Cholangiocarcinoma (Bile Duct Cancer) Clinical Trials

• 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.

• ECOG Performance Status of 0 or 1 with no deterioration (ie, ECOG PS \> 1) over the previous 2 weeks prior to baseline at screening and prior to randomization.

• Adequate bone marrow and organ function.