Losartan and Nivolumab in Combination With FOLFIRINOX and SBRT in Localized Pancreatic Cancer

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Massachusetts General Hospital
Study ID
NCT03563248
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • FOLFIRINOX — DRUG
    FOLFIRINOX is a combination of 4 chemotherapy agents that may help shrink your tumor before surgery * 5-Fluorouracil (5-FU) - 400 mg/m2 on day one, followed by 1200 mg/m2 by continuous infusion for the subsequent 46-48 hours * Oxaliplatin - 85 mg/m2 by intravenous infusion over 120 minutes on day 1 of each 14 day cycle * Irinotecan - administered at a starting dose of 180 mg/m2 by intravenous infusion over 90 minutes on day 1 of each 14 day cycle * Leucovorin - Administered at a starting dose of 400 mg/m2 over 2 hours on day 1 of each 14 day cycle
  • Losartan — DRUG
    Losartan is a drug that is used to lower blood pressure
  • Nivolumab — DRUG
    Nivolumab is an antibody that may cause programmed cell death of cancer cells
  • SBRT — RADIATION
    Radiation therapy is believed to increase the likelihood of response of immunotherapy
  • Surgery — PROCEDURE
    definitive surgical resection

Study Details

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

Key Dates

Start date
Aug 10, 2018
Status verified
Sep 2025
Primary completion
Feb 16, 2022
Completion
Apr 30, 2027

Study Design

Enrollment
168 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: FOLFIRINOX: SBRT: Surgery
    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
  • Experimental: FOLFIRINOX+Losartan:SBRT+Losartan:Surgery
    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
  • Experimental: FOLFIRINOX+Losartan:SBRT+Nivolumab+Losartan:Sur
    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
  • Experimental: FOLFIRINOX x 8 : SBRT + Nivolumab : Surgery
    * 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

Primary Outcome Measure

Proportion of participants with R0 resection [ Time Frame: Up to 8 months after baseline ]

Locations (10)

FacilityCityStateZIPSite coordinators
University of Colorado Cancer CenterAuroraColorado80045-
Sibley Memorial HospitalWashington D.C.District of Columbia20016-
The Johns Hopkins HospitalBaltimoreMaryland21287-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Brigham and Women's HospitalBostonMassachusetts02215-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
Newton Wellesley HospitalNewtonMassachusetts02462-
New York University Langone Medical CenterNew YorkNew York10016-
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Aurora, CO

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
University of Colorado Cancer Center· Aurora, COSibley Memorial Hospital· Washington D.C., DCThe Johns Hopkins Hospital· Baltimore, MDBeth Israel Deaconess Medical Center· Boston, MABrigham and Women's Hospital· Boston, MADana Farber Cancer Institute· Boston, MA

Related Studies