Phase 1 trial of neoadjuvant modified FOLFIRINOX plus nivolumab for borderline-resectable pancreatic ductal adenocarcinoma

A phase 1b/2 trial at the University of Califiornia Los Angeles evaluated neoadjuvant modified FOLFIRINOX (mFFX) plus nivolumab for borderline-resectable pancreatic ductal adenocarcinoma (PDAC). The co-primary safety endpoint was met with 22 of 28 patients (79%) proceeding to surgery and no grade ≥ 3 immune-related adverse events. All grade 3-4 treatment related adverse events were chemotherapy-related. The co-primary pathological response rate endpoint was also met, with 9% of patients achieving a complete response, 9% a near-complete response, and 72% a partial response. Median disease-free survival was 19.7 months (95% CI 7.3-30.8). In post-hoc analyses, median progression-free survival was 26 months (95% CI 14.7-34.3) and median overall survival was 38 months (27.9-NR).