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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...
A phase 2 randomized study of osimertinib versus osimertinib plus chemotherapy for patients with metastatic EGFR-mutant lung cancers that have detectable EGFR mutant cfDNA in plasma after initiation of osimertinib treatment

Principal Investigator:

Catherine Shu, MD

Contact Number:

212-342-5162

NCT Number:

NCT04410796

Population:

Adult

Phase:

II

This study will compare the effectiveness of osimertinib alone to the combination of osimertinib and chemotherapy (carboplatin and pemetrexed) in people with metastatic lung cancer that has a change (mutation) in the gene for the epidermal growth factor receptor (EGFR). Osimertinib alone is the usual treatment for metastatic EGFR-mutant lung cancer. This study will be adding chemotherapy to osimertinib, which could possibly add to the anticancer effects of the usual treatment and may help stop cancer from growing or spreading. Osimertinib binds to the EGFR protein and blocks its activity,...
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 Phase 2 Study of Neoadjuvant PARP Inhibition followed by Radical Prostatectomy in Patientswith Unfavorable Intermediate-Risk or High-Risk Prostate Cancer with BRCA1/2 GeneAlterations (NePtune)

Principal Investigator:

Karie Danielle Keera Runcie, MD

Contact Number:

212-342-5162

NCT Number:

NCT05498272

Population:

Adult

Phase:

II

This is a research study to find out if giving a drug called olaparib with a Luteinizing hormone- releasing hormone (LHRH) agonist (medication that suppresses testosterone) before you undergo a radical prostatectomy (surgery to remove your prostate) decreases the amount of cancer present at the time of surgery and decrease the risk of the disease coming back after surgery. You will receive one of the LHRH agonist: leuprolide, triptorelin or goserelin. Olaparib, leuprolide, triptorelin and goserelin is FDA approved for several types of cancers such as certain types of ovarian, breast,...
A PHASE II RANDOMIZED, OPEN-LABEL, TRIAL OF NAB-PACLITAXEL + GEMCITABINE WITH OR WITHOUT BOTENSILIMAB (AGEN1181) IN PATIENTS WITH METASTATIC PANCREATIC CANCER WHO HAVE PROGRESSED ON PRIOR 5FU + LEUCOVORIN + IRINOTECAN + OXALIPLATIN (FOLFIRINOX)

Principal Investigator:

Gulam A. Manji, MD

Contact Number:

212-342-5162

NCT Number:

NCT05630183

Population:

Adult

Phase:

II

The purpose of this study is to find out if study drug, botensilimab, when given in combination with chemotherapy consisting of nab-paclitaxel + gemcitabine, can help patients with metastatic pancreatic cancer. Botensilimab has not been approved by US Food and Drug Administration (FDA). Nab-paclitaxel + gemcitabine is an approved chemotherapy combination for pancreatic cancer, but they are not FDA approved to treat pancreatic cancer that has progressed after receiving initial treatment. This trial consists of two parts (Part 1 and Part 2). All visits and procedures are the same in both parts...
A Phase II Trial of Durvalumab with Gemcitabine and Cisplatin as Neoadjuvant Therapy for High-Risk Resectable Intrahepatic Cholangiocarcinoma

Principal Investigator:

Linda Y. Wu, MD

Contact Number:

212-342-5162

NCT Number:

NCT06050252

Population:

Adult

Phase:

II

This study is being done to answer the following question: How tolerable is the new combination of durvalumab with classic chemotherapy (gemcitabine and cisplatin) before surgery for your high-risk liver cancer? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your liver cancer. The usual approach is defined as care most people get for liver cancer. Are you Eligible? (Inclusion Criteria) Age ≥ 18 years Patients must have histologically or cytologically confirmed intrahepatic cholangiocarcinoma (iCCA) that is resectable by...
A RANDOMIZED, OPEN-LABEL STUDY EVALUATING THE EFFICACY AND SAFETY OF CEMACABTAGENE ANSEGEDLEUCEL IN PARTICIPANTS WITH MINIMAL RESIDUAL DISEASE AFTER RESPONSE TO FIRST LINE THERAPY FOR LARGE B-CELL LYMPHOMA (ALPHA3)

Principal Investigator:

Ran Reshef, MD, MSc

Contact Number:

212-342-5162

NCT Number:

NCT06500273

Population:

Adult

Phase:

II

The study aims to see if CAR T cells made from healthy donors are an effective study treatment to prevent relapse in participants who have lymphoma DNA detected in their blood by an investigational test. The study evaluates two investigational products – ALLO- 647, an antibody (protein) that may help prepare the body for receiving CAR T cells from healthy donors, and a CAR T cell study treatment called cemacabtagene ansegedleucel or cema-cel. Both ALLO-647 and cema-cel are investigational drugs and therefore not approved by the Food and Drug Administration (FDA). For reference, CAR T...

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