biostudies-literatureUnknownBever KMNational Cancer InstituteNCI NIH HHSNIH HHSPancreatic 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 patientCancer immunology researchhttps://www.ebi.ac.uk/biostudies/studies/S-EPMC12869358biostudies-literatureA randomized phase II study: CRS207/GVAX plus anti-PD1 and anti-CTLA4 recruits mesothelin- and mKRAS-specific T cells into PDAC.PMC12869358P01 CA247886P30 CA006973P30CA006973P01CA247886R21 CA264004R21CA264004S10 OD034407S10OD034407U01 CA253403U01CA253403Bever KMAnders RAHo WJMitchell JTLe DTHernandez AGWang HDanilova LHuff ALDurham JNLee JWJaffee EMMontagne JMTandurella JAWang TShin SMFertig EJWetzel MCoyne EMfalseA randomized phase II study: CRS207/GVAX plus anti-PD1 and anti-CTLA4 recruits mesothelin- and mKRAS-specific T cells into PDAC.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 patient2026-01-01T00:00:00Z2026 Jan2026-07-15T06:18:07.745Z2026-06-30T03:22:35.175ZS-EPMC128693584152457010.1158/2326-6066.cir-25-054510.1158/2326-6066.CIR-25-0545