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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Hepatocellular Carcinoma

In brief

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 HCC. Per amendment version 5, following a memo issued by the Sponsor, participants receiving treatment in the atezolizumab plus bevacizumab plus tiragolumab arm are recommended to discontinue tiragolumab treatment unless the investigator decides the benefit outweighs the risk. Participants receiving treatment in atezolizumab plus bevacizumab plus placebo arm must discontinue placebo treatment. Participants may continue receiving active treatment(s) per protocol until loss of clinical benefit or unacceptable toxicity, whichever occurs first.

Key facts

Study ID: NCT05904886
Run by: Hoffmann-La Roche
People needed: 687
Starts: 2023-09-14
Expected to finish: 2026-09-01
Last updated by the study team: 2025-12-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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
Eastern cooperative oncology group (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.

You may not qualify if…

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 cluster of differentiation 137 (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.

Where it is running

UCSF Fresno at Community Cancer Institute — Clovis, California, United States
City of Hope Cancer Center — Duarte, California, United States
University of California San Diego Moores Cancer Center — La Jolla, California, United States
University of Southern California — Los Angeles, California, United States
Stanford Cancer Center — Palo Alto, California, United States
Va Palo Alto Health Care System — Palo Alto, California, United States
UCLA Cancer Center — Santa Monica, California, United States
Hartford Healthcare Cancer Institute at Hartford Hospital — Hartford, Connecticut, United States
MedStar Washington Hosp Center — Washington D.C., District of Columbia, United States
Florida Cancer Specialists - Fort Myers (Broadway) — Fort Myers, Florida, United States
Miami VA Healthcare System — Miami, Florida, United States
Florida Cancer Specialist, North Region — St. Petersburg, Florida, United States
University of Illinois — Chicago, Illinois, United States
Norton Cancer Institute - Audubon — Louisville, Kentucky, United States
Ochsner Cancer Inst. — New Orleans, Louisiana, United States
Mercy Medical Center — Baltimore, Maryland, United States
Henry Ford Health System — Detroit, Michigan, United States
Cancer & Hematology Centers of Western Michigan — Grand Rapids, Michigan, United States
Mayo Clinic Rochester — Rochester, Minnesota, United States
National Cancer Centre — Singapore, Singapore
Minnesota Oncology Hematology Woodbury — Woodbury, Minnesota, United States
Washington Uni School of Medicine — St Louis, Missouri, United States
NYU Langone — New York, New York, United States
Icahn School of Medicine at Mount Sinai — New York, New York, United States
Genesis Cancer Center — Hot Springs, Arkansas, United States

Full record on ClinicalTrials.gov

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