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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

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

Shreya Badhrinarayanan

F. Hoffmann-La Roche Ltd

1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU, Tokyo

clinical-trials@chugai-pharm.co.jp

Clinical trials information

Chugai Pharmaceutical Co., Ltd.

1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU, Tokyo

+81-120189706

clinical-trials@chugai-pharm.co.jp

Not Recruiting

Oct. 31, 2023

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

-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.

Both

Carcinoma, Hepatocellular

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.

efficacy
Observation and examination, RECIST v1.1

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

+81-19-613-7111

Aug. 18, 2023

Yes

Qualified researchers may request access to individual patient level data through the clinical study data request platform. For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds_request.html).

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