Epacadostat, Pembrolizumab, and CRS-207, With or Without CY/GVAX Pancreas in Patients With Metastatic Pancreas Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

41

Participants

Timeline

Start Date

January 31, 2018

Primary Completion Date

August 22, 2023

Study Completion Date

August 5, 2024

Conditions
Metastatic Pancreatic Adenocarcinoma
Interventions
DRUG

Epacadostat

Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (100, 300, or 600 mg) is taken by mouth twice a day, every day.

DRUG

Pembrolizumab

Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6.

BIOLOGICAL

CRS-207

CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10\^9 CFU) will be administered IV on Day 2 of Cycles 3-6.

DRUG

Cyclophosphamide

Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Cyclophosphamide (200 mg/m\^2) will be administered IV on day 1 of Cycles 1 and 2.

BIOLOGICAL

GVAX Pancreas Vaccine

Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). GVAX will be administered on Day 2 of Cycles 1 and 2.

Trial Locations (1)

21287

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

collaborator

National Cancer Institute (NCI)

NIH

collaborator

Incyte Corporation

INDUSTRY

lead

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

NCT03006302 - Epacadostat, Pembrolizumab, and CRS-207, With or Without CY/GVAX Pancreas in Patients With Metastatic Pancreas Cancer | Biotech Hunter | Biotech Hunter