A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02)

Key inclusion Criteria:

• Histologically confirmed adenocarcinoma of the biliary tract, includingintra-hepatic or extra-hepatic cholangiocarcinoma (CCA) and gallbladder carcinoma (GBC).

• Unresectable locally advanced or metastatic BTC, previously untreated in theadvanced disease setting

• Known PD-L1 status assessed at a central laboratory using an acceptable tumorsample.

• Measurable disease by RECIST 1.1 criteria using CT or MRI and is suitable foraccurate repeated measurements.

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

• Adequate bone marrow and organ function.

Key exclusion Criteria:

• Ampullary carcinoma

• Any prior systemic therapy received for unresectable, locally advanced or metastaticBTC.

• Any prior exposure to any other therapy targeting immune-regulatory receptors ormechanisms.

• Any concurrent chemotherapy, radiotherapy, immunotherapy, investigational, biologic,or hormonal therapy for cancer treatment other than those under investigation inthis study.

• Active or prior documented autoimmune or inflammatory disorders requiring chronictreatment with steroids or other immunosuppressive treatment.

• Active or ongoing interstitial lung disease/pneumonitis (of any grade), seriouschronic gastrointestinal conditions associated with diarrhea, or activenon-infectious skin disease (including any grade rash, urticaria, dermatitis,ulceration, or psoriasis) requiring systemic treatment.