A Phase II, Open-label, Multi-cohort, Multicenter Study in Patients With Unresectable Hepatocellular Carcinoma and Child-pugh B7 and B8 Cirrhosis
Overview
- Phase
- Phase 2
- Intervention
- Atezolizumab
- Conditions
- Hepatocellular Carcinoma
- Sponsor
- Genentech, Inc.
- Enrollment
- 30
- Locations
- 119
- Primary Endpoint
- Percentage of Participants With Adverse Events (AEs)
- Status
- Recruiting
- Last Updated
- last month
Overview
Brief Summary
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.
Detailed Description
This is a Phase II, open-label, multicohort, multicenter study in participants with unresectable, locally advanced, or metastatic HCC who have Child-pugh B7 or B8 liver cirrhosis and have received no prior systemic therapy in this treatment setting. The study is designed to non-comparatively evaluate the safety of atezolizumab plus bevacizumab (Cohort A) or atezolizumab monotherapy (Cohort B) in this population.
Investigators
Eligibility Criteria
Inclusion Criteria
- •General 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 (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)
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 7 days prior to initiation of study treatment
- •Child-pugh B7 or B8 cirrhosis at screening and within 7 days prior to study treatment
- •Adequate hematologic and end-organ function
- •Life expectancy of at least 12 weeks
- •Female participants of childbearing potential must be willing to avoid pregnancy and egg donation
Exclusion Criteria
- •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
- •Treatment with systemic immunostimulatory agents
- •Treatment with systemic immunosuppressive medication
- •Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment
- •Inadequately controlled hypertension
- •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
Arms & Interventions
Cohort B: Atezolizumab
Participants will receive atezolizumab until unacceptable toxicity or loss of clinical benefit, as determined by the investigator.
Intervention: Atezolizumab
Cohort A: Atezolizumab+Bevacizumab
Participants will receive atezolizumab plus bevacizumab until unacceptable toxicity or loss of clinical benefit, as determined by the investigator.
Intervention: Atezolizumab
Cohort A: Atezolizumab+Bevacizumab
Participants will receive atezolizumab plus bevacizumab until unacceptable toxicity or loss of clinical benefit, as determined by the investigator.
Intervention: Bevacizumab
Outcomes
Primary Outcomes
Percentage of Participants With Adverse Events (AEs)
Time Frame: Baseline through the end of the study (up to approximately 36 months)
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.