drugset / Trial / NCT05904886

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

NCT05904886

Phase 3 Active not recruiting 687 enrolled Hoffmann-La Roche Chugai Pharmaceutical · collab
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2023-09-14
Primary completion
2025-05-08
Completion
2026-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Tiragolumab Monoclonal antibody 600 mg Intravenous
Background Atezolizumab Monoclonal antibody 1200 mg Intravenous
Background Bevacizumab Monoclonal antibody 15 mg/kg Intravenous