Trial intelligence / Profile preview

Tiragolumab + atezolizumab + bevacizumab in hepatocellular carcinoma

NCT05904886Phase 3

Key facts

Status: Active, not recruiting
Start: Sep 2023
Primary completion: May 2025
Countries: 27
Sponsor: Roche
Modality: Immune Checkpoint Inhibitors

Drugs: tiragolumab
Conditions: hepatocellular carcinoma (HCC)

Overview

Phase 3, randomised, double-blind trial in hepatocellular carcinoma (HCC) comparing Atezolizumab + Bevacizumab + Tiragolumab with Atezolizumab + Bevacizumab + Placebo (2 arms). Primary endpoints: Progression-Free Survival at 21 months and Overall Survival at 36 months. Started Sep 2023; status: active, not recruiting.

Design

2 arms

Study design: RandomizedDouble-blind

Atezolizumab + Bevacizumab + Tiragolumab
Experimental arm receiving atezolizumab, bevacizumab, and tiragolumab
Atezolizumab + Bevacizumab + Placebo
Control arm receiving atezolizumab, bevacizumab, and placebo

Who it enrols

Patients with untreated locally advanced or metastatic hepatocellular carcinoma, ECOG 0-1, Child-Pugh Class A, no prior systemic treatment, adequate organ function, no autoimmune disease or active infections

Endpoints

Primary

Progression-Free Survival21 months
Overall Survival36 months

Secondary

Objective Response Rate21 months
Duration of Response21 months
Progression-Free Survival Rate at 6 Months6 months
Progression-Free Survival Rate at 12 Months12 months
Overall Survival Rate at 1 Year1 year
Overall Survival Rate at 2 Years2 years
Progression-Free Survival According to HCC mRECIST21 months
Objective Response Rate According to HCC mRECIST21 months

Results

Not all primary endpoints met

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