About this trial
The purpose of this study is to assess the safety of atezolizumab and bevacizumab, or atezolizumab alone, as first-line treatment in participants with unresectable, locally advanced or metastatic hepatocellular carcinoma (HCC) with Child-pugh B7 or B8 cirrhosis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 (including systemic investigational agents) for locally advanced or metastatic and/or unresectable HCC
Measurable disease (at least one untreated target lesion) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Disqualifiers
Pregnancy or breastfeeding
Prior treatment with cluster of differentiation 137 (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
Trial design
Parallel
Treatments tested in this trial
Atezolizumab
DrugAtezolizumab will be administered at a dose of 1200 milligrams (mg) by intravenous (IV) infusion on Day 1 of each 21-day cycle.
Bevacizumab
DrugBevacizumab will be administered at a dose of 15 milligrams per kilogram (mg/kg) by IV infusion on Day 1 of each 21-day cycle.
Treatment groups
Trial outcomes
Primary outcomes
Percentage of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant or clinical study participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Severity is determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0) in Cohorts A and B.
Sponsors and contacts
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