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Spots Global Cancer Trial Database for Losartan and Nivolumab in Combination With FOLFIRINOX and SBRT in Localized Pancreatic Cancer

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Trial Identification

Brief Title: Losartan and Nivolumab in Combination With FOLFIRINOX and SBRT in Localized Pancreatic Cancer

Official Title: A Randomized Phase 2 Study of Losartan and Nivolumab in Combination With FOLFIRINOX and SBRT in Localized Pancreatic Cancer

Study ID: NCT03563248

Study Description

Brief Summary: This research study is studying a combination of interventions as a possible treatment for pancreatic tumor. The interventions involved in this study are: * FOLFIRINOX which is made up of 4 different drugs: * 5-Fluorouracil (5-FU) * Oxaliplatin * Irinotecan * Leucovorin * Losartan * Nivolumab * Radiation Therapy * Surgery

Detailed Description: This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied. The FDA (the U.S. Food and Drug Administration) has approved FOLFIRINOX as a treatment option for this disease. The FDA has not approved losartan or nivolumab for this specific disease but they have been approved for other uses. FOLFIRINOX is a combination of 4 chemotherapy agents that may help shrink your tumor before surgery. Losartan is a drug that is used to lower blood pressure. Nivolumab is an antibody (a cell that attaches to other cells to fight off infection) that may cause programmed cell death of cancer cells. Radiation therapy is believed to increase the likelihood of response of immunotherapy (the prevention/treatment of a disease through an immune response).

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University of Colorado Cancer Center, Aurora, Colorado, United States

Sibley Memorial Hospital, Washington, District of Columbia, United States

The Johns Hopkins Hospital, Baltimore, Maryland, United States

Massachusetts General Hospital, Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

Brigham and Women's Hospital, Boston, Massachusetts, United States

Dana Farber Cancer Institute, Boston, Massachusetts, United States

Newton Wellesley Hospital, Newton, Massachusetts, United States

New York University Langone Medical Center, New York, New York, United States

MD Anderson Cancer Center, Houston, Texas, United States

Contact Details

Name: Theodore S. Hong, MD

Affiliation: Massachusetts General Hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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