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Nivolumab in Combination With Chemotherapy Pre-Surgery in Treating Patients With Borderline Resectable Pancreatic Cancer

NCT03970252 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-08-09

No results posted yet for this study

Summary

This pilot and feasibility study studies how well nivolumab and combination chemotherapy work before surgery in treating patients with pancreatic cancer that could possibly be removed by surgery. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body?s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as fluorouracil, irinotecan hydrochloride, leucovorin calcium and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab in combination with chemotherapy before surgery may work better in treating patients with pancreatic cancer compared to chemotherapy alone.

Conditions

  • Borderline Resectable Pancreatic Adenocarcinoma
  • Resectable Pancreatic Ductal Adenocarcinoma

Interventions

DRUG

Fluorouracil

Given IV

DRUG

Irinotecan

Given IV

DRUG

Irinotecan Hydrochloride

Given IV

DRUG

Leucovorin

Given IV

DRUG

Leucovorin Calcium

Given IV

BIOLOGICAL

Nivolumab

Given IV

DRUG

Oxaliplatin

Given IV

PROCEDURE

Therapeutic Conventional Surgery

Undergo surgery

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • NovoCure Ltd.

    collaborator INDUSTRY

  • Jonsson Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Zev A Wainberg · UCLA / Jonsson Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-24
Primary Completion
2024-05-25
Completion
2024-05-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT03970252 on ClinicalTrials.gov