Prospective trial of nivolumab plus ipilimumab for previously treated advanced gallbladder cancer

Most patients with advanced gallbladder cancer are treated with multiagent chemotherapy. Immune checkpoint inhibitors could offer the possibility of durable response with less toxicity. The prospective SWOG 1609 cohort 48 trial evaluated the combination of nivolumab and ipilimumab among patients with previously treated advanced gallbladder cancer. The treatment was well tolerated and resulted in confirmed complete response in 5% and confirmed partial response in 11%, for an ORR of 16%. The unconfirmed ORR was 32%. The median duration of response was 14.8 months (range 4-35.1+). The 6-month progression-free survival rate was 26% (95% CI 12-55) and the median overall survival was 7.0 months (3.9-19.1). There was one possibly treatment-related death (sepsis with attendant hepatic failure). The authors conclude that ipilimumab plus nivolumab showed modest efficacy with durable responses in previously treated patients with advanced gallbladder cancer.