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

ID#: NCT05904886

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 3

Recruitment Status: Recruiting

Start Date: September 14, 2023

End Date: September 01, 2026

Contact Information:
Reference Study ID Number
888-662-6728 (U.S. Only)
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).
Eligibility:

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 within 5 months after the final dose of atezolizumab, within 6 months after the final dose of bevacizumab, and within 90 days after the final dose of tiragolumab/placebo

- 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/placebo to avoid exposing the embryo.

Exclusion Criteria:

- Pregnancy or breastfeeding within 5 months after the final dose of atezolizumab, within 6 months after the final dose of bevacizumab, and within 90 days after the final dose of tiragolumab/placebo

- 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

- Mixed histology or other subtypes/variants of HCC, including, but not limited to, known liver adenocarcinoma, 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.
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