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Clinical Trials in the UK / NCT05904886
Active, not recruiting Phase 3

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

NCT05904886 · tracked via the Priya Life Science UK tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 3
Started
2023-09-14
Last updated
2025-12-31

Condition(s) studied

Hepatocellular Carcinoma

Investigational drug(s) / intervention(s)

AtezolizumabBevacizumabTiragolumabPlacebo

Atezolizumab: Atezolizumab will be administered by intravenous (IV) infusion at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle.

Bevacizumab: Bevacizumab will be administered by IV infusion at a dose of 15 milligrams per kilogram (mg/kg) on Day 1 of each 21-day cycle.

Tiragolumab: Tiragolumab will be administered by IV infusion at a fixed dose of 600 mg on Day 1 of each 21-day cycle.

Placebo: Placebo matching tiragolumab will be administered by IV infusion on Day 1 of each 21-day cycle.

Study 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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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 * 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. 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 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.

Primary outcome measure(s)

Trial sites (171)

FacilityCityRegionStatus
Genesis Cancer Center Hot Springs Arkansas
UCSF Fresno at Community Cancer Institute Clovis California
City of Hope Cancer Center Duarte California
University of California San Diego Moores Cancer Center La Jolla California
University of Southern California Los Angeles California
Stanford Cancer Center Palo Alto California
Va Palo Alto Health Care System Palo Alto California
UCLA Cancer Center Santa Monica California
Hartford Healthcare Cancer Institute at Hartford Hospital Hartford Connecticut
MedStar Washington Hosp Center Washington D.C. District of Columbia
Florida Cancer Specialists - Fort Myers (Broadway) Fort Myers Florida
Miami VA Healthcare System Miami Florida
Florida Cancer Specialist, North Region St. Petersburg Florida
University of Illinois Chicago Illinois
Norton Cancer Institute - Audubon Louisville Kentucky
Ochsner Cancer Inst. New Orleans Louisiana
Mercy Medical Center Baltimore Maryland
Henry Ford Health System Detroit Michigan
Cancer & Hematology Centers of Western Michigan Grand Rapids Michigan
Mayo Clinic Rochester Rochester Minnesota
Minnesota Oncology Hematology Woodbury Woodbury Minnesota
Washington Uni School of Medicine St Louis Missouri
NYU Langone New York New York
Icahn School of Medicine at Mount Sinai New York New York
Columbia University New York New York
Montefiore Medical Center The Bronx New York
James J Peters VA Hospital / Mental Illness Research Education and Clinic Center The Bronx New York
University of North Carolina at Chapel Hill Chapel Hill North Carolina
Thomas Jefferson Uni Philadelphia Pennsylvania
North Texas VA Medical Center Dallas Texas
Kelsey Seybold Clnic Houston Texas
Virginia Mason Medical Center Seattle Washington
Swedish Cancer Inst. Seattle Washington
Univ of Wisconsin-Madison Madison Wisconsin
Cliniques Universitaires St-Luc Brussels Belgium
UZ Antwerpen Edegem Belgium
AZ Delta (Campus Rumbeke) Roeselare Belgium
CEDOES - Diagnóstico e Pesquisa Vitória Espírito Santo
Oncoclínicas do Brasil - BELO HORIZONTE Belo Horizonte Minas Gerais
Hospital do Cancer de Pernambuco - HCP Recife Pernambuco

+ 131 more sites — see the full list on the official registry below.

On this site

📄 Tecentriq (atezolizumab) drug profile → 📄 Avastin (bevacizumab) drug profile →

More Hoffmann-La Roche trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05904886 on ClinicalTrials.gov ↗ ← All trials in the UK