A Study Evaluating Atezolizumab and Bevacizumab, With or Without Tiragolumab, in Participants With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma (IMbrave152)
Liver Cancer / Hepatoblastoma
18 Years and older, Male and Female
CO44668 (primary)
NCI-2023-06010
2023-503422-39-00
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
- 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.
Treatment Sites in Georgia
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