Phase III, Randomized, Open-label, Global, Multicenter Study of Rilvegostomig or Durvalumab inCombination With Chemotherapy as a First-line Treatment for Patients With Advanced Biliary TractCancer (ARTEMIDE-Biliary02)

The purpose of this study is to understand the effectiveness and safety of rilvegostomig in combination with chemotherapy to that of standard treatment for advanced biliary tract cancer (durvalumab in combination with gemcitabine and cisplatin). We are also performing this study to better understand advanced biliary tract cancer and associated health problems. Rilvegostomig has not been approved by the Food and Drug Administration (FDA). Durvalumab, gemcitabine, and cisplatin are FDA approved to treat biliary tract cancer, but the combination of rilvegostomig, gemcitabine, and cisplatin is not FDA approved. In this study, we will use a special lab test called the investigational Ventana PD-L1 (SP263) CDx assay to check for PD-L1 in your tumor tissue. PD-L1 is a protein found on the surface of some cancer cells. It works like a “shield,” helping cancer cells hide from your immune system so they are harder for your body to find and fight. This test is FDA approved to assess PD-L1 levels in some cancer types, but it is not approved for use with rilvegostomig in biliary tract cancer.

Are you Eligible? (Inclusion Criteria)

• Must be 18 years old or older - Minimum life expectancy of 12 weeks - Must be able to handle gemcitabine or cisplatin chemotherapy.