A randomized phase II study: CRS207/GVAX plus anti-PD1 and anti-CTLA4 recruits mesothelin- and mKRAS-specific T cells into PDAC.

ABSTRACT: Pancreatic ductal adenocarcinoma (PDAC) remains highly lethal and has poor immunogenicity, warranting the use of vaccines to guide and recruit the immune response. Building on prior efforts to achieve clinical immunotherapeutic responses against PDAC, we conducted a phase II study (NCT03190265) that combined attenuated mesothelin-secreting listeria vaccine (CRS-207) and GM-CSF-secreting allogeneic whole-cell vaccine (GVAX) along with checkpoint inhibition. Patients with metastatic PDAC who progressed on chemotherapy were enrolled in one of two treatment arms in a randomized fashion. CRS-207 was given with anti-PD1 (nivolumab) and anti-CTLA4 (ipilimumab) with (Arm A) or without (Arm B) GVAX. Primary endpoint was objective response rate (ORR) and the secondary endpoint was safety. 57 patient

SUBMITTER: Bever KM 

PROVIDER: S-EPMC12869358 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature