Phase 2 Study of Epacadostat, Pembrolizumab, and CRS-207, With or Without Cyclophosphamide and GVAX Pancreas Vaccine in Patients With Metastatic Pancreas Cancer
Overview
- Phase
- Phase 2
- Intervention
- Epacadostat
- Conditions
- Metastatic Pancreatic Adenocarcinoma
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Enrollment
- 41
- Locations
- 1
- Primary Endpoint
- Maximum Tolerated Dose (MTD) of Epacadostat
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This study will enroll patients who have metastatic pancreatic cancer and have progressed on prior chemotherapy.
Part 1 (dose escalation) participants will receive epacadostat/pembrolizumab/cyclophosphamide(CY)/GVAX pancreas vaccine followed by epacadostat/pembrolizumab/CRS-207, Part 1X (dose escalation) participants will receive epacadostat/pembrolizumab/CRS-207. Part 2X (dose expansion) participants will receive epacadostat/pembrolizumab/CRS-207.
The primary objectives of this study are to determine the recommended dose of epacadostat in this combination and assess survival of subjects in both treatment groups.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Part 1: Dose Level 1
Epacadostat/Pembrolizumab/CY/GVAX/CRS-207
Intervention: Epacadostat
Part 1: Dose Level 1
Epacadostat/Pembrolizumab/CY/GVAX/CRS-207
Intervention: Pembrolizumab
Part 1: Dose Level 1
Epacadostat/Pembrolizumab/CY/GVAX/CRS-207
Intervention: CRS-207
Part 1: Dose Level 1
Epacadostat/Pembrolizumab/CY/GVAX/CRS-207
Intervention: Cyclophosphamide
Part 1: Dose Level 1
Epacadostat/Pembrolizumab/CY/GVAX/CRS-207
Intervention: GVAX Pancreas Vaccine
Part 1: Dose Level 2
Epacadostat/Pembrolizumab/CY/GVAX/CRS-207
Intervention: Epacadostat
Part 1: Dose Level 2
Epacadostat/Pembrolizumab/CY/GVAX/CRS-207
Intervention: Pembrolizumab
Part 1: Dose Level 2
Epacadostat/Pembrolizumab/CY/GVAX/CRS-207
Intervention: CRS-207
Part 1: Dose Level 2
Epacadostat/Pembrolizumab/CY/GVAX/CRS-207
Intervention: Cyclophosphamide
Part 1X: Dose Level 3
Epacadostat/Pembrolizumab/CRS-207
Intervention: Epacadostat
Part 1: Dose Level 2
Epacadostat/Pembrolizumab/CY/GVAX/CRS-207
Intervention: GVAX Pancreas Vaccine
Part 1X: Dose Level 2
Epacadostat/Pembrolizumab/CRS-207
Intervention: Epacadostat
Part 1X: Dose Level 2
Epacadostat/Pembrolizumab/CRS-207
Intervention: Pembrolizumab
Part 1X: Dose Level 2
Epacadostat/Pembrolizumab/CRS-207
Intervention: CRS-207
Part 1X: Dose Level 3
Epacadostat/Pembrolizumab/CRS-207
Intervention: Pembrolizumab
Part 1X: Dose Level 3
Epacadostat/Pembrolizumab/CRS-207
Intervention: CRS-207
Part 2: Dose Expansion
Epacadostat/Pembrolizumab/CRS-207
Intervention: Epacadostat
Part 2: Dose Expansion
Epacadostat/Pembrolizumab/CRS-207
Intervention: Pembrolizumab
Part 2: Dose Expansion
Epacadostat/Pembrolizumab/CRS-207
Intervention: CRS-207
Outcomes
Primary Outcomes
Maximum Tolerated Dose (MTD) of Epacadostat
Time Frame: 9 weeks
Dose escalation (part I of the trial only) to determine the maximum tolerated dose (MTD) in mg BID. Epacadostat (100, 300, or 600 mg) was taken by mouth twice a day, every day.
6 Month Survival
Time Frame: 6 months
Number of subjects who are alive 6 months or longer after the date of first treatment.
Secondary Outcomes
- Number of Participants Experiencing Drug-Related Adverse Events (AEs) Requiring Treatment Discontinuation(15 months)