A Study Evaluating Atezolizumab and Bevacizumab, With or Without Tiragolumab, in Participants With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) (IMbrave152)
NCT ID: NCT05904886
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
687 participants
INTERVENTIONAL
2023-09-14
2026-09-01
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Atezolizumab + Bevacizumab + Tiragolumab
Atezolizumab plus bevacizumab plus tiragolumab will be administered every 3 weeks (Q3W) until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
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.
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.
Atezolizumab + Bevacizumab + Placebo
Atezolizumab, bevacizumab plus placebo will be administered Q3W until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
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.
Placebo
Placebo matching tiragolumab will be administered by IV infusion on Day 1 of each 21-day cycle.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Chugai Pharmaceutical
INDUSTRY
Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Genesis Cancer Center
Hot Springs, Arkansas, United States
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
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
Columbia University
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
James J Peters VA Hospital / Mental Illness Research Education and Clinic Center
The Bronx, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Thomas Jefferson Uni
Philadelphia, Pennsylvania, United States
North Texas VA Medical Center
Dallas, Texas, United States
Kelsey Seybold Clnic
Houston, Texas, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Swedish Cancer Inst.
Seattle, Washington, United States
Univ of Wisconsin-Madison
Madison, Wisconsin, United States
Cliniques Universitaires St-Luc
Brussels, , Belgium
UZ Antwerpen
Edegem, , Belgium
AZ Delta (Campus Rumbeke)
Roeselare, , Belgium
CEDOES - Diagnóstico e Pesquisa
Vitória, Espírito Santo, Brazil
Oncoclínicas do Brasil - BELO HORIZONTE
Belo Horizonte, Minas Gerais, Brazil
Hospital do Cancer de Pernambuco - HCP
Recife, Pernambuco, Brazil
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Cancer de Barretos
Barretos, São Paulo, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo, Brazil
Clinicas Oncologicas Integradas - COI
Rio de Janeiro, , Brazil
Juravinski Hospital
Hamilton, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
McGill University Health Centre - Glen Site
Montreal, Quebec, Canada
Baoji Central Hospital
Baoji, , China
Beijing Cancer Hospital
Beijing, , China
The First Hospital of Jilin University
Changchun, , China
Peoples Hospital of Hunan Province
Changsha, , China
Hunan Cancer Hospital
Changsha, , China
West China Hospital - Sichuan University
Chengdu, , China
The First Affliated Hospital Of Fujian Medical University
Fuzhou, , China
Mengchao Hepatobiliary Hospital Of Fujian Medical University
Fuzhou, , China
Nanfang Hospital, Southern Medical University
Guangzhou, , China
Sun yat-sen University Cancer Center
Guangzhou, , China
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, , China
Zhejiang Provincial People?s Hospital
Hangzhou, , China
Harbin Medical University Cancer Hospital
Harbin, , China
Anhui Provincial Hospital
Hefei, , China
The Second Affiliated Hospital of Anhui Medical University
Hefei, , China
Lishui Central Hospital
Lishui, , China
Zhongshan Hospital Fudan Unvierstiy
Shanghai, , China
Renji Hospital Shanghai Jiaotong University School of Medicine
Shanghai, , China
Shengjing Hospital of China Medical University
Shenyang, , China
Tianjin Cancer Hospital
Tianjin, , China
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, , China
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi'an, , China
Xi'an Inernational Medical Center Hospital
Xi'an, , China
Polyclinique Internationale Sainte Anne- Marie (PISAM)
Abidjan, , Côte d’Ivoire
Centre National d'Oncologie Médicale et de Radiothérapie Alassane Ouattara (CNRAO)
Abidjan, , Côte d’Ivoire
CHU CAEN - Hôpital de la Côte de Nacre
Caen, , France
CHRU de Lille - Hopital Claude Huriez
Lille, , France
Hopital Dupuytren
Limoges, , France
Fondation Hopital Saint Joseph
Marseille, , France
Hopital Hotel Dieu Et Hme
Nantes, , France
APHP - Hopital Saint Antoine
Paris, , France
Hopital Robert Debre
Reims, , France
Centre Hospitalier Valence
Valence, , France
Hopitaux de Brabois - Gastro-Entereologie
Vandœuvre-lès-Nancy, , France
Hopital Paul Brousse
Villejuif, , France
Klinikum Esslingen
Esslingen am Neckar, , Germany
Universitätsklinikum Magdeburg Klinik für Gastroenterologie und Hepatologie
Magdeburg, , Germany
Uniklinik Mainz
Mainz, , Germany
Universität Tübingen
Tübingen, , Germany
KBTH
Accra, , Ghana
Sweden Ghana Medical Center
Accra, , Ghana
Queen Mary Hospital
Hong Kong, , Hong Kong
Prince of Wales Hosp
Shatin, , Hong Kong
Az. Osp. G. Panico
Tricase, Apulia, Italy
A.O. S. Orsola Malpighi
Bologna, Emilia-Romagna, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio, Italy
Az. Osp. Uni Ria San Martino
Genoa, Liguria, Italy
IRCCS Istituto Clinico Humanitas
Rozzano, Lombardy, Italy
A.O.U. Policlinico Paolo Giaccone
Palermo, Sicily, Italy
A.O.U.I. Verona-Ospedale Policlinico G.B. Rossi Borgo Roma
Verona, Veneto, Italy
Fujita Health University Hospital
Aichi, , Japan
Chiba University Hospital
Chiba, , Japan
National Cancer Center Hospital East
Chiba, , Japan
Ehime Prefectural Central Hospital
Ehime, , Japan
Kurume University Hospital
Fukuoka, , Japan
Hiroshima University Hospital
Hiroshima, , Japan
Sapporo Kosei General Hospital
Hokkaido, , Japan
Hokkaido University Hospital
Hokkaido, , Japan
Kanazawa University Hospital
Ishikawa, , Japan
Toranomon Branch Hospital
Kanagawa, , Japan
Kanagawa Cancer Center
Kanagawa, , Japan
Kitasato University Hospital
Kanagawa, , Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto, , Japan
Kyoto University Hospital
Kyoto, , Japan
Iwate Medical University Hospital
Numakunai, , Japan
The University of Osaka Hospital
Osaka, , Japan
Kindai University Hospital
Osaka, , Japan
Jichi Medical University Hospital
Tochigi, , Japan
Toranomon Hospital
Tokyo, , Japan
Japanese Red Cross Musashino Hospital
Tokyo, , Japan
University of Nairobi - Institute of Tropical and Infectious Diseases
Nairobi, , Kenya
OncoMed
Mexico City, Mexico CITY (federal District), Mexico
Centro Medico Nacional Siglo Xxi - Imss
Mexico City, Mexico CITY (federal District), Mexico
Instituto Nacional de Ciencias Médicas Y de Nutricion Salvador Zubirán
Mexico City, Mexico CITY (federal District), Mexico
Centro de Investigacion Clinica de Oaxaca
Oaxaca City, Oaxaca, Mexico
Auckland City Hospital
Auckland, , New Zealand
Christchurch Hospital
Christchurch, , New Zealand
Wellington Hospital
Wellington, , New Zealand
Jos University Teaching Hospital
Jos, , Nigeria
Lagos University Teaching Hospital Lagos (LUTH), Lagos State
Lagos, , Nigeria
ID Clinic
Mysłowice, , Poland
NIO im Marii Sklodowskiej-Curie
Warsaw, , Poland
PanOncology Trials
San Juan, , Puerto Rico
National Cancer Centre
Singapore, , Singapore
Charlotte Maxeke Johannesburg Academic Hospital
Johannesburg, , South Africa
Limpopo Cancer Research Institute
Polokwane, , South Africa
National Cancer Center
Goyang-si, , South Korea
CHA Bundang Medical Center
Gyeonggi-do, , South Korea
Chonnam National University Hwasun Hospital
Jeollanam-do, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Ulsan University Hosiptal
Ulsan, , South Korea
Hospital de Navarra
Navarra, Navarre, Spain
Clinica Universitaria de Navarra
Pamplona/iruña, Navarre, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Duran i Reynals
Barcelona, , Spain
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico
Jaén, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Clinica Universitaria de Navarra de Madrid;Servicio de Hepatologia
Madrid, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Universitario Puerta de Hierro
Madrid, , Spain
Hospital Clinico de Valencia
Valencia, , Spain
China Medical University Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan, , Taiwan
Chi-Mei Medical Centre
Tainan, , Taiwan
National Taiwan Uni Hospital
Taipei, , Taiwan
Chang Gung Medical Foundation - Linkou
Taoyuan District, , Taiwan
Chulalongkorn Hospital
Bangkok, , Thailand
Ramathibodi Hospital
Bangkok, , Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, , Thailand
Khon Kaen Uni
Khon Kaen, , Thailand
Adana Baskent University Medical Faculty
Adana, , Turkey (Türkiye)
Ankara Bilkent City Hospital
Ankara, , Turkey (Türkiye)
Gazi Uni Medical Faculty Hospital
Ankara, , Turkey (Türkiye)
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
Edirne, , Turkey (Türkiye)
?zmir Medical Point
Kar?iyaka, , Turkey (Türkiye)
Uganda Cancer Institute
Kampala, , Uganda
Western General Hospital
Edinburgh, , United Kingdom
Royal Free Hospital
London, , United Kingdom
Hammersmith Hospital
London, , United Kingdom
Countries
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References
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Badhrinarayanan S, Cotter C, Zhu H, Lin YC, Kudo M, Li D. IMbrave152/SKYSCRAPER-14: a Phase III study of atezolizumab, bevacizumab and tiragolumab in advanced hepatocellular carcinoma. Future Oncol. 2024;20(28):2049-2057. doi: 10.1080/14796694.2024.2355863. Epub 2024 Jun 10.
Other Identifiers
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2023-503422-39-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CO44668
Identifier Type: -
Identifier Source: org_study_id