be 18 or older.
• Patient must have the ability to understand and sign an approved informed consent form (ICF).
• Patient must have a confirmed diagnosis of advanced Renal Cell Carcinoma (RCC).
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.
Sosman, JeffreySosman, Jeffrey
  • Map it 201 East Huron Street Suite 12-160​
    Chicago, IL
NCT03117309 STU00205969
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Study Coordinator 312 695 1102
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Clinical Database of Prostate Cancer at Northwestern University
The goal of this study is to create a database of prostate cancer patients at Northwestern Memorial Group to better understand, learn about, prevent, treat or cure prostate cancer.
Men ages 18-89 years daignosed with prostate cancer.
Schaeffer, EdwardSchaeffer, Edward
STU00206270
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Khawaja, Faizan 312 694 2417
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(xIRB) DRUG 201973: A phase I/II dose escalation and expansion study to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of GSK525762 in combination with fulvestrant in subjects with ER+ breast cancer
The purpose of this study is to evaluate the safety of the investiga…
The purpose of this study is to evaluate the safety of the investigational drug, GSK525762, and how well it works when taken with fulvestrant, a drug that is a standard treatment for estrogen receptor positive breast cancer. Researchers will test 2 dose levels of GSK525762 and fulvestrant. There will be 2 groups of subjects at each dose level. If dose level 1 is shown to be tolerated without serious side effects, a small number of consenting participants will be enrolled and start a second, higher dose level (dose level 2) of GSK252762. If DL1 is not safe, a lower dose will be given. If the small number of subjects completes DL2 and it is shown to be safe, additional subjects will be randomly assigned to receive either DL1 or DL2.
• Diagnosis of advanced or metastatic estrogen receptor-positive breast cancer (ER+BC) that hasn’t responded to previous endocrine treatment.
• Age of at least 18 years
Gradishar, William JGradishar, William J
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02964507 STU00206335
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Study Coordinator 312 695 1102
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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
  • Map it 201 East Huron Street Suite 12-160​
    Chicago, IL
NCT03397706 STU00206699
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Study Coordinator 312 695 1102
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(xIRB) Alliance A221505: Phase III Randomized Trial of Hypofractionated Post Mastectomy Radiation with Breast Reconstruction
Women with cancer in their lymph nodes after mastectomy have been shown to live longer when they receive radiation therapy. Radiation treatments are given daily over a treatmen…
Women with cancer in their lymph nodes after mastectomy have been shown to live longer when they receive radiation therapy. Radiation treatments are given daily over a treatment course of 5 to 6 weeks. This study will examine whether a shorter course of radiation therapy (3 to 4 weeks) are safe and effective, will lower treatment costs, and improve patient satisfaction.This study has two study groups:  Group 1 will get the usual 5 to 6 weeks radiation therapy used for this type of cancer.  Group 2 will get a shortened course with 3 to 4 weeks radiation therapy for this type of cancer. Participants will be assessed during and after completing radiation, similar to usual care and the study doctor may recommend chemotherapy drugs or anti-estrogen medications that are commonly used before or after radiation therapy.
 Diagnosis with stage 2 or stage 3 breast cancer
 Age of at least 18 years
Donnelly, EricDonnelly, Eric
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03414970 STU00207162
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Study Coordinator 312 695 1102
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(xIRB NCI) ECOG-ACRIN 4151: A Randomized Phase III Trial of Consolidation with Autologous Hematopoietic Cell Transplantation Followed by Maintenance Rituximab vs. Maintenance Rituximab Alone for Patients with Mantle Cell Lymphoma in Minimal Residual Disease-Negative First Complete Remission
The purp…
The purpose of this research study is to determine whether an autotransplant improves survival in MCL patients who have achieved an excellent (MRD-negative) first complete remission (CR). An autotransplant is a procedure in which a high dose of chemotherapy is given, in hopes of reducing the amount of lymphoma more than what standard chemotherapy would generally accomplish. In order to allow the body to safely recover from the high-dose chemotherapy, blood stem cells are collected (prior to the high-dose chemotherapy) and then re-infused after the high dose chemotherapy is cleared from the body.
• Participants must be 18 years or older
• Participants must be diagnosed with mantle cell lymphoma, a type of blood cancer.
Winter, Jane NormaWinter, Jane Norma
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03267433 STU00207302
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Study Coordinator 312 695 1102
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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, AmiShah, Ami
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03147287 STU00207256
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Study Coordinator 1 312 695 1102
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A Phase Ib/ II Study of Sorafenib and Pembrolizumab in Advanced Hepatocellular Cancer (HCC)

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

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

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

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

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

Mahalingam, DevalingamMahalingam, Devalingam
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03211416 STU00207399
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Study Coordinator 312 695 1102
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Perioperative physical activity and sleep among women with gynecologic malignancies
We are studying whether or not Fitbit activity trackers could be a useful tool to incorporate into monitoring patient's post-operative recovery. Participants will be given a Fitbit activity tracker, which they will we…
We are studying whether or not Fitbit activity trackers could be a useful tool to incorporate into monitoring patient's post-operative recovery. Participants will be given a Fitbit activity tracker, which they will wear from the time of enrollment until 6 weeks after surgery. Patients will also answer survey questions involving their post-operative recovery while keeping a sleep journal.
Any patient with a smart phone who is undergoing major surgery for a gynecologic cancer at Northwestern Memorial Hospital.
Barber, EmmaBarber, Emma
  • Map it 250 E. Superior St. Fourth Floor
    Chicago, IL
STU00206524
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Gwynn, Katherine +1 312 472 5726
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(xIRB NCI) ECOG ACRIN 8153: Cabazitaxel with Abiraterone versus Abiraterone alone Randomized Trial for Extensive Disease following Docetaxel: the CHAARTED2 Trial
The purpose of this research study is to compare any good or bad effects of using the chemotherapy drug cabazitaxel(also known as Jevtana®…
The purpose of this research study is to compare any good or bad effects of using the chemotherapy drug cabazitaxel(also known as Jevtana®) with the usual approach of the hormonebased therapy abiraterone acetate (also known as Zytiga®) in combination with prednisone on patients with advanced prostate cancerthat have already undergone treatment with hormone therapy and the chemotherapydrug docetaxel.

· Participants must be 18 years or older

Participants have beendiagnosed with prostate cancer that has spread, and is able to grow even though drugsor other treatments to lower the amount of male sex hormones are being used tomanage the cancer.
VanderWeele, DavidVanderWeele, David
NCT03419234 STU00207949
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Study Coordinator 312 695 1102
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A Phase III, Randomized, Double-Blind, Clinical Trial of Pembrolizumab (MK-3475) plus Chemotherapy (XP or FP) versus Placebo plus Chemotherapy (XP or FP) as Neoadjuvant/Adjuvant Treatment for Subjects with Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma (KEYNOTE-585).
The purpose of this s…
The purpose of this study is to test the safety, efficacy, and tolerability of the research study drug, pembrolizumab (MK-3475) in combination with cisplatin and capecitabine or 5- fluorouracil (5-FU).

You may be eligible for this research study if you have gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma.

Benson III, Al BBenson III, Al B
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03221426 STU00207611
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Study Coordinator 1 312 695 1102
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Protocol ATI001-102 Expansion Substudy: Evaluation of Ad-RTS-hIL-12 + Veledimex in Subjects with Recurrent or Progressive Glioblastoma
This research study involves two investigational drugs, veledimex, an activator ligand (INXN-1001) in combination with an Adenovirus Vector Engineered to Express hIL-…
This research study involves two investigational drugs, veledimex, an activator ligand (INXN-1001) in combination with an Adenovirus Vector Engineered to Express hIL-12 (INXN-2001). IL-12 is a protein that may improve the body's natural response to disease by enhancing the ability of the immune system to kill tumor cells and may interfere with blood flow to the tumor. The main purpose of this study is to evaluate the safety and tolerability of a single tumor injection of INXN-2001 given in combination with oral veledimex.
Inclusion Criteria: 1. Male or female subjects ≥ 18 and ≤ 75 years of age. 2. Histologically confirmed supratentorial glioblastoma from archival tissue. 3. Evidence of tumor recurrence/progression by MRI (RANO criteria) post standard initial therapy. 4. Previous standard of care anti-tumor treatment including surgery and/or biopsy and chemoradiation. 5. Able to undergo standard MRI scans with contrast agent. 6. Karnofsky Performance Status ≥ 70. 7. Adequate bone marrow reserves and liver and kidney function. 8.Male and female subjects must agree to use a highly reliable method of birth control. Exclusion Criteria: 1. Radiotherapy within 4 weeks or less prior to starting first veledimex dose. 2. Subjects with clinically significant increased intracranial pressure or uncontrolled seizures. 3. Known immunosuppressive disease, autoimmune conditions, and /or chronic viral infections. 4. Use of systemic antibacterials, antifungals or antivirals for the treatment of acute clinically significant infection. 5. Use of enzyme-inducing anti-epileptic drugs (EIAED) within 7 days prior to the first dose of study drug. 6. Other concurrent clinically active malignant disease requiring treatment. 7. Nursing or pregnant females. 8. Prior exposure to veledimex. 9. Presence of any contra-indication for a neurosurgical procedure.
Lesniak, MaciejLesniak, Maciej
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02026271 STU00207771
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Amidei, Christina 312 695 9124
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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, ShiraDinner, Shira
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03150693 STU00208162
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(xIRB NCI) Alliance A031501: Phase III Randomized Adjuvant Study Of MK-3475 (pembrolizumab) in Muscle Invasive and Locally Advanced Urothelial Carconima (AMBASSADOR) versus Observation

· · Had surgery to remove bladder cancer which is inthe deep muscle of the bladder wall (called mus…

· · Had surgery to remove bladder cancer which is inthe deep muscle of the bladder wall (called muscle-invasive bladder cancer) orurothelial cancer (in the urine collection area)

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

The purpose of this study isto compare any good and bad effects of using a drug called MK-3475(pembrolizumab) after the removal of your muscle invasive bladder cancer orurothelial cancer. MK-3475 is a drug that uses a person’s own immune system totreat cancer. This study will allow researchers to know whether treatment withMK-3475 is better, the same, or worse than the usual approach. To be better,the MK-3475 should increase life by 9 months or more, compared to observationalone. The use of MK-3475 could prevent your cancer from returning but it couldalso cause side effects. This immunotherapy drug, MK-3475, is alreadyFDA-approved for use in other types of cancers, but for your type of cancer itis considered experimental. There will be about 739 people taking part in thisstudy.

VanderWeele, DavidVanderWeele, David
NCT03244384 STU00208176
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The effect of inflammatory bowel disease flares on serum prostate specific antigen
This study will measure PSA values in men with IBD before, during, and following a flare. In addition, the effect of any PSA increase will be analyzed and correlated to the location of the disease (rectal vs. other). S…
This study will measure PSA values in men with IBD before, during, and following a flare. In addition, the effect of any PSA increase will be analyzed and correlated to the location of the disease (rectal vs. other). Study findings may help men with IBD by identifying pitfalls in prostate cancer screening for this population and help to stratify and understand the effect IBD has on the prostatic milieu. By optimizing how men with IBD are screened for prostate cancer, future unnecessary healthcare encounters and expenditures may be reduced for this patient group.
Men with a confirmed diagnosis of inflammatory bowel disease (IBD) between the ages of 40-69 years old.
Kundu, Shilajit DKundu, Shilajit D
NCT03558048 STU00207583
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Khawaja, Faizan 312 694 2417
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NU 18I01: A Phase 2 study of pembrolizumab in combination with pelareorep in patients with advanced pancreatic adenocarcinoma
This study involves the use of an investigational drug called pelareorep (Reolysin®).“Investigational” means that the drug pelareorep has not been approved by the U.S. Fo…
This study involves the use of an investigational drug called pelareorep (Reolysin®).“Investigational” means that the drug pelareorep has not been approved by the U.S. Food &Drug Administration (FDA) for treating pancreatic adenocarcinoma.The primary goal is to see if a treatment using both pelareorepand pembrolizumab has any effect on pancreatic cancer and also to evaluate the safety ofthis combination of these two drugs. Pelareorep is an investigational product that uses a type ofvirus called reovirus. This virus is commonly found in natural environments throughout the world(such as ponds) and is associated with minor breathing difficulties and stomach upsets inhumans. Infection of cancer cells by this virus is expected to be able to slow cancer lesiongrowth and kill cancer cells.  Pembrolizumab is a drug thatworks on stimulating the immune system to fight the cancer cells and it is currently approvedfor the treatment of other tumors (melanoma and lung). It is not presently known if it will help inthe treatment of pancreatic cancer. The combination of pembrolizumab and pelareorep isexpected to be able to determine if pelareorep will or will not stimulate the immune systemand make it more responsive to therapy with pembrolizumab.
Participants with advancedpancreatic adenocarcinoma.
Mahalingam, DevalingamMahalingam, Devalingam
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03723915 STU00207577
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Study Coordinator 312 695 1102
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(xIRB) DRUG 017004: An Open-Label, Phase 1 Safety and Phase 2 Randomized Study of JCAR017 in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (017004)
JCAR017 is an investigational treatment. Investigational means that it is an experimental therapy that …
JCAR017 is an investigational treatment. Investigational means that it is an experimental therapy that has not yet been approved for sale or use to the public by the United States Food and Drug Administration (FDA). This study is designed to test the safety and effectiveness of a new approach to treating Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma. This study has many parts and you will be asked to participate in one portion of the study. The Phase 1 portion of the study will evaluate whether the treatment works in treating your cancer. In the Phase 1 portion, you may be required to be on another cancer treatment called ibrutinib (IMBRUVICA®). Your study doctor will tell you which group you are eligible to be treated on. The Phase 2 is designed to assess JCAR017 as treatment versus standard of care. The approach involves modifying the patient's own immune cells, called T cells, to enable them to kill their cancer cells. T cells fight infections and can also kill cancer cells in some cases. In most cases, a patient's T cells are not able to kill their own cancer cells. In this study, some of the patient's T cells are removed from their blood, modified in a laboratory, and then given back to them by intravenous (IV) injection. While in the laboratory, researchers will put a new gene into the T cells that allows the patient's T cells to then recognize and kill the lymphoma cells. The method of putting the gene into the T cells uses a weakened virus that cannot multiply or spread. T cells that have genes added in the laboratory are called “genetically modified T cells” or “chimeric antigen receptor T cells (CAR T cells)”. When the genetically modified T cells recognize and attach to cancer cells, they have the ability to become activated and kill them. The modified T cells do not appear to recognize other normal cells in the body, with the exception of normal B cells. However, studies have shown that normal B cells will return after being treated with the modified T cells.
  • Participants must have any of the following types of lymphoma: Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
  • You must have received 2 or 3 prior treatments for your CLL or SLL
  • Participants must have cancer that has returned or has not responded to other treatment.
  • Participants must be 18 or older
Ma, ShuoMa, Shuo
  • Map it 251 E. Huron St.
    Chicago, IL
NCT03331198 STU00208648
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Study Coordinator 312 695 1102
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Phase II Randomized Trial of Neo-Adjuvant Chemotherapy Followed by Surgery and Post-Operative Radiation Versus Surgery and Post-Operative Radiation for Organ Preservation of T3 and T4a Nasal and Paranasal Sinus Squamous Cell Carcinoma (NPNSCC)
The purpose of this research study is to compare any good…
The purpose of this research study is to compare any good and bad effects of using chemotherapy along with surgery and radiation therapy.  The addition of chemotherapy to the usual surgery and radiation could shrink your cancer/prevent it from returning.  
You can take part in this research study because you have cancer of the sinonasal area. 
Samant, SandeepSamant, Sandeep
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03493425 STU00208820
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Study Coordinator 312 695 1102
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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
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03147742 STU00208471
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Study Coordinator 312 695 1102
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(xIRB NCI CIRB) Alliance A011401: Randomized Phase III Trial Evaluating The Role Of Weight Loss In Adjuvant Treatment Of Overweight And Obese Women With Early Breast Cancer
This study is being done to see if losing weight may help prevent breast cancer from coming back. Previous studies have found th…
This study is being done to see if losing weight may help prevent breast cancer from coming back. Previous studies have found that women who are overweight or obese when their breast cancer is found have a greater risk of their breast cancer recurring, as compared to women who were thinner when their cancer was diagnosed. At this time we do not know whether or not losing weight will reduce the risk of breast cancer returning. This study seeks to determine whether or not the higher risk for breast cancer recurrence in women who are overweight or obese when they are diagnosed with breast cancer could be reduced or eliminated if weight is lost. It is important to note that we do not know how much weight would need to be lost to lower the risk of breast cancer recurrence, or whether this strategy would work for all women. This study willhelp to show researchers whether weight loss programs should be a part of breast cancer treatment.

This study seeks to determine whether or not the higher risk for breast cancer recurrence in women who are overweight or obese when they are diagnosed with breast cancer could be reduced or eliminated if weight is lost.

Donnelly, EricDonnelly, Eric
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02750826 STU00208895
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Study Coordinator 312 695 1102
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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, EricDonnelly, Eric
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03488693 STU00208897
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Study Coordinator 1 312 695 1102
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ECOG-ACRIN 6174: STAMP: Surgically Treated Adjuvant Merkel cell Carcinoma with Pembrolizumab, a Phase III Trial

We are asking you to take part in a research study. We do research studies to try to answer questions about how to prevent, diagnose, andtreat diseases like cancer.This study is being do…

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

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

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

Chandra, SunandanaChandra, Sunandana
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03712605 STU00208944
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Study Coordinator 312 695 1102
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NU 18I03: Pilot study of nivolumab in combination with Therasphere (yttrium-90) for treatment of hepatocellular carcinoma (HCC) with intent for resection
The purpose of this study is to evaluate the feasibility of using nivolumab in combination with Y90(Therasphere) to decrease the occurrence of your…
The purpose of this study is to evaluate the feasibility of using nivolumab in combination with Y90(Therasphere) to decrease the occurrence of your HCC from coming back. Also another purposeis to evaluate the efficacy (the effect on the tumor) of nivolumab, when given with standard ofcare Y-90 (Therasphere) in patients. Another purpose of the study is to see what tumor characteristics are different among patientswho undergo resection versus those who do not undergo resection. 
Participants who have advancedhepatocellular carcinoma (HCC). 
Kulik, Laura MKulik, Laura M
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03812562 STU00208542
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Study Coordinator 312 695 1102
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Technology-Supported Physical Activity Intervention for Metastatic Breast Cancer Survivors:Fit2ThriveMB

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

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

Females 18 years of age or older

Diagnosis of metastatic breast cancer

Fluent in spoken and written Englsh

Own a smartphone and have access to the internet

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

Phillips, SiobhanPhillips, Siobhan
STU00208930
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Hood, Susan
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A Multicenter, Open-Label Phase 1b Study to Assess Safety and Efficacy of Venetoclax in Combination with Gilteritinib in Subjects with Relapsed/Refractory Acute Myeloid Leukemia

The purpose of this study is to see if the study drugs, venetoclax and gilteritinib, can be safely and effectively combi…

The purpose of this study is to see if the study drugs, venetoclax and gilteritinib, can be safely and effectively combined for the treatment of patients with acute myeloid leukemia (AML) that has returned after prior treatment or has failed to respond to prior treatment, and to identify potential biomarkers.

Venetoclax has been approved by the United States Food and Drug Administration (FDA) and other health authorities to treat specific blood cancers. Gilteritinib has been approved by the FDA for the treatment of FLT3 mutation positive relapsed or refractory AML. However, the combination of venetoclax and gilteritinib has not been approved for treatment of AML; therefore, the use of these study drugs in combination is investigational (experimental) for the purposes of this study.

This is the first study of venetoclax in combination with gilteritinib. Venetoclax in combination with gilteritinib may or may not work better than either drug alone.

As part of this study, samples will be collected for biomarker research. The purpose of this biomarker research is:

  • To find out why some patients with the disease being studied respond better or worse to the study drug or drugs of the same or similar class;
  • To possibly find out how the disease being studied and related conditions develop and progress and how they can be diagnosed, monitored or treated;
  • To possibly develop tests to identify which patients are likely to have specific diseases, respond to the study drug or drugs of the same or similar class, or to predict the progression of the disease being studied;
  • To possibly develop new therapies, research methods or technologies.

You may be eligible for this research study if you have been diagnosed withAcute Myeloid Leukemia (AML) that has returned after prior treatment (relapsed) or has failed torespond to prior treatment (refractory).
Altman, Jessica KAltman, Jessica K
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03625505 STU00208729
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Study Coordinator 312 695 1102
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NU MSK18U09: Metacure: Multi-arm Multi-modality Therapy for Very High Risk Localized and Low Volume Metastatic Prostatic Adenocarcinoma
Prostate cancer feeds on testosterone, the male hormone. The purpose of this study is to test if treatment with medications that reduce the male hormone level in you…
Prostate cancer feeds on testosterone, the male hormone. The purpose of this study is to test if treatment with medications that reduce the male hormone level in your body for a few months before surgery can shrink the cancer as much as possible, which might reduce the chances of the cancer coming back in the future. These treatments include a hormone injection given monthly or every three months and the study drugs, which include abiraterone acetate, prednisone, and apalutamide. The injection and study drugs can also cause side effects. Radiotherapy will be recommended if there are high risk features when the doctors look at the prostate under the microscope after the surgery.

There are three cohorts inthis study that are based on the status of your cancer and the treatments youhave already received. For each cohort,the study drugs will be combined with other standard treatments for that typeof prostate cancer.

Some of the eligibility criteria include:

• Prostate cancer that has a high risk of coming back after surgery or radiotherapy by spreading to other parts of your body

• Age of at least 18 years

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

Morgans, AliciaMorgans, Alicia
NCT03436654 STU00208899
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Study Coordinator 312 695 1102
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An Open Label, Pilot Study Evaluating the Effect of Low-Dose Oral Minoxidil as Treatment of Permanent Chemotherapy-Induced Alopecia

This study will test if low-dose oral minoxidil has aneffect on permanent chemotherapy-induced alopecia (defined as hair loss afterthe completion of a chemotherapy re…

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

Age 18 and above with a diagnosis of permanentchemotherapy-induced alopecia and agree to use contraception for the durationof the study.

Choi, JenniferChoi, Jennifer
  • Map it 676 N. St. Clair St.
    Chicago, IL
NCT03831334 STU00206882
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Walia, Shikha
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Randomized Phase II Trial in Early Relapsing or Refractory Follicular Lymphoma

The purpose of this study is to compare any good and bad effects of using different drugs in combination with an antibody. An antibody is a protein that can recognize and attack foreign objects (antigens) in the body. H…

The purpose of this study is to compare any good and bad effects of using different drugs in combination with an antibody. An antibody is a protein that can recognize and attack foreign objects (antigens) in the body. Here, the antibody is obinutuzumab. It is looking for CD20, an antigen that is found on tumor cells. Two study drugs will be tested in this study: TGR-1202 and lenalidomide. Each of these study drugs may help the immune system fight cancer. During the study, you will get either obinutuzumab plus TGR-1202, obinutuzumab plus lenalidomide, or obinutuzumab plus the usual approach treatment for your cancer.

The addition of TGR-1202 or lenalidomide could shrink your cancer, but it could also cause side effects. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach. The antibody (obinutuzumab) and the regular chemotherapy approach are FDA-approved for use in follicular lymphoma, but they aren’t usually used together. The immune system drug, TGR-1202, is not FDA approved. The immune system drug lenalidomide is FDA approved, but not for follicular lymphoma.

Another purpose of this study is to test PET/CT scans, which are a way to take pictures of your type of cancer. The researchers want to use PET/CT scans to help diagnose and monitor your cancer. PET/CT scans are a part of regular care for your type of cancer. All of the patients taking part in this study will have PET/CT scans sent to a central PET/CT reviewer.

Another purpose of this study is to see whether a set of gene mutations (called m7-FLIPI) can predict whether your lymphoma will respond better or worse to the study treatment. Mutations are permanent changes in your DNA. The researchers will look for the mutations on your tumor tissue and in tumor cells found in your blood. All of the patients taking part in this study will have blood and tissue submitted for these gene mutation tests.

You may be eligible for this research study if you have follicular lymphoma that has either not responded to previous treatment or that has come back after previous treatment.

Winter, Jane NormaWinter, Jane Norma
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03269669 STU00209296
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Study Coordinator 312 695 1102
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NU 18B05: A Phase II Study of the Determinants of Transdermal Drug Delivery to the Normal and the Radiated Breast
The benefits of anti-estrogen medications taken by mouth as pills (such as tamoxifen) are well-proven to reduce the risk of breast cancer in studies with more than 10 years of follow up. …
The benefits of anti-estrogen medications taken by mouth as pills (such as tamoxifen) are well-proven to reduce the risk of breast cancer in studies with more than 10 years of follow up. However, because tamoxifen is taken by mouth, it circulates through the whole body and may cause harmful effects to other organs. When tamoxifen is taken by mouth, it is broken down by the liver into two main active forms, one of which is 4-hydroxytamoxifen, also called 4-OHT. Tamoxifen is approved by the Food and Drug Administration (FDA) while 4-OHT is not and is, therefore, considered investigational. However, 4-OHT has anti-cancer activity, and has been developed as a quick drying medicated gel that can be applied to the breast skin. Early results from two previous studies show that 4-OHT gel, when applied to the skin, gets into the breast and blocks breast cancer cell growth as effectively as oral tamoxifen. Unlike oral tamoxifen, the gel is concentrated in the breasts and therefore very little tamoxifen reaches the blood or other parts of the body. Also, some women lack the proteins that are responsible for the break-down of tamoxifen. It is possible that the use of 4-OHT gel will be more effective than oral tamoxifen in these women.
Patients who had radiation for breast cancer in one breast and their other breast has not undergone radiation
Khan, Seema Ahsan AhsanKhan, Seema Ahsan Ahsan
  • Map it 250 E. Superior St.
    Chicago, IL
NCT04009044 STU00208708
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Pulliam, Natalie +1 312 472 4767
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A Phase II Randomized Study of Adjuvant Versus Neoadjuvant MK-3475 (Pembrolizumab) for Clinically Detectable Stage III-IV High Risk Melanoma

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

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

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

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

Chandra, SunandanaChandra, Sunandana
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03698019 STU00209408
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Study Coordinator 312 695 1102
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DRUG U31402-A-J101: Phase 1/2, Multicenter, Open-label, Multiple Dose First-In-Human Study of U3-1402, in Subjects with HER3 Positive Metastatic Breast Cancer
In this study we are looking to see whether U3-1402 has any effect on slowing tumor growth inbreast cancer that progressed after previous trea…
In this study we are looking to see whether U3-1402 has any effect on slowing tumor growth inbreast cancer that progressed after previous treatments. The purpose of the study is tounderstand U3-1402 for its safety, how well it works, and how well it is tolerated.U3-1402 is an investigational drug being developed to be given in breast cancer. Aninvestigational drug is a medication that has not been approved by the United States (US) Foodand Drug Administration (FDA). The FDA allows U3-1402 to be used only in research.U3-1402 is a monoclonal antibody that has chemotherapy attached to it. A monoclonal antibody isa molecule that is made to target a specific cancer cells and may affect normal cells.Chemotherapy is a type of cancer treatment that kills cells that grow and divide quickly. This caninclude cancer cells or normal cells. U3-1402 is designed to bring chemotherapy inside HER3-positive cancer cells and kill them. HER3 is one of a number of proteins that are thought to beelevated in breast cancer. A protein is a large molecule that is important for many of the processesthat happen in and around cells in the body. 
You may be eligible for this research study if you have breast cancer and your cancer has grown after prior treatments. Along with that your tumor tissue tested should have showed your cancer to be HER3 positive.
Gradishar, William JGradishar, William J
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02980341 STU00208625
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(xIRB) SWOG 1701: A Randomized Phase II Trial of Carboplatin-Paclitaxel with or Without Ramucirumab in Patients with Unresectable Locally Advanced, Recurrent, or Metastatic Thymic Carcinoma
The purpose of this study is to compare any good and bad effects of using ramucirumabalong with the usual chemo…
The purpose of this study is to compare any good and bad effects of using ramucirumabalong with the usual chemotherapy combination (carboplatin and paclitaxel) to the usualchemotherapy combination alone. Ramucirumab is FDA-approved for non-small cell lungcancer but not for thymic cancer; however, ramucirumab in combination with carboplatin and paclitaxel is considered investigational and is not approved for this indication.Ramucirumab is a monoclonal antibody, a type of protein made in the laboratory that canbind to substances in the body, including cancer cells. Ramucirumab targets the vascularendothelial growth factor receptor 2 (VEGFR 2). VEGFR2 is an important molecule thatsupports the growth of blood vessels by a process called angiogenesis. Growth of theseblood vessels can feed tumors and cause them to grow. Ramucirumab blocks VEGFR2 andmay prevent angiogenesis in advance thymic tumor patients. This study will allow theresearchers to know whether this different approach is better, the same, or worse than theusual approach. To be better, the study approach should extend the amount of time youare cancer-free compared to the usual approach.This chemotherapy combination, carboplatin and paclitaxel, has already beenFDA-approved.
You may be eligible if you have thymic cancer which is not ableto be treated with surgery. People who are not in a study are usually treated with radiationtherapy, hormone therapy or chemotherapy with FDA approved drugs such as doxorubicin,epirubicin, cisplatin, carboplatin, cyclophosphamide, ifosfamide, vincristine, etoposide,paclitaxel, and pemetrexed. 
Mohindra, NishaMohindra, Nisha
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03694002 STU00209617
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(xIRB) NRG-BN005 A Phase II Randomized Trial of Proton vs. Photon Therapy (IMRT) for Cognitive Preservation in Patients with IDH Mutant, Low to Intermediate Grade Gliomas.

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

therapy. Photon…

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

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

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

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

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

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

-Participants must be 18 years of age or older

-Participants must be diagnosed with a brain tumor

Kruser, TimothyKruser, Timothy
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03180502 STU00209631
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312 695 1102
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A Master Protocol To Evaluate Biomarker-Driven Therapies And Immunotherapies In Previously-Treated Non-Small Cell Lung Cancer (Lung-MAP Screening Study)

The purpose of this study is to test your tumor tissue for certain biomarker (which may be the cause of your cancers, such as specific mut…

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

  • Participants must be18 years or older
  • Participants must bediagnosed with non-small cell lung cancer
Chae, Young KwangChae, Young Kwang
  • Map it 251 E. Huron St.
    Chicago, IL
NCT03851445 STU00209659
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DRUG FOR46-001 - A Phase 1 Study of FOR46 Administered Every 21 Days in Patients with Metastatic Castration-Resistant Prostate Cancer (MCRPC)

The purpose of this study is to learn more about an experimental drug called FOR46 for Injection (also called “FOR46” or “study drug” in this consen…

The purpose of this study is to learn more about an experimental drug called FOR46 for Injection (also called “FOR46” or “study drug” in this consent form). FOR46 is an investigational medication, which means that it has not been approved by the FDA to be sold to the public.

FOR46 is being developed to see if it can treat metastatic prostate cancer. FOR46 is made up of an antibody (a type of protein) and an anticancer drug and is given intravenously (IV) (by vein). FOR46 is designed to travel through the bloodstream throughout the body and find cancer cells, and ultimately kill them or delay cancer growth.

During this study, the safety and anticancer activity of FOR46 will be evaluated, including looking for the highest dose level of FOR46 that can be taken safely. It is not known if there is a benefit to using FOR46 to treat metastatic prostate cancer in humans. In animal studies, FOR46 was found to be tolerated and able to kill prostate cancer cells and/or delay the growth of these cells. However, FOR46 has not yet been given to humans.

Males at least 18 years old who have metastatic prostate cancer.

VanderWeele, DavidVanderWeele, David
  • Map it 201 East Huron Street Suite 12-160​
    Chicago, IL
NCT03575819 STU00209324
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(xIRB NCI CIRB) ETCTN 10183: A Pilot Study of Tazemetostat and MK-3475 (Pembrolizumab) in Advanced Urothelial Carcinoma

The purpose of this study is to see how peoplewith advanced urothelial carcinoma respond to an approved treatment for thistype of cancer (MK-3475) in combination with the study d…

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

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

Diagnosis ofadvanced urothelial carcinoma

· Age of at least 18 years

Hussain, MahaHussain, Maha
NCT03854474 STU00209918
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A Randomized Phase III Study of the Addition of Venetoclax to Ibrutinib and Obinutuzumab Versus Ibrutinib and Obinutuzumab in Untreated Younger Patients with Chronic Lymphocytic Leukemia (CLL)

The purpose of this study is to compare the usual treatment of ibrutinib and obinutuzumab to a com…

The purpose of this study is to compare the usual treatment of ibrutinib and obinutuzumab to a combination treatment of ibrutinib and obinutuzumab plus the study drug, venetoclax. The addition of venetoclax to the usual treatment may or may not help shrink your cancer. But, it could also cause side effects, which are described in the risks section below. This study will also compare the usual treatment of indefinite ibrutinib therapy to a time limited therapy schedule of approximately 18 months to better understand their effects on your quality of life and the costs of your care.

This study will help the study doctors find out if these different approaches are equally effective to the usual approaches while requiring a shorter duration of treatment. To decide if they are better, the study doctors will be looking to see if the study drugs do no worse in terms of time to progression and overall survival compared to the usual approach, even though they require a shorter duration of treatment. Ibrutinib, obinutuzumab, and venetoclax are all FDA approved drugs to treat CLL, but they will be considered investigational in the setting of this trial. There will be about 720 people taking part in this study.

  • Participants must be 18 years or olderand < 70
  • Participants must bediagnosed with Chronic Lymphocytic Leukemia (CLL), a type of bloodcancer.
Ma, ShuoMa, Shuo
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    Chicago, IL
NCT03701282 STU00209948
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NU MTBC 18M02: Melanoma Tissue Bank Consortium Protocol

The purpose of this research study is to create a MTBC biorepository (the “MTBC Biobank”) of human biospecimens (the “Biospecimens”) and medical and health history information, for example, test and treatment results, age, gender, hi…

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

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

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

Wayne, Jeffrey DWayne, Jeffrey D
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    Chicago, IL
STU00209847
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NU 18U10: A Phase II Study of sEphB4-HSA in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

The purpose of this study is to test whether the study drug sEphB4-HSA (a form of protein), will treat your prostate cancer that has come back or is not responding to previous treatments. The study …

The purpose of this study is to test whether the study drug sEphB4-HSA (a form of protein), will treat your prostate cancer that has come back or is not responding to previous treatments. The study drug is considered an experimental drug because it has not been approved for sale by the United States Food and Drug Administration (FDA).

The study drug prevents tumor cells from multiplying and blocks several compounds that promote the growth of blood vessels that bring nutrients to the tumor.

Some of the eligibility criteria include:

• Diagnosis of metastatic castration-resistant prostate cancer

• Age of at least 18 years

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

Hussain, MahaHussain, Maha
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    Chicago, IL
NCT04033432 STU00209511
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Study Coordinator 312 695 1102
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(xIRB) DRUG 017006: A Phase 2 Study of Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy in Adult Patients with Aggressive B-cell NHL (017006)
This study is designed to evaluate the safetyand effectiveness of a new approach to treat adults diagnosed with NHL, whohave had their cancer come bac…
This study is designed to evaluate the safetyand effectiveness of a new approach to treat adults diagnosed with NHL, whohave had their cancer come back or didn’t respond to one previous line oftherapy and are not eligible to receive a stem cell transplant. This studytreatment is called JCAR017. JCAR017 (study treatment) is an investigationaltreatment. Investigational means that it is an experimental therapy that hasnot yet been approved for sale or use to the public by the United States Foodand Drug Administration (FDA).
  • Participantsmust have a confirmed diagnosis of aggressive B-cell Non-Hodgkin Lymphoma (NHL)and have received a single previous line of therapy.

Note: This is only a partial list of eligibility criteria. Pleasecontact the Robert H. Lurie Comprehensive Cancer Center of NorthwesternUniversity for complete screening information if you are interested in thisclinical trial.
Gordon, Leo I IGordon, Leo I I
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    Chicago, IL
NCT03483103 STU00210077
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A Randomized Phase III Study of Ibrutinib Plus Obinutuzumab Versus Ibrutinib Plus Venetoclax and Obinutuzumab in Untreated Older Patients (= 70 Years of Age) with Chronic Lymphocytic Leukemia (CLL)

This study is being done to answer the following questions:

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

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

    • Participants must be 70 years orolder
    • Participants must be diagnosed with Chronic LymphocyticLeukemia (CLL), a type of blood cancer.
    Ma, ShuoMa, Shuo
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT03737981 STU00210099
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    Study Coordinator 312 695 1102
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    DRUG KRT-232-103: A Phase 1b/2, Open-Label Study Evaluating the Safety and Efficacy of KRT-232 in Patients with p53 Wild-Type (p53WT) Merkel Cell Carcinoma (MCC) Who Have Failed Anti-PD-1 or Anti-PD-L1 Immunotherapy, or in Combination with Avelumab in MCC Patients who are Anti-PD-1 or Anti-PD-L1 Treatment Naïve

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

    In order to participate in this study, your Merkel cell carcinoma cells must be a certain type of cell, called “p53 wild type” cells (p53wt).
    Chandra, SunandanaChandra, Sunandana
    NCT03787602 STU00209401
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    Study Coordinator 312 695 1102
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    DRUG CD07_TNBC: A Phase Ib/II Study of Leronlimab (PRO 140) Combined with Carboplatin in Patients with CCR5+ Metastatic Triple-Negative Breast Cancer (mTNBC)
    The purpose of this study to find out if the study drug, leronlimab (PRO 140), when given incombination with another chemotherapy drug, carbopl…
    The purpose of this study to find out if the study drug, leronlimab (PRO 140), when given incombination with another chemotherapy drug, carboplatin, is safe and effective for the treatmentof patients with metastatic Triple Negative Breast Cancer (mTNBC).

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

    Cristofanilli, MassimoCristofanilli, Massimo
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03838367 STU00209594
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    Study Coordinator 312 695 1102
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    Alliance A041703: A Phase II Study of Inotuzumab Ozogamicin Followed by Blinatumomab for Ph-negative CD22-positive B-lineage Acute Lymphoblastic Leukemia in Newly Diagnosed Older Adults or Adults with Relapsed or Refractory Disease

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

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

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

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

    Diagnosed with Acute Lymphoblastic Leukemia (ALL) that is untreated or has come back. Participants with untreated ALL must be 60 years of age or older. Participants with ALL that has relapsed or come back must be at least 18 years of age or older. 
    Dinner, ShiraDinner, Shira
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03739814 STU00210163
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    Study Coordinator 312 695 1102
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    A041702: A Randomized Phase III Study of Ibrutinib Plus Obinutuzumab Versus Ibrutinib Plus Venetoclax and Obinutuzumab in Untreated Older Patients (= 70 Years of Age) with Chronic Lymphocytic Leukemia (CLL)
    This study is being done to answer the following questions:1. Is adding a new anti-cancer drug…
    This study is being done to answer the following questions:1. Is adding a new anti-cancer drug (venetoclax) to the usual treatment (ibrutinib plusobinutuzumab) better, the same as, or worse than the usual treatment alone for untreatedolder patients with CLL?2. Can patients who have no detectable CLL after a year of receiving the usual treatmentplus the new anti-cancer drug discontinue therapy? 
    Some of the eligibility criteria include: - Participants must have intermediate or high-risk chronic lymphocyticleukemia that has not been treated before - Participants must be 18 or older - Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
    Ma, ShuoMa, Shuo
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03737981 STU00210225
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    Study Coordinator 312 695 1102
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    Yttrium-90 Radiation Lobectomy: Dose Optimization and Prediction of FLR Hypertrophy to Enable Resection of HCC

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

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

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

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

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

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

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

    You are eligible to participate in this study if:

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

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

    Lewandowski, Robert JLewandowski, Robert J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04390724 STU00209629
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    Kennedy, Kristie +1 312 695 4023
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    NU G18M02: Phase II single-arm multi-center study of adjuvant ipilimumab in combination with nivolumab in subjects with high-risk ocular melanoma

    This is a phase II single-arm multi-center study of adjuvant ipilimumab in combination with nivolumab in subjects with high-risk ocular melanoma.The pur…

    This is a phase II single-arm multi-center study of adjuvant ipilimumab in combination with nivolumab in subjects with high-risk ocular melanoma.The purpose of this study is to compare relapse-free survival (RFS) rate at 3 years of patients with locally treated high-risk ocular melanoma treated with adjuvant nivolumab/ipilimumab combination versus a matched control population. We are asking you to take part in this research study because you have high-risk ocular melanoma.This type of cancer is typically treated with surgery to remove the eye (enucleation) or radiation to the eye (radioactive plaque therapy).

    You may be eligible if you have high risk of ocular melanoma. 
    Chandra, SunandanaChandra, Sunandana
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03528408 STU00209653
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    Study Coordinator 312 695 1102
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    A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line Durvalumab in Combination with Standard of Care Chemotherapy and Durvalumab in Combination with Tremelimumab and Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone in Patients with Unresectable Locally Advanced or Metastatic Urothelial Cancer
    The reason for the study is to find a more effective treatment for advanced urothelialbladder cancer. AstraZeneca is doing this research to find out if the medication calledDurvalumab and Tremelimumab when combined with standard of care (SoC)chemotherapy treatment will work and be safe for the treatment of advanced urothelialbladder cancer. Durvalumab as monotherapy has been approved by the FDA as therapyfor the treatment of locally advanced or metastatic urothelial carcinoma, for patient whose cancers progressed during or after platinum-based chemotherapy. Durvalumab asmonotherapy has also been approved by the FDA and the European Medicines Agency(EMA) for the treatment of patients with locally advanced non-small cell lung cancer afterchemoradiation therapy. Durvalumab, when given in combination with chemotherapy andTremelimumab, is still in the development stage for the treatment of advanced urothelialbladder cancer, and this combination is not approved for treatment of urothelial bladdercancer, except for use in research studies like this. You will also receive chemotherapyon this study, regardless of which treatment arm you are in. This chemotherapy consistsof gemcitabine and cisplatin or carboplatin, which are standard of care treatments givenin to patients with advanced bladder cancer. 
    Some of the eligibility criteria include: - Participants must have advanced urothelial bladder cancer - Participants must be 18 or older - Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
    VanderWeele, DavidVanderWeele, David
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03682068 STU00209828
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    Study Coordinator 312 695 1102
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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
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03815058 STU00209868
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    Study Coordinator 312 695 1102
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    (xIRB) ETCTN 10009: A Phase 1b Study of the Anti-PD1 Antibody Pembrolizumab in Combination with the Histone Deacetylase Inhibitor, Entinostat for Treatment of Patients with Myelodysplastic Syndromes After DNA Methyltransferase Inhibitor Therapy Failure

    Participants who have myelodysplasticsyndrome…

    Participants who have myelodysplasticsyndrome (MDS) or acute myeloid leukemia (AML) that arose from prior MDS andhave already been treated with azacitidine (Vidaza) or decitabine (Dacogen)will be enrolled into this study.

    This study uses a combinationof two drugs: Pembrolizumab which has already been FDA-approved for othercancers but not for MDS or AML and is given by vein. The other drug entinostatis a pill given by mouth and has been tested in some cancers, including MDS andAML, but is not approved for any cancer.

    The purpose of this study isto test whether giving entinostat by mouth along with the other drugpembrolizumab by vein is a safe combination and whether it could help your MDSor AML.

    All the study participants will get the same studydrugs, entinostat in combination pembrolizumab, in either the part 1 or part 2study groups.

    Part1 Dose Escalation Group: Different doses of the study drug entinostat will begiven with a fixed dose of pembrolizumab. The first 3 to 6 study participants received entinostat on day 1 and day8 of each cycle. The next 3 to 6 studyparticipants will receive entinostat only on day 1 of each cycle. If this dosedoes not cause serious side effects, this dose will be used in the next part ofthe study (Dose expansion group-see below).

    Part2 Dose Expansion Group: Once we determine the dose schedule of entinostat incombination with pembrolizumab that is considered safe to be given on thisstudy, we will then recruit 15 more patients at that dose schedule.

    Pathologically confirmed MDS diagnosis or AML

    Ages 18 years or older

    Frankfurt, OlgaFrankfurt, Olga
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02936752 STU00210588
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    Study Coordinator 312 695 1102
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    A randomized, controlled, multi-center, safety and efficacy study of FCR001 cell-based therapy relative to a tacrolimus and mycophenolate-based regimen in de novo living donor renal transplant recipients, and safety in FCR001 donors
    Research study which involves the use of a combination of an Enriche…
    Research study which involves the use of a combination of an Enriched Hematopoetic Stem Cell Infusion (stem cells, produced by the bone marrow, generate the cells that form the blood elements, help fight infection and assist in clotting) and kidney transplantation from the same donor to try to avoid the need for long-term anti-rejection drug therapy. The desired result of this study is to allow your body to develop "tolerance" to the transplanted kidney. Tolerance means that your body would see the transplanted kidney as part of you and not try to get rid of, or reject it. To prevent rejection, drugs called immunosuppressive agents must be taken on a daily basis. The purpose of this study is to determine if this procedure is safe and to try to substantially reduce or even eliminate the need for anti-rejection medications.
    Leventhal, Joseph RLeventhal, Joseph R
    NCT03995901 STU00209928
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    Stare, Dianne 312 694 0240
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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, ShiraDinner, Shira
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03504644 STU00210605
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    Study Coordinator 312 695 1102
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    A Phase 2 Study of pembrolizumab in patients with histiocyte/dendritic cell neoplasms and biologically selected subtypes of relapsed/refractory aggressive lymphomas. (Protocol #17-448)

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

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

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

    Choi, JaehyukChoi, Jaehyuk
    • Map it 676 N. St. Clair St.
      Chicago, IL
    NCT03316573 STU00209675
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    Bagnowski, Katherine +1 312 503 3788
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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
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03601897 STU00210178
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    Study Coordinator 312 695 1102
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    NU UP19B05: Pragmatic Phase III Randomized Trial Of Proton vs. Photon Therapy For Patients With Non-Metastatic Breast Cancer Receiving Comprehensive Nodal Radiation: A Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial
    This study is being conducted to compare two types of standard care…
    This study is being conducted to compare two types of standard care radiation therapy: PHOTON THERAPY (pronouced “fotahn”) and PROTON THERAPY (pronouced “pro-tahn”).
    Patients may be eligible for this study if they have been diagnosed with non-metastatic breast cancer (meaning the cancer has not spread to other organs) and will be having radiation therapy
    Strauss, Jonathan BStrauss, Jonathan B
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00210737
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    1-855-NU-STUDY
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    (XIRB) DRUG IMSA101-101: Phase I/IIA Safety and Efficacy Study of IMSA101 in Patients with Advanced Treatment-Refractory Malignancies

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

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

    All adult subjects ages 18 and above with advanced cancer that is no longer responding to standard of care treatment are eligible to participate.
    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04020185 STU00210768
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    Study Coordinator 312 695 1102
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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.
    Matei, DanielaMatei, Daniela
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03016819 STU00210420
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    Study Coordinator 312 695 1102
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    Effect Of Centering Pre-operative Counseling On Patient Reported Anxiety
    Comprehensive pre-operative counseling and education has been shown to play an important role in quality of life, anxiety and depression among cancer patients. Traditionally, patients are counseled in the office at the time of i…
    Comprehensive pre-operative counseling and education has been shown to play an important role in quality of life, anxiety and depression among cancer patients. Traditionally, patients are counseled in the office at the time of informed surgical consent. However, there are several problems to this model including patient anxiety, confusion, information overload, and time constraints that may lead to sub-optimal counseling. Additionally, multiple studies have reported that patients forget half of what they have been told within 5 minutes of a health consultation and remember only 20% of the information passed on to them. Centering patient counseling has been used in other fields of medicine and has been shown to improve outcome in Obstetrics, Psychiatry, Gastroenterology, and Medical Oncology. The rationale behind centering care is that providers can spend more time counseling and educating a larger audience at once, and it allows the whole group to benefit from individual questions, concerns, and complaints. Additionally, it establishes a network for patients to connect with other women going through similar stressful events.

    The primary objective of the study is to evaluate the effect of pre-operative counseling in a group setting on patient reported anxiety for patients scheduled to undergo surgery for a known or suspected gynecologic malignancy. Patient reported anxiety will be evaluated using a validated Patient-Reported Outcomes Measurement Information System (PROMIS) survey. We hypothesize that the group counseling session will reduce patient reported anxiety by a clinical meaningful level. Secondary objectives will evaluate the effect of the intervention on patient reported depression levels and compare adherence to Enhanced Recovery After Surgery (ERAS) instructions, utilization of unscheduled health care resources, and anxiety/depression levels to historical controls.

    Any patient who is scheduled to undergo major surgery for a gynecologic cancer.
    Barber, EmmaBarber, Emma
    • Map it 250 E. Superior St. Fourth Floor
      Chicago, IL
    NCT04068675 STU00209941
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    Gwynn, Katherine +1 312 472 5726
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    (XIRB) DRUG CPI-006-001: A Phase 1/1b Multicenter Study To Evaluate The Humanized Anti-CD73 Antibody, CPI-006, As A Single Agent or In Combination With Ciforadenant, with Pembrolizumab, And With Ciforadenant Plus Pembrolizumab In Adult Subjects With Advanced Cancers
    The purpose of this research is to…
    The purpose of this research is to evaluate the safety of the study drug called CPI-006 when administered alone, or in combination with another drug called Ciforadenant, or in combination with another drug called Pembrolizumab, or when given with Ciforadenant plus Pembrolizumab.
    All adults subjects 18 years of age or over with advanced or metastatic cancer that has grown, spread, and/or has not responded to previous treatments are eligible to participate.
    Sosman, JeffreySosman, Jeffrey
    • Map it 201 East Huron Street Suite 12-160​
      Chicago, IL
    NCT03454451 STU00210900
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    Study Coordinator 312 695 1102
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    A Phase III, Randomized Study of Nivolumab (Opdivo) Plus AVD or Brentuximab Vedotin (Adcetris) Plus AVD in Patients (Age >/= 12 Years) with Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma

    The purpose of this study is to compare nivolumab plus the three chemotherapy drugs: doxorubic…

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

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

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

    • Participantsmust be 18 years or older
    • Participants must have a confirmed diagnosis newlydiagnosed and previously untreated stage III or IV classical Hodgkin lymphoma
    Winter, Jane NormaWinter, Jane Norma
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT03907488 STU00210926
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    Study Coordinator 312 695 1102
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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, AmiShah, Ami
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04001829 STU00210984
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    Study Coordinator 312 695 1102
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    (xIRB Sterling) DRUG 68284528MMY2003: A Phase 2, Multicohort Open-Label Study of JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA in Subjects with Multiple Myeloma (CARTITUDE-2)
    The purpose of this study is to see if JNJ-68284528 is safe and useful for treating p…
    The purpose of this study is to see if JNJ-68284528 is safe and useful for treating patients with relapsed or refractory multiple myeloma. In this type of treatment, your white blood cells (which are a part of the immune system) will be genetically modified to become JNJ-68284528 and used to treat your multiple myeloma.

    Some of the eligibility criteria include:

    • Participants must have a diagnosis of multiple myeloma
    • Participants must be 18 or older.
    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.
    Singhal, SeemaSinghal, Seema
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04133636 STU00210994
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    Study Coordinator 312 695 1102
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    (xIRB) NCI CIRB ETCTN 10107: Phase 1 Safety Run-In and Phase 2 Randomized Clinical Trial of Anetumab Ravtansine and MK-3475 (Pembrolizumab) Compared to MK-3475 (Pembrolizumab) Alone for Mesothelin-Positive Malignant Pleural Mesothelioma

    Phase 2:

    Participants withmalignant pleural mes…

    Phase 2:

    Participants withmalignant pleural mesothelioma which has grown or has returned after initialtreatment with chemotherapies, and tumor tissue that shows the expression of theprotein mesothelin to a certain degree will be enrolled into Phase 2 of thestudy.

    The purpose of Phase 2is to compare the effects, good and/or bad, of anetumab ravtansine when givenin combination with pembrolizumab to the use of pembrolizumab alone in patientshaving moderate or high levels of a protein called mesothelin in the tumorsample.

    This study will allow researchers to know whether this different approach is better, the same orworse than treatment with MK-3475 (pembrolizumab) alone. Another purpose ofthis study is for researchers to learn whether biomarker tests can help predictwhich patients may respond well to the study drugs. Anetumab ravtansine has notbeen approved by the FDA and is considered experimental.

    Group 1 will receiveMK-3475 (pembrolizumab), and Group 2 will receive anetumab ravtansine andMK-3475 (pembrolizumab).

    All participants willreceive the study drug(s) for up to a maximum of two years. After they finishtreatment with (MK-3475) pembrolizumab and anetumab ravtansine or pembrolizumabonly, their doctor will follow their condition every three months by telephonefor up to one year.

    participants 18 years or older who have malignant pleural mesothelioma which has grown or hasreturned after initial treatment with chemotherapies, and tumor tissue thatshows the expression of the protein mesothelin to a certain degree
    Mohindra, NishaMohindra, Nisha
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03126630 STU00211023
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    Study Coordinator 312 695 1102
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    (xIRB) DRUG 18-0402: A Phase 1A/B Dose-Finding Study Followed by Expansion Cohorts of NGM120, A GFRAL Antagonist Monoclonal Antibody Blocking GDF15 Signaling, In Subjects With Advanced Solid Tumors And Pancreatic Cancer Using Combination Therapy
    find out what effects, both good and/or bad, ofthe stud…
    find out what effects, both good and/or bad, ofthe study drug “NGM120”, as well as the combination of NGM120 and standardtherapy (gemcitabine and Abraxane) may have on you and your type of cancer andyour cancer associated loss of appetite, weight loss and loss of muscle.

    • Participants must be 18 years or older

    •Participants must have a confirmed diagnosis of advanced solid cancers

    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04068896 STU00211037
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    Study Coordinator 312 695 1102
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    (XIRB) DRUG 1801: Actuate 1801: Phase 1/2 Study of 9-ING-41, a Glycogen Synthase Kinase-3 Beta (GSK-3ß) Inhibitor, as a Single Agent and Combined with Chemotherapy, in Patients with Refractory Hematologic Malignancies or Solid Tumors
    The purpose of this research study is to test the safety of 9-ING-…
    The purpose of this research study is to test the safety of 9-ING-41 on its own and see what effects (good and bad) it has on you and your cancer, either by itself or together with standard anti-cancer drugs.
    All subjects 18 and above, who have treatment resistant advanced cancer are eligible to participate.
    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT03678883 STU00211039
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    Study Coordinator 312 695 1102
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    (xIRB) NCI CIRB NRG GY019: A Randomized Phase III, Two-Arm Trial of Paclitaxel/Carboplatin/Maintenance Letrozole Versus Letrozole Monotherapy in Patients with Stage II-IV, Primary Low-Grade Serous Carcinoma of the Ovary or Peritoneum

    The purpose of this study is to compare the treatment of carbopl…

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

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

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

    Participants will get either the combination of paclitaxel and carboplatin for four and a half months followedby letrozole or letrozole alone, as long as they are tolerating the letrozoledrug (i.e., have not developed any allergies or severe side effects with themedication) and have not experienced a recurrence or progression of their disease.

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

    • Diagnosis of low-grade serous carcinoma of the ovary or peritoneum.
    • At least 18 years old.
    Barber, EmmaBarber, Emma
    • Map it 250 E. Superior St.
      Chicago, IL
    NCT04095364 STU00211055
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    Study Coordinator 312 695 1102
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    (xIRB) Phase III Randomized Trial of Standard Systemic Therapy (SST) versus Standard Systemic Therapy plus Definitive Treatment (Surgery or Radiation) of the Primary Tumor in Metastatic Prostate Cancer

    This study is being done to answer the following question:

    Can we lower the chanc…

    This study is being done to answer the following question:

    Can we lower the chance of your prostate cancer growing or spreading by adding either prostate removal surgery or radiation therapy to the usual combination of drugs?

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

    The purpose of this study is to compare the effects, good and/or bad, of adding either prostate removal surgery or radiation therapy to standard systemic therapy (SST), which is used to treat prostate cancer. Standard systemic therapy includes Androgen Deprivation Therapy (ADT) with or without the use of chemotherapy. ADT is an antihormone therapy whose main use is in treating prostate cancer. The combination of SST and surgery or radiation therapy is considered experimental.

    Participants must be 18 years or older

    Participants must have a confirmed diagnosis of metastatic prostate cancer

    VanderWeele, DavidVanderWeele, David
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT03678025 STU00211063
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    Study Coordinator 312 695 1102
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    (xIRB) NCI CIRB NRG HN005: A Randomized Phase II/III Trial of De-Intensified Radiation Therapy for Patients with Early-Stage, P16-Positive, Non-Smoking Associated Oropharyngeal Cancer

    The purpose of PhaseII this study is to compare the usual treatment of a standard-dose radiationgiven over 6 weeks…

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

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

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

    We are asking you to take part in this research study because you have low-risk, Human Papillomavirus (HPV) positive oropharyngeal cancer. 
    Gentile, MichelleGentile, Michelle
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03952585 STU00211079
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    Study Coordinator 312 695 1102
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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
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04113616 STU00211193
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    Study Coordinator 312 695 1102
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    (xIRB) NCI CIRB NRG LU005: Limited Stage Small Cell Lung Cancer (LS-SCLC): A Phase II/III Randomized Study of Chemoradiation Versus Chemoradiation Plus Atezolizumab

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

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

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

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

    • Group 1

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

    • Group 2

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

    Participants ages 18 years or older who have been diagnosed with limited state small cell lung cancer. 
    Mohindra, NishaMohindra, Nisha
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03811002 STU00211222
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    Study Coordinator 312 695 1102
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    (xIRB) NCI CIRB: Alliance A071701: Genomically-Guided Treatment Trial in Brain Metastases

    The purpose of this study is to test good and bad effects of different drugs against metastatic brain tumors with altered genes. This trial is trying to see if tumor genetic testing would be helpful a…

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

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

    • Participantsmust be 18 years or older

    • Participants must have a confirmed diagnosis of cancermetastasized to the brain
    Kumthekar, PriyaKumthekar, Priya
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT03994796 STU00211229
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    Study Coordinator 312 695 1102
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    (xIRB) NCI CIRB: ETCTN 10089: A Randomized Phase 2 Study of CDX-1127 (Varlilumab) in Combination with Nivolumab in Patients with Relapsed or Refractory Aggressive B-cell Lymphomas

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

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

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

    • Participantsmust be 18 years or older
    • Participants must have a confirmed diagnosis of B-celllymphomas that have come back after standard treatment or did not respond tothe standard treatment
    Karmali, ReemKarmali, Reem
    • Map it 251 E. Huron St. Seventh Floor
      Chicago, IL
    NCT03038672 STU00211260
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    Study Coordinator 312 695 1102
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    (xIRB) NCI CIRB Alliance A071801: Phase III Trial of Post-Surgical Single Fraction Stereotactic Radiosurgery (SRS) Compared with Fractionated SRS (FSRS) for Resected Metastatic Brain Disease

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

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

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

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

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

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

    Participants 18 years or older who have resected metastatic brain disease. 
    Sachdev, SeanSachdev, Sean
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04114981 STU00211282
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    Study Coordinator 312 695 1102
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    A Phase III, Randomized, Open-Label, Multi-Center, Global Study to Determine the Efficacy and Safety of Durvalumab in Combination with Gemcitabine+Cisplatin for Neoadjuvant Treatment Followed by Durvalumab Alone for Adjuvant Treatment in Patients with Muscle-Invasive Bladder Cancer (NIAGARA)

    There…

    Thereason for the study is to find more effective treatment for muscle invasivebladder cancer (bladder cancer that invaded the muscles of thebladder). AstraZeneca is doing thisresearch to find out if the medication called durvalumab combined with thestandard of treatment will work and be safe for the treatment of MuscleInvasive Bladder Cancer. Durvalumab has been approved by the FDA as therapy forthe treatment of locally advanced (cancer that has grown outside the bladder)or metastatic urothelial carcinoma (cancer that has spread outside of thelining of the urinary system), for patients whose cancers progressed during orafter platinum-based chemotherapy. Durvalumab has also been approved by the FDA and the EuropeanMedicines Agency (EMA) for the treatment of patients with locally advancednon-small cell lung cancer (cancer that has grown outside the lung cancer afterchemoradiation therapy).

    Participants must be 18 years of age or older

    Participants must be diagnosed with muscle invasive bladder cancer.

    VanderWeele, DavidVanderWeele, David
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03732677 STU00210539
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    Study Coordinator 312 695 1102
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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
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03284385 STU00211328
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    Study Coordinator 312 695 1102
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    DRUG PRELUDEDX : A Prospective Registry Study to Evaluate the Effect of the DCISionRT Test on Treatment Decisions in Patients with DCIS Following Breast Conserving Therapy
    This is a registry study that is keeping track of people who are undergoing therapy for ductal carcinomain situ (DCIS) and who ar…
    This is a registry study that is keeping track of people who are undergoing therapy for ductal carcinomain situ (DCIS) and who are having genomic testing. This type of genomic testing looks athow certain genes are used by your tumor cells.
    The use of the DCISionRT DCIS test results in recommending treatment for your DCIS
    Strauss, Jonathan BStrauss, Jonathan B
    • Map it 250 E. Superior St.
      Chicago, IL
    NCT03448926 STU00210952
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    1-855-NU-STUDY
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    DRUG M14-239: Phase 2, Open-Label Safety and Efficacy Study of Telisotuzumab Vedotin (ABBV-399) in Subjects with Previously Treated c-Met+ Non-Small Cell Lung Cancer
    - The purpose of this study is:

    * To evaluate if telisotuzumab vedotin (the study drug ABBV-399) taken after yourprior treatment has…

    - The purpose of this study is:

    * To evaluate if telisotuzumab vedotin (the study drug ABBV-399) taken after yourprior treatment has not controlled your disease,another line of therapy, will prolongthe time your Non-Small Cell Lung Cancer (NSCLC) is not getting worse.

    *To evaluate the safety and tolerability of telisotuzumab vedotin.

    *To understand why some subjects respond or experience side effects while othersdo not, despite receiving the same treatment.

    Telisotuzumab vedotin (ABBV-399) is a type of drug called an antibody drug conjugate or ADC.ADCs usually have 2 parts: a part that targets tumor cells (the antibody) and a cell-killing part (thetoxin).

    - This study also perform a Biomarker Research.

    - Some ofthese samples (blood/tumor material) may be optional. Biomarker research can help us better understand:

    * How to diagnose, monitor, and treat NSCLC.

    * Why and how some patients with NSCLC respond to the telisotuzumab vedotin or drugsof the same or similar class.

    * How telisotuzumab vedotin may affect and/or interact with your body.All of this research is an effort to develop new therapies, research methods, and/or technologies.

    - You must be 18 years and above to take part in this trial

    - You must have locally advanced or metastatic Non-small cell lung cancer.

    Mohindra, NishaMohindra, Nisha
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03539536 STU00210175
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    Study Coordinator 312 695 1102
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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, SheetalKircher, Sheetal
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04094688 STU00211478
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    Study Coordinator 312 695 1102
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    (xIRB) NCI CIRB ECOG-ACRIN 2182: A Randomized Phase II Study of De-Intensified ChemoRadiation for EarlyStage Anal Squamous Cell Carcinoma (DECREASE)

    This study will helpthe study doctors find out if this different approach is the same as the usualapproach. To decide if it is aseffective, the stud…

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

    This study has 2 studygroups.

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

    · Group 2 (Arm B)

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

    Participants who are 18 years of age or older with anal cancer will beinvited to participant in this study.
    Kircher, SheetalKircher, Sheetal
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04166318 STU00211554
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    Study Coordinator 312 695 1102
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    ETCTN 10214: Immune Checkpoint Blockade for Kidney Transplant Recipients with Selected Unresectable or Metastatic cancers

    This study isbeing done to answer the following question:

    Can we safely andeffectively use nivolumab alone or with ipilimumab to treat cancer in patientswho have receive…

    This study isbeing done to answer the following question:

    Can we safely andeffectively use nivolumab alone or with ipilimumab to treat cancer in patientswho have received a kidney transplant?

    Nivolumab andipilimumab are a type of cancer therapy known as immunotherapy, whichstimulates the immune system to help the body fight cancer. Nivolumab and ipilimumab bind to proteinsfound on T cells (a type of white blood cell). This helps the immune system find and attack cancer cells. Nivolumab and ipilimumab are approved by theFood and Drug Administration (FDA) to treat many types of cancer, but in thistrial, they are considered experimental.

    We are doing this study because we want to findout if this immunotherapy approach is safe for kidney transplant recipients andwhether it is better or worse than the usual approach for your cancer. The usual approach is defined as the caregiven to most people with your cancer.

  • Participantsmust be 18 years or older

  • Participants must have a confirmed diagnosis of Kidneycancer and received a Kidney transplant
  • Sosman, JeffreySosman, Jeffrey
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT03816332 STU00211560
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    1-855-NU-STUDY
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    NU 19C01: Understanding the Patient and Clinician Characteristics that Influence the Decision of Accepting Tumor Treating Fields (TTF) Therapy

    The purpose of this study is to better understand your choice to use or not use the Optune device for glioblastoma treatment. We would like to ident…

    The purpose of this study is to better understand your choice to use or not use the Optune device for glioblastoma treatment. We would like to identify the reasons for making your treatment decision and what characteristics may influence your decision.

    -Participants must be 18 years of age or older

    -Participants must be diagnosed with glioblastoma and have beenoffered Tumor Treating Fields Therapy (TTF) and Optune therapy for treatment.

    Kumthekar, PriyaKumthekar, Priya
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00210799
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    Lacson, Leilani L +1 312 503 3463
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    DRUG D9103C00001: A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab Following Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients with Unresected Stage I/II, Lymph-node negative Non-small Cell Lung Cancer (PACIFIC-4/RTOG-3515)

    This research is being done tofind out if the medication called durvalumab will work and be safe for thetreatment of patients with Stage I/II Non Small Cell Lung Cancer followingstereotactic body radiation therapy.

    If you choose to take part inthis study, after you complete stereotactic body radiation therapy you willreceive either durvalumab or placebo (a ’dummy treatment’ that looks like thestudy medication but contains no active ingredient) once a month for up to 24months.

    Durvalumab (called Imfinzi)is approved and recommended medicine forstage III NSCLC whose disease has not progressed following concurrentplatinum-based chemotherapy and radiation therapy (which is a more advancedform of the disease you have). Durvalumab is still in the development stage forthe treatment of an earlier stage of NSCLC, and is not approved for treatmentof stage I-II NSCLC, except for use in research studies like this.

    • Participantsmust be 18 years or older
    • Participants must have a confirmed diagnosis of stageI/II Non small-cell lung cancer that has not been surgically removed and hasnot spread to the lymph node
    Mohindra, NishaMohindra, Nisha
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT03833154 STU00211012
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    Study Coordinator 312 695 1102
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    Drug Vedolizumab-3035: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Vedolizumab in the Prophylaxis of Intestinal Acute Graft-Versus-Host Disease in Subjects Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
    The main purpose of th…
    The main purpose of this research study is to investigate the safety and effectiveness of Vedolizumab compared to placebo (dummy drug), for prevention of intestinal aGvHD in patients undergoing allo-HSCT from an unrelated donor for a hematologic malignancy, (cancers that affect the blood and/or lymphaticsystem).

    Some of the eligibility criteria include:

    • Participants must not have prior allo-Hematopoietic Stem Cell Transplantation (HSCT).
    • Participants must be 18 or older.
    Note: This is only a partial list of eligibilitycriteria. Please contact the Robert H. LurieComprehensive Cancer Center of Northwestern University for complete screeninginformation if you are interested in this clinical trial.
    Moreira, JonathanMoreira, Jonathan
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT03657160 STU00210880
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    Study Coordinator 312 695 1102
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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, PriyaKumthekar, Priya
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04164901 STU00211620
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    Study Coordinator 312 695 1102
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    A randomized double-blind phase III study of ibrutinib during and following autologous stem cell transplant versus placebo in patients with relapsed or refractory diffuse large B-cell lymphoma of the activated B-cell subtype

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

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

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

    This study isbeing done to answer the following question:

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

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

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

    Moreira, JonathanMoreira, Jonathan
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02443077 STU00211652
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    Moreira, Jonathan 312 695 1102
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    ECOG-ACRIN 4181: A Randomized 3-Arm Phase II Study Comparing 1.) Bendamustine, Rituximab and High Dose Cytarabine (BR/CR) 2.) Bendamustine, Rituximab, High Dose Cytarabine and Acalabrutinib (BR/CR-A), and 3.) Bendamustine, Rituximab and Acalabrutinib (BR-A) in Patients = 70 years old with Untreated Mantle Cell Lymphoma

    This study isbeing done to answer the following question:

    Which combinationof cancer drugs most effectively treats your MCL?

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

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

    3. bendamustine, rituximab andacalabrutinib (BR-A)

    We are doing this study because we want to findout if one of these drug combinations is better or worse than the usualapproach for your MCL. The usual approach is defined as care most people getfor MCL. Acalabrutinib is investigational for treating newly diagnosed MCL. Itis Food and Drug Administration (FDA) approved for MCL that has not respondedto treatment or relapsed
    • Participants must be 18 years orolder and ≤ 70 years old
    • Participants must have a confirmed diagnosis of MantleCell Lymphoma which has not been treated
    Karmali, ReemKarmali, Reem
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04115631 STU00211660
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    Study Coordinator 312 695 1102
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    NU 19H08: Signal Transduction of Type I Interferons in Malignant Cells
    This is a lab study of a group of diseases called myeloproliferative neoplasms (MPN). MPN is abnormal blood coagulation (abnormal or irregular blood clotting) and includes polycythemia vera (PV) and essential thrombocytosis (ET). …
    This is a lab study of a group of diseases called myeloproliferative neoplasms (MPN). MPN is abnormal blood coagulation (abnormal or irregular blood clotting) and includes polycythemia vera (PV) and essential thrombocytosis (ET). The purpose of this research is to learn more about how a drug called interferon stops the growth of MPN blood cells in the laboratory. Alpha-interferon is a natural protein present in the body in small amounts. Treatment with interferon is known to have significant activity in MPN, but the way that this drug works is not fully known.
    • Patients must have a diagnosis of either polycythemia vera (PV) or essential thrombocytosis (ET)
    • Patients must be age 18 years or older.
    Platanias, Leonidas CPlatanias, Leonidas C
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00211647
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    Study Coordinator 312 695 1102
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    DRUG AST-008-102: A Phase 1b/2 Study of Cavrotolimod Combined with Pembrolizumab or Cemiplimab in Patients with Advanced Solid Tumors
    The purpose of this study is to examine the safety and tolerability of the study drug, AST-008, alone and in combination with pembrolizumab in adult patients with adva…
    The purpose of this study is to examine the safety and tolerability of the study drug, AST-008, alone and in combination with pembrolizumab in adult patients with advanced solid tumors. The study is a classical 3+3 design, ascending dose, phase 1b study of AST-008 combined with pembrolizumab in cancer patients. Patients will be dosed twice with the study drug as a monotherapy before adding pembrolizumab, which will be added starting at the second cycle. The study is specifically looking to determine whether the combination of the AST-008 and pembrolizumab is better than pembrolizumab alone. There will be two DLT periods for each patient: a monotherapy DLT period of 15 days (Cycle 1) and a combination DLT period of 22 days (Cycle 2). Participants who consent will be assigned to either phase 1b (dose escalation phase) or Phase 2 (dose expansion phase). You will participate in either Phase 1b or Phase 2 of the study (not both), and your study doctor will tell you which phase you are being asked to participate in. The total amount of treatment that participants may receive is 2 years of treatment on trial.

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

    Chandra, SunandanaChandra, Sunandana
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03684785 STU00211083
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    Study Coordinator 312 695 1102
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    A Phase 2, Randomized, Open-label, 2-Arm Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Subjects with Indolent Non-Hodgkin Lymphoma (iNHL)
    This research study involves studying whetherdifferent dosing schedules of a new drug calledduvelisib or VS-0145 can be used to treat indolentNon…
    This research study involves studying whetherdifferent dosing schedules of a new drug calledduvelisib or VS-0145 can be used to treat indolentNon-Hodgkin Lymphoma (iNHL) that has comeback or that has not responded to standardtreatment. iNHL includes other subtypes oflymphomas known as follicular, marginal zone,and small cell lymphoma. Duvelisib is a drugdesigned to stop cancer growth by blocking PI3kinase activity. PI3 kinase is an enzyme in thebody that is overproduced by some cancers andcan fuel cancer growth. PI3 kinase activity isknown to be increased in many blood cancers.Duvelisib was approved (available to beprescribed or sold) by the Food and DrugAdministration (FDA) in September 2018 for thetreatment of patients with follicular lymphoma thathas come back or that has not responded to twostandard treatment and also a different type ofcancer known as chronic lymphocyticleukemia/small lymphocytic lymphoma (CLL/SLL)that has come back or that has not responded totwo standard treatment.The dose of duvelisib (study drug) currentlyapproved for treatment is 25 mg twice a day. Thisstudy is evaluating the use of different dosingschedules in patients with iNHL that are notcurrently in the US Prescribing Information.
    Participants must be 18 years or older• Participants must have a confirmeddiagnosis of indolent Non-HodgkinLymphoma (iNHL)• Participants must have received at leastone previous treatment for iNHL• Participants must have iNHL that hasworsened over time.
    Gordon, Leo I IGordon, Leo I I
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04038359 STU00211732
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    Study Coordinator 312 695 1102
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    DRUG CKAZ954A12101: A Phase I/IB, Open-label, Multi-Center, Study of KAZ954 as a Single Agent and in Combination With Spartalizumab, NZV930 and NIR178 in Patients with Advanced Solid Tumors
    The purpose of the study is to identify the best dose and treatment schedule of KAZ954 alone,and with Spartaliz…
    The purpose of the study is to identify the best dose and treatment schedule of KAZ954 alone,and with Spartalizumab (PDR001), NIR178 or NZV930 that can be given safely to patients with cancer.
    All patients age 18 and above who have advanced cancers are eligible to participate.
    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 201 East Huron Street Suite 12-160​
      Chicago, IL
    NCT04237649 STU00211372
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    Study Coordinator 312 695 1102
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    DRUG 20170528: A Phase 1 First-In-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 427 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia
    This study is being done to find out if the study drug, AMG 427 is safe when given to patients with…
    This study is being done to find out if the study drug, AMG 427 is safe when given to patients with AML and to understand its side effects.
    All patients 18 and above who have acute myeloid leukemia (AML) that has come back (relapsed) or is not responding to treatment (refractory).
    Altman, Jessica KAltman, Jessica K
    • Map it 201 East Huron Street Suite 12-160​
      Chicago, IL
    NCT03541369 STU00210905
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    Study Coordinator 312 695 1102
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    (xIRB) DRUG BNT411-01: Phase 1/2a, First-In-Human, Open-label, Dose-escalation Trial With Expansion Cohorts To Evaluate Safety, Pharmacokinetics, Pharmacodynamics, And Preliminary Efficacy Of Bnt411 As A Monotherapy In Patients With Solid Tumors And In Combination With Atezolizumab, Carboplatin And Etoposide In Patients With Chemotherapy-Naïve Extensive-stage Small Cell Lung Cancer (ES-SCLC)
    The purpose of this research study is to establish a safe dose of the research study drug called BNT411. This study has two parts: 1A and 1B. Part 1A will include participants with various types of solid tumors that have either spread in the body (metastatic) or that cannot be removed by surgery (unresectable). Part 1B will include participants who have extensive–stage small cell lung cancer (EC-SCLC) that has not been treated by chemotherapy before. If you meet all the criteria for being in the study, BNT411 will be given as an intravenous (IV) infusion.

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

    Treatment regimen for part 1A:

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

    Treatment regimen for part 1B:

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

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

    The order of administration will be as follows:

    Day 1: atezolizumab -> carboplatin -> etoposide

    Day 2: BNT411 -> etoposide

    Day 3: etoposide

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

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

    Some of the eligibility criteria include:

    •Age of at least 18 years

    •Either:

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

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

    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04101357 STU00211880
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    Study Coordinator 312 695 1102
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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
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03989115 STU00211907
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    Study Coordinator 312 695 1102
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    (xIRB) NCI CIRB SWOG 1922: Randomized Phase II Selection Study of Ramucirumab and Paclitaxel Versus FOLFIRI in Refractory Small Bowel Adenocarcinoma

    Thisstudy is being done to answer the following question:

    Can we find out if one or both of two different chemotherapy treatments(Ramucirumab plu…

    Thisstudy is being done to answer the following question:

    Can we find out if one or both of two different chemotherapy treatments(Ramucirumab plus Paclitaxel versus FOLFIRI) is helpful in treating your smallbowel cancer? If both are helpful, canwe find out which is better?
    • Participantsmust be 18 years or older
    • Participants must have a confirmed diagnosis of earlystage (stage 2) of colon cancer at the time of surgery

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

    Mulcahy, Mary FrancesMulcahy, Mary Frances
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04205968 STU00211958
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    Study Coordinator 312 695 1102
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    (xirb) Drug CA209-76K A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy with Nivolumab versus Placebo after Complete Resection of Stage IIB/C Melanoma
    This study is being conducted to find out if nivolumab could help stimulate the body's own immune system as this may help reduce tum…
    This study is being conducted to find out if nivolumab could help stimulate the body's own immune system as this may help reduce tumor resistance. If you think you might be interested in this study, your doctor will first determine if you are eligible to participate. If you are, you will randomly (by chance) be placed into one of two groups. One group will receive nivolumab and the other will receive the nivolumab-matched placebo. Both nivolumab and the placebo will be given once every 4 weeks as an intravenous (IV) infusion (a "drip" into a vein). All patients will receive regular health assessments. 
    Early stage melanoma is the most common and highest risk form of the disease. However, there is currently no clear therapy used to prevent relapse after complete tumor removal. With this study, we are testing how safe and effective the drug nivolumab is in decreasing the risk of relapse in people like you who have stage IIB or IIC melanoma, have been declared free of disease, have not been previously tested for melanoma beyond complete surgical removal of the melanoma lesion and are able to provide samples of tumor tissue taken from unresectable or metastatic site of disease.
    Sosman, JeffreySosman, Jeffrey
    • Map it 675 N. Saint Clair St. Twenty-First Floor, Suite 100
      Chicago, IL
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04099251 STU00211960
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    Study Coordinator 312 695 1102
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    PCCTC c17-191: CASCARA: Castration Sensitive Carboplatin, Cabazitaxel and Abiraterone, A Phase 2 Study of Carboplatin, Cabazitaxel and Abiraterone in Metastatic Castrate Sensitive Prostate Cancer with and without DNA Repair Mutations

    The purpose of this study isto determine if giving carboplatin a…

    The purpose of this study isto determine if giving carboplatin and cabazitaxel, followed by abirateroneimproves cancer control as measured by prostate-specific antigen (PSA) level and disease assessment scans. PSA levels may indicate the presence of prostate cancer. Cancer that has spread beyond the prostate may become difficult to treat. The drugs used in this study are approved by the United States Food and Drug Administration (FDA) for the treatment of cancer; however the combination is not standard and cabazitaxel is approved only for advanced prostate cancer. Carboplatin is an older drug and often used for the treatment of prostate cancer, although it is only FDA approved for ovarian cancer. For this reason,cabazitaxel and its use with carboplatin is considered investigational.

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

    You will receive carboplatin and cabazitaxel treatment over approximately 4 ½ months (once every 3 weeks).Within 4 weeks of completing carboplatin and cabazitaxel treatment, you will receive abiraterone and be seen approximately every 3 months for a disease reassessment for up to 2 years. Study participation will end early if you have a worsening of your disease or need a change in treatment.

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

    Diagnosis of metastatic, castration-resistant prostate cancer

    Age of at least 18 years

    VanderWeele, DavidVanderWeele, David
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT03934840 STU00211376
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    Study Coordinator 312 695 1102
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    (xIRB) NCI CIRB ECOG-ACRIN 5163: EA5163/S1709 INSIGNA : A Randomized, Phase III Study of Firstline Immunotherapy Alone or in Combination with Chemotherapy in Induction/Maintenance or Postprogression in Advanced Nonsquamous Non-Small Cell Lung Cancer (NSCLC) with Immunobiomarker SIGNature-Driven Analysis

    The purpose of this study is to compare any good and bad effects of using only the immunotherapy drug, MK-3475 (pembrolizumab), alone first versus the combination of the immunotherapy drug, MK-3475 (pembrolizumab), and chemotherapy. This study will also compare if adding chemotherapy to immunotherapy when the disease is growing is helpful. The addition of chemotherapy regimens to the usual immunotherapy could shrink cancer or prevent it from returning.

    This study will help the study doctors find out if this different approach is better, the same, orworse than the usual approach. The study doctors are looking to see if the study approach reduces the number of side effects compared to the usual approach without affecting life expectancy. They also hope that it will increase the life of patients by 5 months or more compared to the usual approach.

    This immunotherapy drug, MK-3475 (pembrolizumab), is already approved by the FDA for use in metastatic lung cancer whose tumors express high levels of PD-L1 or when chemotherapy has stopped working.

    This study has 3 study groups.

    Group 1

    Participants in this group will get the immunotherapy drug, MK-3475 (pembrolizumab), for up to 2years, unless their disease gets worse sooner than 2 years or the side effects become too severe.

    Group 2

    Participants in this group will get the immunotherapy drug, MK-3475 (pembrolizumab), for up to 2years, unless their disease gets worse sooner than 2 years or the side effects become too severe.

    Group 3

    Participants in this group will get the immunotherapy drug, MK-3475 (pembrolizumab), and the chemotherapy drugs, pemetrexed and carboplatin until their disease gets worse or the side effects become too severe.

    Participants who are 18 years or older who have non-squamous non-small cell lung cancer that hasspread outside their lungs.

    Mohindra, NishaMohindra, Nisha
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03793179 STU00211971
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    Study Coordinator 312 695 1102
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    (xIRB) NCI CIRB SWOG 1900B: A Phase II Study of LOXO-292 in Patients with RET Fusion-Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Sub-Study)
    Participants who have non-small cell lung cancer that has spread outsideof their lungs and who have a tumor sample that is positive for a…
    Participants who have non-small cell lung cancer that has spread outsideof their lungs and who have a tumor sample that is positive for a RET fusion willbe asked to participate in this study. The purpose of this study is to test the good and bad effects of the drugcalled LOXO-292. LOXO-292 could shrink cancer. The study doctors hope to learnif the treatment will shrink the participant's tumor. Another purpose of thisstudy is for the study doctors to learn if a biomarker test for RET fusions ishelpful in assigning treatment.LOXO-292 is not approved by the FDA for use in advanced non-small cell lungcancer. For this treatment study, participants will be assigned to treatment with aninvestigational drug called LOXO-292. Participants will take LOXO-292 bymouth twice daily for each cycle. Each cycle is 28 days long. Participants willget the study drug LOXO-292 daily until their disease gets worse, the sideeffects become too severe, or they desire to discontinue the studyAfter participants finish study treatment, their doctor will continue to followtheir condition for up to three years from the time they went on study andwatch them for side effects. If their disease has not gotten worse, follow upvisits will occur every 3 months. If their disease has gotten worse, follow upvisits will occur every 6 months for 2 years, and then at the end of the 3years from the time they went on study.
    Participants 18 years of age or older who have RETFusion-Positive Advanced Non-Small Cell Lung Cancer will be enrolled into this study.

    Chae, Young KwangChae, Young Kwang
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04268550 STU00211972
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    Study Coordinator 312 695 1102
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    NRG LU006: Phase III Randomized Trial of Pleurectomy/Decortication Plus Chemotherapy with or Without Adjuvant Hemithoracic Intensity-Modulated Pleural Radiation Therapy (IMPRINT) For Malignant Pleural Mesothelioma (MPM)

    This study isbeing done to answer the following question: Can we extend your l…

    This study isbeing done to answer the following question: Can we extend your life by addingradiation therapy to the lining of the lung to the usual treatment of surgeryand chemotherapy?

    We are doing this study because we want to findout if this approach is better or worse than the usual approach for yourcancer. The usual approach is defined ascare most people get for MPM.

    · Participantsmust be 18 years or older

    Participants must have a confirmed diagnosis MalignantPleural Mesothelioma (MPM)
    Kruser, TimothyKruser, Timothy
    • Map it 251 E. Huron St.
      Chicago, IL
    STU00211980
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    Study Coordinator 312 695 1102
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    SWOG 1827: A Randomized Phase III Trial of MRI Surveillance with or Without Prophylactic Cranial Irradiation (PCI) in Small-Cell Lung Cancer

    This study is being done to answer the following question:

    Does the use of brain scans alone instead of brain scans plus preventive brain radiation a…

    This study is being done to answer the following question:

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

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

    • Participantsmust be 18 years or older
    • Participants must have a confirmed diagnosis Small-CellLung cancer
    Kruser, TimothyKruser, Timothy
    • Map it 251 E. Huron St.
      Chicago, IL
    STU00211982
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    Study Coordinator 312 695 1102
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    (xIRB) DRUG IMGN632-0802: A Phase 1b/2 Study of IMGN632 as Monotherapy or Combination with Venetoclax and/or Azacitidine for Patients with CD123-Positive Acute Myeloid Leukemia

    The purposes of this research study are:

    •To combine IMGN632 (study drug), an experimental drug, with standard th…

    The purposes of this research study are:

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

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

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

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

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

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

    •Combination A: IMGN632 + azacitidine

    •Combination B: IMGN632 + venetoclax

    •Combination C: IMGN632 + azacitidine + venetoclax

    •Combination D: IMGN632

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

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

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

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

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

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

    Some of the eligibility criteria include:

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

    •Age of at least 18 years

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

    Altman, Jessica KAltman, Jessica K
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04086264 STU00212068
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    Study Coordinator 312 695 1102
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    (xIRB) DRUG JCAR017-FOL-001: A Phase 2, Open-Label, Single-Arm, Multicohort, Multicenter Trial to Evaluate the Efficacy and Safety of jcar017 in Adult Subjects with Relapsed or Refractory Indolent B-Cell Non-Hodgkin Lymphoma (NHL) (Transcend FL)

    The purpose of this research study is to determineif…

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

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

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

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

    Age of at least 18 years

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

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

    Karmali, ReemKarmali, Reem
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04245839 STU00212069
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    Study Coordinator 312 695 1102
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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
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04241835 STU00212081
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    Study Coordinator 312 695 1102
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    (xirb) DRUG SMX 18001 : An Open-label, Randomized, Multicenter Study Evaluating the Activity of Lasofoxifene Relative to Fulvestrant for the Treatment of Pre- and Postmenopausal Women with Locally Advanced or Metastatic ER+/HER2− Breast Cancer with an ESR1 Mutation Study
    The purpose of this resear…
    The purpose of this research study is to compare the effects of a drug called fulvestrant to theeffects of a drug called lasofoxifene on breast cancer. This study will determine if the timeto progression while receiving lasofoxifene improves compared to fulvestrant withoutincreasing side effects. 
    Breast cancer that has spread and has stopped responding to current treatment. 
    Shah, AmiShah, Ami
    • Map it 250 E. Superior St.
      Chicago, IL
    NCT03781063 STU00212362
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    1-855-NU-STUDY
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    ECOG-ACRIN 2183: A Phase III Study of Consolidative Radiotherapy in Patients with Oligometastatic HER2 Negative Esophageal and Gastric Adenocarcinoma (EGA)

    This study is being done to answer the following question:

    Will adding radiotherapy after the usual combination of drugs used to treat o…

    This study is being done to answer the following question:

    Will adding radiotherapy after the usual combination of drugs used to treat oligometastatic esophageal and gastric adenocarcinoma help you live longer?

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

    · Participantsmust be 18 years or older

    Participants must have a confirmed diagnosis of Gastricor Her2-negative esophageal cancers
    Hayes, John PHayes, John P
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04248452 STU00212379
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    Study Coordinator 312 695 1102
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    NRG GY020: A Phase III Randomized Trial of Radiation +/- MK-3475 (Pembrolizumab) for Newly Diagnosed Early Stage High Intermediate Risk Mismatch Repair Deficient (dMMR) Endometrioid Endometrial Cancer

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

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

    • Diagnosis of Stage I endometrioid endometrial cancer OR Stage II endometrioid endometrial cancer
    • At least 18 years old.
    Barber, EmmaBarber, Emma
    • Map it 250 E. Superior St.
      Chicago, IL
    NCT04214067 STU00212389
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    Study Coordinator 312 695 1102
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    (xIRB) DRUG AMV564-301: A Phase 1 Dose Escalation With Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMV564 Alone and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors

    The purpose of this clinical research study is to learn more abou…

    The purpose of this clinical research study is to learn more about the safety of AMV564, to find the highest tolerable dose that can be given to patients with advanced solid tumors, either alone or in combination with pembrolizumab and to recommend a dose to be used in future studies. Another purpose of this study is to learn how AMV564 affects your cancer-specific cells and other blood cells. In addition, the study will look at how long AMV564 can be measured in your blood to better understand how your body processes AMV564. While approved for many indications, the use of pembrolizumab in combination with AMV564 in this trial is investigational.

    If you qualify, you will be given AMV564 on a 5-2-5 dosing schedule, which means you will receive AMV564 for 5 days, no drug for 2 days, and then you will receive AMV564 again for another 5 days. AMV564 will be administered via a subcutaneous injection. It is required that you be hospitalized for inpatient observation for at least the first 72 hours after your first study treatment (Days 1 3), and then again for 24 hours on Day 8. After you are released from inpatient observation, you will still need to return to the clinic daily to receive the injections. When available, you may be able to administer the study treatment yourself without needing to return to the clinic daily.

    In addition, the study will be performed in 2 different stages, a dose escalation stage and a dose expansion stage. The dose escalation stage will determine the maximum safe dose of AMV564. Approximately 66 patients will take part in the dose escalation stage, either alone or in combination with pembrolizumab. During the dose escalation stage, patients will receive AMV564 at increasing dose levels (there will be up to 7 dose levels). Once a dose level has been completed and any safety risks have been reviewed, the next, higher dose level will be assigned. You will be assigned a dose level that is open at the time you are enrolled into the study.

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

    The Treatment Period begins when you receive your first dose of AMV564 and will end after the completion of all assessments for toxicity and/or response to AMV564. Once you have completed treatment with AMV564, you will be required to undergo follow-up evaluations, including a clinic visit 30 days after your last AMV564 injection and possibly for response assessments (CT and/or MRI) until you start a new treatment for your cancer or your cancer progresses. Regardless of how long you receive study treatment, you will be asked to come back to the clinic for a safety follow-up visit about 30 days after your last injection.

    Treatment with AMV564 may be continued beyond Cycle 1, if the doctor thinks it is in your best interest. It is estimated that the average patient will receive 4 cycles of AMV564, though the number of cycles you receive will vary based on how well the study treatment is tolerated and how your cancer responds. Each cycle, including treatment and follow-up visits, lasts up to 21 days, so you may be in the Treatment Period for up to 84 days (approximately 3 months) or longer (from Screening to the last Treatment Period study visit) if you go on to receive more than 4 cycles.

    You will be taken off study treatment if intolerable side effects occur. You may be taken off study treatment if your condition worsens. However, even if you stop the study treatment, the doctor may ask you to continue with the scheduled study tests to monitor your safety and response to the study treatment.

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

    Some of the eligibility criteria include:

    •Diagnosis of a certain type of cancer that is either resistant to treatment or has returned after treatment.

    •Age of at least 18 years

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

    Sosman, JeffreySosman, Jeffrey
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04128423 STU00212410
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    Study Coordinator 312 695 1102
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    DRUG CA20977T : A Phase 3, Randomized, Double-blind Study of Neoadjuvant Chemotherapy plus Nivolumab versus Neoadjuvant Chemotherapy plus Placebo, followed by Surgical Resection and Adjuvant Treatment with Nivolumab or Placebo for Participants with Resectable Stage II-IIIB Non-small Cell Lung Cancer
    The purpose of this study is to see if treatment with nivolumab in combination with chemotherapybefore the surgery followed by treatment with nivolumab after the surgery is better at preventing thereturn of the cancer and better at improving survival when compared to treatment with chemotherapyalone. This study will also test the safety, and tolerability of nivolumab combined with chemotherapy inpatients with resectable Non-small Cell Lung Cancer.

    OPDIVO® (nivolumab) is a type of immunotherapy. Immunotherapy works by encouraging the body'sown immune system to attack the cancer cells. Nivolumab is approved for the treatment of certain typesof cancer, including skin, kidney, blood, head and neck, bladder and lung, in multiple countriesincluding the United States (US, Dec-2014), the European Union (EU, Jun-2015), and Japan (Jul2014). The use of nivolumab in combination with chemotherapy in this study as described above isinvestigational. An investigational use is one that is not approved by Health Canada or the UnitedStates Food and Drug Administration (FDA).

    - Be atleast 18 years old

    - You should be new to anti cancer treatment

    - Be able to provide surgical or biopsy tumor tissue for biomarkers.

    - If you are suspected or confirmed with Stage II A to IIIB Non-Small Cell Lung Cancer, with disease that is considered resectable (removable).

    Patel, Jyoti D DPatel, Jyoti D D
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04025879 STU00212448
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    Study Coordinator 312 695 1102
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    COVID-19 Convalescent Blood BioBank (SeroCore)
    Individuals will have blood drawn on enrollment as well as 6, 12 and 24 months later.  Blood will be used for genetic testing to identify factors associated with disease severity and immunologic responses.  Blood will be used to interrogate imm…
    Individuals will have blood drawn on enrollment as well as 6, 12 and 24 months later.  Blood will be used for genetic testing to identify factors associated with disease severity and immunologic responses.  Blood will be used to interrogate immunologic responses over time.  Blood will be shared with other investigators to validate serologic testing assays and to facilitate vaccine development.  
    Individuals who have recovered from COVID-19 are eligible for enrollment.  Patients will need to be confirmed to have had COVID-19 either through PCR testing or a positive antibody test prior to enrollment.  
    Ison, Michael GIson, Michael G
    • Map it 676 N. Saint Clair St. Suite 940
      Chicago, IL
    STU00212371
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    Goudy, Leah +1 312 694 0242
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    (xIRB) DRUG CO-338-100: LODESTAR: A Phase 2 MuLticenter, Open-label Study of Rucaparib as Treatment for SoliD Tumors Associated with DEleteriouS MuTations in Homologous RecombinAtion Repair Genes
    The goal of this study is to find biomarkers in subjects with different types of cancers with specific HR…
    The goal of this study is to find biomarkers in subjects with different types of cancers with specific HRR gene mutations to help doctors decide if rucaparib is a good study treatment option. One of the main goals of biomarker research is to develop a diagnostic test that might help show which subjects are most likely to benefit from study treatment with rucaparib.

    - Aged at least 18 years old

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

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

    - Have received at least 1 line of available therapy

    Kalyan, AparnaKalyan, Aparna
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00212482
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    Study Coordinator 312 695 1102
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    DRUG RAIN-701: A Phase 2 Study to Evaluate the Clinical Activity of Tarloxotinib in Patients with Non-Small Cell Lung Cancer that Harbors Either an EGFR Exon 20 Insertion or a HER2-Activating Mutation and Other Advanced Solid Tumors with NRG1/ERBB Family Gene Fusions
    The purpose of this research stud…
    The purpose of this research study is to gather data that will be used to evaluate the safety and effectiveness of the investigational drug, Tarloxotinib. Tarloxotinib is an investigational drug, meaning the study drug is still being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA) or Health Canada (HC). Tarloxotinib is used in patients with NSCLC or other advanced solid tumors. The study is being done to evaluate the response rate of Tarloxotinib. The study is also being done to see how Tarloxotinib controls the tumor, how long the tumor responds, how the drug controls the cancer, and to determine progression-free survival and overall survival rates. The study is being done to investigate the pharmacokinetics (PK) of Tarloxotinib. Pharmacokinetics is the study of how long the study drug stays in your blood, and how your body gets rid of the drug.

    If you meet all the criteria for being in the study, Tarloxotinib will be given as an intravenous (IV) infusion using an IV infusion or syringe pump (IV pump).

    All prospective patients will undergo screening tests to determine if they are eligible to take part in the study. Tarloxotinib will be given as an intravenous (IV) infusion using an IV infusion or syringe pump (IV pump). It will be given every week, approximately every 6 to 8 days. The dose level will be based on height and weight, as well as tolerance to the study treatment when given previously. Study treatment will be given in “cycles”; a cycle is a 28-day period. The study treatment will be given on the 1st, 8th, 15th, and 22nd day of every 28-day cycle

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

    Some of the eligibility criteria include:

    •Age of at least 18 years

    •Either:

    o Diagnosis of non-small cell lung cancer (NSCLC), Stage IV, Stage IIIB, or III C, and the cancer is not responding to curative-intent therapy or

    o Recurrent NSCLC after a prior diagnosis of Stage I-III or

    o Locally advanced or metastatic solid tumor

    Patel, Jyoti D DPatel, Jyoti D D
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT03805841 STU00211888
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    Study Coordinator 312 695 1102
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    (xIRB) DRUG TAK-788-3001: A Randomized Phase 3 Multicenter Open-label Study to Compare the Efficacy of TAK-788 as First-line Treatment Versus Platinum-Based Chemotherapy in Patients With Non–Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations
    The purpose of this study is to determine how s…
    The purpose of this study is to determine how safe and how well TAK-788 works as an initial therapy in patients with a certain kind of lung cancer (NSCLC with EGFR exon 20 insertion mutations). The results in these patients will be compared with results in patients receiving standard of care chemotherapy (platinum-doublet chemotherapy).

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

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

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

    * Combination of premetrexed and cisplatin OR

    * Combination of premetrexed and carboplatin

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

    - Be atleast 18 years old

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

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

    Patel, Jyoti D DPatel, Jyoti D D
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04129502 STU00212504
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    Study Coordinator 312 695 1102
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    (xIRB) First-In-Human Dose Escalation Study of STP1002 in Patients with Advanced-Stage Solid Tumors

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

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

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

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

    Some of the eligibility criteria include:

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

    •Age of at least 18 years

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.
    Benson III, Al BBenson III, Al B
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04505839 STU00212555
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    Study Coordinator 1-855-NU-STUDY
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    (xirb) Drug ACE1702-001 : A Phase I, Open Label, Dose Escalation Study of ACE1702 Cell Immunotherapy in Subjects with Advanced or Metastatic HER2-expressing Solid Tumors

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

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

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

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

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

    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04319757 STU00212562
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    Study Coordinator 1-855-NU-STUDY
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    NU COVID-19 INT20L02 - International registry on thoracic cancer patients with COVID 19 - TERAVOLT (Thoracic cancERs international coVid 19 cOLlaboraTion)
    An early report of COVID-19 cases indicated that cancer patients had an increased risk of developing severe COVID-19-related symptoms compared to …
    An early report of COVID-19 cases indicated that cancer patients had an increased risk of developing severe COVID-19-related symptoms compared to COVID-19 patients without cancer. The purpose of this registry is to collect clinical information like symptoms, treatments, and outcomes of thoracic cancer patients (NSCLC, SCLS, MPM, and TETs) with COVID-19 to help develop risk assessment strategies and treatment recommendations for thoracic cancer patients.

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

    Patel, Jyoti D DPatel, Jyoti D D
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00212311
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    For more information on this study please contact us:

    Study Coordinator 312 695 1102
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    NU COVID-19 MSK20H04: Examining COVID19 Course and Outcomes in Patients Previously Diagnosed with Chronic Lymphocytic Leukemia (CLL)
    This multicenter, retrospective cohort study will include patientstreated at national and international medical centers. Patients will be included if they have a prior …
    This multicenter, retrospective cohort study will include patientstreated at national and international medical centers. Patients will be included if they have a prior diagnosis of CLL, havebeen diagnosed with COVID19, and received care at a participating medicalcenter.

    Primary Aim:

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

    Secondary Aims:

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

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

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

    Chronic lymphocytic leukemia (CLL) patients diagnosed with COVID19.
    Ma, ShuoMa, Shuo
    • Map it 251 E. Huron St.
      Chicago, IL
    STU00212455
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    Study Coordinator 312 695 1102
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    NU 19H11 - Identifying Molecular Markers That Predict Relapse After Therapy Discontinuation In Chronic Myeloid Leukemia

    Many patients with CML have long term “complete molecular” remissions with tyrosine kinase

    inhibitor drugs (such as imatinib or dasatinib). This refers to the inability…

    Many patients with CML have long term “complete molecular” remissions with tyrosine kinase

    inhibitor drugs (such as imatinib or dasatinib). This refers to the inability to detect any leukemia

    in the blood or bone marrow. Some patients with a complete molecular remission can stop

    treatment, but 50% of those who do will have their CML return within 2-3 years. We do not

    currently have a way to predict which patients will relapse (cancer returns) versus remain in

    sustained remission (all signs and symptoms of cancer have disappeared) after stopping

    therapy. The purpose of this study is to examine blood or bone marrow cells from patients with

    CML who are stopping treatment. By doing this study, we hope to identify characteristics of

    blood cells that predict the likelihood of relapse after stopping therapy.

    • 18-85 years of age
    • confirmed diagnosis of Chronic Myeloid Leukemia (CML) that meets the criteria for stopping therapy because of long term "complete molecular" remission
    • previous treatment with any tyrosine kinase inhibitor (TKI) drugs
    Eklund, Elizabeth AEklund, Elizabeth A
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00212526
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    Study Coordinator 312 695 1102
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    Wearable sensor to monitor and track COVID-19-like signs and symptoms to develop better care strategies for COVID-19 pandemic
    Specific Aims:1. Develop a wearable sensor package to gather data on COVID-19-like signs andsymptoms such as elevated body temperature, respiratory parameters, heart rate ,cou…
    Specific Aims:1. Develop a wearable sensor package to gather data on COVID-19-like signs andsymptoms such as elevated body temperature, respiratory parameters, heart rate ,coughand gait.2. Create algorithms to monitor and track changes to COVID19-like signs and symptomsfor developing a better care and isolation strategies for COVID-19 pandemic

    Ages between 18-95 years old

    Currently experiencing any COVID-like signs and symptoms such as fever, cough,shortness of breath, trouble breathing, persistent pain or pressure in the chest, confusionor inability to arouse, bluish lips or face
    Jayaraman, ArunJayaraman, Arun
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00212522
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    McGee, Lori Lyn Lyn 312 238 2091
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    NU FC19L02: Phase II randomized trial of carboplatin + pemetrexed + bevacizumab, with or without atezolizumab in stage IV non-squamous NSCLC patients who harbor a sensitizing EGFR mutation or have never smoked
    The purpose of this research study is to determine if the combination therapy of carboplati…
    The purpose of this research study is to determine if the combination therapy of carboplatin, pemetrexed, bevacizumab (Avastin) and atezolizumab (Tecentriq) is better at controlling disease progression in patients with sensitizing EGFR mutation induced NSCLC or patients with NSCLC who are never-smokers as compared to the combination without Tecentriq.

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

    •Arm A: Carboplatin + Pemetrexed + Avastin + Tecentriq

    •Arm B: Carboplatin + Pemetrexed + Avastin

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

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

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

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

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

    Some of the eligibility criteria include:

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

    •Age of at least 18 years

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

    Patel, Jyoti D DPatel, Jyoti D D
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT03786692 STU00211923
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    Study Coordinator 312 695 1102
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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, ShiraDinner, Shira
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04313881 STU00212732
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    Study Coordinator 312 695 1102
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    Immune checkpoint inhibitor-associated acute kidney injury
    Since 2011, six immune checkpoint inhibitors (ICIs), a type of immunotherapy, have been approved by the Federal Drug Administration for use in patients with cancer.  These medications have been demonstrated to have great promise for trea…
    Since 2011, six immune checkpoint inhibitors (ICIs), a type of immunotherapy, have been approved by the Federal Drug Administration for use in patients with cancer.  These medications have been demonstrated to have great promise for treating a variety of cancers.  However, there are toxicities associated with these agents, known as immune-related adverse events (AKI), some of which can be fatal.  Affected organs include the skin (rash), gastrointestinal tract(diarrhea), and the kidneys (acute kidney injury [AKI]). This study, led by Drs. Shruti Gupta and David Leaf at Brigham and Women’s Hospital, has the goal of collecting data on over 300 ICI-associated acute kidney injury cases from more than 30 academic medical centers worldwide.  We will characterize the clinical features of ICI-associated AKI in the hope that this will help us to determine predictors  of toxicity and best practices for management. 
    Aggarwal, VikramAggarwal, Vikram
    STU00212602
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    Aggarwal, Vikram 1-855-NU-STUDY
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    (xIRB) Drug MRTX849-002 : A Phase 1/2 Trial of MRTX849 in Combination with TNO155 in Patients with Advanced Solid Tumors with KRAS G12C Mutation
    This study will evaluate if people with cancer that has a KRAS G12C mutation will benefit fromtreatment with MRTX849 and TNO155. It will also look at what s…
    This study will evaluate if people with cancer that has a KRAS G12C mutation will benefit fromtreatment with MRTX849 and TNO155. It will also look at what side effects occur and howoften they occur. Other objectives of the study include assessing how quickly MRTX849 andTNO155 are absorbed into the blood stream and how fast it is removed by the body. Severallaboratory tests will be performed using samples of tumor tissue or blood to understand how andwhy the drug may work.

    If you are found to be eligible to take part in this study, and you decide to participate, the dose ofMRTX849 that you will receive will be 600 mg twice a day (BID). The starting dose of TNO155will be 20 mg once a day (QD).

    If no intolerable side effects are experienced at the starting dose in three subjects, the next 3subjects will be given MRTX849 600 mg twice a day (BID) and TNO155 at a higher dose level.Two or more subjects may be added at a dose level if more experience is needed to decide if thedose is tolerable for most people. This dose escalation process will continue until the highestdose of MRTX849 and the highest dose of TNO155 that can be given without intolerable sideeffects is identified.

    - Age ≥ 18 years

    - You have a diagnosis of advanced cancer for which there are no standard therapies beyond those you have been offered and/or already received.

    - Advanced Solid Tumors (Non-small Cell Lung Cancer / Colorectal Cancer) with KRAS G12C Mutation.

    -Life expectancy of at least 3 months.

    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.

    Mohindra, NishaMohindra, Nisha
    • Map it 201 East Huron Street Suite 12-160​
      Chicago, IL
    NCT04330664 STU00212919
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    Study Coordinator 312 695 1102
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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, NishaMohindra, Nisha
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04092283 STU00212961
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    For more information on this study please contact us:

    Study Coordinator 312 695 1102
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    (xirb) Drug CT-7001_001 :A Modular, Multipart, Multiarm, Open-label, Phase I/IIa Study to Evaluate the Safety and Tolerability of CT7001 Alone and in Combination with Anti-cancer Treatments in Patients with Advanced Malignancies
    The main goal of the CT7001_001 trial is to find the safest and mosteffe…
    The main goal of the CT7001_001 trial is to find the safest and mosteffective dose of CT7001 and then test this dose in different cancers and possibly incombination with other cancer medicines.  This study is called Module 2 Part A for breast cancer.
    HormoneReceptor (HR) positive and Human Epidermal Growth Factor 2 (HER 2) negative breastcancer with worsening of the disease after prior treatment with an aromatase inhibitor
    Gradishar, William JGradishar, William J
    • Map it 250 E. Superior St.
      Chicago, IL
    NCT03363893 STU00212990
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    Diaz, Carmen 312 695 0990
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    (xIRB) DRUG NIT-106: A Phase 1b/2a, Open Label Study to Evaluate Anti-Tumor Efficacy and Safety of rhIL-7-hyFc (NT-I7) in Combination with Anti-PD-L1 (Atezolizumab) in Patients with Anti-PD-1/PD-L1 Naïve or Relapsed/Refractory High-Risk Skin Cancers

    The purpose of this research study is to test t…

    The purpose of this research study is to test the safety and to find out what effects, good and/or bad, that the study treatment has on you and your high-risk skin cancer. The study treatment consists of two immunotherapy drugs, NT-I7 and atezolizumab. We call these drugs immunotherapies because they work by stimulating the immune system to destroy cancer cells and potentially generate an anti-tumor effect. This study tests different doses of NT-I7 to see which dose is safer and potentially more effective when combined with atezolizumab for treating high-risk skin cancers.

    This study is comprised of a screening period, 21-day cycles of treatment, the End of Treatment visit, and Safety Follow-up. If you join this study, you would receive study treatment for up to 2 years and return for follow-up visits 1, 2 and 3 months after your last dose of study treatment.

    All prospective patients will undergo screening tests to determine if they are eligible to take part in the study. All study participants will receive the study treatment which will be given in cycles. A cycle lasts 21 days. Study treatment will be given to you on Day 1 of each cycle, beginning with Cycle 1, for up to 2 years.

    During cycles 1 and 2, you will visit the study site on Days 1 and 8. If you are a Step 1 participant, you will also visit the study site on Day 2 of Cycle 1. For all remaining cycles you will only visit the study site on Day 1. On the days you receive study treatment, you will first be given NT-I7 as an injection into your muscle. Atezolizumab will then be given to you through a vein in your arm over 45-75 minutes on the first day of the first cycle. During the following cycle(s), the infusion time may be reduced to 20-40 minutes, if the first infusion went well. Atezolizumab will be given on Day 1 of every cycle, even if your NT-I7 dose is skipped for that cycle. All study participants will receive the same dose of atezolizumab.

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

    Some of the eligibility criteria include:

    •Diagnosis of a high-risk skin cancer, such as melanoma, Merkel Cell Carcinoma, or cutaneous Squamous Cell Carcinoma

    •Age of at least 18 years

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

    Sosman, JeffreySosman, Jeffrey
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT03901573 STU00213029
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    Study Coordinator 312 695 1102
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    NCICOVID: NCI COVID-19 in Cancer Patients Study (N-CCaPS): A Longitudinal Natural History Study

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

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

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

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

    Participants 18 years or older who are being treated for cancer and have COVID-19 will be enrolled.
    Wehbe, FirasWehbe, Firas
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00213072
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    Study Coordinator 312 695 1102
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    ACCRU SC-1601: A Phase III, Randomized, Controlled, Double-Blind Study Evaluating the Safety of Two Doses of Apixaban for Secondary Prevention of Cancer Related Venous Thrombosis in Subjects Who Have Completed at Least Six Months of Anticoagulation Therapy
    compare the effects, good and/or bad, of two…
    compare the effects, good and/or bad, of twodifferent doses of apixaban (Eliquis®)2.5 mg or 5 mg on you and yourbloodclot,to find out which is better inpreventing and treating blood clots.

    Some of the eligibility criteria include:

    • Ability to provide informed written consent.
    • Participants must be 18 or older.

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

    Martin, KarlynMartin, Karlyn
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03080883 STU00212552
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    Study Coordinator 312 695 1102
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    DRUG CX-839-012: A Phase 1b/2, Open label, Dose Escalation and Expansion Study of the Glutaminase Inhibitor Telaglenastat (CB-839) in Combination with the CDK4/6 Inhibitor Palbociclib in Patients with Advanced or Metastatic Solid Tumors
    The purpose of this study is to determine a safe and tolerable d…
    The purpose of this study is to determine a safe and tolerable dose of telaglenastat (an “investigational” drug), given together with palbociclib (an “approved” drug),  
    All participants in Part 2 of the study must be 18 years of-age or older and be diagnosed with advanced or metastatic CRC or NSCLC.
    Chae, Young KwangChae, Young Kwang
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03965845 STU00212083
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    1-855-NU-STUDY
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    (xIRB) DRUG EZH-108: A Phase 1, Open-Label Multi-Dose Two-Part Study to Characterize the Effects of a Strong CYP3A4 Inhibitor on the Steady-State Pharmacokinetics of Tazemetostat (EPZ-6438), And The Effects Of A Strong CYP3A4 Inducer on the Steady- State Pharmacokinetics of Tazemetostat in Subjects with Advanced Malignancies

    The purpose of this study is to:

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

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

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

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

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

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

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

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

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

    1)Screening will last up to 30 days.

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

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

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

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

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

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

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

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

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

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

    Some of the eligibility criteria include:

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

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

    •Age of at least 18 years

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

    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04537715 STU00213166
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    Study Coordinator 312 695 1102
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    DRUG APG1252SU101: A Multi-Center, Phase Ib/II Study of Combination Treatment of APG-1252 With Paclitaxel In Patients With Relapsed/Refractory Small Cell Lung Cancer

    The purpose of this study is to find answers to the following research questions:

    •What is the dose of APG-1252 that works b…

    The purpose of this study is to find answers to the following research questions:

    •What is the dose of APG-1252 that works best without causing significant side effects to patients when given with paclitaxel?

    •How the size of the tumor changes in response to combination therapy of APG-1252 plus paclitaxel?

    •What are the side effects of APG-1252 when given along with paclitaxel?

    •How much of the study drug is in the blood at specific times after administration and how does the body get rid of the study drug (called “pharmacokinetic” or “PK” testing)?

    •What effects, good and/or bad, does the study drug have on you and your specific cancer (called “pharmacodynamic” or “PD” testing)?

    Researchers want to understand how the drug works in your body and how your body will react to it. This study is made up of 2 parts (phases): Phase Ib and Phase II. In Phase Ib, patients will receive APG-1252 at the selected dose-level plus a fixed-dose of paclitaxel to determine the maximum tolerated dose (MTD) / Recommended Phase 2 Dose (RP2D) (dose that works best without causing severe side effects) of APG-1252. In Phase II, patients will receive APG-1252 at the RP2D dose determined in the Phase Ib portion plus fixed-dose of paclitaxel. Both APG-1252 and paclitaxel is given as an injection or infusion into the vain (intravenous, IV).

    All prospective patients will undergo screening tests to determine if they are eligible to take part in the study. If eligible, your time in this research study will be followed in cycles. One cycle is 21 days (3 weeks) in duration. You will need to come to the study site at least 1 time before you begin to receive study drug to see if you are eligible to be in the study. After you start the study drug and if you are in Phase Ib, you will visit the study site 6 times during Cycle 1 and 3 times during Cycle 2 and each following cycle. And if you are in Phase II, you will visit the study site 6 times during Cycle 1 and 3 times during Cycle 2 and each following cycle. You may need to visit the study site at some unscheduled times if some side effects are observed. The total number of cycles you go through in the study will depend on how you tolerate the study drug, and if your cancer gets worse.

    If you are in Phase Ib study and on RP2D dose-level, you will be eligible for Part 2 analysis.

    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 small cell lung cancer (SCLC) for which standard drugs to treat the disease are no longer effective or no reliably effective treatment is known for this type of cancer.

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

    Mohindra, NishaMohindra, Nisha
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04210037 STU00212694
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    Study Coordinator 312 695 1102
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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, AmiShah, Ami
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04316117 STU00213217
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    Study Coordinator 312 695 1102
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    DRUG ARV-110-mCRPC-101: A Phase 1/2, Open-label, Dose Escalation and Cohort Expansion Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ARV-110 in Patients with Metastatic Castration-resistant Prostate Cancer
    The purpose of this research study is to assess…
    The purpose of this research study is to assess the safety and tolerability of the investigational study drug (ARV-110) in men with metastatic cancer of the prostate which has progressed after multiple previous therapies. The study also seeks to evaluate how the drug moves within the body after administration (Pharmacokinetics {PK}) and what effects the drug has on your body after administration (Pharmacodynamics {PD}).

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

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

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

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

    Some of the eligibility criteria include:

    •Age of at least 18 years

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

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

    Hussain, MahaHussain, Maha
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT03888612 STU00212897
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    Study Coordinator 312 695 1102
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    NRG HN006: Randomized Phase II/III Trial of Sentinel Lymph Node Biopsy Versus Elective Neck Dissection for Early-Stage Oral Cavity Cancer

    This study is being done to answer the following questions: 1) will neck and shoulder function and discomfort be better if you have a procedure called sentinel …

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

    This study has 2 parts. In the first part,doctors will try to learn the answer to question #1 above. If the answer shows that neck and shoulder function and discomfort is better in patients who have the SLN biopsy, then the study will go on to the second part, and doctors will try to answer question #2.
    • Participants must be 18 years or older
    • Participants must have a confirmed diagnosis of early-stage oral cavity cancer
    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.
    Samant, SandeepSamant, Sandeep
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04333537 STU00213298
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    Study Coordinator 312 695 1102
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    (xIRB) NCI CIRB ETCTN 10208: A Phase I Study of Anetumab Ravtansine in Combination with Either Anti-PD-1 Antibody, or Anti-CTLA4 and Anti-PD-1 Antibodies or Anti-PD-1 Antibody and Gemcitabine in Mesothelin-Positive Advanced Pancreatic Adenocarcinoma

    The purpose of this study is to test the …

    The purpose of this study is to test the safety of the drug combinations anetumab ravtansine and nivolumab

    (Group 1) or nivolumab and ipilimumab (Group 2) or gemcitabine and nivolumab (Group 3). This study

    tests different doses of the drug to see which dose is safer for people with pancreatic cancer who have

    received at least a systemic therapy, such as chemotherapy

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

    In the dose escalation part of this study, people with mesothelin positive pancreatic cancer will get different

    doses of the study drug depending on what group they are assigned to. This part of the study has three groups.

    •Group 1

    Participants in this group will get anetumab ravtansine with nivolumab.

    •Group 2

    Participants in this group will get anetumab ravtansine with nivolumab and Ipilimumab.

    •Group 3

    Participants in this group will get anetumab ravtansine with gemcitabine and nivolumab.

    Once the safer combination is determined in the dose escalation part of the study, the dose expansion part

    will open. This part of the study will have a lead-in phase of 1 week where participants receive either:

    -Anetumab ravtansine (Groups 1 or 2)

    -Anetumab ravtansine and gemcitabine (Group 3)

    In this part of this study, people with mesothelin positive pancreatic cancer will be placed into ONE

    of the following; Group 1, 2, or 3 depending on the finding observed in the dose-escalation.

    This will help study doctors to better understand the side effects that may occur with these drugs and evaluate the potential effect of the combination on pancreatic cancer.

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

    or until your cancer has progressed if you did not come off intervention for progression.

    This will be completed over the phone or in clinic every 8 weeks.

    Participants 18 years of age or older who have pancreatic adenocarcinoma that has spread outside of your pancreas, and you have already received a treatment considered effective for your disease but your cancer has now progressed.

    Kalyan, AparnaKalyan, Aparna
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03816358 STU00213324
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    Study Coordinator 312 695 1102
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    (xIRB) NCI CIRB ECOG-ACRIN 2186: A Randomized Phase II Study of Gemcitabine and Nab-Paclitaxel Compared with 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan in Older Patients with Treatment Naïve Metastatic Pancreatic Cancer (GIANT)

    The purpose of this study is to determine whether Gemcitabi…

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

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

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

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

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

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

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

    of the two approaches shows better results.

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

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

    This study has 2 study groups.

    Group 1 (Arm A)

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

    Group 2 (Arm B)

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

    and Liposomal Irinotecan.

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

    and watch you for side effects and monitor your cancer.

    Vulnerable patients over the age of 70 with newly diagnosed metastaticpancreatic cancer (mPCA).
    Kalyan, AparnaKalyan, Aparna
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04233866 STU00213326
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    Study Coordinator 312 695 1102
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    (xIRB) NCI CIRB Alliance A081801: INTEGRATION OF IMMUNOTHERAPY INTO ADJUVANT THERAPY FOR RESECTED NSCLC: ALCHEMIST CHEMO-IO (ACCIO)

    Thepurpose of this study is to compare the usual treatment alone to usingpembrolizumab plus the usual treatment in participants who had non-small cell lungcancer remo…

    Thepurpose of this study is to compare the usual treatment alone to usingpembrolizumab plus the usual treatment in participants who had non-small cell lungcancer removed, and their cancer has a change in the gene called the PD-L1 gene.

    Thisstudy will help the study doctors find out if this different approach is betterthan the usual approach. To decide if itis better, the study doctors will be looking to see if the pembrolizumabincreases the life of patients by 1.5 years or more compared to the usualapproach.

    Participants will either get chemotherapy alone for about4 months, chemotherapy for about 4 months followed by treatment with animmunotherapy drug called pembrolizumab for up to 1 year, or chemotherapy andpembrolizumab for 4 months followed by treatment with pembrolizumab for up to10 months.

    After treatment is finished, the doctor and study teamwill check you every 3 months for 2 years after treatment. After that, they will check you every 6months for 3 years, then after that they will check on you every year foranother 5 years. This means you will keep seeing your doctor for 10 years aftertreatment.

    Thisstudy has 3 study groups.

    Group 1

    Chemotherapyfor 4 cycles, possibly followed by radiation therapy, then followed by nofurther therapy

    Group 2

    Chemotherapyfor 4 cycles, possibly followed by radiation therapy, then 17 treatments withpembrolizumab

    Group 3

    Chemotherapy and pembrolizumab for 4 cycles,possibly followed by radiation therapy, then 13 more pembrolizumab treatments

    Participants who are 18 years of age or older whohadnon-small cell lung cancer removed, and their cancer has a change in the genecalled the PD-L1 gene.

    Mohindra, NishaMohindra, Nisha
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04267848 STU00213329
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    Study Coordinator 312 695 1102
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    (xIRB NCI CIRB) ECOG-ACRIN 1181: Preoperative THP and Postoperative HP in Patients Who Achieve a Pathologic Complete Response Part 1 Component of: The CompassHER2 Trials (COMprehensive Use of Pathologic Response ASSessment to Optimize Therapy in HER2-Positive Breast Cancer) (CompassHER2-pCR)

    This…

    This study isbeing done to answer the following question:

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

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

    The names of thestudy drugs involved in this study are:

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

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

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

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

    Cristofanilli, MassimoCristofanilli, Massimo
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04266249 STU00213352
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    Study Coordinator 312 695 1102
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    (xIRB) DRUG ARC-6: A Phase 1b/2, Open-Label, Randomized Platform Study Evaluating the Efficacy and Safety of AB928-Based Treatment Combinations in Patients with Metastatic Castrate Resistant Prostate Cancer
    The purpose of this study is to understand whether an experimental treatment, AB928, is safe a…
    The purpose of this study is to understand whether an experimental treatment, AB928, is safe and effective when given in combination with other treatments to patients with metastatic castrate resistant prostate cancer (mCRPC). AB928 may be combined with other experimental drugs, known as AB680 and zimberelimab (AB122), or may be combined with drugs that are approved by the US Food and Drug Administration (FDA) and other government agencies to treat mCRPC.

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

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

    •Enzalutamide (Stage 2 only)

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

    •Docetaxel (Stage 2 only)

    •AB928 + zimberelimab (Stage 1 and Stage 2)

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

    •AB928 + AB680 (Stage 1 and Stage 2)

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

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

    This research study is made up of the following parts:

    •Screening

    •Treatment

    •End of Study and Long-Term Safety Follow Up

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

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

    Some of the eligibility criteria include:

    •Age of at least 18 years

    •Diagnosis of metastatic castrate resistant prostate cancer

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

    VanderWeele, DavidVanderWeele, David
    • Map it 251 E. Huron St.
      Chicago, IL
    STU00213357
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    Study Coordinator 312 695 1102
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    DRUG CCTL019B2003I: Managed Access Program (MAP) to provide access to CTL019, for acute lymphoblastic leukemia (ALL) or large B-cell lymphoma patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release.

    The purpose of th…

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

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

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

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

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

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

    Some of the eligibility criteria include:

    · Age of at least 18 years

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

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

    Karmali, ReemKarmali, Reem
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT03601442 STU00213101
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    Study Coordinator 312 695 1102
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    (xIRB) NCI CIRB NRG CC008: A Non-Randomized Prospective Clinical Trial Comparing the Non-Inferiority of Salpingectomy to Salpingo-oophorectomy to Reduce the Risk of Ovarian Cancer Among BRCA1 Carriers [SOROCk]

    The main purpose of this study is to determine if two surgical procedures, the usual app…

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

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

    Barber, EmmaBarber, Emma
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04251052 STU00213473
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    1-855-NU-STUDY
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    DRUG QBGJ398-302: Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial of Infigratinib for the Adjuvant Treatment of Subjects with Invasive Urothelial Carcinoma with Susceptible FGFR3 Genomic Alterations (PROOF 302)

    The PROOF 302 trial is a clinical research study that aims to …

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

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

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

    Meeks, Joshua JMeeks, Joshua J
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04197986 STU00211963
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    Smith, Dioblo 1-855-NU-STUDY
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    (xIRB) NCI CIRB SWOG 1823: A Prospective Observational Cohort Study to Assess mRNA 371 for Outcome Prediction in Patients with Newly Diagnosed Germ Cell Tumors

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

    in patients with germ cel…

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

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

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

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

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

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

    Kundu, Shilajit DKundu, Shilajit D
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00213585
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    Study Coordinator 312 695 1102
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    DRUG ME-522-001: A Phase 1, Open-Label, Study of Voruciclib in Subjects with Relapsed and/or Refractory B Cell Malignancies or Acute Myeloid Leukemia After Failure of Prior Standard Therapies
    This study has been designed to look at the safety of voruciclib (also known as the study drug), how your bod…
    This study has been designed to look at the safety of voruciclib (also known as the study drug), how your body tolerates the drug, how effective the drug may be, and how the drug is taken up by your body when administered orally after multiple doses over the course of the study. This study is being conducted to determine the highest safely tolerated dose of voruciclib in patients that have relapsed and/or refractory B cell type cancers or acute myeloid leukemia.
    Must be diagnosed with a certain type of B cell cancer or acute myeloidleukemia (AML) that has relapsed (come back) or is refractory (did not respondto previous treatment). The types of B cell cancers in this study includefollicular lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphoma(MZL), small lymphocytic lymphoma (SLL), chronic lymphocytic leukemia (CLL), ordiffuse large B-cell lymphoma (DLBCL).
    Frankfurt, OlgaFrankfurt, Olga
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03547115 STU00213009
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    Study Coordinator 312 695 1102
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    (xIRB) NCI CIRB ETCTN 10276: A Phase I/II Study of M3814 and Avelumab in Combination with Hypofractionated Radiation in Patients with Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies
    Phase 1:

    The purpose of this study is to test the safety of a drugcalled M3814 in combination with…

    Phase 1:

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

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

    Phase 2:

    Phase 2 has twostudy groups:

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

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

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

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

    Phase 1:

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

    Phase 2:

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

    Kalyan, AparnaKalyan, Aparna
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00213617
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    Study Coordinator 312 695 1102
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    Alliance A021806: A Phase III Trial of Perioperative Versus Adjuvant Chemotherapy for Resectable Pancreatic Cancer

    This study is being done to answer the following question:

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

    This study is being done to answer the following question:

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

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

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

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

    Chawla, AkhilChawla, Akhil
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04340141 STU00213664
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    Study Coordinator 312 695 1102
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    DRUG RPM-CART-001 : An Observational Study to Evaluate a Wearable Temperature Monitoring Device in Subjects Receiving Car-T Therapy
    The study participant will participate in thestudy by wearing a patch and keeping an android phone within range of the patch24-hours a day for 42 days. Patientswill als…
    The study participant will participate in thestudy by wearing a patch and keeping an android phone within range of the patch24-hours a day for 42 days. Patientswill also take their own oral temperature in a place of their choosing 3-4 timesa day.

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

    Karmali, ReemKarmali, Reem
    • Map it 675 N. St. Clair St.
      Chicago, IL
    STU00213145
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    1-855-NU-STUDY
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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
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04417517 STU00213414
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    Study Coordinator 312 695 1102
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    ETCTN 10366: A Phase 1/2 Study of M3814 (Peposertib) in Combination with Hypofractionated Radiotherapy for the Treatment of Locally Advanced Pancreatic Adenocarcinoma
    This research study involves a drug called M3814, which is a drug that inhibits a protein involved in DNA repair process called DNA-Pr…
    This research study involves a drug called M3814, which is a drug that inhibits a protein involved in DNA repair process called DNA-Protein Kinase (DNA-PK). This drug is being tested in combination with radiation therapy. There are two parts to the study, phase 1 & phase 2.Phase 1 is being done to answer the following question: Is M3814 (peposertib) well-tolerated and safe in locally advanced pancreatic cancer patients undergoing radiation therapy? Phase 2 is being done to answer the following question:Can we lower the chance of your locally advanced pancreatic cancer growing or spreading by adding a new drug to the radiation therapy used prior to surgery?We are doing this study because we want to find out if this approach is better or worse than the usual approach for your locally advanced pancreatic cancer. The usual approach is defined as care most people get for pancreatic cancer
    • Participants must be 18 years or older
    • Participants must have a confirmed diagnosis of pancreatic adenocarinoma
    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.
    Hayes, John PHayes, John P
    • Map it 251 E. Huron St.
      Chicago, IL
    STU00213715
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    For more information on this study please contact us:

    Study Coordinator 312 695 1102
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    DRUG ELVCAP-001-01: A Phase 2 Study of Seribantumab in Adult Patients with Neuregulin-1 (NRG1) Fusion Positive Locally Advanced or Metastatic Solid Tumors

    The purpose of this study is to test an experimental drug called seribantumab. This means that seribantumab is still being studied to better un…

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

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

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

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

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

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

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

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

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

    •Induction Treatment period: Weekly visits for 4 weeks.

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

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

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

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

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

    Some of the eligibility criteria include:

    •Age of at least 18 years

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

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

    Chae, Young KwangChae, Young Kwang
    • Map it 251 E. Huron St.
      Chicago, IL
    STU00213426
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    Study Coordinator 312 695 1102
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    (xIRB) NCI CIRB ETCTN 10273: A Phase I Study of M3814 in Combination with MEC in Patients with Relapsed or Refractory Acute Myeloid Leukemia

    The purpose of this study is to test how safe and tolerable the study drug M3814 is in combination with

    the usual drugs, mitoxantrone, etoposide, and …

    The purpose of this study is to test how safe and tolerable the study drug M3814 is in combination with

    the usual drugs, mitoxantrone, etoposide, and cytarabine. We are doing this study because we want to find out if this approach is better or worse than the usual approach to treat acute myeloid leukemia. There are two parts in this study, a dose escalation part and a dose expansion part. You will only be enrolled into one part.

    In the dose escalation part of this study, different people will get different doses of the study drugs M3814 and etoposide. In addition to these study drugs, people will also be given mitoxantrone and cytarabine.

    The first three people taking part in this study will get the lowest dose. If the study drugs did not cause serious side effects, the next group of people in the study will get a higher dose. The study doctor will watch each group carefully as they increase the dose. The doses will continue to increase for every new group until people have serious side effects that require the dose to be lower. Once the highest dose of study drugs that does not cause unacceptable side effects is found, the dose escalation is stopped.

    In the dose expansion part of this study, participants will get the highest dose with manageable side effect. The study drug, M3814 is not approved by the FDA for treatment of AML.

    Participants who decide to take part in this study will get the study drug M3814 in addition to the usual drugs mitoxantrone, etoposide, and cytarabine for up to 28 days, or until their disease gets worse, or side effects become too severe; whichever occurs first. After treatment is finished, participants will be contacted by phone every 3 months for 1 year after the completion of the study and every 6 months thereafter up to 5 years after end of study treatment.

    Participants 18 years of age or older who have acute myeloid leukemia (AML) that has either relapsed or

    become resistant to treatment will be enrolled into this study.

    Frankfurt, OlgaFrankfurt, Olga
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00213762
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    Study Coordinator 312 695 1102
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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
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00213763
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    Study Coordinator 312 695 1102
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    BTCRC LUN19-396: A phase II study of adjuvant treatment with cisplatin-based chemotherapy plus concomitant atezolizumab in patients with stage I (tumors > 4cm), IIA, IIB, and select IIIA [T3N1, T4N0-1] resected non-small cell lung cancer (NSCLC) and the clearance of circulating tumor DNA (ctDNA): Big Ten Cancer Research Consortium BTCRC-LUN19-396
    - Circulating tumor DNA (ctDNA) is genetic material in the bloodstream that comes from yourtumor. The purpose of this study is to estimate how many people with measurable ctDNA in theblood at baseline have unmeasurable ctDNA after receiving 1 year of chemotherapy andatezolizumab.

    - The usual approach for patients who are not in a study is to receive chemotherapy after lungcancer surgery. The goal of chemotherapy is to kill any remaining cancer cells that may be leftafter surgery. This study will add a drug called atezolizumab to the usual chemotherapy drugs.Researchers think atezolizumab will also help kill cancer cells that may be left after surgery.

    - The chemotherapy drugs used in this study are standard drugs used to treat non-small cell lungcancer:

    *Cisplatin is approved by the United States Food and Drug Administration (FDA) for usein advanced testicular, ovarian and bladder cancers.

    *Docetaxel is approved by the FDA for use in advanced non-small cell lung cancer andother cancers.

    *Pemetrexed is approved by the FDA for use in advanced non-small cell lung cancer andmesothelioma (cancer of the lining of the lungs).

    - You should be 18 years and above

    - You should have early stage non-small celllung cancer that has been completely removed by surgery.

    - No prior PD-1 or PD-L1 inhibitors are permitted

    Mohindra, NishaMohindra, Nisha
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04367311 STU00213467
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    Study Coordinator 312 695 1102
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    (xIRB) NCI CIRB SWOG 1905: A Phase I/II Study of AKR1C3-Activated Prodrug OBI-3424 (OBI-3424) In Patients with Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia (T-ALL)/T-Cell Lymphoblastic Lymphoma (T-LBL)

    The purpose of this study is to test the good and bad effects of the drug OBI-3424. <…

    The purpose of this study is to test the good and bad effects of the drug OBI-3424.

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

    In the first phase of the study, different doses of OBI-3424 will be given to several study

    participants. The first several study participants will receive the lowest dose. If the drug does

    not cause serious side effects, it will be given to the next several study participants at a higher

    dose. The doses will continue to increase for every group of study participants until side effects

    occur that require the dose to be lowered. When the maximum dose is reached, the study will be

    expanded to additional patients to learn more about that dose.

    Participants will get OBI-3424 through a vein in their arm on the first and eighth days of each cycle.

    Each cycle lasts 21 days. This study has up to 17 cycles (51 weeks).

    Participants will be followed on this study for 5 years after registration.

    Participants whose leukemia or lymphoma gets better, have two treatment choices that can be made

    with their study doctor. You and your study doctor may decide that it is best to remove you

    from the study drug and for you to get a bone marrow transplant. This is a standard of care treatment

    for your leukemia or lymphoma. If this happens, after you stop taking the study drug,

    your doctor will continue to follow your condition for up to five years and watch you for

    side effects of the study drug.

    The second treatment choice may be that it is best for you to continue on the study drug for up to

    17 cycles. If the leukemia or lymphoma in your body does not get better or if there is still

    leukemia or lymphoma that can be seen in the bone marrow/blood, you will continue on the study

    drug and you will be followed every 3 weeks until the end of treatment. After you finish the

    study treatment, your doctor will continue to follow your condition and watch you for side effects.

    After you finish your study treatment, you will see your doctor every month for the first year

    after treatment. After that, they will check you every 2 months for the second year,

    every 3 months for the third year and then every 6 months until 5 years and watch you for side effects.

    Participants ages 18 years or older who have leukemia or lymphoma that has come back

    or did not go away after treatment will be enrolled into this study.

    Dinner, ShiraDinner, Shira
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00213885
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    Study Coordinator 312 695 1102
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    DRUG UCART123_01: Phase I, Open Label Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Expansion, Persistence and Clinical Activity of UCART123 (Allogeneic Engineered T-cells Expressing Anti-CD123 Chimeric Antigen Receptor), Administered in Patients With Relapsed/Refractory Acute Myeloid Leukemia

    The study involves the use of an investigational medicinal product known as “UCART123” or “study product”.

    UCART123 is a collection of special types of cells called T-cells that have been collected from a healthy donor and then are genetically modified (changed) to help kill leukemic cells. T-cells are related to your immune system, which helps to fight infection.

    UCART123 is an investigational medication. This means that UCART123 is still being studied. It also means that the U.S. FDA and other regulatory authorities do not allow it to be sold for treating patients. The regulatory authorities only allow UCART123 to be used in research.

    The study is being performed to look at:

    •How much of the UCART123 is safe and able to be tolerated

    •How well UCART123 works for the treatment of AML

    •How long it takes for the body to get rid of the UCART123

    •How much UCART123 gets into the bloodstream

    There are 2 phases to the study: (1) dose escalation and (2) dose expansion.

    The goal of Phase 1 of this study, dose escalation, is to test the safety and tolerability of different doses of UCART123 and to find the best dose of UCART123 that can be given to patients with AML that is relapsed (has come back) or refractory (has not responded to treatment).

    The goal of Phase 2 of the study, dose expansion, is to learn about the safety and efficacy of the best dose of UCART123 that can be given in future studies to patients with AML that is relapsed, or refractory.

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

    If you qualify, the study will consist of the following parts:

    Lymphodepletion Period

    After screening, and before you receive UCART123 infusion, you will receive chemotherapy to help prepare your bone marrow and immune system to receive UCART123. This is called lymphodepletion and is needed to prepare you for the UCART123 treatment.

    Treatment Period

    This period will start when you receive the dose of UCART123. From this day you will stay in the hospital for about 2 weeks. You will be discharged once you are deemed fit and well enough for outpatient care and followed up in the outpatient setting. This period will last up to 12 weeks or until your disease progresses whichever comes first. During this period, you will have study tests done to look at the safety and effectiveness of the study product.

    Follow Up Period

    After the Treatment Period, you will enter the Follow-up Period and have study tests done every 3 months for 2 years from your initial UCART123 administration, or until your disease progresses or you withdraw consent, whichever comes first.

    Long-Term Follow-Up Period

    Your health status will be monitored for 15 years. You will not take the study product during this time.

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

    Some of the eligibility criteria include:

    •Diagnosis of Acute Myeloid Leukemia (AML) that has come back or has not responded to treatment.

    •Age of at least 18 years

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

    Dinner, ShiraDinner, Shira
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT03190278 STU00213504
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    Study Coordinator 312 695 1102
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    BTCRC GI15-067: A phase II study to evaluate the efficacy of liposomal irinotecan in combination with oxaliplatin, leucovorin, and 5-fluorouracil for patients with locally advanced pancreatic carcinoma: Big Ten Cancer Research Consortium BTCRC-GI15-067

    The purpose of this voluntary research study …

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

    This study will see if the drugs:

    1.are tolerable as a combination therapy

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

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

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

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

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

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

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

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

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

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

    Some of the eligibility criteria include:

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

    •Age of at least 18 years

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

    Benson III, Al BBenson III, Al B
    • Map it 251 E. Huron St.
      Chicago, IL
    STU00213639
    More Info

    For more information on this study please contact us:

    Study Coordinator 312 695 1102
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