Combined Therapy for Pancreatic Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but if you are on ACE or ARB therapy for hypertension or renal protection, you may only be eligible for a specific part of the study. Additionally, you cannot use cimetidine, as it affects one of the trial drugs.
Is the combined therapy for pancreatic cancer safe for humans?
The combination of 5-fluorouracil (5-FU), irinotecan, and oxaliplatin has been studied in various trials for pancreatic cancer, showing that while it can be effective, it often comes with significant side effects. Patients in these studies experienced adverse events (unwanted side effects), which sometimes required additional medications to manage.12345
What makes the combined therapy for pancreatic cancer unique?
This treatment combines 5-Fluorouracil (5-FU), Irinotecan, Nivolumab, and Oxaliplatin, which is unique because it includes Nivolumab, an immunotherapy drug that helps the immune system fight cancer, alongside the FOLFIRINOX regimen, which is already used for pancreatic cancer. This combination aims to enhance the effectiveness of treatment by using both chemotherapy and immunotherapy.56789
What data supports the effectiveness of the drug combination of 5-Fluorouracil, Irinotecan, and Oxaliplatin for pancreatic cancer?
Who Is on the Research Team?
Theodore S Hong, MD
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
This trial is for adults over 18 with localized pancreatic adenocarcinoma that's potentially resectable or advanced. Participants must have stable blood pressure, normal organ/marrow function, and an ECOG status of 0-1. Women should use contraception; those pregnant or breastfeeding are excluded. People can't join if they've had certain allergic reactions, severe infections like TB, HIV/AIDS, uncontrolled health issues, recent major surgery without recovery, prior treatments for their tumor or live vaccines within a month.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Chemotherapy
Participants receive FOLFIRINOX regimen every 14 days for 8 cycles
Radiation
SBRT is administered 2-6 weeks after completing chemotherapy, with concurrent Nivolumab
Surgery
Participants undergo an attempt at definitive surgical resection following SBRT
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- 5-Fluorouracil (5-FU)
- Irinotecan
- Losartan
- Nivolumab
- Oxaliplatin
- SBRT
- Surgery
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
Bristol-Myers Squibb
Industry Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania
Stand Up To Cancer
Collaborator
Lustgarten Foundation
Collaborator