O-009A Phase II multi institutional study of nivolumab in patients with advanced refractory biliary tract cancers (BTC)

Introduction: Biliary tract cancers (BTC) typically include intra and extrahepatic cholangiocarcinoma and cancers of the gallbladder. There is no established second line option for patients with advanced BTC who have failed one prior systemic therapy. There are pre-clinical and small series of clinical data which supports the usage of immune modulatory agents in BTC. Therefore we propose to evaluate the anti-PD1 agent nivolumab in advanced, refractory BTC.