A Study Evaluating Atezolizumab, With or Without Bevacizumab, in Participants With Unresectable Hepatocellular Carcinoma and Child-pugh B7 and B8 Cirrhosis

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGenentech, Inc.

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Atezolizumab

    Drug

    Atezolizumab will be administered at a dose of 1200 milligrams (mg) by intravenous (IV) infusion on Day 1 of each 21-day cycle.

  • Bevacizumab

    Drug

    Bevacizumab 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

30 Participants
are divided into 2 treatment groups
Group A: Cohort A: Atezolizumab+BevacizumabExperimental treatment 2 interventions
Group B: Cohort B: AtezolizumabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline through the end of the study (up to approximately 36 months)

Secondary outcomes

Other outcomes

Sponsors and contacts

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