a study evaluating atezolizumab and bevacizumab, with or without tiragolumab, in participants with untreated locally advanced or metastatic hepatocellular carcinoma (imbrave152)

Conditions: Carcinoma, Hepatocellular

Summary: the purpose of this study is to assess the efficacy and safety of tiragolumab, an anti-tigit monoclonal antibody, when administered in combination with atezolizumab and bevacizumab as first-line treatment, in participants with unresectable, locally advanced or metastatic hepatocellular carcinoma (hcc).


Eligibility criteria:
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 within 5 months after the final dose of atezolizumab, within 6 months after the final dose of bevacizumab, and within 90 days after the final dose of tiragolumab/placebo * 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/placebo to avoid exposing the embryo. exclusion criteria: * pregnancy or breastfeeding within 5 months after the final dose of atezolizumab, within 6 months after the final dose of bevacizumab, and within 90 days after the final dose of tiragolumab/placebo * 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 * mixed histology or other subtypes/variants of hcc, including, but not limited to, known liver adenocarcinoma, 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.