Clinical Trials

Inclusion Criteria:

• Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology/cytology or clinically by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic participants.
• Disease that is not amenable to curative surgical and/or locoregional therapies.
• No prior systemic treatment for locally advanced or metastatic and/or unresectable HCC.
• Measurable disease according to RECIST v1.1.
• ECOG Performance Status of 0 or 1 within 7 days prior to randomization.
• Child-Pugh Class A within 7 days prior to randomization.
• Adequate hematologic and end-organ function.
• Female participants of childbearing potential must be willing to avoid pregnancy.
• Male participants with a female partner of childbearing potential or pregnant female partner must remain abstinent or use a condom during the treatment period. and for 6 months after the final dose of bevacizumab and for 90 days after the final dose of tiragolumab to avoid exposing the embryo.

Exclusion Criteria:

• Pregnancy or breastfeeding.
• Prior treatment with CD137 agonists or immune checkpoint blockade therapies.
• Treatment with investigational therapy within 28 days prior to initiation of study treatment.
• Treatment with locoregional therapy to liver within 28 days prior to initiation of study treatment, or non-recovery from side effects of any such procedure.
• Treatment with systemic immunostimulatory agents.
• Treatment with systemic immunosuppressive medication.
• Untreated or incompletely treated esophageal and/or gastric varices with bleeding or that are at high risk for bleeding.
• A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment.
• 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 (CT) scan.
• History of malignancy other than HCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death.
• Known fibrolamellar HCC, sarcomatoid HCC, other rare HCC variant, or mixed cholangiocarcinoma and HCC.
• Co-infection with hepatitis B virus (HBV) and hepatitis C virus (HCV).
• Acute Epstein-Barr virus (EBV) infection or known or suspected chronic active EBV infection.
• Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 7/26/23. Questions regarding updates should be directed to the study team contact.