NIPH Clinical Trials Search

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

Basic Information

Recruitment status	Not Recruiting
Health condition(s) or Problem(s) studied	Carcinoma, Hepatocellular
Date of first enrollment	11/10/2023
Target sample size	650
Countries of recruitment	US,Japan,Belgium,Japan,Brazil,Japan,Canada,Japan,China,Japan,Cote D'Ivoire,Japan,France,Japan,Germany,Japan,Hong Kong,Japan,Italy,Japan,South Korea,Japan,Mexico,Japan,Morocco,Japan,New Zealand,Japan,Nigeria,Japan,Poland,Japan,Puerto Rico,Japan,Singapore,Japan,South Africa,Japan,Spain,Japan,Taiwan,Japan,Thailand,Japan,Turkey,Japan,United Kingdom,Japan
Study type	Interventional
Intervention(s)	Tiragolumab: Tiragolumab will be administered by intravenous (IV) infusion at a fixed dose of 600 mg on Day 1 of each 21-day cycle. Atezolizumab: Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle. Bevacizumab: Bevacizumab will be administered by IV infusion at a dose of 15 mg/kg on Day 1 of each 21-day cycle.

Outcome(s)

Primary Outcome	efficacy Observation and examination, RECIST v1.1
Secondary Outcome	safety, efficacy, phamacokinetics,other Observation and examination, RECIST v1.1

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include 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 -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.
Exclude criteria	-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.