Combined Therapy for Pancreatic Cancer

Recruiting at9 trial locations

Overseen by Theodore S Hong, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Massachusetts General Hospital

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

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

Research Team

Theodore S Hong, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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

I am older than 18 years.

My pancreatic cancer is confirmed and may be operable or advanced but not spread.

Your blood pressure is higher than 100 mm Hg when the study starts.

Exclusion Criteria

I am allergic to certain chemotherapy drugs or losartan.

Participation in any investigational drug study within 4 weeks preceding the start of study treatment

I had major surgery less than 4 weeks ago and haven't fully recovered.

Treatment Details

Interventions

• 5-Fluorouracil (5-FU) (Chemotherapy)
• Irinotecan (Chemotherapy)
• Losartan (Angiotensin II Receptor Blocker)
• Nivolumab (Monoclonal Antibodies)
• Oxaliplatin (Chemotherapy)
• SBRT (Radiation)
• Surgery (Procedure)

Trial Overview The study tests a combination treatment for pancreatic cancer including FOLFIRINOX (a mix of four drugs), Losartan (a blood pressure medication), Nivolumab (an immunotherapy drug), radiation therapy and surgery to see how well they work together in treating the tumor.

Participant Groups

Group I: FOLFIRINOX+Losartan:SBRT+Nivolumab+Losartan:Sur Experimental Treatment 5 Interventions

The FOLFIRINOX regimen will be administered intravenously. Treatment will be every 14 days +3/ -1 at physician discretion * Losartan will be administered orally as a tablet to be taken by the patient at home every day * SBRT should be administered 2-6 weeks after completing chemotherapy * Participants will receive nivolumab during SBRT * All participants will undergo an attempt at definitive surgical resection following SBRT

Group II: FOLFIRINOX+Losartan:SBRT+Losartan:Surgery Experimental Treatment 4 Interventions

The FOLFIRINOX regimen will be administered intravenously. Treatment will be every 14 days +3/ -1 at physician discretion * Losartan will be administered orally as a tablet to be taken by the patient at home every day * SBRT should be administered 2-6 weeks after completing chemotherapy * All participants will undergo an attempt at definitive surgical resection following SBRT

Group III: FOLFIRINOX x 8 : SBRT + Nivolumab : Surgery Experimental Treatment 4 Interventions

* The FOLFIRINOX regimen will be administered intravenously. Treatment will be every 14 days +3/ -1 at physician discretion * SBRT should be administered 2-6 weeks after completing chemotherapy * Participants will receive nivolumab during SBRT * All participants will undergo an attempt at definitive surgical resection following SBRT

Group IV: FOLFIRINOX: SBRT: Surgery Active Control 3 Interventions

The FOLFIRINOX regimen will be administered intravenously. Treatment will be every 14 days +3/ -1 at physician discretion * SBRT should be administered 2-6 weeks after completing chemotherapy * All participants will undergo an attempt at definitive surgical resection following SBRT

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Dr. William Curry

Massachusetts General Hospital

Chief Medical Officer

MD from Harvard Medical School

Dr. Anne Klibanski

Massachusetts General Hospital

Chief Executive Officer since 2019

MD from Harvard Medical School

Bristol-Myers Squibb

Industry Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

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

Trials

53

Recruited

40,100+

Lustgarten Foundation

Collaborator

Trials

27

Recruited

5,500+