Cancer
Conditions
Interventions
Sponsors
Roche
Eligibility
Sex/Gender
All
Inclusion 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 within 5 months after the final dose of atezolizumab, within 6 months after the final dose of bevacizumab, and within 90 days after the final dose of tiragolumab/placebo. 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/placebo to avoid exposing the embryo.
Exclusion criteria
Exclusion criteria: Pregnancy or breastfeeding within 5 months after the final dose of atezolizumab, within 6 months after the final dose of bevacizumab, and within 90 days after the final dose of tiragolumab/placebo. 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. 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. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigator-Assessed Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Time Frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 36 months) ;Overall Survival (OS) [ Time Frame: From randomization to death from any cause | — |
Secondary
| Measure | Time frame |
|---|---|
| Investigator-Assessed Confirmed ObjectiveResponse Rate (ORR) According to RECIST v1.1;Investigator-Assessed Duration of Objective Response (DOR) According to RECIST v1.1;Investigator-Assessed PFS Rate According to RECIST v1.1 at 6 and 12 Months;Investigator-Assessed PFS According to Hepatocellular Carcinoma (HCC) Modified RECIST (mRECIST);Investigator-Assessed Confirmed ORR According to HCC mRECIST;Investigator-Assessed DOR According to HCC mRECIST;Time to Confirmed Deterioration (TTCD) Assessed Using European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Cancer 30 (QLQ-C30) Subscales;Change from Baseline in GHS/QoL, Physical Functioning, and Role Functioning Assessed Using the EORTC QLQ-C30;Percentage of Participants With Adverse Events;Serum Concentrations of Atezolizumab;Serum Concentrations of Tiragolumab;Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab;Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab | — |
Countries
Nigeria
Contacts
Public ContactTerver Akindigh
Clinical Operations Lead
Outcome results
None listed