drugset / Trial / NCT03006302
Epacadostat, Pembrolizumab, and CRS-207, With or Without CY/GVAX Pancreas in Patients With Metastatic Pancreas Cancer
Phase 2
Completed
41 enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Incyte Corporation · collabMerck Sharp & Dohme LLC · collabNational Cancer Institute (NCI) · collab
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2018-01-31
- Primary completion
- 2023-08-22
- Completion
- 2024-08-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 200 mg/m2 | Intravenous |
| Subject | Epacadostat | Small molecule | 100 mg | Oral |
| Subject | Epacadostat | Small molecule | 300 mg | Oral |
| Subject | Epacadostat | Small molecule | 600 mg | Oral |
| Subject | GVAX Pancreas Vaccine | Vaccine | — | — |
| Background | CRS-207 | Vaccine | 1e+09 unknown | Intravenous |
| Background | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |