Trial of Neoadjuvant and Adjuvant Nivolumab and BMS-813160 With or Without GVAX for Locally Advanced Pancreatic Ductal Adenocarcinomas.

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

December 12, 2019

Primary Completion Date

February 1, 2025

Study Completion Date

February 1, 2025

Conditions
Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC)Pancreatic Ductal Adenocarcinoma
Interventions
RADIATION

Stereotactic Body Radiation (SBRT)

SBRT (6.6 Gy over 5 days) will be administered between 2 to 4 weeks after chemotherapy. (Prior to surgery)

DRUG

Nivolumab

Nivolumab (480 mg) will be administered IV over 30 minutes, on day 1 of cycle 1 (within 1 to 2 weeks after SBRT prior to surgery). Post - surgery Nivolumab will be given on Day 1 of cycles 2-5. Cycles are 4 weeks long.

DRUG

CCR2/CCR5 dual antagonist

CCR2/CCR5 dual antagonist (150 mg capsules) will be administered orally twice a day, on days 1-28 of cycle 1 (within 1 to 2 weeks after SBRT prior to surgery). Post - surgery CCR2/CCR5 dual antagonist will be given daily on cycles 2-5. Cycles are 4 weeks long.

DRUG

GVAX

Vaccine (5x10\^8 cells) will be administered on day 2 of cycle 1 (within 1 to 2 weeks after SBRT prior to surgery). Post - surgery GVAX will be given on Day 2 of cycles 2-5. Cycles are 4 weeks long. Six intradermal injections every 4 weeks.

Trial Locations (1)

21231

Sidney Kimmel Comprehensive Cancer Center, Baltimore

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER