Durvalumab with Chemotherapy as First Line Treatment in Patients with Advanced Biliary Tract Cancers (aBTCs) - TOURMALINE

Exclusion Criteria

• -Any evidence of diseases such as severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diseases, active infection, active interstitial lung disease/pneumonitis, serious chronic gastrointestinal conditions associated with diarrhoea, psychiatric illness/social situations, history of uncontrolled or symptomatic cardiac disease, and history of allogenic organ transplant
• -Active or prior documented autoimmune or inflammatory disorders
• -History of another primary malignancy, except for malignancy treated with curative intent and with no known active disease ≥ 5 years before the first dose of study intervention
• -History of leptomeningeal carcinomatosis
• -History of active primary immunodeficiency
• -Known to have tested positive for human immunodeficiency virus [HIV] (positive HIV 1/2 antibodies) or active tuberculosis infection
• -Participants co-infected with Hepatitis B virus (HBV) and Hepatitis C virus (HCV) or co-infected with HBV and Hepatitis D virus (HDV)
• -Persistent toxicities (Common Terminology Criteria for Adverse Events [CTCAE] Grade > 1) caused by previous anticancer therapy
• -Central nervous system metastases requiring treatment or history of spinal cord compression
• -Known allergy or hypersensitivity to any of the study intervention or any of the study intervention
• excipients.
• -Any concurrent chemotherapy, other than the one allowed in the study, investigational medicinal product (IMP), biologic, or hormonal therapy for cancer treatment
• -Palliative radiotherapy with a limited field of radiation within 2 weeks of the first dose of study intervention, or radiotherapy with a wide field of radiation or radiotherapy affecting more than 30% of the bone marrow within 4 weeks before the first dose of study intervention
• -Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention
• -Major surgical procedure within 28 days prior to the first dose of IMP
• -Prior exposure to immune-mediated therapy excluding therapeutic anticancer vaccines
• -Receipt of the last dose of anticancer therapy within 28 days prior to the first dose of IMP