Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)

Inclusion Criteria

• Histologically confirmed adenocarcinoma of the biliary tract (intrahepatic or extrahepatic cholangiocarcinoma (CCA) or muscle invasive gallbladder cancer (GBC)) after macroscopically complete resection (R0 or R1)
• Provision of a tumor sample collected at surgical resection.
• Randomization within 12 weeks after resection with adequate healing and removal of drains.
• Confirmed to be disease-free by imaging within 28 days prior to randomization.
• Eastern Cooperative Oncology Group performance status of 0 or 1

Exclusion Criteria

• Participants with locally-advanced, unresectable, or metastatic disease at initial diagnosis.
• Ampullary cancer, neuroendocrine, mixed neuroendocrine and non-neuroendocrine neoplasms and nonepithelial tumors.
• Any anti-cancer therapy for BTC prior to surgery
• Active or prior documented autoimmune or inflammatory disorders or any severe or uncontrolled systemic disease
• Current or prior use of immunosuppressive medication within 14 days before the first dose
• Thromboembolic event within 3 months
• Active HBV or HCV infection unless treated.