The purpose of this study is to measure the efficacy and safety of rilvegostomig with gemcitabine plus cisplatin vs. durvalumab with gemcitabine plus cisplatin as first line treatment for patients with advanced BTC.
Histologically confirmed adenocarcinoma of the biliary tract, including intra-hepatic or extra-hepatic cholangiocarcinoma (CCA) and gallbladder carcinoma (GBC).
Unresectable locally advanced or metastatic BTC, previously untreated in the advanced disease setting
Known PD-L1 status assessed at a central laboratory using an acceptable tumor sample.
Measurable disease by RECIST 1.1 criteria using CT or MRI and is suitable for accurate repeated measurements.
Ampullary carcinoma
Any prior systemic therapy received for unresectable, locally advanced or metastatic BTC.
Any prior exposure to any other therapy targeting immune-regulatory receptors or mechanisms.
Any concurrent chemotherapy, radiotherapy, immunotherapy, investigational, biologic, or hormonal therapy for cancer treatment other than those under investigation in this study.