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

JRCT ID: jRCT2021230021

Registered date:04/09/2023

Basic Information

• Recruitment status: 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,France,Japan,Germany,Japan,Hong Kong,Japan,Italy,Japan,South Korea,Japan,Mexico,Japan,New Zealand,Japan,Poland,Japan,Puerto Rico,Japan,Singapore,Japan,South Africa,Japan,Spain,Japan,Taiwan,Japan,Thailand,Japan,Turkey,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.

Related Information

• Primary Sponsor: Shreya Badhrinarayanan
• Secondary ID(s): NCT05904886