J16173-Phase 2 Study of Epacadostat, Pembrolizumab, and CRS-207, with or without Cyclophosphamide and GVAX Pancreas Vaccine in Patients with Metastatic Pancreatic Cancer
Johns Hopkins Kimmel Cancer Center in Baltimore
The goal of this protocol is to determine the safety and effectiveness of epacadostat, pembrolizumab, and CRS-207, with or without pancreatic cancer vaccine (GVAX) in patients with metastatic pancreatic cancer that has been previously treated with systemic therapy
Patients with histologically proven pancreatic adenocarcinoma who have received at least one prior line of systemic treatment for metastatic disease. Adequate hematologic, renal, and liver function. No prior treatment with immunotherapy agents directed against PD-1/PD-L1 or IDO. No implants at high risk for infection and not easily removed. No history of autoimmune diseases. No history of HIV, Hepatitis B or C. No immunosuppressive agents (systemic steroids) for 14 days prior to starting treatment. No live vaccinations within 28 days.
In the first part of the study, up to 18 patients will receive treatment with cyclophosphamide/GVAX and pembrolizumab, and epacadostat for 2 cycles 3 weeks apart, then will receive CRS-207, pembrolizumab, and epacadostat for 4 cycles 3 weeks apart. The dose of epacadostat will be escalated to determine the best dose. In part 2 of the study, subjects will be randomly assigned to receive treatment with pembrolizumab and epacadostat, with CRS-207 in all cycles or with cyclophosphamide/GVAX in cycles 1-2 and CRS-207 in cycles 3-6. Treatment will occur on 3-week cycles, with 6 cycles constituting one course. Pembrolizumab +/- cyclophosphamide are given IV on day 1 of each cycle, followed by GVAX or CRS-207 on day 2. Epacadostat is taken orally continuously. Courses may be repeated for up to two years if the subject is clinically benefitting and has not experienced significant toxicities.
01/19/2020 05:03 AM