drugset
drugset / Trial / NCT04770896

A Study of Atezolizumab With Lenvatinib or Sorafenib Versus Lenvatinib or Sorafenib Alone in Hepatocellular Carcinoma Previously Treated With Atezolizumab and Bevacizumab

NCT04770896 ↗

Phase 3 Active not recruiting 557 enrolled Hoffmann-La Roche
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a Phase III, open-label, multicenter, randomized, two-arm study designed to evaluate the efficacy and safety of atezolizumab plus either lenvatinib or sorafenib versus lenvatinib or sorafenib alone in participants with locally advanced or metastatic Hepatocellular Carcinoma (HCC) who have progressed on prior systemic treatment with atezolizumab plus bevacizumab combination.

Timeline

Start
2021-04-26
Primary completion
2026-06-30
Completion
2026-06-30

Outcome

Missed primary endpoint

release “where IMbrave 251 study did not meet its primary endpoint.” medivir.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Atezolizumab Monoclonal antibody 1200 mg Intravenous
Subject Lenvatinib Small molecule 8 mg Oral
Subject Lenvatinib Small molecule 12 mg Oral
Subject Sorafenib Small molecule 800 mg Oral

Indications

hepatocellular carcinoma