A Study Evaluating Atezolizumab and Bevacizumab, With or Without Tiragolumab, in Participants With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma (IMbrave152)
- Conditions
- Carcinoma, Hepatocellular
- Registration Number
- jRCT2021230021
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 650
-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 -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 -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 to avoid exposing the embryo.
-Pregnancy or breastfeeding -Prior treatment with 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 -Known 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.
Study & Design
- Study Type
- Interventional
- Study Design
- parallel assignment
- Primary Outcome Measures
Name Time Method - efficacy
Observation and examination, RECIST v1.1
- Secondary Outcome Measures
Name Time Method