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Trials
NU 05H6: Acute Leukemias and Map Kinase

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

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

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

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

Platanias, Leonidas CPlatanias, Leonidas C
  • Map it 201 E. Huron St.
    Chicago, IL
STU00004841
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NCI 02X3: SPORE in Pancreatic Cancer Tissue Core

The purpose of this research study is to examine many aspects of gastrointestinal disease including pancreatic and colon cancer, including its genetics, its early stages, and the effects of cancer on other tissues such as muscle and adipose (fat) ti…

The purpose of this research study is to examine many aspects of gastrointestinal disease including pancreatic and colon cancer, including its genetics, its early stages, and the effects of cancer on other tissues such as muscle and adipose (fat) tissue. Tissues from patients (with cancer as well as from those without), who are undergoing pancreatic surgery, will be used in this research.

You may be eligible for this research study if you are visiting the high risk clinic and/or are undergoing surgery to remove a portion of your pancreas.

Yang, Guang-YuYang, Guang-Yu
  • Map it 201 E. Huron St.
    Chicago, IL
STU00007180
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NUGene: Gene-Disease Associations and Treatment Outcomes

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

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

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

Must be a patient at Northwestern or one of its affiliates.
Chisholm, Rex LChisholm, Rex L
  • Map it 201 East Huron Street Suite 12-160​
    Chicago, IL
STU00010003
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NU 00X3: Pathology Core Facility

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

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

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

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

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

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

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

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

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

You may be eligible for this research study if you are a woman with breast cancer undergoing biopsy or surgical procedures for the diagnosis, treatment, or prevention of your cancer. 
Wei, Jian-JunWei, Jian-Jun
  • Map it 201 E. Huron St.
    Chicago, IL
STU00023488
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Peripheral Neuropathy Research Registry (PNRR)
National Peripheral Neuropathy Research Registry (PNRR), a collection of different types ofinformation, such as patient medical, family, and social histories and blood samples. Theinformation is carefully maintained so that it can be studied repeatedly i…
National Peripheral Neuropathy Research Registry (PNRR), a collection of different types ofinformation, such as patient medical, family, and social histories and blood samples. Theinformation is carefully maintained so that it can be studied repeatedly in the future. The registryaims to help researchers’ access large amounts of information about people with PN. By using thisregistry, researchers will facilitate both basic and clinical research studies that will bring improvedunderstandings of the etiology (origination) and pathogenesis (development) of PN. They willspecifically ask why some patients with peripheral neuropathy develop neuropathic pain and othersdo not, and what the characteristics of patients with painful peripheral neuropathy are in terms oftheir symptoms, examination findings, and blood tests. Ultimately this research may result inimproved diagnosis, more effective treatments, and possibly prevention.
Inclusion criteria: 1. Diabetic Peripheral Neuropathy 2. Chemo-therapy Induced Peripheral Neuropathy 3. HIV-induced Peripheral Neuropathy 4. Idiopathic Peripheral Neuropathy; Exclusion criteria: Any other type of Peripheral Neuropathy
Ajroud-Driss, SendaAjroud-Driss, Senda
  • Map it 675 N. St. Clair St. Suite 20-100
    Chicago, IL
STU00048864
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NU 04H7: Molecular Mechanisms of Disease Progression in Myeloid Malignancy

In this research project, samples of blood and bone marrow will be studied in the laboratory to learn more about the nature of chronic myelogenous leukemia (CML) cells and how various medications and chemical agents affect …

In this research project, samples of blood and bone marrow will be studied in the laboratory to learn more about the nature of chronic myelogenous leukemia (CML) cells and how various medications and chemical agents affect them.

The purpose of this study is to learn about how CML leukemia cells become resistant to medications or progress to acute leukemia (blast crisis). This may prove to be helpful in the design of new more effective drugs for the treatment of CML in the future.

You may be eligible to take part in this research study if you have been diagnosed with chronic myelogenous leukemia (CML), a chronic form of leukemia, OR if you are a normal individual without any blood disorders.

Eklund, Elizabeth AEklund, Elizabeth A
  • Map it 201 E. Huron St.
    Chicago, IL
STU00039629
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A Randomized Open-Label Pilot Trial to Evaluate the Safety and Efficacy of Repetitive Transcranial Magnetic Stimulation in Cancer Patients with Depression and Anxiety
The primary goals of this study are to determine if rTMS is safe and tolerable in depressed cancer patients and to determine how well …
The primary goals of this study are to determine if rTMS is safe and tolerable in depressed cancer patients and to determine how well these two methods of rTMS work in treating cancer-related depression. You are being asked to take part in this study because you are a cancer patient in remission who is depressed currently. In the future, we hope to be able to use rTMS on depressed cancer patients who are actively receiving cancer treatment. However, since this is a preliminary study, we will only include patients in remission. Finally, anxiety often accompanies depression. So, we are also interested in understanding your current level of anxiety and how rTMS affects any anxiety that you might have. Your participation in this study will last for approximately seven weeks and will involve 31 visits.
Dokucu, Mehmet EDokucu, Mehmet E
NCT01701284 STU00063218
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The Genetics of Prostate Cancer in Active Surveillance
Our study uses saliva samples to detect whether or not active surveillance is the best option for the subject, based on their their genetic makeup and susceptibility to aggressive prostate cancer.
1. Patients diagnosed with prostate cancer
2. Patients with Gleason ≤ 3+3 prostate cancer
3. Patients with fewer than 3 cores involved with cancer. If a patient has 3 or more cores involved with cancer but still meets all pathologic criteria and after discussing risks and benefits does not want definitive treatment, he may still be eligible for active surveillance.
4. Patients with no more than 50% of any 1 core involved with prostate cancer. If a patient has more than 50% of any 1 core involved with prostate cancer but still meets all pathologic criteria and after discussing risks and benefits does not want definitive treatment, he may still be eligible for active surveillance.
5. Patients age > 18. Patients are typically offered AS if they are ≥ 60 years of age. However, if a man meets pathologic criteria and is < 60, he can be entered in AS if, after discussing risks and benefits, does not want definitive treatment.
6. Most patients will have PSA value ≤ 10 ng/ml. However, since PSA is prostate specific and not prostate cancer specific, many patients with elevated PSA levels > 10 ng/ml will not have prostate cancer, and PSA is elevated due to conditions such as BPH or inflammation. If a patient has a PSA value > 10 ng/ml, but still meets all pathologic criteria, he may still be eligible for active surveillance
Kundu, Shilajit DKundu, Shilajit D
  • Map it 201 E. Huron St.
    Chicago, IL
STU00059221
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NCI 12H13: Molecular Mechanisms of Relapse After Therapy Discontinuation in Chronic Myeloid Leukemia

In this research study, samples of bone marrow or peripheral blood will be collected from patients with chronic myeloid leukemia (CML) to learn more about the effect of some new drugs on CML cells …

In this research study, samples of bone marrow or peripheral blood will be collected from patients with chronic myeloid leukemia (CML) to learn more about the effect of some new drugs on CML cells in the laboratory. The purpose of this study is to understand how these new drugs stop leukemia cells from growing. This research may prove to be helpful in the design of new and more effective treatments for leukemia in the future.

You may be eligible for this research study if you have been diagnosed with chronic myeloid leukemia, a cancer of the blood and are scheduled to have a bone marrow biopsy.

Eklund, Elizabeth AEklund, Elizabeth A
  • Map it 201 E. Huron St.
    Chicago, IL
STU00074258
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NUDB 13C03: Northwestern Brain Tumor Institute Research Database

The Northwestern Brain Tumor Institute (NBTI) currently uses an electronic database to collect and store information about patients who come to the NBTI for evaluations, including diagnosis, treatment, follow-up, and/or to obtain add…

The Northwestern Brain Tumor Institute (NBTI) currently uses an electronic database to collect and store information about patients who come to the NBTI for evaluations, including diagnosis, treatment, follow-up, and/or to obtain additional opinions. This database is called the Northwestern Brain Tumor Institute Database or NBTIDB, and it was developed to replace older paper methods for collecting and storing information.

The purpose of this study is to allow researchers involved with the NBTIDB to use data stored in it for future research studies and projects. The NBTIDB also allows researchers to track whether or not patients have agreed to allow their information to be linked to their leftover tissue samples, which are kept in the hospital’s pathology department, for future research studies.

You may be eligible to take part in the research component of the NBTIDB if you are either a new or returning patient, over the age of 18, who is being seen by one of the clinicians at the NBTI and are or will be entered into the NBTIDB, or a patient who is not coming to the NBTI for evaluation, but would still like to participate in the NBTIDB.

Kumthekar, Priya UKumthekar, Priya U
  • Map it 201 E. Huron St.
    Chicago, IL
STU00087359
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A 36 month multi-center, open label, randomized, comparator study to evaluate the efficacy and safety of everolimus immunosuppression treatment in liver transplantation for hepatocellular carcinoma exceeding Milan criteria.
This study is a prospective Phase IV study to determine if the …
This study is a prospective Phase IV study to determine if the use of Everolimus results in lower liver tumor recurrence and improved patient and graft survival after liver transplant for hepatocellular carcinoma (HCC). The immunosuppressive comparators will be Everolimus and Tacrolimus therapy compared to Tacrolimus and Mycophenolic acid/Mycophenolate Mofetil. Primary outcomes data is disease free survival (the time from randomization to HCC recurrence or death). Secondary outcomes are rate of recurrence of Hepatitis C, problems related to wound healing, hernia repair within the first 12 months, hepatic arterial thrombosis, renal function, acute cellular rejection, post-transplant diabetes, hypertension, and hyperlipidemia.
Kulik, Laura MKulik, Laura M
NCT02081755 STU00083409
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B-WELL-Mom (Breathe-Wellbeing, Environment, Lifestyle, and Lung Function)
This NIH funded research study is to better understand how the lungs function during pregnancy and how the immune system responds to pregnancy. This study will help us to better understand why some women with asthma experience…
This NIH funded research study is to better understand how the lungs function during pregnancy and how the immune system responds to pregnancy. This study will help us to better understand why some women with asthma experience worsening of their symptoms while others improve. Because pregnancy affects lung function and immune response of all women, we are looking for both women with and without asthma to participate. The study consists of 4 clinic visits (1st, 2nd, and 3rd trimesters of pregnancy and 4 months postpartum), and an at-home diary.
-Pregnant women at least 18 years old.
-Less than 15 weeks pregnant with a single baby.
-Women with and without asthma are eligible to participate. -No diagnosis of Multiple Sclerosis, Lupus, Rheumatoid Arthritis, HIV, or Mixed Connective Tissue Disease.
Grobman, William AGrobman, William A
STU00093038
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Development of a Kidney Cancer Patient Outcomes Database
Purpose This study is evaluating an on-line registry for kidney cancer patients called ‰ÛÏMyQOL,‰Û which stands for My Quality of Life. Overview A registry is a repository (database) of information about a group of people who …
Purpose This study is evaluating an on-line registry for kidney cancer patients called ‰ÛÏMyQOL,‰Û which stands for My Quality of Life. Overview A registry is a repository (database) of information about a group of people who share a common characteristic - in this case, kidney cancer. MYQOL registry participants enter information about their disease, treatment, symptoms, health status, and quality of life into an on-line, password-protected database on a regularly scheduled basis. Participants can use the registry to track many of their symptoms and their health status over time and to compare themselves (anonymously) with other groups of people (for example, how their level of fatigue compares with the average level of fatigue reported by other participants in the registry). Participants can also choose to share relevant information about themselves (from the registry) with their health care provider(s), by printing copies of their completed forms. Registry participants will be offered opportunities to join in other research studies when available. Description of Treatment Participants in this study will be asked to do the following for a 1-year trial period: 1) enroll in the on-line registry; 2) complete questionnaires about their health and treatment every 3 months ; and 3) be willing to have MYQOL researchers contact them confidentially about participating in other research studies. This does not mean that participants are obligated to participate in future research studies; only that they agree to be contacted.
Some of the eligibility criteria include:

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

Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Cella, DavidCella, David
  • Map it 201 E. Huron St.
    Chicago, IL
STU00070200
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NRG HN001: Randomized Phase II And Phase III Studies of Individualized Treatment for Nasopharyngeal Carcinoma Based on Biomarker Epstein Barr Virus (EBV) Deoxyribonucleic Acid (DNA)
There are two study questions the investigators are asking in this randomized phase II/III trial b…
There are two study questions the investigators are asking in this randomized phase II/III trial based on a blood biomarker, Epstein Barr virus (EBV) deoxyribonucleic acid (DNA) for locoregionally advanced non-metastatic nasopharyngeal cancer. All patients will first undergo standard concurrent chemotherapy and radiation therapy. When this standard treatment is completed, if there is no detectable EBV DNA in their plasma, then patients are randomized to either standard adjuvant cisplatin and fluorouracil chemotherapy or observation. If there is still detectable levels of plasma EBV DNA, patients will be randomized to standard cisplatin and flurouracil chemotherapy versus gemcitabine and paclitaxel. Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, fluorouracil, gemcitabine hydrochloride, and paclitaxel work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving cisplatin and fluorouracil is more effective than gemcitabine hydrochloride and paclitaxel after radiation therapy in treating patients with nasopharyngeal cancer.
Mittal, Bharat BMittal, Bharat B
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02135042 STU00200330
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Ex vivo interactions between high-density-like nanoparticles and human blood
This research is significant because the high-density lipoprotein like nanoparticles (HDL-NPs) being investigated have been shown to have tremendous therapeutic properties when evaluated in in vitro and in vivo settings. Pr…
This research is significant because the high-density lipoprotein like nanoparticles (HDL-NPs) being investigated have been shown to have tremendous therapeutic properties when evaluated in in vitro and in vivo settings. Prior to initiating large-scale in vivo animal and human studies it is imperative that we obtain an in-depth knowledge of the interaction of the HDL-NPs with human blood cells using safe ex vivo experiments.
Healthy, non-pregnant adult (age >18-75 years) volunteers.
Thaxton, Colby SThaxton, Colby S
  • Map it 201 E. Huron St.
    Chicago, IL
STU00200368
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NCI 15H01: Triad1 Regulates Myelopoiesis and Functions as a Leukemia Suppressor

Researchers have found that about 60% of patients with acute myeloid leukemia (AML) will obtain a remission following treatment with combinations of chemotherapy drugs. However, relapse after treatment remains a proble…

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

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

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

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

Eklund, Elizabeth AEklund, Elizabeth A
  • Map it 201 E. Huron St.
    Chicago, IL
STU00200435
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A large-scale multicenter phase II study evaluating the protective effect of a tissue selective estrogen complex (TSEC) in women with newly diagnosed ductal carcinoma in situ.
The main purpose of this study is to determine if taking the study drug, conjugated estrogens/bazedoxife…
The main purpose of this study is to determine if taking the study drug, conjugated estrogens/bazedoxifene (Duavee®) causes any changes in the proliferation markers within the breast tissue of the study subjects. The study drug is approved by the US Food and Drug Administration in healthy postmenopausal women to treat certain symptoms of menopause such as hot flashes. Since it is not approved in women with DCIS, its use in this study is experimental. This study will also look at whether taking the study drug causes any significant or undesirable side effects in women with DCIS. The researchers hope that this study will help them determine if taking the study drug is safe in women taking DCIS and if it can possibly reduce the risk of developing breast cancer in women with DCIS.
Some of the eligibility criteria include:

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

Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Kulkarni, SwatiKulkarni, Swati
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02694809 STU00202100
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NU 15N01: Head and Neck Tissue Bank

Researchers would like to create a bio-specimen bank of tissue, blood, urine and saliva, which would then be used to study cancer and find better ways to detect, prevent, diagnose, treat and provide better care for future patients. Some of these studies may be a…

Researchers would like to create a bio-specimen bank of tissue, blood, urine and saliva, which would then be used to study cancer and find better ways to detect, prevent, diagnose, treat and provide better care for future patients. Some of these studies may be about how genes affect the development of cancer, response or resistance to treatment as well as prognosis (course of disease and overall outcome including survival). Other studies may aim to identify measurable substances in the blood and/or urine (known as biomarkers) that can indicate early development of cancer, worsening or relapse of disease and response to treatment. Some studies may lead to new products, such as drugs or tests for detection of cancer.

You may be eligible to take part in our head and neck specimen banking study if you have one of the following conditions:

a) You have a tumor or an abnormal area in the head and neck area, suspicious for cancer, or pre-cancerous condition or other pathology of interest, and you’re scheduled to have biopsy and/or surgery at Northwestern Memorial Hospital.

b) You will receive treatment and/or regular follow up for further management for your head and neck cancer or precancerous condition, or other pathology at Northwestern Memorial Hospital and/or Northwestern Medicine Developmental Therapeutics Institute (NMDTI).

Samant, SandeepSamant, Sandeep
  • Map it 201 E. Huron St.
    Chicago, IL
STU00202177
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NU 15N02: Northwestern Head and Neck Cancer Registry

The purpose of this registry is to collect clinical information on all consenting head and neck cancer patients seen at the Northwestern Medical Group (NMG) or Northwestern Memorial Hospital (NMH). With this information, researchers will conduct…

The purpose of this registry is to collect clinical information on all consenting head and neck cancer patients seen at the Northwestern Medical Group (NMG) or Northwestern Memorial Hospital (NMH). With this information, researchers will conduct studies to learn more about the subtypes of head and neck cancers and determine the most effective treatments. The registry will also allow us to identify possible subjects for future studies.

You may be eligible to take part in this research study if you are being treated or have been treated for a tumor or cancer of the head and neck.

Samant, SandeepSamant, Sandeep
  • Map it 201 E. Huron St.
    Chicago, IL
STU00202162
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Culturally Adapted Cognitive Behavioral Stress and Self-Management (C-CBSM) Intervention for Prostate Cancer
Este estudio está diseñado para ayudar a los hombres a mejorar la calidad de vida y reducir los síntomas del cáncer de próstata. El estudio imparte habilidades de manejo de estrés y prom…
Este estudio está diseñado para ayudar a los hombres a mejorar la calidad de vida y reducir los síntomas del cáncer de próstata. El estudio imparte habilidades de manejo de estrés y promueve la salud. Este programa de salud e intervención para hombres diagnosticados con cáncer de próstata, ofrece información sobre cómo reducir el estrés y aprender a relajarse. Este estudio dentro Northwestern University está financiado por el Instituto Nacional del Cáncer. El objetivo del estudio es examinar cómo los programas de salud pueden mejorar la calidad de vida de los hombres tratados por cáncer de próstata.
(a) ≥ 18 years of age;
(b) Hispanic/Latino self-identification;
(c) Spanish speakers (including bilinguals who express interest in a Spanish-based psychosocial intervention); (d) Willingness to be randomized and followed for approximately 12 months.
(d) Primary diagnosis of localized Prostate Cancer (T1-T3, N0, M0);
(e) Surgical or radiation treatment (e.g., external beam, brachytherapy, proton) within the past 48 months prior to participating in the study
Miller, GregMiller, Greg
  • Map it 633 N. St. Clair St.
    Chicago , IL
NCT03344757 STU00203197
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NU 15U06: A Phase 1 Dose-Escalation Study of Intravesical Pembrolizumab and Bacillus Calmette-Guerin (BCG) in Subjects with High Risk and BCG-Refractory Non-Muscle-Invasive Bladder Cancer
Purpose The purpose of this study is to evaluate the efficacy (the effect of drug on tumor) and the tolerabili…
Purpose The purpose of this study is to evaluate the efficacy (the effect of drug on tumor) and the tolerability (the effect of drug on the body) of Pembrolizumab, when given as a single agent in patients with bladder tumors. Another purpose of the study is to see what tumor characteristics are associated with increased efficacy of the Pembrolizumab. Overview Pembrolizumab (MK-3475) is an antibody (a human protein that sticks to a part of the tumor and/or immune cells) designed to allow the body‰Ûªs immune system to work against tumor cells. Pembrolizumab is FDA approved for the treatment of advanced melanoma (a type of skin cancer) and some types of lung cancer. It is not yet approved by the USFDA for bladder cancer, hence it is considered an investigational agent for this disease. Description of Treatment All study participants will take the same study drug, Pembrolizumab. Pembrolizumab will be given intravesically through urethra. With intravesical therapy, doctor administers the drug directly into the bladder (through a catheter), rather than giving it by mouth or injecting it into a vein. During the first six weeks of therapy, one will also receive treatment with BCG as a standard of care. We expect that one will receive treatment for up to 1 year or until your disease gets worse (whichever occurs first). After completing treatment, the study team will continue to watch you for side effects for at least 30 days. The study team will also continue to check periodically to see how you are doing until your disease returns.
Some of the eligibility criteria include:

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

Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Meeks, Joshua JMeeks, Joshua J
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02808143 STU00202754
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A Double Blind, Randomized, Vehicle Controlled, Crossover Study to Evaluate the Safety and Efficacy of Topical Naloxone Hydrochloride Lotion 0.5% for the Relief of Pruritus in Patients with the Mycosis Fungoides (MF) or Sézary Syndrome (SS) Forms of Cutaneous T-Cell Lymphoma (CTCL)
The main goal of …
The main goal of this study is to test the efficacy and safety of topical Naloxone for itching in patients with MF.
21 years of age or older with a diagnosis of mycosis fungoides (MF) with itching present on a daily basis for more than one month and willing to fill out a diary for 7 days to provide severity of itch before enrollment.
Guitart, JoanGuitart, Joan
  • Map it 676 N. St. Clair St.
    Chicago, IL
NCT02811783 STU00203078
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Phase II Multicenter Study of Natalizumab Plus Standard Steroid Treatment for High Risk Acute Graft-Versus-Host Disease

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

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

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

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

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

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

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

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

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

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

- Adults at least 18 years of age

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

- Have an IDH1 or IDH2 gene mutation

- Not candidates to receive intensive IC.

Frankfurt, OlgaFrankfurt, Olga
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02677922 STU00203231
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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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Physical activity and DNA methylation among women with high breast density
The purpose of this study is to learn more about how physical activity may influence your genes through a mechanism called DNA methylation. Our goal is to determine if being physically active may be associated with a healthy p…
The purpose of this study is to learn more about how physical activity may influence your genes through a mechanism called DNA methylation. Our goal is to determine if being physically active may be associated with a healthy pattern of DNA methylation in your immune system cells. Exercising and being physically active are believed to be important for preventing cancer. It may be particularly important for women with high breast density, and may help reduce risk for breast cancer. However, we do not understand what physical activity changes within the body to alter risk of breast cancer. DNA methylation is a biological process that may help explain the relationship between physical activity and cancer risk.
Generally healthy women with a history of heterogeneously or extremely dense breasts, aged 40-74 with no history of cancer (other than non-melanoma skin cancer), diabetes, and cardiovascular disease.
Hibler, Elizabeth AHibler, Elizabeth A
  • Map it 680 N. Lake Shore Drive Suite 1410
    Chicago, IL
STU00204639
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Melanoma and Skin Cancer Tissue Repository

The purpose of this study is to allow researchers studying and treating melanoma and other cancers to have access to tissue for research purposes only. Northwestern University may use your medical record information, as well as tumor, blood, saliva, urine…

The purpose of this study is to allow researchers studying and treating melanoma and other cancers to have access to tissue for research purposes only. Northwestern University may use your medical record information, as well as tumor, blood, saliva, urine, and fecal samples (collectively called “tissue”) for research studies to help us understand melanoma and other skin cancers. Biopsies and surgery of your cancer will not be a part of this study but will be performed as part of your standard care.

You may be eligible to take part in the research component of the Northwestern Melanoma and Skin Cancer Tissue Repository if you are either a new or returning patient and have a skin cancer or pre-cancer lesion.

Sosman, Jeffrey AlanSosman, Jeffrey Alan
  • Map it 201 E. Huron St.
    Chicago, IL
STU00204151
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The Role of Positron Emission Tomography and Magnetic Resonance Imaging (without Fluorodeoxyglucose or Gadolinium) in Yttrium-90 Radioembolization Treatment Planning for Patients with Liver Malignancies
Patients who are already scheduled to receive Y90 radioembolization, will first be treated with Y9…
Patients who are already scheduled to receive Y90 radioembolization, will first be treated with Y90 radioembolization for liver cancer or metastasis in the liver.  They will then have a Positron Emission Tomography (PET/MR) scan done a few hours after the treatment. You will be placed inside a small tube for 2-3 hours for the PET/MR scan.  There is no contrast or radiation involved in the PET/MR scan.  The purpose of the PET/MR scan is to capture specific images of the liver to see where the Y90 radioactive particles are a few hours after treatment.  These images will be used to compare determine how much of the radioactive particles went to the tumor(s) compared to how much of them went to healthy liver tissue.  We hope to use this information to help develop care that is more specific to the patient.
Inclusion Criteria (patients must meet these criteria):

1. 18 years of age or older.

2. Diagnosed with primary liver cancer or metastasis in the liver.

3. Planning to have Y90 radioembolization treatment at Northwestern Medicine.

4. Be able to have an MRI- not claustrophobic or have any other contraindications to MRI.

Riaz, AhsunRiaz, Ahsun
STU00205918
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Clinical Database of Prostate Cancer at Northwestern University
The goal of this study is to create a database of prostate cancer patients at Northwestern Memorial Group to better understand, learn about, prevent, treat or cure prostate cancer.
Men ages 18-89 years daignosed with prostate cancer.
Schaeffer, Edward MatthewSchaeffer, Edward Matthew
STU00206270
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PET/MRI using [18F]-DCFPyL for the Staging of Newly Diagnosed Prostate Cancer
This research study involves the use of a scanner that is capable of taking PET and MR images at the same time. A PET scan is a test that uses radioactive glucose (sugar) and a computer to create images of how organs and ti…
This research study involves the use of a scanner that is capable of taking PET and MR images at the same time. A PET scan is a test that uses radioactive glucose (sugar) and a computer to create images of how organs and tissues in the body are functioning. Abnormal cells in the body use glucose at a different rate than normal cells and this allows the scanner to create a detailed picture of how your body is working. A MR scan uses strong magnets and computers to created detailed images of the soft tissue in your body. The purpose of this study is to gain understanding how PET-MR (positron emission tomography-magnetic resonance imaging) using the substance 18F-DCFPyL (PyL) may help in diagnosing prostate cancer and in determining the stage of prostate cancer before surgery.
Men with biopsy-proven prostate cancer and a diagnosis of high risk, very high risk or locally advanced prostate cancer per NCCN guidelines.
Schaeffer, Edward MatthewSchaeffer, Edward Matthew
NCT03392181 STU00205957
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Palbociclib after CDK and Endocrine Therapy (PACE): A Randomized Phase II study of Fulvestrant, Palbociclib, and Avelumab for Endocrine Pre-treated ER+/HER2- Metastatic Breast Cancer

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

  • Ar…

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    Karmali, ReemKarmali, Reem
    • Map it 201 East Huron Street Suite 12-160​
      Chicago, IL
    NCT03704714 STU00207793
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    (xIRB NCI CIRB) ALLIANCE A041501: A PHASE III TRIAL TO EVALUATE THE EFFICACY OF THE ADDITION OF INOTUZUMAB OZOGAMICIN (A CONJUGATED ANTI-CD22 MONOCLONAL ANTIBODY) TO FRONTLINE THERAPY IN YOUNG ADULTS (AGES 18-39 YEARS) WITH NEWLY DIAGNOSED PRECURSOR B-CELL ALL
    The first purpose of this study is to te…
    The first purpose of this study is to test the safety of adding a new drug called inotuzumab to the usual chemotherapy drugs. The second purpose of this study is to compare any good and bad effects of using inotuzumab along with the usual chemotherapy treatment to using the usual treatment alone. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach. Inotuzumab is investigational and is not FDA-approved.
    You may be able to take part in this study if you have acute lymphoblastic leukemia (ALL) and are 18 to 39 years old.
    Dinner, Shira NaomiDinner, Shira Naomi
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03150693 STU00208162
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    The effect of inflammatory bowel disease flares on serum prostate specific antigen
    This study will measure PSA values in men with IBD before, during, and following a flare. In addition, the effect of any PSA increase will be analyzed and correlated to the location of the disease (rectal vs. other). S…
    This study will measure PSA values in men with IBD before, during, and following a flare. In addition, the effect of any PSA increase will be analyzed and correlated to the location of the disease (rectal vs. other). Study findings may help men with IBD by identifying pitfalls in prostate cancer screening for this population and help to stratify and understand the effect IBD has on the prostatic milieu. By optimizing how men with IBD are screened for prostate cancer, future unnecessary healthcare encounters and expenditures may be reduced for this patient group.
    Men with a confirmed diagnosis of inflammatory bowel disease (IBD) between the ages of 40-69 years old.
    Kundu, Shilajit DKundu, Shilajit D
    NCT03558048 STU00207583
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    Mobile – PrOmoting Wellness after cancER Study: M-POWER Feasibility Study

    M-POWER is an 8-week weight loss study in the Department of Preventive Medicine at Northwestern University. The participant will be given a smartphone application and have weekly telephone calls with health coaches. Partic…

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

    You are a cancer survivor (breast, melanoma, prostate or colorectal) between the ages of 18 and 84 years old. You own a smartphone; you are living with obesity and willing to participate in a weight-loss research study that focuses on health behavior changes.
    Spring, BonnieSpring, Bonnie
    • Map it 680 N. Lake Shore Drive Suite 1410
      Chicago, IL
    STU00207968
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    NU 18I01: A Phase 2 study of pembrolizumab in combination with pelareorep in patients with advanced pancreatic adenocarcinoma
    This study involves the use of an investigational drug called pelareorep (Reolysin®).“Investigational” means that the drug pelareorep has not been approved by the U.S. Fo…
    This study involves the use of an investigational drug called pelareorep (Reolysin®).“Investigational” means that the drug pelareorep has not been approved by the U.S. Food &Drug Administration (FDA) for treating pancreatic adenocarcinoma.The primary goal is to see if a treatment using both pelareorepand pembrolizumab has any effect on pancreatic cancer and also to evaluate the safety ofthis combination of these two drugs. Pelareorep is an investigational product that uses a type ofvirus called reovirus. This virus is commonly found in natural environments throughout the world(such as ponds) and is associated with minor breathing difficulties and stomach upsets inhumans. Infection of cancer cells by this virus is expected to be able to slow cancer lesiongrowth and kill cancer cells.  Pembrolizumab is a drug thatworks on stimulating the immune system to fight the cancer cells and it is currently approvedfor the treatment of other tumors (melanoma and lung). It is not presently known if it will help inthe treatment of pancreatic cancer. The combination of pembrolizumab and pelareorep isexpected to be able to determine if pelareorep will or will not stimulate the immune systemand make it more responsive to therapy with pembrolizumab.
    Participants with advancedpancreatic adenocarcinoma.
    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03723915 STU00207577
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    (xIRB) DRUG 017004: An Open-Label, Phase 1 Safety and Phase 2 Randomized Study of JCAR017 in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (017004)
    JCAR017 is an investigational treatment. Investigational means that it is an experimental therapy that …
    JCAR017 is an investigational treatment. Investigational means that it is an experimental therapy that has not yet been approved for sale or use to the public by the United States Food and Drug Administration (FDA). This study is designed to test the safety and effectiveness of a new approach to treating Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma. This study has many parts and you will be asked to participate in one portion of the study. The Phase 1 portion of the study will evaluate whether the treatment works in treating your cancer. In the Phase 1 portion, you may be required to be on another cancer treatment called ibrutinib (IMBRUVICA®). Your study doctor will tell you which group you are eligible to be treated on. The Phase 2 is designed to assess JCAR017 as treatment versus standard of care. The approach involves modifying the patient's own immune cells, called T cells, to enable them to kill their cancer cells. T cells fight infections and can also kill cancer cells in some cases. In most cases, a patient's T cells are not able to kill their own cancer cells. In this study, some of the patient's T cells are removed from their blood, modified in a laboratory, and then given back to them by intravenous (IV) injection. While in the laboratory, researchers will put a new gene into the T cells that allows the patient's T cells to then recognize and kill the lymphoma cells. The method of putting the gene into the T cells uses a weakened virus that cannot multiply or spread. T cells that have genes added in the laboratory are called “genetically modified T cells” or “chimeric antigen receptor T cells (CAR T cells)”. When the genetically modified T cells recognize and attach to cancer cells, they have the ability to become activated and kill them. The modified T cells do not appear to recognize other normal cells in the body, with the exception of normal B cells. However, studies have shown that normal B cells will return after being treated with the modified T cells.
    • Participants must have any of the following types of lymphoma: Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
    • You must have received 2 or 3 prior treatments for your CLL or SLL
    • Participants must have cancer that has returned or has not responded to other treatment.
    • Participants must be 18 or older
    Ma, ShuoMa, Shuo
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT03331198 STU00208648
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    (xIRB NCI CIRB) CCTG MA.39: TAILOR RT: A Randomized Trial Of Regional Radiotherapy In Biomarker Low Risk Node Positive Breast Cancer
    In addition to endocrine therapy and possibly chemotherapy, many women with node positive breast cancer will also receive radiotherapy to the whole breast/chest area an…
    In addition to endocrine therapy and possibly chemotherapy, many women with node positive breast cancer will also receive radiotherapy to the whole breast/chest area and the surrounding lymph glands (called regional radiotherapy). Because no one really knows whether patients with low risk breast cancer need to receive regional radiotherapy, it is possible that some women who get it may not actually need it. These women may be exposed to the side effects of their treatment without benefit. The purpose of this study is to learn if not giving regional radiotherapy is just as good as using regional radiotherapy by comparing any good and bad effects of both approaches. The study has two randomly assigned study groups; Group 1 will receive regional radiotherapy and Group 2 will not. 
    Patients who are of 40 years of age or older may be able to take part in this study if they have newly diagnosed breast cancer that has been treated with breast-conserving surgery or mastectomy and has not spread to other parts of the body.
    Donnelly, Eric DonaldDonnelly, Eric Donald
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03488693 STU00208897
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    NU 18I03: Pilot study of nivolumab in combination with Therasphere (yttrium-90) for treatment of hepatocellular carcinoma (HCC) with intent for resection
    The purpose of this study is to evaluate the feasibility of using nivolumab in combination with Y90(Therasphere) to decrease the occurrence of your…
    The purpose of this study is to evaluate the feasibility of using nivolumab in combination with Y90(Therasphere) to decrease the occurrence of your HCC from coming back. Also another purposeis to evaluate the efficacy (the effect on the tumor) of nivolumab, when given with standard ofcare Y-90 (Therasphere) in patients. Another purpose of the study is to see what tumor characteristics are different among patientswho undergo resection versus those who do not undergo resection. 
    Participants who have advancedhepatocellular carcinoma (HCC). 
    Kulik, Laura MKulik, Laura M
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03812562 STU00208542
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    Technology-Supported Physical Activity Intervention for Metastatic Breast Cancer Survivors:Fit2ThriveMB

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

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

    Females 18 years of age or older

    Diagnosis of metastatic breast cancer

    Fluent in spoken and written Englsh

    Own a smartphone and have access to the internet

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

    Phillips, Siobhan MPhillips, Siobhan M
    STU00208930
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    Hood, Susan
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    An Open Label, Pilot Study Evaluating the Effect of Low-Dose Oral Minoxidil as Treatment of Permanent Chemotherapy-Induced Alopecia

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

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

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

    Choi, Jennifer NamChoi, Jennifer Nam
    • Map it 676 N. St. Clair St.
      Chicago, IL
    NCT03831334 STU00206882
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    NU 18B05: A Phase II Study of the Determinants of Transdermal Drug Delivery to the Normal and the Radiated Breast
    The benefits of anti-estrogen medications taken by mouth as pills (such as tamoxifen) are well-proven to reduce the risk of breast cancer in studies with more than 10 years of follow up. …
    The benefits of anti-estrogen medications taken by mouth as pills (such as tamoxifen) are well-proven to reduce the risk of breast cancer in studies with more than 10 years of follow up. However, because tamoxifen is taken by mouth, it circulates through the whole body and may cause harmful effects to other organs. When tamoxifen is taken by mouth, it is broken down by the liver into two main active forms, one of which is 4-hydroxytamoxifen, also called 4-OHT. Tamoxifen is approved by the Food and Drug Administration (FDA) while 4-OHT is not and is, therefore, considered investigational. However, 4-OHT has anti-cancer activity, and has been developed as a quick drying medicated gel that can be applied to the breast skin. Early results from two previous studies show that 4-OHT gel, when applied to the skin, gets into the breast and blocks breast cancer cell growth as effectively as oral tamoxifen. Unlike oral tamoxifen, the gel is concentrated in the breasts and therefore very little tamoxifen reaches the blood or other parts of the body. Also, some women lack the proteins that are responsible for the break-down of tamoxifen. It is possible that the use of 4-OHT gel will be more effective than oral tamoxifen in these women.
    Patients who had radiation for breast cancer in one breast and their other breast has not undergone radiation
    Khan, Seema AhsanKhan, Seema Ahsan
    • Map it 250 E. Superior St.
      Chicago, IL
    NCT04009044 STU00208708
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    (xIRB NCI) SWOG 1706: A Phase II Randomized Trial of Olaparib (NSC-747856) Administered Concurrently with Radiotherapy versus Radiotherapy Alone for Inflammatory Breast Cancer

    The purpose of this study is to determine if including thedrug olaparib taken along with radiation treatment decreases the…

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

    inflammatory breast cancer who have already had chemotherapy and surgery to remove the cancer
    Donnelly, Eric DonaldDonnelly, Eric Donald
    • Map it 201 East Huron Street Suite 12-160​
      Chicago, IL
    NCT03598257 STU00209490
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    DRUG U31402-A-J101: Phase 1/2, Multicenter, Open-label, Multiple Dose First-In-Human Study of U3-1402, in Subjects with HER3 Positive Metastatic Breast Cancer
    In this study we are looking to see whether U3-1402 has any effect on slowing tumor growth inbreast cancer that progressed after previous trea…
    In this study we are looking to see whether U3-1402 has any effect on slowing tumor growth inbreast cancer that progressed after previous treatments. The purpose of the study is tounderstand U3-1402 for its safety, how well it works, and how well it is tolerated.U3-1402 is an investigational drug being developed to be given in breast cancer. Aninvestigational drug is a medication that has not been approved by the United States (US) Foodand Drug Administration (FDA). The FDA allows U3-1402 to be used only in research.U3-1402 is a monoclonal antibody that has chemotherapy attached to it. A monoclonal antibody isa molecule that is made to target a specific cancer cells and may affect normal cells.Chemotherapy is a type of cancer treatment that kills cells that grow and divide quickly. This caninclude cancer cells or normal cells. U3-1402 is designed to bring chemotherapy inside HER3-positive cancer cells and kill them. HER3 is one of a number of proteins that are thought to beelevated in breast cancer. A protein is a large molecule that is important for many of the processesthat happen in and around cells in the body. 
    You may be eligible for this research study if you have breast cancer and your cancer has grown after prior treatments. Along with that your tumor tissue tested should have showed your cancer to be HER3 positive.
    Gradishar, William JGradishar, William J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02980341 STU00208625
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    (xIRB) NRG-BN005 A Phase II Randomized Trial of Proton vs. Photon Therapy (IMRT) for Cognitive Preservation in Patients with IDH Mutant, Low to Intermediate Grade Gliomas.

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

    therapy. Photon…

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

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

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

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

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

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

    -Participants must be 18 years of age or older

    -Participants must be diagnosed with a brain tumor

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

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

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

    • Participants must be18 years or older
    • Participants must bediagnosed with non-small cell lung cancer
    Chae, Young KwangChae, Young Kwang
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT03851445 STU00209659
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    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, David JamesVanderWeele, David James
    • 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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    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
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00209847
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    A Randomized Phase III Study of Ibrutinib Plus Obinutuzumab Versus Ibrutinib Plus Venetoclax and Obinutuzumab in Untreated Older Patients (= 70 Years of Age) with Chronic Lymphocytic Leukemia (CLL)

    This study is being done to answer the following questions:

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

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

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

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

    In order to participate in this study, your Merkel cell carcinoma cells must be a certain type of cell, called “p53 wild type” cells (p53wt).
    Chandra, SunandanaChandra, Sunandana
    NCT03787602 STU00209401
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    A041702: A Randomized Phase III Study of Ibrutinib Plus Obinutuzumab Versus Ibrutinib Plus Venetoclax and Obinutuzumab in Untreated Older Patients (= 70 Years of Age) with Chronic Lymphocytic Leukemia (CLL)
    This study is being done to answer the following questions:1. Is adding a new anti-cancer drug…
    This study is being done to answer the following questions:1. Is adding a new anti-cancer drug (venetoclax) to the usual treatment (ibrutinib plusobinutuzumab) better, the same as, or worse than the usual treatment alone for untreatedolder patients with CLL?2. Can patients who have no detectable CLL after a year of receiving the usual treatmentplus the new anti-cancer drug discontinue therapy? 
    Some of the eligibility criteria include: - Participants must have intermediate or high-risk chronic lymphocyticleukemia that has not been treated before - Participants must be 18 or older - Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
    Ma, ShuoMa, Shuo
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03737981 STU00210225
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    Yttrium-90 Radiation Lobectomy: Dose Optimization and Prediction of FLR Hypertrophy to Enable Resection of Hepatic Malignancies

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

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

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

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

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

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

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

    You are eligible to participate in this study if:

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

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

    Lewandowski, Robert JLewandowski, Robert J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04390724 STU00209629
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    Phase III Randomized Trial of Concurrent Chemoradiotherapy with or without Atezolizumab in Localized Muscle Invasive Bladder Cancer
    Thepurpose of this study is to compare the effects, good and/or bad, ofchemotherapy and radiation therapy with or without the use of atezolizumab,which is used to treat …
    Thepurpose of this study is to compare the effects, good and/or bad, ofchemotherapy and radiation therapy with or without the use of atezolizumab,which is used to treat bladder cancer. The combination of chemotherapy,radiation therapy and the immunotherapy atezolizumab is consideredexperimental.
    • Participants must be 18 years orolder
    • Participants must be diagnosed with bladder cancer thathas not spread beyond the bladder.
    Sachdev, SeanSachdev, Sean
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT03775265 STU00210415
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    A randomized, controlled, multi-center, safety and efficacy study of FCR001 cell-based therapy relative to a tacrolimus and mycophenolate-based regimen in de novo living donor renal transplant recipients, and safety in FCR001 donors
    Research study which involves the use of a combination of an Enriche…
    Research study which involves the use of a combination of an Enriched Hematopoetic Stem Cell Infusion (stem cells, produced by the bone marrow, generate the cells that form the blood elements, help fight infection and assist in clotting) and kidney transplantation from the same donor to try to avoid the need for long-term anti-rejection drug therapy. The desired result of this study is to allow your body to develop "tolerance" to the transplanted kidney. Tolerance means that your body would see the transplanted kidney as part of you and not try to get rid of, or reject it. To prevent rejection, drugs called immunosuppressive agents must be taken on a daily basis. The purpose of this study is to determine if this procedure is safe and to try to substantially reduce or even eliminate the need for anti-rejection medications.
    Leventhal, Joseph RLeventhal, Joseph R
    NCT03995901 STU00209928
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    (xIRB NCI CIRB) ECOG-ACRIN 9152: A Phase Ib/II Study of Venetoclax (ABT-199) in Combination with Liposomal Vincristine in Patients with Relapsed or Refractory T-cell or Bcell Acute Lymphoblastic Leukemia
    This study is being done to determine what effects (good and bad) the therapy venetoclax has on y…
    This study is being done to determine what effects (good and bad) the therapy venetoclax has on your type of cancer (acute lymphoblastic leukemia, also known as ALL). This investigational therapy will be added to what is a standard, liposomal vincristine, to treat relapsed acute lymphoblastic leukemia.
    You may be eligible for this research study if you have acute lymphoblastic leukemia, which has grown after your first treatment regimen or has recurred.
    Dinner, Shira NaomiDinner, Shira Naomi
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03504644 STU00210605
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    A Phase 2 Study of pembrolizumab in patients with histiocyte/dendritic cell neoplasms and biologically selected subtypes of relapsed/refractory aggressive lymphomas. (Protocol #17-448)

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

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

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

    Choi, JaehyukChoi, Jaehyuk
    • Map it 676 N. St. Clair St.
      Chicago, IL
    NCT03316573 STU00209675
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    lymphoma
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    (XIRB) DRUG IMSA101-101: Phase I/IIA Safety and Efficacy Study of IMSA101 in Patients with Advanced Treatment-Refractory Malignancies

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

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

    All adult subjects ages 18 and above with advanced cancer that is no longer responding to standard of care treatment are eligible to participate.
    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04020185 STU00210768
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    DRUG AL3818-US-004: A Phase III Study of AL3818 (Catequentinib, Anlotinib) Hydrochloride Monotherapy in Subjects with Metastatic or Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma and Synovial Sarcoma

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

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

    You may be eligible for this research study if you have a soft tissue sarcoma (STS) - specifically alveolar soft part sarcoma (ASPS), leiomyosarcoma (LMS), or synovial sarcoma (SS) - and you either need new treatment or your prior treatments have not been effective.
    Pollack, Seth MichaelsPollack, Seth Michaels
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03016819 STU00210420
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    RTK inhibitor
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    BTCRC HN17-111: Phase II trial of androgen deprivation therapy (ADT) and pembrolizumab for advanced stage androgen receptor-positive salivary gland carcinoma
    This study is being done to study two investigational drugs called pembrolizumab and goserelin to see if they shrink your cancer or stop it fro…
    This study is being done to study two investigational drugs called pembrolizumab and goserelin to see if they shrink your cancer or stop it from growing. 
    You may be eligible for this research study if you have salivary gland carcinoma that has grown or has come back after treatment.
    Boumber, YanisBoumber, Yanis
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03942653 STU00210435
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    (xIRB) A Phase III Randomized, Placebo-Controlled Study of Pembrolizumab (MK-3475) in addition to Paclitaxel and Carboplatin for Measurable Stage III or IVA, Stage IVB or Recurrent Endometrial Cancer

    This study is being done to answer the following question: Can we lower the chance of your endomet…

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

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

    • Stage III, IVA, IVB, or recurrent endometrial cancer.
    • No chemotherapy within 12 months and no radiation therapy within 4 weeks.
    Matei, Daniela ElenaMatei, Daniela Elena
    • Map it 250 E. Superior St.
      Chicago, IL
    NCT03914612 STU00210842
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    PD-inhibitor (Nivolumab) and Ipilimumab followed by nivolumab vs. VEGF TKI cabozantinib with nivolumab in metastatic untreated REnal Cell CancEr [PDIGREE]

    This study is being done to answer the following question: Can we prolong life for patients with

    advanced kidney cancer, by adding a drug…

    This study is being done to answer the following question: Can we prolong life for patients with

    advanced kidney cancer, by adding a drug called cabozantinib to another treatment after

    receiving the standard treatment?

    We are doing this study because we want to find out if this approach isbetter or worse than the usual approach for your advanced kidney cancer. The usual approach is defined as care mostpeople get for advanced kidney cancer.

    -Participants must be 18 years of age or older

    -Participants must be diagnosed with advanced kidney cancer

    VanderWeele, David JamesVanderWeele, David James
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03793166 STU00210884
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    (XIRB) DRUG CPI-006-001: A Phase 1/1b Multicenter Study To Evaluate The Humanized Anti-CD73 Antibody, CPI-006, As A Single Agent or In Combination With Ciforadenant, with Pembrolizumab, And With Ciforadenant Plus Pembrolizumab In Adult Subjects With Advanced Cancers
    The purpose of this research is to…
    The purpose of this research is to evaluate the safety of the study drug called CPI-006 when administered alone, or in combination with another drug called Ciforadenant, or in combination with another drug called Pembrolizumab, or when given with Ciforadenant plus Pembrolizumab.
    All adults subjects 18 years of age or over with advanced or metastatic cancer that has grown, spread, and/or has not responded to previous treatments are eligible to participate.
    Sosman, Jeffrey AlanSosman, Jeffrey Alan
    • Map it 201 East Huron Street Suite 12-160​
      Chicago, IL
    NCT03454451 STU00210900
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    RANDOMIZED PHASE II TRIAL OF NIRAPARIB WITH STANDARD COMBINATION RADIOTHERAPY AND ANDROGEN DEPRIVATION THERAPY (ADT) IN HIGH RISK PROSTATE CANCER (WITH INITIAL PHASE I)

    The purpose ofthe study is to compare the usual treatment alone to using the study drug,Niraparib plus the usual treatment. Thea…

    The purpose ofthe study is to compare the usual treatment alone to using the study drug,Niraparib plus the usual treatment. Theaddition of niraparib to the usual treatment could prevent your cancer fromgrowing or returning. But, it could alsocause side effects, which are described in the risks section below. The studydrug is not approved by the Food and Drug Administration (FDA) for use inpatients with prostate cancer.

    There are twoparts to the study. The purpose of the first part is to assess whether it issafe to add Niraparib to the standard treatment by looking at whether thepatients treated experience side effects. This study will help identify thesafe initial dose that can be used in the second part of the study.

    The second partstudy will help the study doctors find out if this different approach isbetter, the same, or worse than the usual approach in preventing your cancerfrom growing or returning.

    · Participants must be 18 years or older

    Participants must have a confirmed diagnosis ofprostate cancer at a high risk or recurrance
    Sachdev, SeanSachdev, Sean
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04037254 STU00210909
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    A Phase III, Randomized Study of Nivolumab (Opdivo) Plus AVD or Brentuximab Vedotin (Adcetris) Plus AVD in Patients (Age >/= 12 Years) with Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma

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

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

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

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

    • Participantsmust be 18 years or older
    • Participants must have a confirmed diagnosis newlydiagnosed and previously untreated stage III or IV classical Hodgkin lymphoma
    Winter, Jane NormaWinter, Jane Norma
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT03907488 STU00210926
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    (xIRB) NCI CIRB: ECOG-ACRIN Z171: Prospective validation trial of taxane therapy (docetaxel or weekly paclitaxel) and risk of chemotherapy-induced peripheral neuropathy in African American women

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

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

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

    Shah, Ami NShah, Ami N
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04001829 STU00210984
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    (xIRB Sterling) DRUG 68284528MMY2003: A Phase 2, Multicohort Open-Label Study of JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA in Subjects with Multiple Myeloma (CARTITUDE-2)
    The purpose of this study is to see if JNJ-68284528 is safe and useful for treating p…
    The purpose of this study is to see if JNJ-68284528 is safe and useful for treating patients with relapsed or refractory multiple myeloma. In this type of treatment, your white blood cells (which are a part of the immune system) will be genetically modified to become JNJ-68284528 and used to treat your multiple myeloma.

    Some of the eligibility criteria include:

    • Participants must have a diagnosis of multiple myeloma
    • Participants must be 18 or older.
    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.
    Singhal, SeemaSinghal, Seema
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04133636 STU00210994
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    (xIRB) DRUG 18-0402: A Phase 1/2 Dose-Finding Study Followed by Expansion Cohorts of NGM120, A GFRAL Antagonist Monoclonal Antibody Blocking GDF15 Signaling, In Subjects With Advanced Solid Tumors And Pancreatic Cancer Using Combination Therapy
    find out what effects, both good and/or bad, ofthe study…
    find out what effects, both good and/or bad, ofthe study drug “NGM120”, as well as the combination of NGM120 and standardtherapy (gemcitabine and Abraxane) may have on you and your type of cancer andyour cancer associated loss of appetite, weight loss and loss of muscle.

    • Participants must be 18 years or older

    •Participants must have a confirmed diagnosis of advanced solid cancers

    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04068896 STU00211037
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    (xIRB) NCI CIRB NRG GY019: A Randomized Phase III, Two-Arm Trial of Paclitaxel/Carboplatin/Maintenance Letrozole Versus Letrozole Monotherapy in Patients with Stage II-IV, Primary Low-Grade Serous Carcinoma of the Ovary or Peritoneum

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

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

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

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

    Participants will get either the combination of paclitaxel and carboplatin for four and a half months followed by letrozole or letrozole alone. Patients who are assigned to letrozole monotherapy will continue taking the letrozole for as long as they are tolerating the drug (i.e., have not developed any allergies or severe side effects with the medication) and have not experienced a recurrence or progression of their disease.

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

    • New diagnosis of stage II-IV low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum.
    • At least 18 years old.
    • Must start within 8 weeks of primary surgery
    Barber, Emma LongleyBarber, Emma Longley
    • Map it 250 E. Superior St.
      Chicago, IL
    NCT04095364 STU00211055
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    (xIRB) NCI CIRB NRG HN005: A Randomized Phase II/III Trial of De-Intensified Radiation Therapy for Patients with Early-Stage, P16-Positive, Non-Smoking Associated Oropharyngeal Cancer

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

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

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

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

    We are asking you to take part in this research study because you have low-risk, Human Papillomavirus (HPV) positive oropharyngeal cancer. 
    Mittal, Bharat BMittal, Bharat B
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03952585 STU00211079
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    (xIRB) NCI CIRB: Alliance A071701: Genomically-Guided Treatment Trial in Brain Metastases

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

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

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

    • Participantsmust be 18 years or older

    • Participants must have a confirmed diagnosis of cancermetastasized to the brain
    Kumthekar, Priya UKumthekar, Priya U
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT03994796 STU00211229
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    (xIRB) NCI CIRB Alliance A071801: Phase III Trial of Post-Surgical Single Fraction Stereotactic Radiosurgery (SRS) Compared with Fractionated SRS (FSRS) for Resected Metastatic Brain Disease

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

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

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

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

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

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

    Participants 18 years or older who have resected metastatic brain disease. 
    Sachdev, SeanSachdev, Sean
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04114981 STU00211282
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    DRUG PRELUDEDX : A Prospective Registry Study to Evaluate the Effect of the DCISionRT Test on Treatment Decisions in Patients with DCIS Following Breast Conserving Therapy
    This is a registry study that is keeping track of people who are undergoing therapy for ductal carcinomain situ (DCIS) and who ar…
    This is a registry study that is keeping track of people who are undergoing therapy for ductal carcinomain situ (DCIS) and who are having genomic testing. This type of genomic testing looks athow certain genes are used by your tumor cells.
    The use of the DCISionRT DCIS test results in recommending treatment for your DCIS
    Strauss, Jonathan BStrauss, Jonathan B
    • Map it 250 E. Superior St.
      Chicago, IL
    NCT03448926 STU00210952
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    DCIS DCISionRT
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    (xIRB) NCI CIRB Alliance A021703: Randomized Double-blind Phase III Trial of Vitamin D3 Supplementation in Patients with Previously Untreated Metastatic Colorectal Cancer (SOLARIS)

    Participants with colorectal cancer will beinvited to participant in this study. The purpose of this study is to comp…

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

    This study has two groups:

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

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

    Participants who are at least 18 years of age or older who have advanced colorectal cancer. 
    Kircher, Sheetal MehtaKircher, Sheetal Mehta
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04094688 STU00211478
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    Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP II TR): A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter tricuspid valve repair with the Edwards PASCAL Transcatheter Valve Repair System and optimal medical therapy (OMT) compared to OMT alone in patients with tricuspid regurgitation
    This study is enrolling patients with severe Tricuspid Regurgitation (TR), a condition in the heart’s tricuspid valve does not close tightly which causes the blood to flow in the wrong direction. The standard medical treatments generally available to patients with tricuspid regurgitation who do not undergo surgery, may temporarily alleviate some symptoms, but will not permanently alleviate or cure tricuspid regurgitation.  The goal of this trial is to evaluate the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System (hereinafter referred to as the PASCAL System) with optimal medical therapy (OMT) compared to OMT alone in the treatment of participants with symptomatic severe tricuspid regurgitation who may not be ideal candidates for tricuspid valve surgery (performed via open-heart surgery) and may be eligible for transcatheter tricuspid valve repair (minimally invasive procedure that repairs the valve). Optimal Medical Therapy (OMT) refers to standard of care treatment using recommended medications
    Davidson, Charles JDavidson, Charles J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04097145 STU00211052
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    (xIRB) NCI CIRB ECOG-ACRIN 2182: A Randomized Phase II Study of De-Intensified ChemoRadiation for EarlyStage Anal Squamous Cell Carcinoma (DECREASE)

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

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

    This study has 2 studygroups.

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

    · Group 2 (Arm B)

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

    Participants who are 18 years of age or older with anal cancer will beinvited to participant in this study.
    Kircher, Sheetal MehtaKircher, Sheetal Mehta
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04166318 STU00211554
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    A randomized double-blind phase III study of ibrutinib during and following autologous stem cell transplant versus placebo in patients with relapsed or refractory diffuse large B-cell lymphoma of the activated B-cell subtype

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

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

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

    This study isbeing done to answer the following question:

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

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

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

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

    This study isbeing done to answer the following question:

    Which combinationof cancer drugs most effectively treats your MCL?

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

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

    3. bendamustine, rituximab andacalabrutinib (BR-A)

    We are doing this study because we want to findout if one of these drug combinations is better or worse than the usualapproach for your MCL. The usual approach is defined as care most people getfor MCL. Acalabrutinib is investigational for treating newly diagnosed MCL. Itis Food and Drug Administration (FDA) approved for MCL that has not respondedto treatment or relapsed
    • Participants must be 18 years orolder and ≤ 70 years old
    • Participants must have a confirmed diagnosis of MantleCell Lymphoma which has not been treated
    Karmali, ReemKarmali, Reem
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04115631 STU00211660
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    NU 19H08: Signal Transduction of Type I Interferons in Malignant Cells
    This is a lab study of a group of diseases called myeloproliferative neoplasms (MPN). MPN is abnormal blood coagulation (abnormal or irregular blood clotting) and includes polycythemia vera (PV) and essential thrombocytosis (ET). …
    This is a lab study of a group of diseases called myeloproliferative neoplasms (MPN). MPN is abnormal blood coagulation (abnormal or irregular blood clotting) and includes polycythemia vera (PV) and essential thrombocytosis (ET). The purpose of this research is to learn more about how a drug called interferon stops the growth of MPN blood cells in the laboratory. Alpha-interferon is a natural protein present in the body in small amounts. Treatment with interferon is known to have significant activity in MPN, but the way that this drug works is not fully known.
    • Patients must have a diagnosis of either polycythemia vera (PV) or essential thrombocytosis (ET)
    • Patients must be age 18 years or older.
    Platanias, Leonidas CPlatanias, Leonidas C
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00211647
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    Randomized controlled trial assessing transperineal prostate biopsy to reduce infection complications

    Prostate cancer is the most commonly diagnosed malignancy in U.S. men. There are approximately 1 million prostate biopsy performed annually in the U.S. Almost all biopsies are performed as an offi…

    Prostate cancer is the most commonly diagnosed malignancy in U.S. men. There are approximately 1 million prostate biopsy performed annually in the U.S. Almost all biopsies are performed as an office based procedure in under 15 minutes. The precision of biopsy has improved over the last decade with the introduction of MRI guidance/targeting of suspicious lesions within the prostate.

    However, significant limitations remain with this approach, including a significantly increasing risk of post-biopsy infection. This arises because more than 97% of all prostate biopsy are performed via a transrectal approach that introduces rectal bacteria with each pass of the biopsy needle into the sterile urinary tract. The current risk of post-transrectal biopsy infection, even with antimicrobial prophylaxis, is high at approximately 7% overall with 3% (30,000 men) requiring hospitalization annually.

    Transperineal biopsy is an alternate approach that eliminates the direct introduction of bacteria from the rectum to the prostate. This approach, which is perfomed without antimicrobial prophylaxis, instead passes the biopsy needle through the perineal skin and pelvic floor.

    Transperineal biopsy has not been widely adopted for several reasons. Historically, it has been considered too painful for patients in the clinic and thus was traditionally performed under general anesthesia. The added time, inconvenience and cost has limited its national adoptance. Second, when transrectal biopsy was initially adopted over 40 years ago, antibiotic resistance of rectal flora was not a challenge.

    Beyond the potential for in-office transperineal biopsy to significantly reduce or eliminate biopsy infections, transperineal biopsy may also improve cancer detection: studies of transperineal biopsy (performed under general anesthesia) demonstrate higher detection rates for prostate cancer, particularly for anterior zone tumors, compared to transrectal biopsy. This is notable, as anterior tumors are difficult to sample with transrectal. Anterior tumors are also twice as likely to occur in African American men. In fact, our research demonstrates that some of the outcomes disparities in African American men may stem from an underdiagnosis of anterior prostate cancers.

    Although transrectal biopsy is used widely, it is associated with a significant and increasing risk of biopsy infections due to growing antibiotic resistance, highlighting the urgent need for a safer alternative approach to prostate biopsy. The study investigators have refined a transperineal approach under local anesthesia with MRI-targeting/guidance without the need for antibiotic prophylaxis. The investigators hypothesize that transperineal MRI targeted biopsy will: (1) largely eliminate post-biopsy infections and costly hospitalizations for urosepsis; (2) be performed in the office with similar discomfort and non-infectious complications compared to transrectal MRI targeted biopsy; and (3) have significantly better detection of prostate cancer.

    This multi-center randomized controlled trial will be conducted to evaluate in-office transperineal MRI targeted vs. transrectal MRI targeted biopsy, the current gold standard. This has transformative impact to change current standard of practice.

    This study will include allmen who are recommended to undergo prostate biopsy as part of routine clinicalcare.
    Schaeffer, Edward MatthewSchaeffer, Edward Matthew
    NCT03632655 STU00211699
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    DRUG CKAZ954A12101: A Phase I/IB, Open-label, Multi-Center, Study of KAZ954 as a Single Agent and in Combination With Spartalizumab, NZV930 and NIR178 in Patients with Advanced Solid Tumors
    The purpose of the study is to identify the best dose and treatment schedule of KAZ954 alone,and with 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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    SWOG 1827: A Randomized Phase III Trial of MRI Surveillance with or Without Prophylactic Cranial Irradiation (PCI) in Small-Cell Lung Cancer

    This study is being done to answer the following question:

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

    This study is being done to answer the following question:

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

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

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

    The purposes of this research study are:

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

    The purposes of this research study are:

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

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

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

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

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

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

    •Combination A: IMGN632 + azacitidine

    •Combination B: IMGN632 + venetoclax

    •Combination C: IMGN632 + azacitidine + venetoclax

    •Combination D: IMGN632

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

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

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

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

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

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

    Some of the eligibility criteria include:

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

    •Age of at least 18 years

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

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

    The purpose of this research study is to determineif…

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

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

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

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

    Age of at least 18 years

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

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

    Karmali, ReemKarmali, Reem
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04245839 STU00212069
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    A PHASE II STUDY TO EVALUATE THE SAFETY AND EFFICACY OF OQL011 ON VEGFR INHIBITOR-ASSOCIATED HAND-FOOT SKIN REACTION IN CANCER PATIENTS
    This study is trying to determine whether an ointment is safe and effective for the treatment of hand-foot skin reaction induced by VEGRF inhibitors. 
    Participants must be over the age of 18 and have hand-foot skin reaction after taking anti-cancer medications calls VEGRF inhibitors. 
    Choi, Jennifer NamChoi, Jennifer Nam
    • Map it 676 N. St. Clair St.
      Chicago, IL
    NCT04088318 STU00211322
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    COVID-19 Convalescent Blood BioBank (SeroCore)
    Individuals will have blood drawn on enrollment as well as 6, 12 and 24 months later.  Blood will be used for genetic testing to identify factors associated with disease severity and immunologic responses.  Blood will be used to interrogate imm…
    Individuals will have blood drawn on enrollment as well as 6, 12 and 24 months later.  Blood will be used for genetic testing to identify factors associated with disease severity and immunologic responses.  Blood will be used to interrogate immunologic responses over time.  Blood will be shared with other investigators to validate serologic testing assays and to facilitate vaccine development.  
    Individuals who have recovered from COVID-19 are eligible for enrollment.  Patients will need to be confirmed to have had COVID-19 either through PCR testing or a positive antibody test prior to enrollment.  
    Ison, Michael GIson, Michael G
    • Map it 676 N. Saint Clair St. Suite 940
      Chicago, IL
    STU00212371
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    (xIRB) DRUG HPN424-1001: A Phase 1 Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmacokinetics of HPN424 in Patients with Advanced Prostate Cancer Refractory to Androgen Therapy

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

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

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

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

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

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

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

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

    Some of the eligibility criteria include:

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

    • Age of at least 18 years

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

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

    - Aged at least 18 years old

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

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

    - Have received at least 1 line of available therapy

    Kalyan, AparnaKalyan, Aparna
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04171700 STU00212482
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    (xIRB) DRUG TAK-788-3001: A Randomized Phase 3 Multicenter Open-label Study to Compare the Efficacy of TAK-788 as First-line Treatment Versus Platinum-Based Chemotherapy in Patients With Non–Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations
    The purpose of this study is to determine how s…
    The purpose of this study is to determine how safe and how well TAK-788 works as an initial therapy in patients with a certain kind of lung cancer (NSCLC with EGFR exon 20 insertion mutations). The results in these patients will be compared with results in patients receiving standard of care chemotherapy (platinum-doublet chemotherapy).

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

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

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

    * Combination of premetrexed and cisplatin OR

    * Combination of premetrexed and carboplatin

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

    - Be atleast 18 years old

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

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

    Patel, Jyoti DPatel, Jyoti D
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04129502 STU00212504
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    (xirb) Drug ACE1702-001 : A Phase I, Open Label, Dose Escalation Study of ACE1702 Cell Immunotherapy in Subjects with Advanced or Metastatic HER2-expressing Solid Tumors

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

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

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

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

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

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

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

    Patel, Jyoti DPatel, Jyoti D
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00212311
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    NU COVID-19 MSK20H04: Examining COVID19 Course and Outcomes in Patients Previously Diagnosed with Chronic Lymphocytic Leukemia (CLL)
    This multicenter, retrospective cohort study will include patientstreated at national and international medical centers. Patients will be included if they have a prior …
    This multicenter, retrospective cohort study will include patientstreated at national and international medical centers. Patients will be included if they have a prior diagnosis of CLL, havebeen diagnosed with COVID19, and received care at a participating medicalcenter.

    Primary Aim:

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

    Secondary Aims:

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

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

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

    Chronic lymphocytic leukemia (CLL) patients diagnosed with COVID19.
    Ma, ShuoMa, Shuo
    • Map it 251 E. Huron St.
      Chicago, IL
    STU00212455
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    Wearable sensor to monitor and track COVID-19-like signs and symptoms to develop better care strategies for COVID-19 pandemic
    Specific Aims:1. Develop a wearable sensor package to gather data on COVID-19-like signs andsymptoms such as elevated body temperature, respiratory parameters, heart rate ,cou…
    Specific Aims:1. Develop a wearable sensor package to gather data on COVID-19-like signs andsymptoms such as elevated body temperature, respiratory parameters, heart rate ,coughand gait.2. Create algorithms to monitor and track changes to COVID19-like signs and symptomsfor developing a better care and isolation strategies for COVID-19 pandemic

    Ages between 18-95 years old

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

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

    •Arm A: Carboplatin + Pemetrexed + Avastin + Tecentriq

    •Arm B: Carboplatin + Pemetrexed + Avastin

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

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

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

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

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

    Some of the eligibility criteria include:

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

    •Age of at least 18 years

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

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

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

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

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

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

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

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

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

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

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

    Some of the eligibility criteria include:

    •Age of at least 18 years

    •Diagnosis of Myelodysplastic Syndrome (MDS)

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

    Additional information can be found by visiting the NIH website:

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

    Dinner, Shira NaomiDinner, Shira Naomi
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04313881 STU00212732
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    Immune checkpoint inhibitor-associated acute kidney injury
    Since 2011, six immune checkpoint inhibitors (ICIs), a type of immunotherapy, have been approved by the Federal Drug Administration for use in patients with cancer.  These medications have been demonstrated to have great promise for trea…
    Since 2011, six immune checkpoint inhibitors (ICIs), a type of immunotherapy, have been approved by the Federal Drug Administration for use in patients with cancer.  These medications have been demonstrated to have great promise for treating a variety of cancers.  However, there are toxicities associated with these agents, known as immune-related adverse events (AKI), some of which can be fatal.  Affected organs include the skin (rash), gastrointestinal tract(diarrhea), and the kidneys (acute kidney injury [AKI]). This study, led by Drs. Shruti Gupta and David Leaf at Brigham and Women’s Hospital, has the goal of collecting data on over 300 ICI-associated acute kidney injury cases from more than 30 academic medical centers worldwide.  We will characterize the clinical features of ICI-associated AKI in the hope that this will help us to determine predictors  of toxicity and best practices for management. 
    Aggarwal, VikramAggarwal, Vikram
    STU00212602
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    (xIRB) DRUG AVM-003-HC: Phase 3 Multicenter, Double-Blind, Placebo-Controlled Trial of Viralym-M (ALVR-105) for the Treatment of Patients With Virus-Associated Hemorrhagic Cystitis After Allogeneic Hematopoietic Cell Transplant.

    The purpose of this study is to determine if the study drug, ALVR-105…

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

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

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

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

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

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

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

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

    Some of the eligibility criteria include:

    •Age of at least 18 years

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

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

    Moreira, JonathanMoreira, Jonathan
    NCT04390113 STU00213027
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    NCICOVID: NCI COVID-19 in Cancer Patients Study (N-CCaPS): A Longitudinal Natural History Study

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

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

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

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

    Participants 18 years or older who are being treated for cancer and have COVID-19 will be enrolled.
    Wehbe, FirasWehbe, Firas
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04387656 STU00213072
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    COVID-19
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    (xIRB) NCI CIRB ECOG-ACRIN 2185: Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs

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

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

    This study has 2 study groups:

    Group 1

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

    Group 2

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

    Participants will be enrolled forup to five years.

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

    Yang, Anthony DYang, Anthony D
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04239573 STU00213102
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    DRUG CX-839-012: A Phase 1b/2, Open label, Dose Escalation and Expansion Study of the Glutaminase Inhibitor Telaglenastat (CB-839) in Combination with the CDK4/6 Inhibitor Palbociclib in Patients with Advanced or Metastatic Solid Tumors
    The purpose of this study is to determine a safe and tolerable d…
    The purpose of this study is to determine a safe and tolerable dose of telaglenastat (an “investigational” drug), given together with palbociclib (an “approved” drug),  
    All participants in Part 2 of the study must be 18 years of-age or older and be diagnosed with advanced or metastatic CRC or NSCLC.
    Chae, Young KwangChae, Young Kwang
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03965845 STU00212083
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    (xirb) DRUG 7465-CL-202 : An Open-label, Multicenter, Multicohort, Phase 2 Study to Evaluate Enfortumab Vedotin in Subjects with Previously Treated Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)

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

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

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

    Participants may withdraw at any time.

    Mulcahy, Mary FrancesMulcahy, Mary Frances
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04225117 STU00213246
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    Nectin-4
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    (xIRB) DRUG M15-954: A Randomized, Double-Blind, Phase 3 Study Evaluating the Safety and Efficacy of Venetoclax in Combination with Azacitidine in Patients Newly Diagnosed with Higher-Risk Myelodysplastic Syndrome (Higher-Risk MDS)

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

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

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

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

    Subjects will be randomly assigned to receive:

    •Venetoclax and azacitidine

    OR

    •Placebo and azacitidine.

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

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

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

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

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

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

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

    Some of the eligibility criteria include:

    •18 years of age or older

    •Have been diagnosed with Higher Risk Myelodysplastic Syndrome

    •Have not received prior treatment for Myelodysplastic Syndrome

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

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

    Frankfurt, OlgaFrankfurt, Olga
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04401748 STU00213254
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    DRUG ARV-110-mCRPC-101: A Phase 1/2, Open-label, Dose Escalation and Cohort Expansion Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ARV-110 in Patients with Metastatic Castration-resistant Prostate Cancer
    The purpose of this research study is to assess…
    The purpose of this research study is to assess the safety and tolerability of the investigational study drug (ARV-110) in men with metastatic cancer of the prostate which has progressed after multiple previous therapies. The study also seeks to evaluate how the drug moves within the body after administration (Pharmacokinetics {PK}) and what effects the drug has on your body after administration (Pharmacodynamics {PD}).

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

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

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

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

    Some of the eligibility criteria include:

    •Age of at least 18 years

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

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

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

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

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

    This study has 2 parts. In the first part,doctors will try to learn the answer to question #1 above. If the answer shows that neck and shoulder function and discomfort is better in patients who have the SLN biopsy, then the study will go on to the second part, and doctors will try to answer question #2.
    • Participants must be 18 years or older
    • Participants must have a confirmed diagnosis of early-stage oral cavity cancer
    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.
    Samant, SandeepSamant, Sandeep
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04333537 STU00213298
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    Prospective Molecular Profiling To Guide Therapeutic Decision-making in Patients with Advanced Hepatocellular Cancer (HCC): An Insight to Next Generation Sequencing-Matched Systemic Therapy in Liver Cancer (PROTOLIGHT STUDY)

    Hepatocellular carcinoma (HCC) is the most common form of liver cancer, m…

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

    Eligible participants are at least 18 years of age and have advanced hepatocellular cancer (HCC) or recurrent HCC for which they have not yet received systemic therapy for, and are are not candidates for resection, transplant or liver-directed therapies.
    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00212975
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    Impact of immunotherapy-related skin diseases on quality of life
    The purpose of this study is to characterize the effects of cutaneous side effects from immunotherapies on quality of life. Participants will complete a one time survey. 
    Participants need to be 18 years and older, receiving immunotherapy, and may be experiencing a dermatologic side effect. 
    Choi, Jennifer NamChoi, Jennifer Nam
    • Map it 676 N. St. Clair St.
      Chicago, IL
    STU00212205
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    (xIRB NCI CIRB) ECOG-ACRIN 1181: Preoperative THP and Postoperative HP in Patients Who Achieve a Pathologic Complete Response Part 1 Component of: The CompassHER2 Trials (COMprehensive Use of Pathologic Response ASSessment to Optimize Therapy in HER2-Positive Breast Cancer) (CompassHER2-pCR)

    This…

    This study isbeing done to answer the following question:

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

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

    The names of thestudy drugs involved in this study are:

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

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

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

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

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

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

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

    •Enzalutamide (Stage 2 only)

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

    •Docetaxel (Stage 2 only)

    •AB928 + zimberelimab (Stage 1 and Stage 2)

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

    •AB928 + AB680 (Stage 1 and Stage 2)

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

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

    This research study is made up of the following parts:

    •Screening

    •Treatment

    •End of Study and Long-Term Safety Follow Up

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

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

    Some of the eligibility criteria include:

    •Age of at least 18 years

    •Diagnosis of metastatic castrate resistant prostate cancer

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

    VanderWeele, David JamesVanderWeele, David James
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04381832 STU00213357
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    A Phase 1/2 Study of Oral LOXO-305 in Patients With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Non-Hodgkin's Lymphoma (NHL)

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

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

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

    LOXO -305 is currently not approved by the FDA

    · Participants must be 18 years orolder

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

    The purpose of th…

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

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

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

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

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

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

    Some of the eligibility criteria include:

    · Age of at least 18 years

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

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

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

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

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

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

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

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

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

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

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

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

    Some of the eligibility criteria include:

    •Age of at least 18 years

    •Newly Diagnosed or Recurrent Glioblastoma

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

    Kumthekar, Priya UKumthekar, Priya U
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04421378 STU00213433
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    (xIRB) NCI CIRB NRG CC008: A Non-Randomized Prospective Clinical Trial Comparing the Non-Inferiority of Salpingectomy to Salpingo-oophorectomy to Reduce the Risk of Ovarian Cancer Among BRCA1 Carriers [SOROCk]

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

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

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

    Barber, Emma LongleyBarber, Emma Longley
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04251052 STU00213473
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    DRUG 209626: A Phase I Study to Evaluate the Pharmacokinetics and Safety of Belantamab Mafodotin Monotherapy in Participants with Relapsed or Refractory Multiple Myeloma Who Have Normal and Varying Degrees of Impaired Renal Function (DREAMM 12)
    The purpose of this study is to find out the relationshi…
    The purpose of this study is to find out the relationship between kidney function and safety and pharmacokinetics of the study drug. Pharmacokinetics means study of the movement of drug through the body, and this study will be looking to see if kidney disease affects that movement. Patients with well-functioning kidneys will be invited into the study as well as patients with kidneys that do not work well (or not at all).

    This is a study in people with relapsed (returning)and/or refractory (not responding to treatment) multiple myeloma (RRMM) with normal or reduced kidney function to test how the study drug belantamab mafodotin impacts kidney function. There are 2-parts to the study. Participants with RRMM from 4 groups based on how well your kidneys work will be enrolled.

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

    The screening assessment will be performed within 21 days before the first dose. After your screening period, if you are eligible, you will need to visit the study site repeatedly (at least every 3 weeks) to receive the study treatment and take part in additional exams, tests, or procedures. Study drug will be infused through a vein over approximately 30 minutes. Study visits will take as little as 3 hours or as much as 12 hours of your time.

    Participants who are at least 18 years of age or older who have been diagnosed with relapsed or refractory multiple myeloma and who have impaired renal function will be enrolled into this study.

    Singhal, SeemaSinghal, Seema
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04398745 STU00213490
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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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    (xIRB) NCI CIRB ETCTN 10300: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 1 (BLAST MRD AML-1): A Randomized Phase 2 Study of the Anti-PD-1 Antibody Pembrolizumab in Combination with Conventional Intensive Chemotherapy as Frontline Therapy in Patients with Acute Myeloid Leukemia

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

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

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

    Group 1

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

    Group 2

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

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

    Dinner, Shira NaomiDinner, Shira Naomi
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04214249 STU00213544
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    (xIRB) NCI CIRB SWOG 1823: A Prospective Observational Cohort Study to Assess mRNA 371 for Outcome Prediction in Patients with Newly Diagnosed Germ Cell Tumors

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

    in patients with germ cel…

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

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

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

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

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

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

    Kundu, Shilajit DKundu, Shilajit D
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00213585
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    DRUG ME-522-001: A Phase 1, Open-Label, Study of Voruciclib in Subjects with Relapsed and/or Refractory B Cell Malignancies or Acute Myeloid Leukemia After Failure of Prior Standard Therapies
    This study has been designed to look at the safety of voruciclib (also known as the study drug), how your bod…
    This study has been designed to look at the safety of voruciclib (also known as the study drug), how your body tolerates the drug, how effective the drug may be, and how the drug is taken up by your body when administered orally after multiple doses over the course of the study. This study is being conducted to determine the highest safely tolerated dose of voruciclib in patients that have relapsed and/or refractory B cell type cancers or acute myeloid leukemia.
    Must be diagnosed with a certain type of B cell cancer or acute myeloidleukemia (AML) that has relapsed (come back) or is refractory (did not respondto previous treatment). The types of B cell cancers in this study includefollicular lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphoma(MZL), small lymphocytic lymphoma (SLL), chronic lymphocytic leukemia (CLL), ordiffuse large B-cell lymphoma (DLBCL).
    Frankfurt, OlgaFrankfurt, Olga
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03547115 STU00213009
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    (xIRB) DRUG CA209-7FL: A Randomized, Multicenter, Double-blind, Placebo-controlled Phase 3 Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Patients With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer (CheckMate 7FL)

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

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

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

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

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

    OR

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

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

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

    There are 4 periods to the study:

    oScreening Period

    oPre-surgery (Neoadjuvant) Treatment Period

    oPost-surgery (Adjuvant) Treatment Period

    oFollow-up Period

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

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

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

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

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

    Some of the eligibility criteria include:

    •Age of at least 18 years

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

    epidermal growth factor receptor 2 negative (HER2-) breast cancer.

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

    Gradishar, William JGradishar, William J
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04109066 STU00213659
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    Alliance A021806: A Phase III Trial of Perioperative Versus Adjuvant Chemotherapy for Resectable Pancreatic Cancer

    This study is being done to answer the following question:

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

    This study is being done to answer the following question:

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

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

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

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

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

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

    Karmali, ReemKarmali, Reem
    • Map it 675 N. St. Clair St.
      Chicago, IL
    STU00213145
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    CART-T RPM Patch
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    DRUG AT148002: A Phase 1/2 Study of ALX148 in Combination with Azacitidine in Patients with Higher Risk Myelodysplastic Syndrome (MDS) (ASPEN-02)
    The purpose of this research study is to learn about the effects of the study drug, ALX148, in combination with azacitidine (AZA), a standard treatment for…
    The purpose of this research study is to learn about the effects of the study drug, ALX148, in combination with azacitidine (AZA), a standard treatment for MDS. The study is being done to assess the safety and tolerability of ALX148, to document the levels of ALX148 in the blood, and to document the effects of ALX148 on your cancer when given together with AZA.

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

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

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

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

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

    Some of the eligibility criteria include:

    •Age of at least 18 years

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

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

    Altman, Jessica KAltman, Jessica K
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04417517 STU00213414
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    DRUG ELVCAP-001-01: A Phase 2 Study of Seribantumab in Adult Patients with Neuregulin-1 (NRG1) Fusion Positive Locally Advanced or Metastatic Solid Tumors

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

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

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

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

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

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

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

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

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

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

    •Induction Treatment period: Weekly visits for 4 weeks.

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

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

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

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

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

    Some of the eligibility criteria include:

    •Age of at least 18 years

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

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

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

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

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

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

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

    for small cell lung cancer.

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

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

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

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

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

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

    The treatment part of the study has two groups:

    Group 1

    Participants in group 1 will be given atezolizumab.

    Group 2

    Participants in group 2 will get talazoparib plus atezolizumab.

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

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

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

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

    participate in this study.

    Chae, Young KwangChae, Young Kwang
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04334941 STU00213765
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    ETCTN 10388: A Phase I Trial of Triapine and Lutetium Lu 177 Dotatate in Combination for Well-Differentiated Somatostatin Receptor-Positive Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)
    This study is being done to answer the following question: What is the highest dose of triapine in combin…
    This study is being done to answer the following question: What is the highest dose of triapine in combination with Lutetium Lu 177 Dotatate that is safe and tolerable in patients with neuroendocrine tumors? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your neuroendocrine tumor. The usual approach is defined as care most people get for neuroendocrine tumors. There is evidence that the study drug, triapine, can make cancer more sensitive to the usual treatment, Lutetium Lu 177 Dotatate. The combination of triapine and Lutetium Lu 177 Dotatate is not approved by the Food and Drug Administration (FDA) for any cancer.This is the first time these drugs will be tested together in humans.
    • Participants must be 18 years or older
    • Participants must have had a confirmed diagnosis of gastroeneteropancreatic neuroendocrine tumors (GEP-NETs)
    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.
    Mulcahy, Mary FrancesMulcahy, Mary Frances
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04234568 STU00213770
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    Serial Monitoring of Circulating Tumor Cells During Radiotherapy for Women with Non-Metastatic Breast Cancer: A Prospective Observational Cohort Study

    The purpose of this research is to determine whether radiotherapy after surgery to remove a breast cancer can help decrease the number of circulati…

    The purpose of this research is to determine whether radiotherapy after surgery to remove a breast cancer can help decrease the number of circulating tumor cells (CTCs) in the blood. Circulating tumor cells are cancer cells that are shed from the tumor into the blood stream and are believed to be one of the first indicators that breast cancer cells may remain after surgery. Approximately 20% of women with early-stage breast cancer can be found to have CTCs in a small sample of blood taken several weeks after surgery. Radiotherapy is used after surgery to remove a breast cancer in order to sterilize any cancer cells that may be remaining in the breast. It is not known if radiotherapy can help decrease or eliminate CTCs that are found in the blood. This study aims to find out if testing for CTCs can be clinically useful for guiding radiotherapy treatment decisions. Another aim of this study is to evaluate whether CTCs can be used to measure the effectiveness of radiotherapy in an individual patient.

    Eligible participants are post-menopausal women that have been diagnosed with non-metastatic, ER-positive and Her2-nonamplifed breast cancer and are planning on receiving radiation and hormone therapy.

    Strauss, Jonathan BStrauss, Jonathan B
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00212971
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    NRG BN007: A Randomized Phase II/III Open-Label Study of Ipilimumab and Nivolumab Versus Temozolomide in Patients with Newly Diagnosed MGMT (Tumor O-6-Methylguanine DNA Methyltransferase) Unmethylated Glioblastoma
    This study is being done to answer the following question: Can we lengthen time without…
    This study is being done to answer the following question: Can we lengthen time without your brain tumor returning or growing and can we extend your life by replacing the usual chemotherapy with immune therapy? We are doing this study because we want to find out if this approach is better, the same, or worse than the usual approach for your brain tumor. The usual approach is defined as care most people get for glioblastoma brain tumors.
    • Participants must be 18 years or older
    • Participants must have a confirmed diagnosis of newly diagnosed Glioblastoma with a specific biomarker known as unmethylated MGMT.
    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.
    Dixit, Karan SinghDixit, Karan Singh
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04396860 STU00213865
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    (xIRB) DRUG 20190135: A Phase 1b, Master Protocol Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Sotorasib in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation

    PURPOSE: The purpose of this study isto evaluate the safety and tolerability of sotorasib (AMG 510) in…

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

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

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

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

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

    OVERVIEW:

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

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

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

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

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

    Patel, Jyoti DPatel, Jyoti D
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04185883 STU00213909
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    ECOG-ACRIN 9181: A Phase III Randomized Trial of Steroids + Tyrosine Kinase Inhibitor Induction with Chemotherapy or Blinatumomab for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults
    This study is being done to answer the following question: This study is being done to determin…
    This study is being done to answer the following question: This study is being done to determine what effects (good or bad) using the combination of potent TKI, steroids and blinatumomab versus treatment with steroids, TKI and chemotherapy. This investigational therapy will be added to what has traditionally been used to treat your specific sub-type of ALL. Studies are being done in ALL and other blood cancers with blinatumomab. We are doing this study because we want to find out if this approach is better or worse than the usual approach for you. The usual approach is defined as care most people get for ALL.
    • Participants must be 18 years or older
    • Participants must have a confirmed diagnosis of newly diagnosed BCR-ABL-positive Acute Lymphoblastic Leukemia (ALL).
    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.
    Dinner, Shira NaomiDinner, Shira Naomi
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04530565 STU00213941
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    (xirb) DRUG 7051-ONC-101: A Phase 1 Study of FT-7051 in Men with Metastatic Castration-Resistant Prostate Cancer
    This research is being performed because improvements are needed in the management ofpatients with cancer. FT-7051 may help treat prostate cancer by blocking a receptor in the tumor c…
    This research is being performed because improvements are needed in the management ofpatients with cancer. FT-7051 may help treat prostate cancer by blocking a receptor in the tumor cell, called theandrogen receptor. The major purpose of this study is to To test the safety of FT-7051 and see what effects (good and bad) it has on cancer, and to find the highest dose of FT-7051 that can be given alone without causing serious side effects. 

    Some of the eligibility criteria include:

    1. ≥ 18 years of age

    2. Life expectancy of ≥ 3 months

    3. Diagnosis of mCRPC with either adenocarcinoma or mixed histology

    VanderWeele, David JamesVanderWeele, David James
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04575766 STU00213972
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    (xirb) DRUG SGN35-033 : A Phase 2 Study of Brentuximab Vedotin in Combination with Pembrolizumab in Subjects with Metastatic Solid Malignancies After Progression on Prior Pd-1 Inhibitor Treatment
    This is a phase 2 clinical trial designed to evaluate effectiveness and safety of brentuximab vedotin in …
    This is a phase 2 clinical trial designed to evaluate effectiveness and safety of brentuximab vedotin in combination with pembrolizumab (alsocalled KEYTRUDA® ) in patients with lung or skin cancer who had tumorprogression, after they had PD-1 inhibitor treatment.

    We’re asking you to take part in a clinical trial (study) because you have lung or skin cancer that has spread to other parts of your body. And your cancer has come back or gotten worse since your last treatment.
    Chandra, SunandanaChandra, Sunandana
    NCT04609566 STU00213974
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    (xIRB) NCI CIRB ECOG-ACRIN 8191: Phase III Study of PET-Directed Local or Systemic Therapy Intensification in Prostate Cancer Patients with Post-Prostatectomy Biochemical Recurrence

    The purpose of this study is to compare the usual treatment alone

    to using PET/CT imaging to look for cancer …

    The purpose of this study is to compare the usual treatment alone

    to using PET/CT imaging to look for cancer that has spread to the pelvis plus the usual treatment.

    We want to see if we can provide a more targeted treatment to this type of cancer by treating up to 5

    specific lesions that are seen on the PET/CT scan. Part of the purpose of this study is also to see

    whether adding apalutamide and directed radiation works better than the usual approach to help treat

    prostate cancer that has returned after surgery.

    This study will help the study doctors find out if this different approach is better than the usual

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

    increases the time before cancer growth or if the cancer causes major additional symptoms.

    This study has 4 study groups. Participants will be assigned to 1 of 4 possible treatment groups

    depending on the results of your PET/CT scan. After you finish your study treatment, your doctor will

    continue to follow your condition for up to 10 years and watch you for side effects and monitor the

    progression of your cancer.

    Group 1 (Negative for Extra Pelvic-Metastases)

    If you are in this group, it means your PET/CT scan did not show evidence that your cancer has spread

    to outside of the pelvis. You will get the usual appropriate care that is used to treat this type of

    cancer, the planned standard of care treatment with radiation therapy (SOC RT) and STAD for 6 months.

    Group 2 (Negative for Extra Pelvic-Metastases)

    If you are in this group, it means your PET/CT scan did not show evidence that your cancer has spread

    to areas outside of the pelvis. You will get a study treatment, planned SOC RT + STAD + apalutamide

    for 6 months.

    Group 3 (Positive for Extra Pelvic-Metastases)

    If you are in this group, it means that your cancer has spread to areas outside of your pelvis.

    You will get planned SOC RT + STAD + apalutamide for 6 months.

    Group 4 (Positive for Extra Pelvic-Metastases)

    If you are in this group, your cancer has spread to areas outside of your pelvis.

    You will get a planned SOC RT + STAD + apalutamide for 6 months + directed radiation therapy to

    where the cancer has spread. Each patient will undergo another (or additional) PET/CT scan,

    which will take place about one year after starting treatment or if clinically necessary at an

    earlier time point.

    Male participants 18 years of age or older who have prostate cancer that has come back after surgery

    will be enrolled into this study.

    Sachdev, SeanSachdev, Sean
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04423211 STU00214021
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    (xIRB) NCI CIRB ETCTN 10220: A Phase II Basket Trial of Glutaminase Inhibitor (BeGIN) CB-839 HCl in Patients with NF1 Aberrations, NF1 Mutant Malignant Peripheral Nerve Sheath Tumors (MPNST), KEAP1/NRF2 and LKB1 Aberrant Tumors

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    The purpose of this voluntary research study …

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

    This study will see if the drugs:

    1.are tolerable as a combination therapy

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

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

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

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

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

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

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

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

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

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

    Some of the eligibility criteria include:

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

    •Age of at least 18 years

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

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

    Adult patients with a diagnosis of platinum-resistant ovarian, fallopian or primary peritoneal cancer.
    Matei, Daniela ElenaMatei, Daniela Elena
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04753216 STU00213582
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    (xIRB) DRUG LOXO-IDH-20001: A Phase 1 Study of Oral LY3410738 in Patients with Advanced Hematologic Malignancies with IDH1 or IDH2 Mutations

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

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

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

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

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

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

    Dose Escalation

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

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

    Dose Expansion

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

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

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

    Some of the eligibility criteria include:

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

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

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

    •Age of at least 18 years

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

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

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

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

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

    Intravesical Procedure

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

    CG0070 and DDM Administration

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

    Pembrolizumab Administration

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

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

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

    Some of the eligibility criteria include:

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

    •Age of at least 18 years

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

    Meeks, Joshua JMeeks, Joshua J
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04387461 STU00213631
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    DRUG Q702-ONC-P1-US001 A Phase 1 Multicenter, Open-label, Dose-Escalation, Safety, Pharmacodynamic, Pharmacokinetic Study of Q702 with a Cohort Expansion at the RP2D in Patients with Advanced Solid Tumors
    The major purpose of this study is to determine the highest dose of Q702 that does not result in…
    The major purpose of this study is to determine the highest dose of Q702 that does not result in severe side effects, the dose that is tolerated, and once this dose is found, if it has any effect against the cancer in patients with solid cancer tumors. This study is being done:

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

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

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

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

    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04648254 STU00213510
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    NU MDA20L01: An Open-Label Randomized Phase II Study of Combining Osimertinib with and without Ramucirumab in TKI-naïve EGFR-mutant Locally Advanced or Metastatic NSCLC
    The purpose of this study is to compare the usual treatment osimertinib alone to ramucirumabplus the usual treatment (osimertinib).…
    The purpose of this study is to compare the usual treatment osimertinib alone to ramucirumabplus the usual treatment (osimertinib). The addition of ramucirumab to the usual treatment could help osimertinib control the abnormal EGFR protein for a longer duration and in turn, for you tohave a longer period of time that your disease is inactive.We are doing this study because we want to find out if this approach is better or worse than theusual approach for your cancer. The usual approach is defined as care most people get for thetreatment of non-small cell lung cancer. 
    Age ≥ 18 years at the time of consent, Histologically or cytologically confirmed non-squamous, nonsmall cell lung cancer, Locally advanced or metastatic disease, not amenable tocurative surgery or radiotherapy.
    Patel, Jyoti DPatel, Jyoti D
    • Map it 201 East Huron Street Suite 12-160​
      Chicago, IL
    NCT03909334 STU00212727
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    (xIRB) NCI CIRB Alliance A071702: A Phase II Study of Checkpoint Blockade Immunotherapy in Patients with Somatically Hypermutated Recurrent Glioblastoma

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

    called nivolumab and ipilimumab. T…

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

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

    stability or reduction in the size of your tumor.

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

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

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

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

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

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

    months for 3 years and watch you for side effects.

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

    Kumthekar, Priya UKumthekar, Priya U
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04145115 STU00214358
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    (xIRB) NCI CIRB NRG BN009: Phase III Trial of Salvage Stereotactic Radiosurgery (SRS) or SRS + Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) for First or Second Distant Brain Relapse After Upfront SRS With Brain Metastasis Velocity >/= 4 Brain Metastases/Year

    The purpose of this study is…

    The purpose of this study is to compare the usual treatment of SRS alone to SRS plus HA-WBRT

    (whole brain radiation therapy with hippocampus avoidance) and memantine for patients with cancer

    that has spread to the brain and come back in other areas of the brain after earlier treatment with SRS.

    The addition of HA-WBRT and memantine to the usual treatment could better control your brain cancer.

    This study will help the study doctors find out if this different approach is better, the same,

    or worse than the usual approach.

    Memantine is FDA approved for treating dementia and is commonly used off-label

    (that is, for a purpose for which it is not FDA approved) for patients receiving whole-brain

    radiation therapy for cancer that has spread to the brain.

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

    Group 1

    If you are in this group, you will get the usual treatment, SRS. In addition to the usual

    SRS treatment, you will also receive HA-WBRT. You will also be given the drug memantine,

    which has also been shown to preserve memory function. Memantine will be taken for up to 6 months.

    Group 2

    If you are in this group, you will get the usual treatment of SRS.

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

    follow your condition. They will check you every 2 to 3 months for at least 1 year after you finish

    SRS. If you are receiving memantine, your doctor will continue to see you in the clinic as needed.

    Participants age 18 years or older who have receivedstereotactic radiosurgery to treat cancer that spread to the brain, and now thecancer has returned in other areas of the brain will be enrolled into thisstudy.

    Lukas, Rimas VincasLukas, Rimas Vincas
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04588246 STU00214371
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    BTCRC GU19-404: A Single Arm, Phase I/II Trial of Neoadjuvant Androgen Deprivation, Darolutamide, and Ipatasertib in Men with Localized, High Risk Prostate Cancer With Lead-In Cohort in Men with Castration Resistant Prostate Cancer

    The purpose of this voluntary research study is to answer the foll…

    The purpose of this voluntary research study is to answer the following questions:

    •Phase I: Is it safe to combine drug called ipatasertib with androgen deprivation therapy (ADT) and a drug called darolutamide in men with prostate cancer?

    •Phase II: Can combining a drug called ipatasertib with androgen deprivation therapy (ADT) and a drug called darolutamide for 6 months before surgery cause prostate cancer tumors to completely resolve or almost resolve?

    Phase II will start after Phase I is finished.

    If you are eligible and agree to participate, you will receive ADT as part of your usual care and the study drugs darolutamide and ipatasertib.

    You will have tests, exams and procedures that are part of your regular care and for study purposes. After you stop the study drugs, your doctor will continue to watch you for side effects and follow your condition.

    All prospective patients will undergo screening tests to determine if they are eligible to take part in the study. Darolutamide and ipatasertib are pills taken by mouth. The drugs will be given in units of time called cycles. One cycle equals 28 days (4 weeks).

    Phase I: The cycles will repeat until your cancer gets worse, or you have severe side effects. We expect that you’ll be in the study for 42 months (about 3½ years). You will have tests, exams and procedures that are part of your regular care and for study purposes. After you stop the study drugs, your doctor will continue to follow your condition for 1 month and watch you for side effects.

    Phase II: The cycles will repeat until you receive 6 cycles of drug (about 6 months) until you have surgery to remove your prostate, or if your cancer gets worse, or you have severe side effects. We expect that you’ll be in the study for 30 months (about 2½ years).

    You will have tests, exams and procedures that are part of your regular care and for study purposes. After you stop the study drugs, your doctor will continue to watch you for side effects and follow your condition every 6 months for 2 years.

    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

    •Phase I: diagnosis of castrate-resistant prostate cancer.

    •Phase II: diagnosis of localized, untreated prostate cancer with high risk features. Your tumor must also have a genetic change called PTEN loss.

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

    VanderWeele, David JamesVanderWeele, David James
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04737109 STU00214064
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    DRUG SGNLVA-005: Open-Label Phase 2 Study of Ladiratuzumab Vedotin (LV) for Unresectable Locally Advanced or Metastatic Solid Tumors

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

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

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

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

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

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

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

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

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

    Some of the eligibility criteria include:

    •Age of at least 18 years

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

    osmall cell lung cancer (SCLC)

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

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

    ohead and neck squamous cell carcinoma (HNSCC)

    oesophageal squamous cell carcinoma (ESCC)

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

    oprostate cancer

    omelanoma

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

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

    The purpose of thisstudy is…

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

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

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

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

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

    Male participants ages 18 years or older who have had surgery forprostate cancer will be enrolled in this study.
    Ross, Ashley EvanRoss, Ashley Evan
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04484818 STU00214490
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    (xIRB) NCI CIRB Alliance A091902: A Multicenter Phase II Trial of Paclitaxel with and Without Nivolumab in Taxane Naïve, and Nivolumab and Cabozantinib in Taxane Pretreated Subjects with Angiosarcoma

    The purpose of thisstudy is to compare treatment with chemotherapy (paclitaxel) alone to using ac…

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

    This study has 2 study groups.

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

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

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

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

    Participants ages 18 years or older who have a type of cancer called angiosarcoma.
    Pollack, Seth MichaelsPollack, Seth Michaels
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04339738 STU00214492
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    angiosarcoma
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    (xIRB) NCI CIRB ECOG-ACRIN 3161: A Phase III Randomized Study of Maintenance Nivolumab versus Observation in Patients with Locally Advanced, Intermediate Risk HPV Positive OPCA

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

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

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

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

    •Age of at least 18 years

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

    OR

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

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

    Boumber, YanisBoumber, Yanis
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03811015 STU00214496
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    DRUG JCAR017-EAP-001: Expanded Access Protocol (EAP) for Patients Receiving Lisocabtagene Maraleucel That Is Nonconforming for Commercial Release

    The purpose of this expanded access protocol is to allow patients to receive lisocabtagene maraleucel T cells that did not meet all of the prespecified …

    The purpose of this expanded access protocol is to allow patients to receive lisocabtagene maraleucel T cells that did not meet all of the prespecified release criteria (nonconforming) to be used as a routine prescription drug. The study will evaluate the safety and effectiveness of this therapy through the collection of information.

    Participation in this treatment plan involves receiving the nonconforming product and performing tests as part of your routine clinical care. The information or results from these evaluations will be collected for research purposes.

    If you are eligible and choose to participate in this EAP, you will be asked to complete test as part of routine care, you will undergo lymphodepleting therapy (chemotherapy administered to help prepare your bone marrow and immune system to receive lisocabtagene maraleucel), and receive the nonconforming lisocabtagene maraleucel product through your vein as an intravenous (IV) infusion.

    Approximately 3 months after receiving your nonconforming lisocabtagene maraleucel, your participation in this study will end.

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

    Some of the eligibility criteria include:

    •Age of at least 18 years

    Karmali, ReemKarmali, Reem
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04400591 STU00214152
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    (xIRB) DRUG VS-6766-202: A Phase 2 Study of VS-6766 (Dual RAF/MEK Inhibitor) as a Single Agent and In Combination with Defactinib (FAK Inhibitor) in Recurrent KRAS-Mutant (KRAS-MT) Non-Small Cell Lung Cancer (NSCLC)

    The main aims of this clinical study are to:

    •Find out if the best course …

    The main aims of this clinical study are to:

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

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

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

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

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

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

    The 2 study treatment groups are:

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

    •Combination Therapy: VS-6766 3.2 mg by mouth, twice weekly (Monday/Thursday or Tuesday/Friday) and defactinib 200 mg by mouth, twice a day, 3 weeks on and 1 week without study drug (each 4-week period is considered a cycle).

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

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

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

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

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

    Some of the eligibility criteria include:

    •Age of at least 18 years

    •Diagnosis of have KRAS-mutant non-small cell lung cancer (NSCLC).

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

    Patel, Jyoti DPatel, Jyoti D
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04620330 STU00214623
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    (xIRB) NCI CIRB ETCTN 10384: A Phase 1b/2 Study of Hu5F9-G4 (Magrolimab) in Combination with Mogamulizumab in Relapsed/Refractory Treated T-Cell Lymphoma

    The purpose of phase 1 of this study is to test the safety of a drug called Hu5F9-G4 (magrolimab) in combination with mogamulizumab. This combi…

    The purpose of phase 1 of this study is to test the safety of a drug called Hu5F9-G4 (magrolimab) in combination with mogamulizumab. This combination of drugs has been tested in animals, but has not been tested in people and is not approved by the FDA for treatment of this type of cancer. This study tests different doses of Hu5F9-G4 (magrolimab) to see which dose is safer for people when given together with mogamulizumab.

    Participants enrolled into phase 1will get the study drug Hu5F9-G4 (magrolimab) in combination with mogamulizumab for up to 1 year or until the side effects become too severe or their cancergets worse.

    The purpose of phase 2of this study is to compare mogamulizumab alone to using Hu5F9-G4 (magrolimab) plus mogamulizumab. This study will help the study doctors find out if this different approach is better than the usual approach. The study drug, Hu5F9-G4 (magrolimab) is not approved by the FDA for treatment of this type of cancer. Mogamulizumab is approved by the FDA for treatment of this type of cancer.

    Phase 2 has two study groups:

    Group 1 – participants in this group will get the usual drug used to treat this type of cancer, mogamulizumab, plus a study drug called Hu5F9-G4 (magrolimab).

    Group 2 – participants in this group will get the usual drug used to treat this type of cancer, mogamulizumab.

    In both phases, after the last treatment, participants will be followed for 2years until their cancer gets worse, or until the start of any significant treatment.

    This study has two phases. In phase1, participants ages 18 years or older who have T-cell (a type of immune cell) lymphoma that has returned after or does not respond to treatment will be enrolled. In phase 2, participants ages 18 years or older who have T-cell lymphoma affecting the skin that has returned after or does not respond to treatment will be enrolled. Participants will participate in either phase 1 or phase 2.

    Moreira, JonathanMoreira, Jonathan
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04541017 STU00214653
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    (xIRB) NCI CIRB SWOG 1931: Phase III Trial of Immunotherapy-Based Combination Therapy with or Without Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma (PROBE Trial)

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

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

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

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

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

    Participants ages 18 years or older who havekidney cancer that has spread outside of the kidney will participate in this study.
    Sosman, Jeffrey AlanSosman, Jeffrey Alan
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04510597 STU00214655
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    kidney SST
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    (xIRB) NCI CIRB ECOG-ACRIN 8185: Phase 2 Study of Bladder-SparIng ChemoradiatioN with MEDI4736 (Durvalumab) in Clinical Stage 3, Node PosItive BladdeR CancEr (INSPIRE)

    The purpose of this study is to compare the usual treatment of chemotherapy and radiation to adding MEDI4736 (durvalumab) immunoth…

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

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

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

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

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

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

    VanderWeele, David JamesVanderWeele, David James
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04216290 STU00214716
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    NU UC20L05: A Randomized Phase I Trial to Evaluate Concurrent Or Sequential Ipilimumab, Nivolumab, and Stereotactic Body Radiotherapy in Patients with Stage IV Non-Small Cell Lung Cancer (COSINR Study)
    This purpose of this study is to find the dose of radiation therapy which can be optimally given to…
    This purpose of this study is to find the dose of radiation therapy which can be optimally given to tumors in specific areas of the body (such as the lung or liver) after nivolumab and ipilimumab has already begun.

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

    The study will consist of the following parts:

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

    •A treatment period of up to 2 years

    •End-of-treatment visit

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

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

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

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

    Some of the eligibility criteria include:

    •Age of at least 18 years

    •Diagnosis of advanced non-small cell lung cancer.

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

    Patel, Jyoti DPatel, Jyoti D
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT03223155 STU00214288
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    (xIRB) NCI CIRB ETCTN 10285: Phase 1/2 Study of an EZH2 Inhibitor (Tazemetostat) in Combination with Dual BRAF/MEK Inhibition in Patients with BRAF- Mutated Metastatic Melanoma Who Progressed on Prior BRAF/MEK Inhibitor Therapy

    This study hastwo phases. Phase 1 and Phase 2.

    The purpo…

    This study hastwo phases. Phase 1 and Phase 2.

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

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

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

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

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

    Chandra, SunandanaChandra, Sunandana
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00214795
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    (xIRB) NCI CIRB ETCTN 10411: Phase 2 Study of Rogaratinib (BAY 1163877) in the Treatment of Patients with Sarcoma Harboring Alterations in Fibroblast Growth Factor Receptor (FGFR) 1-4 and SDH-Deficient Gastrointestinal Stromal Tumor (GIST)

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

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

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

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

    Pollack, Seth MichaelsPollack, Seth Michaels
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04595747 STU00214810
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    NU MSK20C04: PROTECT Study: A Phase II, Open-Label Trial of PROphylactic Skin Toxicity ThErapy with Clindamycin and Triamcinolone in Glioblastoma Patients Treated with Tumor Treating Fields

    Studyparticipants are being treated with Tumor Treating Fields (TTFields) formalignant glioma. The TTFields …

    Studyparticipants are being treated with Tumor Treating Fields (TTFields) formalignant glioma. The TTFields device uses low-intensity electrical fields totreat cancer, and this type of therapy can cause skin side effects, such asitching, sores, or infections. Researchers want to know if using clindamycingel and triamcinolone topical (on the skin) lotion before these side effectsoccur may be able to prevent their appearance, so that TTFields can be usedwith less need for interruptions

    Key eligibility criteria include:

    • Diagnosis of newly diagnosed GBM or any malignant glioma with plan to initiate treatment with TTFields with or without systemic therapy, confirmed by the enrolling institution
    • Able to self-administer topical interventions or has available another person who can apply the topical agents
    • Treatment with TTF should be initiated within 7 days of planned initiation in this trial
    • Age of at least 18 years old

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

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

    Kumthekar, Priya UKumthekar, Priya U
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04469075 STU00213944
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    DRUG KN035SAR201: ENVASARC: A Pivotal Trial of Envafolimab, and Envafolimab in Combination with Ipilimumab, in Patients with Advanced or Metastatic Undifferentiated Pleomorphic Sarcoma or Myxofibrosarcoma Who Have Progressed on Prior Chemotherapy

    The purposeof this study is to determine the effect…

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

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

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

    Pollack, Seth MichaelsPollack, Seth Michaels
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04480502 STU00214197
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    (xIRB) NCI CIRB SWOG 2007: A Phase II Trial of Sacituzumab Govitecan (IMMU-132) (NSC #820016) for Patients with HER2-Negative Breast Cancer and Brain Metastases

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

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

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

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

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

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

    The purpos…

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

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

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

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

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

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

    Kalyan, AparnaKalyan, Aparna
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00215008
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    UWI2015-05-01 Phase Ib 9cUAB30 in Early Stage Breast Cancer to Evaluate Biologic Effect
    This phase 1b trial studies the biologic effect of 9cUAB30 on early stage breast cancer. 9cUAB30 is a retinoid X receptor (RXR)-selective retinoid that acts in a tissue selective manner with the goal of minimizing…
    This phase 1b trial studies the biologic effect of 9cUAB30 on early stage breast cancer. 9cUAB30 is a retinoid X receptor (RXR)-selective retinoid that acts in a tissue selective manner with the goal of minimizing side effects, a necessary feature of agents under development for cancer prevention.
    Khan, Seema AhsanKhan, Seema Ahsan
    NCT02876640 STU00215041
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    DRUG AN2025H0301: The BURAN Study of Buparlisib (AN2025) In Combination with Paclitaxel Compared to Paclitaxel Alone, in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

    The purpose of this open-label research study is to assess the effectiveness and safety of once-daily…

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

    The study will consist of the following parts:

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

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

    •End-of-treatment visit

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

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

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

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

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

    •80 mg/m2/week paclitaxel intravenous infusion

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

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

    Some of the eligibility criteria include:

    •Age of at least 18 years

    •Diagnosis of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

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

    Boumber, YanisBoumber, Yanis
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04338399 STU00214841
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    (xIRB) DRUG ALXN1210-TMA-313: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Ravulizumab in Adult and Adolescent Participants who have Thrombotic Microangiopathy (TMA) after Hematopoietic Stem Cell Transplant (HSCT)

    This study looks at an investigational drug called …

    This study looks at an investigational drug called ravulizumab. This study drug is being developed to treat HSCT-TMA by blocking complement activity. The complement system is part of the immune system which fights against infections. In patients with HSCT-TMA, abnormal complement activity is present, which may cause destruction of the red blood cells and platelets in the blood stream and can damage some organs such as the kidney, heart, lung and brain.

    The study will consist of the following parts:

    •A preliminary (screening) period to determine eligibility

    •A treatment period that will last approximately 6 months. Participants will be asked to visit the study center 14 times overall.

    •Follow up period of approximately 6 months (3 visits)

    On Day 1, of the study treatment period, participants will receive an intravenous (IV) infusion (given through a vein) of either the study drug ravulizumab or the placebo. Five (5), ten (10) and fifteen (15) days after the first IV, participants will receive additional IVs of either the study drug or the placebo. After Day 15, participants will receive two additional doses on Day 71 and Day 127.

    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 with Thrombotic Microangiopathy (TMA) after Hematopoietic Stem Cell Transplant (HSCT)

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

    Adekola, KehindeAdekola, Kehinde
    • Map it 251 E. Huron St.
      Chicago, IL
    STU00215091
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    DRUG MK-3475-B21-00: A Phase 3, Randomized, Double-Blind Study of Pembrolizumab versus Placebo in Combination With Adjuvant Chemotherapy With or Without Radiotherapy for the Treatment of Newly Diagnosed High-Risk Endometrial Cancer After Surgery With Curative Intent (KEYNOTE-B21 / ENGOT-en11 / GOG-3053)

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

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

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

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

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

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

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

    •Group 1: Pembrolizumab

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

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

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

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

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

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

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

    Some of the eligibility criteria include:

    •Age of at least 18 years

    •Diagnosis of high-risk endometrial cancer and have no cancer remaining after having surgery.

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

    Barber, Emma LongleyBarber, Emma Longley
    STU00214464
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    DRUG BB2121-MM-007: An Exploratory Phase 1/2 Trial to Determine Recommended Phase 2 Dose (RP2D), Safety and Preliminary Efficacy of bb2121 (Ide-cel) Combinations in Subjects with Relapsed/Refractory Multiple Myeloma (KarMMa-7)

    The purpose of this research study is to testthe safety and effectivene…

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

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

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

    Treatment Arm

    Treatment

    A

    bb2121 + CC-220 (± dexamethasone)

    B

    bb2121 + BMS-986405 (JSMD194)

    C Cohort 1

    bb2121 + Daratumumab, Pomalidomide and Dexamethasone

    C Cohort 2

    bb2121 + Pomalidomide, Bortezomib, and Dexamethasone

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

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

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

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

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

    Singhal, SeemaSinghal, Seema
    NCT04855136 STU00214619
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