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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
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).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: Theodore S. Hong, MD
Affiliation: Massachusetts General Hospital
Role: PRINCIPAL_INVESTIGATOR