A Study Evaluating Atezolizumab and Bevacizumab, With or Without Tiragolumab, in Participants With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma (IMbrave152)
a study on Liver Cancer Carcinoma Hepatocellular Cancer
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at Clovis, California and other locations
- Dates
- study startedcompletion around
Description
Summary
The purpose of this study is to assess the efficacy and safety of tiragolumab, an anti-TIGIT monoclonal antibody, when administered in combination with atezolizumab and bevacizumab as first-line treatment, in participants with unresectable, locally advanced or metastatic hepatocellular carcinoma (HCC).
Official Title
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
Keywords
Carcinoma, Hepatocellular, Carcinoma, Hepatocellular Carcinoma, Bevacizumab, Atezolizumab, Tiragolumab, Atezolizumab + Bevacizumab + Tiragolumab
Eligibility
You can join if…
Open to people ages 18 years and up
- 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.
You CAN'T join if...
- 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.
Locations
- UCSF Fresno at Community Cancer Institute
accepting new patients
Clovis California 93611 United States - Kaiser Permanente - San Francisco (2238 Geary)
accepting new patients
San Francisco California 94115 United States - Kaiser Permanente - Oakland
in progress, not accepting new patients
Oakland California 94611 United States - Kaiser Permanente - Walnut Creek
in progress, not accepting new patients
Walnut Creek California 94596 United States - Stanford Cancer Center
in progress, not accepting new patients
Palo Alto California 94304 United States - Va Palo Alto Health Care System
in progress, not accepting new patients
Palo Alto California 94304 United States - Kaiser Permanente; Oncology Clinical Trials
accepting new patients
Vallejo California 94589 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Hoffmann-La Roche
- ID
- NCT05904886
- Phase
- Phase 3 research study
- Study Type
- Interventional
- Participants
- Expecting 650 study participants
- Last Updated
Frequently Asked Questions
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If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT05904886.