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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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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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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.
Gharzai, LailaGharzai, Laila
  • 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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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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NUDB 16Z01: The OncoSET Program Database and Biobank - Combining Clinical Outcomes with Next Generation Sequencing and other Advanced Molecular Testing for Genetic Aberrations in Patients with Advanced Solid Malignancies

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

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

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

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

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

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

Wehbe, FirasWehbe, Firas
  • Map it 201 E. Huron St.
    Chicago, IL
STU00203944
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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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A Randomized Phase II Study of Topical Steroids as Preemptive Therapy for Epidermal Growth Factor Receptor Inhibitor-Induced Papulopustular Eruption
EGFR inhibitors are biologic agents used to treat certain cancers including non-small cell lung, colorectal, head and neck, and pancreatic carcinomas. T…
EGFR inhibitors are biologic agents used to treat certain cancers including non-small cell lung, colorectal, head and neck, and pancreatic carcinomas. These agents often have a side effect of an acne like rash that in some cases can be quite severe. This rash has been shown to be inflammatory in origin but is currently treated with antibiotics if it appears. The main goal of this study is to test if patients treated with steroid cream, (added) which is an anti-inflammatory medication, (added) before a rash develops have a less severe rash than patients who do not use a steroid cream before a rash develops.
Must be 18 years of age or older with a diagnosis of cancer and starting an (changed from 'and') EGFR inhibitor. During the study you must be willing to fill out a daily diary, use sunscreen and cream daily, and fill out 2 questionnaires and have photographs taken every 2 weeks for 4 visits.
Choi, Jennifer NamChoi, Jennifer Nam
  • Map it 676 N. St. Clair St.
    Chicago, IL
NCT03115567 STU00203631
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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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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. If you are interested in participating, please complete our eligibility here: https://tinyurl.com/2p86cm5a

    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 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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    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 an effect on permanent chemotherapy-induced alopecia (defined as hair loss after the completion of a chemotherapy …

    This study will test if low-dose oral minoxidil has an effect on permanent chemotherapy-induced alopecia (defined as hair loss after the completion of a chemotherapy regimen that persists for over six months). In this study, you will receive the study drug; there is no placebo option. The effectiveness 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 permanent chemotherapy-induced alopecia and agree to use contraception for the duration of 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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    Characterization of the microbiome in cutaneous T cell lymphoma
    The purpose of this study is to investigate the organisms that reside on the skin, in the gut, and nasal cavity and study their relationship with Cutaneous T-Cell Lymphoma (CTCL).
    • Be between the ages of 18-89
    • Be able and willing to provide informed consent
    • You must not have cutaneous t-cell lymphoma (CTCL)
    • You must not be currently pregnant
    • You must not be on or exposed to systemic antibiotics with 4 weeks of beginning study participation
    Zhou, AlanZhou, Alan
    • Map it 676 N. St. Clair St.
      Chicago, IL
    STU00209226
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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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    (xIRB) NRG-BN005 A Phase II Randomized Trial of Proton vs. Photon Therapy (IMRT) for Cognitive Preservation in Patients with IDH Mutant, Low to Intermediate Grade Gliomas.

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

    therapy. Photon…

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

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

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

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

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

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

    -Participants must be 18 years of age or older

    -Participants must be diagnosed with a brain tumor

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

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

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

    • Participants must be18 years or older
    • Participants must bediagnosed with non-small cell lung cancer
    Chae, Young KwangChae, Young Kwang
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT03851445 STU00209659
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    (xIRB NCI CIRB) ETCTN 10183: A Pilot Study of Tazemetostat and MK-3475 (Pembrolizumab) in Advanced Urothelial Carcinoma

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

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

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

    Diagnosis ofadvanced urothelial carcinoma

    · Age of at least 18 years

    Hussain, MahaHussain, Maha
    NCT03854474 STU00209918
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    (xIRB NCI CIRB) NRG-GY014: A Phase II Study of Tazemetostat (EPZ-6438) in Recurrent or Persistent Endometrioid or Clear Cell Carcinoma of the Ovary, and Recurrent or Persistent Endometrioid Endometrial Adenocarcinoma

    The purpose of this study is to answer thefollowing question:

    Can we…

    The purpose of this study is to answer thefollowing question:

    Can we lower the chance of your ovarian orendometrial cancer growing by using a new drug?

    We are doing this study because we want to findout if this approach is better or worse than the usual approach for ovarianor endometrial cancer.

    The usual approach for patients who are not in astudy is treatment with surgery, radiation, or drugs including: carboplatin,paclitaxel, gemcitabine, pegylated liposomal doxorubicin, topotecan, and bevacizumab (allFDA approved agents; bevacizumab is only FDA approved in ovarian cancer). Sometimes,combinations of these treatments are used.

    Participants previously treated withchemotherapy, who have been off of chemotherapy for 6 months or more, wwill beeligible for retreatment with a chemotherapy regimen containing a platinum drug(i.e. carboplatin).

    Participants who decide to take part in thisstudy will get the study drug tazemetostat until their disease gets worse orthe side effects become too severe.

    After participants finish treatment withtazemetostat, their doctor and study team will continue to follow theircondition and watch for side effects during clinic visits or by phone ifparticipants are unable to visit the clinic. Participants will bechecked on every three months for two years after treatment. Afterthat, they will be checked on for every six months for threeyears. Participants will keep seeing their doctor for up to 5 years aftertreatment.

    Recurrent or persistent endometrioid or clearcell cancer of the ovary and recurrent or persistent endometrioid cancer of theuterus.

    Age 18 or older.

    Matei, Daniela ElenaMatei, Daniela Elena
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT03348631 STU00209921
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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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    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 has not 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 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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    (xIRB) NCI CIRB Alliance A021703: Randomized Double-blind Phase III Trial of Vitamin D3 Supplementation in Patients with Previously Untreated Metastatic Colorectal Cancer (SOLARIS)

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

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

    This study has two groups:

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

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

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

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

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

    This study has 2 studygroups.

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

    · Group 2 (Arm B)

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

    Participants who are 18 years of age or older with anal cancer will beinvited to participant in this study.
    Kircher, Sheetal MehtaKircher, Sheetal Mehta
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04166318 STU00211554
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    DRUG KO-MEN-001: A Phase 1/2A First in Human Study of the Menin-MLL(KMT2A) Inhibitor KO-539 in Patients with Relapsed or Refractory Acute Myeloid Leukemia
    The main purpose of this study is to determine the tolerability and the potential safety of a new drug called KO-539 in treating your cancer. …
    The main purpose of this study is to determine the tolerability and the potential safety of a new drug called KO-539 in treating your cancer. 
    You may be eligible to take part in this research study if you have a type of cancer called acute myeloid leukemia (AML) that has not responded to standard therapy.
    Altman, Jessica KAltman, Jessica K
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04067336 STU00211062
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    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
    NCT04843566 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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    NRG GY020: A Phase III Randomized Trial of Radiation +/- MK-3475 (Pembrolizumab) for Newly Diagnosed Early Stage High Intermediate Risk Mismatch Repair Deficient (dMMR) Endometrioid Endometrial Cancer

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

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

    • Diagnosis of Stage I endometrioid endometrial cancer OR Stage II endometrioid endometrial cancer
    • At least 18 years old.
    Barber, Emma LongleyBarber, Emma Longley
    • Map it 250 E. Superior St.
      Chicago, IL
    NCT04214067 STU00212389
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    COVID-19 Convalescent Blood BioBank (SeroCore)
    Individuals will have blood drawn on enrollment as well as 6, 12 and 24 months later.  Blood will be used for genetic testing to identify factors associated with disease severity and immunologic responses.  Blood will be used to interrogate imm…
    Individuals will have blood drawn on enrollment as well as 6, 12 and 24 months later.  Blood will be used for genetic testing to identify factors associated with disease severity and immunologic responses.  Blood will be used to interrogate immunologic responses over time.  Blood will be shared with other investigators to validate serologic testing assays and to facilitate vaccine development.  
    Individuals who have recovered from COVID-19 are eligible for enrollment.  Patients will need to be confirmed to have had COVID-19 either through PCR testing or a positive antibody test prior to enrollment.  
    Ison, Michael GIson, Michael G
    • Map it 676 N. Saint Clair St. Suite 940
      Chicago, IL
    STU00212371
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    (xIRB) DRUG 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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    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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    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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    (xIRB) NCI CIRB ECOG-ACRIN 2185: Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs

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

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

    This study has 2 study groups:

    Group 1

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

    Group 2

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

    Participants will be enrolled forup to five years.

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

    Yang, Anthony DYang, Anthony D
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04239573 STU00213102
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    (xirb) 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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    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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    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 ETCTN 10334: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 2 (BLAST MRD AML-2): A Randomized Phase 2 Study of the Venetoclax, Azacitadine, and Pembrolizumab (VAP) Versus Venetoclax and Azacitadine as First Line Therapy in Older Patients with Acute Myeloid Leukemia (AML) Who Are Ineligible or Who Refuse Intensive Chemotherapy

    The purpose of this study is to compare the usual treatment alone to adding MK-3475 (pembrolizumab)

    to the usual treatment. 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 addition of pembrolizumab results in fewer detectable leukemia using new methods.

    MK-3475 (pembrolizumab), is already approved by the FDA for use in several cancers.

    However, MK-3475 (pembrolizumab) is not approved by the FDA or known to be safe for use in AML either alone or in combination with standard chemotherapy.

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

    Group 1

    Participants in this group will get the usual study drugs, azacitidine on Days 1-7 and

    venetoclax on Days 1-28 of the first cycle and on Days 1-21 or Days 1-28 of each cycle thereafter

    depending on the results of your blood count. If you are unable to receive azacitidine over

    the weekend, your doctor may give it to you for 5 days in week 1 and 2 days in week 2.

    If you derive a clinical benefit within the first 6 cycles of therapy, you will continue

    with the second part of therapy that consists of the same combination for up to 3 years

    provided you do not stop responding at any time during the second part of therapy.

    Group 2

    Participants in this group will get the usual study drugs, azacitidine on Days 1-7 and

    venetoclax on Days 1-28 of the first cycle and on Days 1-21 or Days 1-28 of each cycle thereafter

    depending on the results of your blood count. If you are unable to receive azacitidine over

    the weekend, your doctor may give it to you for 5 days in week 1 and 2 days in week 2.

    You will receive MK-3475 (pembrolizumab) on Day 8 of the first cycle and every 3 weeks thereafter.

    If you derive a clinical benefit within the first 6 cycles of therapy,

    you will continue with the second part of therapy that consists of the same combination

    for up to 3 years provided you do not stop responding.

    Participants ages 60 years or older who have newly diagnosed AML will be enrolled in this study. 
    Dinner, Shira NaomiDinner, Shira Naomi
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04284787 STU00213545
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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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    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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    (XIRB) Drug MT5111_001; A Phase 1b open-label, multicenter dose escalation and expansion study of MT-5111 in subjects with previously treated advanced HER2-positive solid tumors

    The investigational drug tested in this study, called MT-5111, is a biologic drug that is an antibody attached to a toxi…

    The investigational drug tested in this study, called MT-5111, is a biologic drug that is an antibody attached to a toxin. An antibody is a protein and in the case of the study drug it is connected to atoxin that has been shown to slow the growth of cancer cells or to kill cancer cells in laboratory experiments and in animals with cancer. The antibody recognizes and binds to the HER2 on the surface of cancer cells and afterwards kills these cells.

    This is the first research study involving MT-5111 (study drug) in humans. The study drug is experimental. It has not been approved for the treatment of cancer by any regulatory authorities and is not commercially available.

    The trial will be divided into two parts: Part A (dose-escalation) and Part B (doseexpansion).

    The objective of Part A is to determine the highest tolerable dose of study drug with the goal of defining the recommended dose to be used in Part B.

    The purpose of Part B is to confirm the safety and tolerability of the recommended dose of study drug that was determined during Part A, and to start to assess whether the study drug is a useful treatment for subjects with certain types of advanced HER2-positive solid tumors.

    Key eligibility criteria include: •Subject must have histologically confirmed, unresectable, locally advanced or metastatic solid cancers. oa. In Part A, all HER2-positive solid cancers are eligible. ob. In Part B, HER2-positive breast, GEA and other HER2- positive solid cancers are eligible for the respective expansion groups.• All subjects in both parts of the study must be HER2-positive in the latest tumor sample tested for HER2 (it is required that testing is done on a metastatic lesion in cases of metastatic cancers for subjects with metastatic disease), according to standard testing procedures. For the purpose of this study, HER2-positivity is defined as: oa. Tumors tested by IHC: must have an IHC status of 2+ or 3+, regardless of ISH result OR ob. BC or GEA tumors tested by ISH only (no IHC available): must be HER2-positive. Note: cancers other than BC and GEA must be tested via IHC and must have a status of 2+ or 3+, regardless of ISH result.•Age of at least 18 years 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..

    .

    Gradishar, William JGradishar, William J
    • Map it 201 East Huron Street Suite 12-160​
      Chicago, IL
    NCT04029922 STU00213784
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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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    (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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    NU 20H02: Phase II Study of Brentuximab Vedotin in Combination with Pembrolizumab in Patients with Recurrent Systemic Peripheral T-Cell Lymphoma (PTCL)

    The purpose of this study is to assess the antineoplastic efficacy of brentuximab vedotin in combination with pembrolizumab in previously t…

    The purpose of this study is to assess the antineoplastic efficacy of brentuximab vedotin in combination with pembrolizumab in previously treated patients with PTCL.

    Relapsed and refractory T-cell lymphomas remain an ongoing challenge with repeated courses of cytotoxic chemotherapy often yielding diminishing results. The 5-year overall survival (OS) and progression free survival (PFS) in transplant ineligible patients with T-cell lymphomas was 32% and 20%, respectively. There remains a significant need for more active therapies and combinations.

    Brentuximab vedotin is an FDA approved antibody-drug and is an effective agent in PTCL. Studies have shown this drug has a response rate of upto 40 % in PTCL

    Pembrolizumab is an FDA approved antibody-drug which targets the programmed death-1 (PD-1) immune checkpoint pathway and restores bodies natural antitumor immune responses.

    An early study with nivolumab and a more recent study with pembrolizumab showed that PD1 blockade is associated with antitumor effects in PTCL. A recent report showed significant single agent activity of pembrolizumab in NK-T cell lymphoma. Seven patients who had failed asparaginase-containing regimens were treated with single agent pembrolizumab, and all patients responded, with 5 of the CRs still ongoing at a median follow-up of 6 months. Additionally, in patients with recurrent Hodgkin lymphoma (HL), the combination of nivolumab and brentuximab vedotin was shown to be safe and effective.

    Together, the two agents could yield improved response rates and improved durability of responses, potentially leading to better long-term outcomes.

    · The target population for this study ispatients with CD30-expressing relapsed/refractory peripheral T-cell lymphoma

    Moreira, JonathanMoreira, Jonathan
    • Map it 675 N. St. Clair St.
      Chicago, IL
    NCT04795869 STU00213618
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    (xIRB) DRUG LOXO-IDH-20001: A Phase 1 Study of Oral LY3410738 in Patients with Advanced Hematologic Malignancies with IDH1 or IDH2 Mutations

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

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

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

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

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

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

    Dose Escalation

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

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

    Dose Expansion

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

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

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

    Some of the eligibility criteria include:

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

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

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

    •Age of at least 18 years

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

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

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

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

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

    Intravesical Procedure

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

    CG0070 and DDM Administration

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

    Pembrolizumab Administration

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

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

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

    Some of the eligibility criteria include:

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

    •Age of at least 18 years

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

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

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

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

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

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

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

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

    called nivolumab and ipilimumab. T…

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

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

    stability or reduction in the size of your tumor.

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

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

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

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

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

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

    months for 3 years and watch you for side effects.

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

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

    The purpose of this study is…

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

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

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

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

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

    or worse than the usual approach.

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

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

    radiation therapy for cancer that has spread to the brain.

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

    Group 1

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

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

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

    Group 2

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

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

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

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

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

    Lukas, Rimas VincasLukas, Rimas Vincas
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04588246 STU00214371
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    DRUG SGNLVA-005: Open-Label Phase 2 Study of Ladiratuzumab Vedotin (LV) for Unresectable Locally Advanced or Metastatic Solid Tumors

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

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

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

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

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

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

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

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

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

    Some of the eligibility criteria include:

    •Age of at least 18 years

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

    osmall cell lung cancer (SCLC)

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

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

    ohead and neck squamous cell carcinoma (HNSCC)

    oesophageal squamous cell carcinoma (ESCC)

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

    oprostate cancer

    omelanoma

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

    Mulcahy, Mary FrancesMulcahy, Mary Frances
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04032704 STU00214153
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    (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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    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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    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
    More Info
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    (xIRB) NCI CIRB Alliance A011801: The COMPASSHER2 Trials (COMprehensive Use of Pathologic Response ASSessment to Optimize Therapy in HER2-Positive Breast Cancer): COMPASSHER2 Residual Disease (RD), A Double-Blinded, Phase III Randomized Trial of T-DM1 and Placebo Compared with T-DM1 and Tucatinib

    The purpose of this study is to compare the usual treatment with T-DM1 alone toT-DM1 plus tucatinib. This study will help the study doctors find out if this different approach is better than the usual approach. T-DM1 is already approved by the FDA for use in patients with HER2-positive cancer. Tucatinib has not been FDA-approved to treat breast cancer.

    Participants who decide to participate will either get treatment with T-DM1 and placebo (a pill that looks like the study drug but contains no medication) or T-DM1 and tucatinib, for up to 14 cycles, unless the breast cancer returns or the side effects become too severe.

    After study treatment is finished, the study doctor will follow participants to watch for side effects and for signs of breast cancer returning. This may include a clinic visit every 6 months for 10 years.

    Participants age 18 years or older who have HER2-positive breast cancer, and who have already received treatment with chemotherapy and anti-HER2 targeted therapies followed by surgery. At the time of the surgery, cancer was still present in the breast and/or lymph nodes and was removed by a surgeon, will be enrolled into this study.

    Stein, Regina MStein, Regina M
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04457596 STU00214807
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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) Drug R5668-ONC-1938: Phase 1/2 Study of REGN5668 (MUC16 X CD28, a Costimulatory Bispecfic) Administered in Combination with Cemiplimab OR REGN4018 (MUC16 X CD3)

    The main purposes of this study are to learn about the safety and profile of any side effects from the study drugs and to determin…

    The main purposes of this study are to learn about the safety and profile of any side effects from the study drugs and to determine the highest, safe dose that can be given to patients with ovarian cancer and to look for signs that the study drugs can treat ovarian 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.

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

    Roque, Dario RRoque, Dario R
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04590326 STU00214950
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    (xirb) Drug BGB-11417-101: A Phase 1/1b Open-Label Dose Escalation and Expansion Study of Bcl-2 Inhibitor BGB-11417 in Patients with Mature B-Cell Malignancies

    This study will look at the safety and tolerability of an investigational anticancer drug currently known as BGB-11417. In addition, this …

    This study will look at the safety and tolerability of an investigational anticancer drug currently known as BGB-11417. In addition, this study also aims to look at the safety of BGB-11417 when given in combination with zanubrutinib (also known as BGB-3111).

    BGB-11417 is made by BeiGene, Ltd. BGB-11417 is an experimental drug. This means that it has not been approved for treatment by the Food and Drug Administration (FDA) in the United States or other regulatory agencies outside the United States where the Sponsor seeks approval of BGB-11417. As of 04 February 2021, BGB-11417 as a single drug has been given to over 9 participants enrolled in this research study.

    This study aims to determine the range of BGB-11417 doses that can safely be used, the safest dosing schedule to minimize side effects when first taking BGB-11417, what side effects may be experienced when taking this drug, how your body processes this drug, and if this drug is effective against your cancer.

    Key eligibility criteria include:

    ·

    · Age of at least 18 years

    Allprospective patients will undergo screening tests to determine if they areeligible to take part in the study

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

    Ma, ShuoMa, Shuo
    • Map it 201 East Huron Street Suite 12-160​
      Chicago, IL
    NCT04277637 STU00214957
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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) NU MC21B04: Genetic Risk Estimation of Breast Cancer Prior to Decisions on Preventive Therapy Uptake, Risk Reducing Surgery or Intensive Imaging Surveillance: A Study to Determine if a Polygenic Risk Score Influences the Decision Making Options Amongst High Risk Women

    The purpose of this r…

    The purpose of this research is to determine whether providing an individual polygenic risk score (PRS), in addition to the Breast Cancer Risk Assessment Tool (BCRAT) or Tyrer-Cuzick (IBIS) score, to women at high risk of breast cancer will improve their ability to make a better informed decision to accept preventive therapy and/or supplemental breast cancer screening.

    Study participation involves: 2 separate visits at which you will be asked to complete surveys and blood draws; and 8 annual visits of which you will be asked to complete surveys remotely.

    Some of the eligibility criteria include:

    •Adult woman of at least 18 years of age

    •Have been determined to be at risk of developing 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.

    Khan, Seema AhsanKhan, Seema Ahsan
    • Map it 251 E. Huron St.
      Chicago, IL
    STU00215127
    More Info
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    Training Swallowing Initiation during Expiration: Impact on Safety and Efficiency Following Treatment for Oropharyngeal Head and Neck Cancer
    Dr. Bonnie Martin-Harris and her team are studying a new swallowing therapy to improve eating, drinking, health, and quality-of-life of individuals with head an…
    Dr. Bonnie Martin-Harris and her team are studying a new swallowing therapy to improve eating, drinking, health, and quality-of-life of individuals with head and neck cancer. Therapy will be conducted remotely. 

    If you were recently diagnosed with oropharyngeal head and neck cancer, you might be eligible to participate in this study.

    Martin-Harris, BonnieMartin-Harris, Bonnie
    NCT05278039 STU00214730
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    (xirb) Drug AT148005: A PHASE 1/2 STUDY OF ALX148 IN COMBINATION WITH VENETOCLAX AND AZACITIDINE IN PATIENTS WITH ACUTE MYELOID LEUKEMIA (AML) (ASPEN-05)

    The purpose of this research study is to learn about the effects of the study drug, ALX148, (also known as evorpacept) in combination with…

    The purpose of this research study is to learn about the effects of the study drug, ALX148, (also known as evorpacept) in combination with azacitidine (AZA) and venetoclax (VEN), a standard treatment regimen for AML. This Phase 1/2 study includes three parts. In the Phase 1a part of this study, increasing doses of ALX148 will be given together with AZA and VEN. In the Phase 1b and Phase 2 parts of the study, ALX148 will be given at a dose selected from the Phase 1a part in combination with AZA and VEN.

    Cytologically or histologically confirmed diagnosis of relapsed/refractory or newly diagnosed AML per WHO 2016 classification; Phase 1a and 1b: AML that is relapsed/refractory; Phase 1a and 2: Previously untreated AML that is classified as adverse risk per ELN guidelines; 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.

    .

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    Abaza, YasminAbaza, Yasmin
    • Map it 675 N. Saint Clair St.
      Chicago, IL
    NCT04755244 STU00215182
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    (XIRB) Drug MORAb 202-G000-201: A Multicenter, Open-Label Phase 1/2 Trial Evaluating the Safety, Tolerability, and Efficacy of MORAb-202, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC) in Subjects With Selected Tumor Types

    There are two parts to this study:

    The Dose…

    There are two parts to this study:

    The Dose Escalation part, was toidentify the highest tolerable safe dose of MORAb-202 and is now complete.

    The DoseConfirmation part is to further evaluate the safety, tolerability and effectivenessof MORAb-202 in subjects with ovarian cancer and endometrial cancer at selecteddoses.

    Ovarian cancer or primary peritoneal cancer orfallopian tube cancer and had progression of disease after previous treatmentwith a platinum-containing chemotherapy regimen.

    · · Age of at least 18 years.

    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.

    Allprospective patients will undergo screening tests to determine if they areeligible to take part in the study

    Matei, Daniela ElenaMatei, Daniela Elena
    NCT04300556 STU00215228
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    DRUG BB2121-MM-007: An Exploratory Phase 1/2 Trial to Determine Recommended Phase 2 Dose (RP2D), Safety and Preliminary Efficacy of bb2121 (Ide-cel) Combinations in Subjects with Relapsed/Refractory Multiple Myeloma (KarMMa-7)

    The purpose of this research study is to testthe safety and effectivene…

    The purpose of this research study is to testthe safety and effectiveness of an investigational drug (bb2121) in combinationwith other treatments for patients diagnosed with multiple myeloma, a cancer ofthe plasma cells (a type of immune cell that produces antibodies), which hasreturned after a recent treatment regimen (relapsed), or has not responded to arecent treatment regimen (refractory).

    Screening: the study doctor will perform tests foreligibility purposes. This may take up 28 days.

    Treatment: If eligible,participants will be assigned to one of the following Treatment Arms.

    Treatment Arm

    Treatment

    A

    bb2121 + CC-220 (± dexamethasone)

    B

    bb2121 + BMS-986405 (JSMD194)

    C Cohort 1

    bb2121 + Daratumumab, Pomalidomide and Dexamethasone

    C Cohort 2

    bb2121 + Pomalidomide, Bortezomib, and Dexamethasone

    The maximum time spent in the research study will depend on theparticipant’s response to treatment. Participants will be required to returnfor a visit at the time of study treatment discontinuation (End of TreatmentVisit) (except for Treatment Arm B). Participants may be followed up for up to15 years.

    In this research study, T cells will be collected from theparticipant’s blood in a procedure called leukapheresis. The collected cellswill then be modified in a laboratory. In the laboratory, a new gene will beinserted into your T cells using a genetically modified virus. Afterapproximately 4 to 6 weeks the modified T cells, now called bb2121 T cells,will be infused back into the participant’s blood.

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

    · · Diagnosis of multiplemyeloma, a cancer of the plasma cells (a type of immune cell that producesantibodies), which has returned after your most recent treatment regimen(relapsed), or has not responded to your most recent treatment regimen(refractory).

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

    Singhal, SeemaSinghal, Seema
    NCT04855136 STU00214619
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    DRUG CPI 0610-04: A Phase 3, Randomized, Double-blind, Active-Control Study of CPI-0610 and Ruxolitinib vs. Placebo and Ruxolitinib in JAKi Treatment Naive MF Patients

    This study (also known as MANIFEST-2) is being done to find out if a study drug called pelabresib (CPI-0610) can help decrease spl…

    This study (also known as MANIFEST-2) is being done to find out if a study drug called pelabresib (CPI-0610) can help decrease spleen size and make participants with MF feel better.

    Myelofibrosis is commonly treated with a drug called ruxolitinib; which is an FDA (Food and Drug Administration) approved drug to treat patients with myelofibrosis in the US. Since ruxolitinib is approved, it is usually a doctor’s first choice of treatment. This study will see if taking ruxolitinib and the study drug pelabresib together works better than taking only ruxolitinib. The study drug (pelabresib) is also called an investigational drug. An investigational drug is a drug that is not yet approved for sale in the US by the FDA.

    There are two different treatment groups or arms in this study. One arm is called the ‘Experimental Arm’, those getting pelabresib and ruxolitinib. The second arm is the ‘Control Arm’, those getting ruxolitinib and placebo. The placebo is a harmless pill that looks like pelabresib but has no medication in it. Participants will have an equal chance (50:50), like flipping a coin, of being randomly assigned to either the Experimental Arm or the Control Arm.

    The screening period is up to 4 weeks – this is the time prior to receiving any drug. Each study treatment cycle is 3 weeks. Participants will see the study doctor for a study visit after each cycle. The study doctor will decide if participants will continue to another cycle. If the study doctor decides to continue to another cycle, participants will receive another cycle of study treatment. Average time on study is expected to be about 18 months. The amount of time on study depends on how well the study treatment works against the progression of a participant’s disease. Participants may decide to stop at any time.

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

    Some of the eligibility criteria include:

    •Age of at least 18 years

    •Diagnosis of myelofibrosis

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

    Stein, Brady LeeStein, Brady Lee
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04603495 STU00214989
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    (xirb) Drug BA3011-001: DRUG BA3011-001 A Phase 1/2 Dose Escalation and Dose Expansion Study of BA3011 Alone and in Combination with Nivolumab in Adult and Adolescent Patients 12 Years and Older with Advanced Solid Tumors

    The purpose of this research study includes the following:

      The purpose of this research study includes the following:

      • To test the safety of different doses of BA3011and to find out what effects, good and/or bad, it has on cancer.
      • To choose which dose amount should be studied in future studies. (Part A only)
      • To test greater numbers of patients with the dose level selected during Part A. (Part B only)
      • To identify the highest dose of the study drug to be used in this study that patients can receive without having severe symptoms.
      • To understand how the body absorbs and processes different doses of BA3011 by measuring the amount of the study drug in the blood before, during and after receiving BA3011. This is called pharmacokinetics (PK) testing.
      • To understand whether BA3011 causes a response by the immune system that leads to the development of antibodies (proteins made in the body that respond to a substance that is foreign to the body) which may prevent the study drug from working and/or increase risk of side effects. These antibodies are called anti-drug antibodies (ADA)

    Phase 1:Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumor and have failed available standard of care therapy and for whom no curative therapy is available or who are not eligible, intolerant to or refuse standard therapy.

    Phase 2: Patients must:

    • Have histologically or cytologically confirmed locally advanced unresectable or metastatic sarcoma.

    • Have documented progression according to Response Evaluation Criteria in Solid Tumors (RECIST)Version 1.1 criteria within the 6 months prior to enrollment.

    • Be ineligible for chemotherapy or have received at least 1 regimen containing anthracycline and a maximum of 3 previous lines of approved systemic therapy for metastatic disease (no more than 2 lines of combination regimens),including pazopanib, trabectedin, eribulin mesylate, or tazemetostat, if applicable per regional prescribing information. The requirements for prior treatments do not apply to sarcoma subtypes for which no treatment is approved
    • Age of at least 18years

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

    Pollack, Seth MichaelsPollack, Seth Michaels
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03425279 STU00215527
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    Drug 42756493BLC2003: A Randomized Phase 2 Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Subjects Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) and FGFR Mutations or Fusions

    The purpose of this …

    The purpose of this study is to see if erdafitinibis safe and useful for treating patients with high risk non-muscle invasivebladder cancer (NMIBC) that recurred (came back) after BCG therapy and has agene mutation or fusion called FGFR.

    1) Histologically confirmed, recurrent, non-muscle invasive urothelial carcinoma of the bladder

    2) Age of at least 18 years

    3) There are other tests required to confirm if you are eligible. All prospective patient will undergo these tests to determine if they are eligible to take part in the study.

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

    Meeks, Joshua JMeeks, Joshua J
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04172675 STU00215238
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    DRUG DS3201-A-U202: Single-Arm, Phase 2 Study of Valemetostat Tosylate Monotherapy in Subjects with Relapsed/Refractory Peripheral T-Cell Lymphoma

    The purpose of this study is to learn if the study drug, valemetostat tosylate, can help patients with relapsed/refractory (R/R) peripheral T-cell lymp…

    The purpose of this study is to learn if the study drug, valemetostat tosylate, can help patients with relapsed/refractory (R/R) peripheral T-cell lymphoma (PTCL) or adult T-cell leukemia/lymphoma (ATL). Any potentially harmful effects as a result of the use of valemetostat tosylate will also be studied.

    The study has two cohorts (or groups), one for PTCL patients and the other for ATL patients.

    We expect participants to be in this research study for about 56 months.

    The study has three parts:

    •Screening

    •Treatment

    •Follow-up

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

    Study drug will be administered in tablet form to be taken orally under fasting conditions (at least 1 hour before or at least 2 hours after a meal) at a dose of 200 mg once daily over a 28-day cycle.

    At each applicable visit, the study drug will be given to participants to take at home on the days they are not at the clinic.

    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 relapsed/refractory (R/R) peripheral T-cell lymphoma (PTCL) or adult T-cell leukemia/lymphoma (ATL)

    •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.

    Moreira, JonathanMoreira, Jonathan
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04703192 STU00215549
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    Drug C4471001: A TWO-PART, PHASE 1A/B, OPEN-LABEL, MULTICENTER TRIAL EVALUATING PHARMACOKINETICS, SAFETY AND EFFICACY OF PF-07284890 (ARRY-461) IN PARTICIPANTS WITH BRAF V600-MUTANT SOLID TUMORS WITH AND WITHOUT BRAIN INVOLVEMENT

    The purpose of this study is to learn about the safety and th…

    The purpose of this study is to learn about the safety and the effects of study drug PF-07284890 and to find the best dose for treating certain cancer(s) when it is given alone or with binimetinib. Binimetinib, alsoknown as Mektovi®, is a cancer medicine that is approved by the FDA to be given together with a different drug that, like PF-07284890, also blocks the BRAF enzyme and makes that combination drug work better against certain cancers. The study drug PF-07284890 is an investigational drug because it is not approved for use in this country. In this study, the study drug binimetinib is considered investigational as well because, although it is approved for use in patients already, it is not approved for use in combination withPF-07284890.

    We expect that you will be in this research study for 10-14 months. The time could be longer or shorter than this, depending on how your body is affected by the study drug(s). You will be assigned to receive the study drug PF-07284890 with or without binimetinib.

    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:

    -We are asking you to take part in this research study because you have a type of cancer that has a specific change in the BRAF gene (BRAFV600 mutation) and is advanced (cancer that has grown or spread outside the organ it started in) and available treatment(s) are no longer effective in controlling your 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.

    Chandra, SunandanaChandra, Sunandana
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04543188 STU00215417
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    NU 21S02: Pilot Study to Investigate Tumor Infiltrating Lymphocytes (TILs) in Sarcoma Samples

    Patients will be asked to give a blood sample during blood draw for routine laboratory testing(before surgery).

    Fresh tissue will be collected during scheduled surgery, which is a part of standard…

    Patients will be asked to give a blood sample during blood draw for routine laboratory testing(before surgery).

    Fresh tissue will be collected during scheduled surgery, which is a part of standard of care.

    Tumor draining lymph nodes removed duringsurgery may also be collected, if appropriate and available.

    After fresh tissue collection, if available, archival tissuemay be obtained if the study doctor feels it is necessary.

    The study team will access patient medical records after your surgery until death, patient withdrawal from data collection,patient being lost to follow up, data collection for the study is considered complete or at PIdecision (whichever comes first).

    Patients who are 18 years or older, havebeen diagnosed with sarcoma OR other cancers, and are scheduled or will be schedule for a standard of care surgery to remove the tumor.
    Pollack, Seth MichaelsPollack, Seth Michaels
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00215595
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    Drug 0739-CL-0101: A Phase 1/2 Open-label Study Investigating the Safety, Tolerability and Efficacy of ASP0739 as a Single Agent and in Combination with Pembrolizumab in Patients with Advanced Solid Tumors known to Express NY-ESO-1

    The purpose of this study is to see ifASP0739 is both safe and eff…

    The purpose of this study is to see ifASP0739 is both safe and effective as a treatment for patients who have been diagnosed with a solid tumor that isknown to express NY-ESO-1. Anotherpurpose is to find a suitable dose for ASP0739. In this study, ASP0739 will begiven either by itself or together with another drug called pembrolizumab inorder to compare the effects this might have on your cancer.

    The United States Food and DrugAdministration (U.S. FDA) has not approved ASP0739 for sale or for treatment ofcancer.

    •The patient has been diagnosed with a solid tumor that is known to express NY-ESO-1 (New York Esophageal Squamous Cell Carcinoma 1). NY-ESO-1 is a group of proteins seen in numerous cancer types. Patient has also been treated with all standard therapies and their disease has progressed or they no longer qualify for standard therapy in the opinion of their study doctor.

    •Age of at least 18 years

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

    Pollack, Seth MichaelsPollack, Seth Michaels
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04939701 STU00215634
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    (XIRB) Phase 2 Study of Pembrolizumab and Chemotherapy in Patients With Newly Diagnosed Classical Hodgkin Lymphoma (KEYNOTE-C11)

    The purpose of this researchstudy is to test pembrolizumab (pembro) and chemotherapy (chemo) in people withnewly diagnosed classical Hodgkin Lymphoma (cHL).Pembro (also …

    The purpose of this researchstudy is to test pembrolizumab (pembro) and chemotherapy (chemo) in people withnewly diagnosed classical Hodgkin Lymphoma (cHL).Pembro (also calledKEYTRUDA®) has been approved by the U.S. Food and Drug Administration (FDA) totreat many types of cancer. Treatment with pembro and chemo has not been approvedto treat your type of cancer. It is experimental.Thechemo drugs in this trial are: AVD (doxorubicin in combination with vinblastineand dacarbazine) and escBEACOPP (bleomycin in combination with etoposide,doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone). Theseare standard treatments for your type of cancer.

    Thistrial is being done to test the safety of pembro and chemo, to see how wellparticipants tolerate pembro and chemo, to see if cHL responds to treatmentwith pembro and chemo and to see if participants who get pembro and chemo livelonger

    · Age of at least18 years

    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.

    Winter, Jane NormaWinter, Jane Norma
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT05008224 STU00216076
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    NU 20H09: Phase II, Single-arm, Open-label, Multicenter study Evaluating the Efficacy of Adjunctive Zanubrutinib and CAR T-cell therapy in Aggressive B-cell Non-Hodgkin’s Lymphoma
    We are asking you to take part in this research studybecause you have and aggressive B-cell Non-Hodgkin’s Lymphoma th…
    We are asking you to take part in this research studybecause you have and aggressive B-cell Non-Hodgkin’s Lymphoma that couldbenefit from standard of care , chimeric antigen receptor (CAR) T-cell therapy.CAR T-cell therapy is a promisingtreatment where immune cells originally collected from your body called T-cells (a type of white blood cell), are modifiedand then reintroduced into your body to fight and destroy lymphoma cells.However, CAR T-cell therapy can sustain anti-cancer response beyond 6 months in only 30-40% ofcases. Thus, there is need to enhanceefficacy of CAR T-cell therapy in lymphoma. Lymphoma cells are also known to make a protein called Burton’s TyrosineKinase (“BTK” ), that helps in the proliferation of these cancers. Zanubrutinib is targeted drug that is FDAapproved for a related lymphoma called “Mantel Cell Lymphoma” ( MCL). It isknown to inhibit the BTK protein ( BTK inhibitor ) and can enhance T cell function. Thus, it is expected that it couldenhance CAR T-cell therapy. The investigators of his clinical trialhypothesize that the administration of Zanubrutinib before CAR T-cell therapy and after CAR T-cell therapy can enhance itsanti-cancer effect for your lymphoma

    · Participantsmust be 18 years or older

    The target populationfor this study is patients with aggressive B-cell Non-Hodgkin’s Lymphoma
    Karmali, ReemKarmali, Reem
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT05202782 STU00215064
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    DRUG ALLO-605-201: A Single-Arm, Open-Label, Phase 1/2 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-647 and ALLO-605, an Anti-BCMA Allogeneic CAR T Cell Therapy in Patients with Relapsed/Refractory Multiple Myeloma

    The purpose of this research study is to t…

    The purpose of this research study is to test the safety of ALLO-605 and ALLO-647, and how effective ALLO-605 is in treating multiple myeloma, along with ALLO-647. Treatment with ALLO-647 and ALLO-605 is experimental and is not approved in the United States by the Food and Drug Administration (FDA) for use in the general public, although both treatments have been cleared for testing in clinical trials.

    Pre-screening: Participants will have a blood test to determine eligibility for the main study.

    Main study: Participants who qualify and agree to participate are expected to be in the study for approximately 36 months.

    The screening period will last up to 28 days. Once screening is complete and participants are determined to be eligible, they will enter the treatment phase of the study.

    While in the trial, participants will be asked to come to the clinic for approximately 27 study visits. At six of these visits participants will receive study treatment (i.e., lymphodepletion with fludarabine, cyclophosphamide, and ALLO-647, or treatment with ALLO-605). The remaining visits will involve procedures to monitor safety, and to evaluate any effect on the participant’s multiple myeloma.

    The study is made up of two parts. The first part is called dose escalation (Phase 1) and the second part is called dose expansion (Phase 2). In the dose escalation phase, the study will test different doses of ALLO-605, following lymphodepletion with a combination of medicines that includes different doses of ALLO-647, to determine safety and which is most effective. In the dose expansion phase of the study, one ALLO-605 dose level and a lymphodepleting regimen will be chosen for further evaluation, and additional patients treated with those doses.

    Some of the eligibility criteria include:

    •Age of at least 18 years

    •Diagnosis of multiple myeloma

    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
    NCT05000450 STU00215605
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    DRUG DT2216-001: A Phase 1, Open-Label, Dose Escalation, and Cohort Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Clinical Activity of DT2216, an Antiapoptotic Protein Targeted Degradation Compound, in Subjects with Relapsed or Refractory Malignancies

    The main pur…

    The main purpose of this study is to determine if the investigational drug, called DT2216, is safe, and to determine the anti-cancer activity. This is the first time that the study drug has been used in people.

    The study will consist of the following parts:

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

    •A treatment period of up to 1 year

    •A follow-up visit 28 days after the last dose of drug

    •Continued follow-up to monitor health status every 3 months for up to 2 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.

    On the first day of the study treatment period (Day 1), the study doctor will perform some tests before participants receive the first dose of study drug. After these are completed, participants will receive a single dose of study drug by intravenous (IV) line on Day 1 and again on Day 4 each week for at least 4 weeks (this is known as 1 cycle of study treatment). During each cycle clinic visits, the study doctor will perform some tests to check for health status.

    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 cancer, 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 eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04886622 STU00215654
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    DRUG RAIN-3201: A Randomized Multicenter Phase 3 Study of Milademetan Versus Trabectedin in Patients with Dedifferentiated Liposarcoma

    If the study requirements are met, patients will be randomly assigned (like flipping a coin) to receive one of two study drugs: milademetan or trabectedin. …

    If the study requirements are met, patients will be randomly assigned (like flipping a coin) to receive one of two study drugs: milademetan or trabectedin. This is an open-label study, meaning you will know which study drug you are assigned to receive.

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

    •Milademetan: given on Days 1 to 3 and Days 15 to 17 of each cycle

    OR

    •Trabectedin: given on Day 1 of each cycle

    All patients will be contacted every 12 weeks (±7 days) for up to 24 months following your final dose of study drug, to check on patient health status after receiving the study treatment.

    • Age of at least 18 years
    • Has histologically confirmed DD liposarcoma, with or without a WD component (WD/DD liposarcoma), by local pathologic review; central pathologic review will also be performed but is not required for inclusion
    Patient must be willing to provide an archival tumor tissue sample that is ≤ 3 years old and of adequate quality or willing to provide a fresh pretreatment biopsy sampl
    • Has documented advanced unresectable (i.e., where resection is deemed to cause unacceptable morbidity or mortality) and/or metastatic WD/DD liposarcoma

    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.

    Pollack, Seth MichaelsPollack, Seth Michaels
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04979442 STU00216180
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    (xIRB) DRUG BST005: A Phase I/II Dose Escalation and Expansion Study of BST-236 plus Venetoclax in Patients with Newly Diagnosed Acute Myeloid Leukemia Unfit for Intensive Induction Chemotherapy

    The main purpose of this study is to determine the safety of BST-236 at different dose levels when admi…

    The main purpose of this study is to determine the safety of BST-236 at different dose levels when administered in combination with venetoclax and to find out what effects, good and/or bad, the study drug (BST-236) in combination with venetoclax has. The first part of this study will have up to 6 groups (cohorts) of subjects who will receive different doses of the study drug, BST-236, with different doses of venetoclax. In the second part of the study subjects will receive the selected dose of BST-236 and venetoclax that were found most appropriate according to the data from the first part of the study.

    The study will consist of the following parts:

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

    •Up to 5 courses of treatment depending on your response study

    •follow-up visits every month after the last dose of study drug, for up to 1 year

    •Post study follow-up by remote (phone ) visits for an additional 1 year

    Participation in the study may last up to two years. This will involve visits to the study doctor, which will include inpatient stays for study treatment and monthly follow-ups. Participants will receive study treatment for 7 days (Cohorts 1, 2, 3, 4) or 14 days (Cohort 5) for each of the 2 initial study treatment cycles. If participants respond to the initial study treatment, they will also receive up to 3 additional cycles of 6 days study treatment with BST-236 alone. At the end of study , the study doctor will continue to monitor participants for one year.

    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 acute myeloid leukemia (AML)

    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.

    Abaza, YasminAbaza, Yasmin
    • Map it 251 E. Huron St.
      Chicago, IL
    STU00216910
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    TELLOMAK: T-cell Lymphoma anti-KIR3DL2 therapy An open label, multi-cohort, multi-center phase II study evaluating the efficacy and safety of IPH4102 alone or in combination with chemotherapy in patients with Advanced T-cell lymphoma

    The purpose of this study is to evaluate the effectiveness and s…

    The purpose of this study is to evaluate the effectiveness and safety of a new experimental drug named lacutamab (IPH4102).

    • Be at least 18 years of age
    • Be diagnosed with one of the following types of cancer: Sezary Syndrome (SS), or mycosis fungoides (MF)
    • Have received at least two prior systemic therapies (treatments that use substances that travel through the bloodstream, reaching and affecting cells all over the body)
    • Prior treatment with mogamulizumab
    Zhou, AlanZhou, Alan
    • Map it 676 N. St. Clair St.
      Chicago, IL
    STU00215713
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