A Study Evaluating Atezolizumab and Bevacizumab, With or Without Tiragolumab, in Participants With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) (IMbrave152)
Condition(s) studied
Investigational drug(s) / intervention(s)
Atezolizumab: Atezolizumab will be administered by intravenous (IV) infusion at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle.
Bevacizumab: Bevacizumab will be administered by IV infusion at a dose of 15 milligrams per kilogram (mg/kg) on Day 1 of each 21-day cycle.
Tiragolumab: Tiragolumab will be administered by IV infusion at a fixed dose of 600 mg on Day 1 of each 21-day cycle.
Placebo: Placebo matching tiragolumab will be administered by IV infusion on Day 1 of each 21-day cycle.
Study 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 HCC.
Per amendment version 5, following a memo issued by the Sponsor, participants receiving treatment in the atezolizumab plus bevacizumab plus tiragolumab arm are recommended to discontinue tiragolumab treatment unless the investigator decides the benefit outweighs the risk. Participants receiving treatment in atezolizumab plus bevacizumab plus placebo arm must discontinue placebo treatment. Participants may continue receiving active treatment(s) per protocol until loss of clinical benefit or unacceptable toxicity, whichever occurs first.
Eligibility
Primary outcome measure(s)
- Investigator-assessed Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) — From randomization to the first occurrence of disease progression (PD) or death from any cause, whichever occurs first (up to approximately 21 months)
- Overall Survival (OS) — From randomization to death from any cause (up to approximately 36 months)
Trial sites (171)
| Facility | City | Region | Status |
|---|---|---|---|
| Genesis Cancer Center | Hot Springs | Arkansas | |
| UCSF Fresno at Community Cancer Institute | Clovis | California | |
| City of Hope Cancer Center | Duarte | California | |
| University of California San Diego Moores Cancer Center | La Jolla | California | |
| University of Southern California | Los Angeles | California | |
| Stanford Cancer Center | Palo Alto | California | |
| Va Palo Alto Health Care System | Palo Alto | California | |
| UCLA Cancer Center | Santa Monica | California | |
| Hartford Healthcare Cancer Institute at Hartford Hospital | Hartford | Connecticut | |
| MedStar Washington Hosp Center | Washington D.C. | District of Columbia | |
| Florida Cancer Specialists - Fort Myers (Broadway) | Fort Myers | Florida | |
| Miami VA Healthcare System | Miami | Florida | |
| Florida Cancer Specialist, North Region | St. Petersburg | Florida | |
| University of Illinois | Chicago | Illinois | |
| Norton Cancer Institute - Audubon | Louisville | Kentucky | |
| Ochsner Cancer Inst. | New Orleans | Louisiana | |
| Mercy Medical Center | Baltimore | Maryland | |
| Henry Ford Health System | Detroit | Michigan | |
| Cancer & Hematology Centers of Western Michigan | Grand Rapids | Michigan | |
| Mayo Clinic Rochester | Rochester | Minnesota | |
| Minnesota Oncology Hematology Woodbury | Woodbury | Minnesota | |
| Washington Uni School of Medicine | St Louis | Missouri | |
| NYU Langone | New York | New York | |
| Icahn School of Medicine at Mount Sinai | New York | New York | |
| Columbia University | New York | New York | |
| Montefiore Medical Center | The Bronx | New York | |
| James J Peters VA Hospital / Mental Illness Research Education and Clinic Center | The Bronx | New York | |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | |
| Thomas Jefferson Uni | Philadelphia | Pennsylvania | |
| North Texas VA Medical Center | Dallas | Texas | |
| Kelsey Seybold Clnic | Houston | Texas | |
| Virginia Mason Medical Center | Seattle | Washington | |
| Swedish Cancer Inst. | Seattle | Washington | |
| Univ of Wisconsin-Madison | Madison | Wisconsin | |
| Cliniques Universitaires St-Luc | Brussels | Belgium | |
| UZ Antwerpen | Edegem | Belgium | |
| AZ Delta (Campus Rumbeke) | Roeselare | Belgium | |
| CEDOES - Diagnóstico e Pesquisa | Vitória | Espírito Santo | |
| Oncoclínicas do Brasil - BELO HORIZONTE | Belo Horizonte | Minas Gerais | |
| Hospital do Cancer de Pernambuco - HCP | Recife | Pernambuco |
+ 131 more sites — see the full list on the official registry below.
More Hoffmann-La Roche trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05904886 on ClinicalTrials.gov ↗ ← All trials in Italy