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A Randomized Phase 2 Study of Losartan and Nivolumab in Combination With FOLFIRINOX and SBRT in Localized Pancreatic Cancer
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
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).
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of Colorado Cancer Center
Aurora, Colorado, United States
Sibley Memorial Hospital
Washington D.C., 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
Start Date
August 10, 2018
Primary Completion Date
February 16, 2022
Completion Date
April 1, 2027
Last Updated
October 1, 2025
168
ACTUAL participants
FOLFIRINOX
DRUG
Losartan
DRUG
Nivolumab
DRUG
SBRT
RADIATION
Surgery
PROCEDURE
Lead Sponsor
Massachusetts General Hospital
Collaborators
NCT05053971
NCT04550494
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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