NCT05904886

A Study Evaluating Atezolizumab and Bevacizumab, With or Without Tiragolumab, in Participants With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) (IMbrave152)

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 687 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.
DRUG	Tiragolumab	Tiragolumab will be administered by IV infusion at a fixed dose of 600 mg on Day 1 of each 21-day cycle.
OTHER	Placebo	Placebo matching tiragolumab will be administered by IV infusion on Day 1 of each 21-day cycle.

Timeline

• Start date: 2023-09-14
• Primary completion: 2025-05-08
• Completion: 2026-09-01
• First posted: 2023-06-15
• Last updated: 2025-12-31

Locations

171 sites across 27 countries: United States, Belgium, Brazil, Canada, China, Côte d’Ivoire, France, Germany, Ghana, Hong Kong, Italy, Japan, Kenya, Mexico, New Zealand, Nigeria, Poland, Puerto Rico, Singapore, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), Uganda, United Kingdom

Regulatory

• FDA-regulated drug study