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A Study Evaluating Atezolizumab and Bevacizumab, With or Without Tiragolumab, in Participants With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) (IMbrave152)
Sponsor: Hoffmann-La Roche
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.
Official title: A Phase III, Randomized, Double-blind, Placebo-controlled Study Evaluating Atezolizumab and Bevacizumab, With or Without Tiragolumab, in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
687
Start Date
2023-09-14
Completion Date
2026-09-01
Last Updated
2025-12-31
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (171)
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
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