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A Phase II, open-label, multi-cohort, multicenter study in patients with unresectable HEPATOCELLULAR CARCINOMA and CHILDPUGH B7 and B8 Cirrhosis

Primary objective:
To evaluate the safety of the study treatments in Cohorts A and B

Secondary Objectives:
To evaluate the efficacy of the study treatments in Cohorts A and B
To evaluate patient-reported tolerability of the study treatments in Cohorts A and B from the participant s perspective

Exploratory Objective:
To identify biomarkers as follows:
Those associated with response to atezolizumab + bevacizumab or atezolizumab monotherapy
Those that are early surrogates of efficacy, are associated with progression to a more severe disease state (i.e., prognostic biomarkers)
OR
Those that can increase the knowledge of disease biology and drug safety in Cohorts A and B

Protocol Number: 072309
Phase: Phase II
Applicable Disease Sites: Liver
Drugs Involved: Atezolizumab (MPDL3280A)
BEVACIZUMAB
Principal Investigator: Howard Hochster
Scope: National
Therapies Involved: Chemotherapy multiple agents systemic
Chemotherapy single agent systemic
Participating Institutions:
  • Rutgers University
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

For further information about clinical trials, please contact us at 732-235-7356.