Last updated 33 days ago
A Study Evaluating Atezolizumab and Bevacizumab, With or Without Tiragolumab, in Participants With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma (IMbrave152)
650 patients around the world
Available in Puerto Rico, Spain, Brazil, United States
Hoffmann-La Roche
5Research sites
650Patients around the world
This study is for people with
Liver Cancer
Hepatocellular Carcinoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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 participantsDisease that is not amenable to curative surgical and/or locoregional therapiesNo prior systemic treatment for locally advanced or metastatic and/or unresectable HCCMeasurable disease according to RECIST v1.1ECOG Performance Status of 0 or 1 within 7 days prior to randomizationChild-Pugh Class A within 7 days prior to randomizationAdequate hematologic and end-organ functionFemale 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/placeboMale 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.
- 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/placeboPrior treatment with CD137 agonists or immune checkpoint blockade therapiesTreatment with investigational therapy within 28 days prior to initiation of study treatmentTreatment with locoregional therapy to liver within 28 days prior to initiation of study treatment, or non-recovery from side effects of any such procedureTreatment with systemic immunostimulatory agentsTreatment with systemic immunosuppressive medicationUntreated or incompletely treated esophageal and/or gastric varices with bleeding or that are at high risk for bleedingA prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatmentActive or history of autoimmune disease or immune deficiencyHistory of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scanHistory of malignancy other than HCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or deathMixed 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 HCCCo-infection with hepatitis B virus (HBV) and hepatitis C virus (HCV)Acute Epstein-Barr virus (EBV) infection or known or suspected chronic active EBV infectionSymptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
Sites
Hospital de Amor Amazônia
Recruiting
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Recruiting
INSCER - Instituto do Cérebro da PUC-RS
Recruiting
Hospital de Câncer de Barretos - Fundação PIO XII
Recruiting
PanOncology Trials
Recruiting
StudySKYSCRAPER-14
SponsorHoffmann-La Roche
Conditions
Hepatocellular Carcinoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05904886
