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

ML44719

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.

2024-05-31

2026-05-02

2026-11-16

Recruiting

Early phase I

120

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 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 * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}

2024-05-29