Trial details

Trial short name: IMbrave152

Official title: A Study Evaluating Atezolizumab and Bevacizumab, With or Without Tiragolumab, in Participants With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma

Principal Investigator: Dr. Anthony Lott

Cancer type: Gastrointestinal
Cancer location: Gastrointestinal
Disease stage: Early Cancer
Trial phase: Phase 3
Intervention: Drug: Atezolizumab Drug: Bevacizumab Drug: Tiragolumab Other: Placebo

Registration #: NCT05904886

Contact e-mail: cancerclinicaltrials@sunnybrook.ca

Trial description:
Key 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 • Child-Pugh Class A • ECOG Performance Status of 0 to 1 within 7 days prior to randomization • Measurable disease according to RECIST v1.1 within 7 days prior to randomization • Adequate hematologic and end-organ function Key Exclusion Criteria: • Prior treatment with CD137 agonists or immune checkpoint blockade therapies • Treatment with investigational therapy within 28 days prior to initiation of study treatment • 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 • 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 • Active or history of autoimmune disease or immune deficiency • 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 • Mixed histology or other subtypes/variants of HCC, including, but not limited to, known liver adenocarcinoma, fibrolamellar HCC, sarcomatoid HCC, other rare HCC variant, or mixed cholangiocarcinoma and HCC • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan