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

Inclusion Criteria:

• Histologically confirmed adenocarcinoma of the biliary tract (intrahepatic orextrahepatic 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 ofdrains.

• 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 initialdiagnosis.

• Ampullary cancer, neuroendocrine, mixed neuroendocrine and non-neuroendocrineneoplasms and nonepithelial tumors.

• Any anti-cancer therapy for BTC prior to surgery

• Active or prior documented autoimmune or inflammatory disorders or any severe oruncontrolled systemic disease

• Current or prior use of immunosuppressive medication within 14 days before the firstdose

• Thromboembolic event within 3 months

• Active HBV or HCV infection unless treated.