BMS-813160 With Nivolumab and Gemcitabine and Nab-paclitaxel in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC)

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

August 31, 2018

Primary Completion Date

October 28, 2021

Study Completion Date

July 25, 2024

Conditions
Pancreatic Ductal Adenocarcinoma
Interventions
DRUG

BMS-813160

BMS-813160 will be supplied by Bristol Myers Squibb

DRUG

Nivolumab

Nivolumab will be supplied by Bristol Myers Squibb

DRUG

Gemcitabine

Gemcitabine will be given as per routine care from commercial supply.

DRUG

Nab-paclitaxel

Nab-paclitaxel will be given as per routine care from commercial supply.

PROCEDURE

Biopsy

Pre-treatment, end of cycle 2, end of treatment for patients who progress or otherwise do not go to surgery, and surgery for patients who do go to surgery

PROCEDURE

Peripheral blood

-Cycle 1 Day 1 before treatment begins, after 2 cycles of treatment +/- 3 days of mandatory tumor biopsy, end of treatment for patients who progress or otherwise do not go to surgery, and no more than 24 hours prior to time of surgery (if applicable)

Trial Locations (1)

63110

Washington University School of Medicine, St Louis

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

collaborator

The Foundation for Barnes-Jewish Hospital

OTHER

collaborator

National Institutes of Health (NIH)

NIH

collaborator

National Cancer Institute (NCI)

NIH

lead

Washington University School of Medicine

OTHER