A Study Evaluating Atezolizumab and Bevacizumab, With or Without Tiragolumab, in Participants With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma (IMbrave152)

• Status: Not yet recruiting
• Trial end date: 2026-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the efficacy and safety of tiragolumab, an anti-TIGIT monoclonal antibody, when administered in combination with atezolizumab and bevacizumab as first-line treatment, in participants with unresectable, locally advanced or metastatic hepatocellular carcinoma (HCC).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Collaborator: Chugai Pharmaceutical
• Treatments: Atezolizumab; Bevacizumab

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 participants

• Disease that is not amenable to curative surgical and/or locoregional therapies

• No prior systemic treatment for locally advanced or metastatic and/or unresectable HCC

• Measurable disease according to RECIST v1.1

• ECOG Performance Status of 0 or 1 within 7 days prior to randomization

• Child-Pugh Class A within 7 days prior to randomization

• Adequate hematologic and end-organ function

• Female participants of childbearing potential must be willing to avoid pregnancy

• Male participants with a female partner of childbearing potential or pregnant female partner must remain abstinent or use a condom during the treatment period and for 6 months after the final dose of bevacizumab and for 90 days after the final dose of tiragolumab to avoid exposing the embryo.

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

• 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

• 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 5 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

• Co-infection with hepatitis B virus (HBV) and hepatitis C virus (HCV)

• Acute Epstein-Barr virus (EBV) infection or known or suspected chronic active EBV infection

• Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.