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A Phase II, Open-Label, Multi-Cohort, Multicenter Study in Patients With Unresectable Hepatocellular Carcinoma and Child-Pugh B7 and B8 Cirrhosis

Description

Brief Summary
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.


Detailed 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.

Phase

N/A

Inclusion and Exclusion 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

  • 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
  • History of malignancy other than HCC within 3 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
  • 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

Sites

Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
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