A Study of Atezolizumab With or Without Bevacizumab in Combination With Cisplatin Plus Gemcitabine in Patients With Untreated, Advanced Biliary Tract Cancer

Exclusion Criteria

• •Recurrent disease \<=6 months after curative surgery or \<= 6 months after the completion of adjuvant therapy
• •Prior local regional therapy such as radioembolization
• •Combined or mixed hepatocellular/cholangiocarcinoma
• •Clinically significant hepatic encephalopathy within the 12 months prior to Day 1 of Cycle 1
• •National Cancer Institute Common Terminoogy Criteria for Adverse Events Grade \>= 2 peripheral neuropathy
• •Prior bleeding event due to untreated or incompletely treated esophageal and/or gastric varices within 6 months prior to Day 1 of Cycle 1
• •Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the final dose of atezolizumab or within 6 months after the final dose of bevacizumab, cisplatin or gemcitabine
• •Active or history of autoimmune disease or immune deficiency
• •History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan
• •History of malignancy other than BTC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
• •Symptomatic, untreated, or actively progressing CNS metastases
• •For patients with lung metastases, if one of the following criteria applies: Large, centrally located pulmonary metastases; Clear tumor infiltration into the thoracic great vessels seen on imaging; Clear cavitation of pulmonary lesions seen on imaging
• •Active tuberculosis
• •Co-infection with HBV and HCV
• •Treatment with systemic immunostimulatory agents or immunosuppressive medication
• •Inadequately controlled arterial hypertension
• •History of hypertensive crisis or hypertensive encephalopathy
• •Significant vascular disease
• •Evidence of bleeding diathesis or significant coagulopathy
• •Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture
• •Chronic daily treatment with a non-steroidal anti-inflammatory drug (NSAID)
• •Preexisting renal impairment, myelosuppression, or hearing impairment