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A Study to Evaluate Atezolizumab and Bevacizumab, with and without Tiragolumab, In Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma
EU CTIS ID: 2023-503422-39-00
What this study is testing
To evaluate the efficacy of atezolizumab plus bevacizumab plus tiragolumab compared with atezolizumab plus bevacizumab on the basis of investigator-assessed progression-free survival (PFS) and overall survival (OS)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
- No prior systemic treatment (including systemic investigational agents) for locally advanced or metastatic and/or unresectable HCC
- Measurable disease (at least one untreated target lesion) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
- Eastern Cooperative Oncology Group (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
You likely can't join if
- Pregnancy or breastfeeding, or intention of becoming pregnant during the study or 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
- Known fibrolamellar HCC, sarcomatoid HCC, other rare HCC variant, or mixed cholangiocarcinoma and HCC
- Co-infection with HBV and HCV
- Acute Epstein-Barr virus (EBV) infection or known or suspected chronic active EBV infection at screening
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including, but not limited to, anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti- TIGIT therapeutic antibodies
- 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
See the full eligibility 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
- No prior systemic treatment (including systemic investigational agents) for locally advanced or metastatic and/or unresectable HCC
- Measurable disease (at least one untreated target lesion) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
- Eastern Cooperative Oncology Group (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
- Negative human immunodeficiency virus (HIV) test at screening
- Documented virology status of hepatitis, as confirmed by screening tests for hepatitis B virus (HBV) and hepatitis C virus (HCV)
- Agreement to use protocol defined methods of contraception by both male and female participants
- Pregnancy or breastfeeding, or intention of becoming pregnant during the study or 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
- Known fibrolamellar HCC, sarcomatoid HCC, other rare HCC variant, or mixed cholangiocarcinoma and HCC
- Co-infection with HBV and HCV
- Acute Epstein-Barr virus (EBV) infection or known or suspected chronic active EBV infection at screening
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including, but not limited to, anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti- TIGIT therapeutic antibodies
- 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 within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment and immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment
- Untreated or incompletely treated esophageal and/or gastric varices with bleeding or that are at high risk for bleeding
- Active tuberculosis (TB), as documented by a positive purified protein derivative (PPD) skin test, TB blood test or TB PCR test and confirmed by a positive chest X-ray or chest CT scan within 3 months prior to initiation of study treatment
- History of malignancy other than HCC within 5 years prior to screening
- Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina
- History of hypertensive crisis or hypertensive encephalopathy
The study team makes the final eligibility decision.
Where it's taking place
- South Africa
- Mexico
- New Zealand
- United Kingdom
- Singapore
- Taiwan
- Korea, Republic of
- China
- Canada
- Brazil
- Turkey
- United States
- Thailand
- Hong Kong
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include South Africa; Mexico; New Zealand; United Kingdom; Singapore; Taiwan and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.