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

Sponsor: Genentech, Inc.

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06096779

Patient View

This Phase II, open-label study evaluates the safety and efficacy of atezolizumab, with or without bevacizumab, in patients with unresectable HCC and Child-Pugh B7/B8 cirrhosis. Eligible participants have no prior systemic treatment, measurable disease, and adequate organ function. Atezolizumab is given at 1200 mg, and bevacizumab at 15 mg/kg, both via IV infusion every 21 days.

Patient Parameters

Program Overview

The purpose of this study is to assess the safety and efficacy 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.

Description

This is a Phase II, open-label, multicohort, multicenter study in participants with unresectable, locally advanced, or metastatic hepatocellular carcinoma (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 and efficacy of atezolizumab plus bevacizumab (Cohort A) or atezolizumab monotherapy (Cohort B) in this population.

Eligibility Criteria

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 patients
  • 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 RECIST v1.1
  • 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

General

Exclusion Criteria

  • Pregnancy or breastfeeding
  • Prior treatment with 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
  • Patients who have a known concurrent malignancy that is progressing or requires active treatment, who have not completely recovered from treatment, or who have a significant malignancy history that, in the opinion of the investigator, should preclude participation.
  • Known fibrolamellar HCC, sarcomatoid HCC, other rare HCC variant, or mixed cholangiocarcinoma and HCC
  • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
  • Prior allogeneic stem cell or solid organ transplantation
  • Listed for liver transplantation
  • Co-infection with hepatitis B virus (HBV) and hepatitis C virus (HCV)
  • Untreated or incompletely treated esophageal and/or gastric varices with bleeding or that are at high risk for bleeding
  • A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment
  • Grade ≥3 hemorrhage or bleeding event within 6 months prior to initiation of study treatment
  • History of hepatic encephalopathy requiring hospitalization or treatment escalation within 6 months prior to study treatment, or any continued symptoms of encephalopathy despite medical management
  • History, planned, or recommended placement of transjugular intrahepatic portosystemic shunt (TIPS)
  • History of ascites requiring therapeutic paracentesis over the last 3 months
  • History of spontaneous bacterial peritonitis within last 12 months

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