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An International, Seamless Phase II/III Responsive Adaptive Randomization Platform Trial Designed To Evaluate Multiple Regimens In Newly Diagnosed and Recurrent GBM (GBM AGILE)

Principal Investigator:

Andrew B. Lassman, MD, FAAN, FASCO

Contact Number:

212-342-5162

NCT Number:

NCT03970447

Population:

Adult

Phase:

II/III

The purpose of this study is to evaluate multiple investigational treatments for either newly diagnosed or recurrent brain tumors to determine if any of these study treatment(s) improve overall survival as compared to standard treatments. Investigational means that these are new treatments sometimes called “study drugs” and are not approved by the Food and Drug Administration (FDA) to be used for your type of cancer. The investigational treatments in this study have been previously tested in people. Are you Eligible? (Inclusion Criteria) Are you 18 years of age or older? Do you...
A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study of BLU-263 in Indolent Systemic Mastocytosis

Principal Investigator:

Joseph G. Jurcic, MD

Contact Number:

212-342-5162

NCT Number:

NCT04910685

Population:

Adult

Phase:

II/III

You are being asked to participate in this study because you have indolent SM (ISM) or because you have Monoclonal mast cell activation syndrome (mMCAS). Currently, there are no available targeted therapies for patients with ISM or mMCAS. The study will test the drug BLU-263. BLU-263 is a new study drug that is being developed for treating people like you, with ISM and/or mMCAS. BLU-263 is not yet approved for treating ISM and/or mMCAS by the Food and Drug Administration (FDA). BLU-263 is the first study drug in a group of drugs that prevents a specific DNA change called KIT D816V. The goal...
LCH-IV International Collaborative Treatment Protocol for Children and Adolescents with Langerhans Cell Histiocytosis

Principal Investigator:

Justine Kahn, MD

Contact Number:

212-342-5162

NCT Number:

NCT02205762

Population:

Pediatrics

Phase:

II/III

The LCH-IV is an international, multicenter, prospective clinical study for pediatric Langerhans Cell Histiocytosis LCH (age < 18 years). LCH is a rare disease of the immune system that may affect any age group. It can affect many different organs, including the skeleton, skin, lymph nodes, liver, lungs, spleen, hematopoiesis, or central nervous system (CNS). There are two widely recognized disease extent categories: single-system LCH (involvement of a single organ or system) and multisystem LCH (involvement of 2 or more organ systems). Patients with SS-LCH of the skeleton, skin, or the...
A Phase II trial of avutometinib in combination with defactinib in metastatic diffuse gastric cancer

Principal Investigator:

Ryan H. Moy, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT06487221

Population:

Adult

Phase:

II

There are two main types of stomach cancer based on the appearance under the microscope: intestinal-type and diffuse-type. Some stomach cancers also have a mix of intestinal-type and diffuse-type (mixed type). You are being invited to take part in this research study because you have been diagnosed with stomach cancer that has spread to other parts of the body and/or cannot be surgically removed, has diffuse-type or mixed-type cells or has gene alterations that are associated with diffuse-type stomach cancers (such as mutations in the genes CDH1 or RHOA), and you have already been treated...
Advanced Renal Cell Cancer Combination ImmunoThErapy Clinical Trial (ARCITECT)

Principal Investigator:

Karie Danielle Keera Runcie, MD

Contact Number:

212-342-5162

NCT Number:

NCT05928806

Population:

Adult

Phase:

II

The purpose of this study is to find out if the combination of botensilimab and balstilimab is more effective and safer at treating in clear cell Renal Cell Cancer (ccRCC) [kidney cancer] that has spread to other parts of the body (metastatic) than the standard combination of nivolumab and ipilimumab. The combination of nivolumab and ipilimumab has already been approved by the Food and Drug Administration (FDA) for use in advanced kidney cancer. The combination of balstilimab and botensilimab is investigational and has not been approved by the Food and Drug Administration (FDA). Are you...
A Phase 2 Study of Erdafitinib in Patients with Recurrent or Progressive IDH-Wild Type Glioma with an FGFR-TACC Gene Fusion

Principal Investigator:

Aya Haggiagi, MD

Contact Number:

212-342-5162

NCT Number:

NCT05859334

Population:

Adult

Phase:

II

This study is being done to answer the following question: Will erdafitinib treatment be able to shrink or slow the growth of brain cancer that has returned or gotten worse after treatment? This study is being done to find out if treatment with erdafitinib is better or worse than the usual approach for your brain cancer. The usual approach is defined as care most people get for brain cancer: treatment with surgery, radiation, or FDA-approved drugs such as lomustine or bevacizumab. Sometimes, combinations of these treatments are used. Are you Eligible? (Inclusion Criteria) Are you 18 years of...
A RANDOMIZED PHASE II, DOUBLE-BLIND, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF AUTOGENE CEVUMERAN PLUS NIVOLUMAB VERSUS NIVOLUMAB AS ADJUVANT THERAPY IN PATIENTS WITH HIGH-RISK MUSCLE-INVASIVE UROTHELIAL CARCINOMA

Principal Investigator:

Alexander Z. Wei, MD

Contact Number:

212-342-5162

NCT Number:

NCT06534983

Population:

Adult

Phase:

II

This study is testing a drug called autogene cevumeran in combination with nivolumab, a cancer treatment drug known for treating bladder cancer. The purpose of this study is to compare the effects, good or bad, of autogene cevumeran plus nivolumab versus nivolumab on patients with Muscle Invasive Urothelial Carcinoma (MIUC.) In this study, you will get either autogene cevumeran plus nivolumab or saline plus nivolumab. Autogene Cevumeran is not approved by the Food and Drug Administration to treat muscle-invasive urothelial cancer. Are you Eligible? (Inclusion Criteria) 18 years or older - For...
A PHASE II MULTICENTER OPEN -LABEL TRIAL OF TAGRAXOFUSP (TAG) IN COMBINATION WITH VENETOCLAX AND AZACITIDINE (VEN/AZA) IN ADULTS WITH PREVIOUSLY UNTREATED CD123+ ACUTE MYELOID LEUKEMIA (AML) WHO ARE INELIGIBLE FORINTENSIVE CHEMOTHERAPY

Principal Investigator:

Sunil Girish Iyer, MD

Contact Number:

212-342-5162

NCT Number:

NCT06456463

Population:

Adult

Phase:

II

The purpose of this study is to determine if tagraxofusp (Tag) in combination with venetoclax (Ven) and azacitidine (Aza) can safely treat cancer in patients who have not received study treatment for their acute myeloid leukemia (AML) before. The combination of Tag with Ven and Aza is experimental and this combination of all 3 drugs is not approved by the United States Food and Drug Administration (FDA) for the treatment for patients with AML. Are you Eligible? (Inclusion Criteria) Are you 18 years or older? -Are you able to give written informed consent and be able to comply with all study...
A PHASE II, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY OF THE EFFICACY AND SAFETY OF ADJUVANT AUTOGENE CEVUMERAN PLUS ATEZOLIZUMAB AND mFOLFIRINOX VERSUS mFOLFIRINOX ALONE IN PATIENTS WITH RESECTED PANCREATIC DUCTAL ADENOCARCINOMA

Principal Investigator:

Gulam A. Manji, MD

Contact Number:

212-342-5162

NCT Number:

NCT05968326

Population:

Adult

Phase:

II

The purpose of this study is to compare the effects, good or bad, of autogene cevumeran plus atezolizumab and mFOLFIRINOX compared with mFOLFIRINOX (standard of care chemotherapy) alone on patients with resected pancreatic ductal adenocarcinoma (PDAC). In this study, the participant will get either the combination of autogene cevumeran plus atezolizumab and mFOLFIRINOX or mFOLFIRINOX alone. Autogene cevumeran is a personalized drug product that will be made specifically for the participant and is designed to activate and train your immune system to find and kill cancer cells. Autogene...
A Randomized Phase II trial of consolidation therapy following CD19 CAR T-cell treatment for Relapsed/Refractory Large B-cell Lymphoma or Grade IIIB Follicular Lymphoma

Principal Investigator:

Hua-Jay J Cherng, MD

Contact Number:

212-342-5162

NCT Number:

NCT05633615

Population:

Adult

Phase:

II

This study is being done to answer the following question: Can we lower the chance of Diffuse Large B-cell Lymphoma (DLBCL) cancer growing or spreading by adding treatment to the usual therapy? This study is being done to find out if this approach is better or worse than the usual approach for DLBCL patients receiving chimeric antigen receptor (CAR) T-cell therapy. The usual approach for Relapsed/Refractory DLBCL patients who have a partial response or stable disease after CAR T-cell therapy is follow-up visits with no further therapy. Some patients will improve their response over time, but...

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