MedTrace Logo

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

NCT03563248 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2025-10-01

No results posted yet for this study

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

Conditions

Interventions

DRUG

FOLFIRINOX

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

DRUG

Losartan

Losartan is a drug that is used to lower blood pressure

DRUG

Nivolumab

Nivolumab is an antibody that may cause programmed cell death of cancer cells

RADIATION

SBRT

Radiation therapy is believed to increase the likelihood of response of immunotherapy

PROCEDURE

Surgery

definitive surgical resection

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Stand Up To Cancer

    collaborator OTHER

  • Lustgarten Foundation

    collaborator OTHER

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Jennifer Y. Wo, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-10
Primary Completion
2022-02-16
Completion
2027-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03563248 on ClinicalTrials.gov