A Study Evaluating Atezolizumab and Bevacizumab, With or Without Tiragolumab, in Participants With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma (IMbrave152) (SKYSCRAPER-14)
Carcinoma, Hepatocellular
About this trial
This is an interventional treatment trial for Carcinoma, Hepatocellular
Eligibility Criteria
Inclusion 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. Exclusion 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.
Sites / Locations
- City of Hope Cancer Center; Division of Medical Oncology & Experimental TherapeuticsRecruiting
- Mercy Medical CenterRecruiting
- Washington Uni School of MedicineRecruiting
- Kelsey Seybold ClnicRecruiting
- Swedish Cancer Institute - Edmonds CampusRecruiting
- Swedish Cancer Institute - IssaquahRecruiting
- Swedish Cancer Inst.Recruiting
- Mengchao Hepatobiliary Hospital Of Fujian Medical UniversityRecruiting
- Zhejiang Provincial People?s HospitalRecruiting
- The Second Affiliated Hospital of Anhui Medical UniversityRecruiting
- Shandong Cancer HospitalRecruiting
- The First Affiliate Hospital of Guangxi Medical UniversityRecruiting
- Zhongshan Hospital Fudan UnvierstiyRecruiting
- Renji Hospital Shanghai Jiaotong University School of MedicineRecruiting
- Iwate Medical University HospitalRecruiting
- National Cancer CenterRecruiting
- CHA Bundang Medical CenterRecruiting
- Chonnam National University Hwasun HospitalRecruiting
- Seoul National University HospitalRecruiting
- Asan Medical CenterRecruiting
- Samsung Medical CenterRecruiting
- Ulsan University HosiptalRecruiting
- Auckland City HospitalRecruiting
- Wellington HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Atezolizumab + Bevacizumab + Tiragolumab
Atezolizumab + Bevacizumab + Placebo
Atezolizumab plus bevacizumab plus tiragolumab will be administered every 3 weeks (Q3W) until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Atezolizumab, bevacizumab plus placebo will be administered every 3 weeks (Q3W) until unacceptable toxicity or loss of clinical benefit as determined by the investigator.