Study Evaluating the Benefit of Adding Ipilimumab to the Combination of Atezolizumab and Bevacizumab in Patients With Hepatocellular Carcinoma Receiving First-line Systemic Therapy

Phase 2/3 Completed 229 enrolled Federation Francophone de Cancerologie Digestive

RandomizedParallel-groupOpen-labelTreatment

Summary

TRIPLET HCC is a phase II-III trial that assess the effectivness of addition of ipilimumab to the combination atezolizumab-bevacizumab, on global survival and response to the treatment, for patients with advanced or metastatic hepatocellular carcinoma. The theoretical duration of the study is 5 years. In the scope of this study, each patient will have 2 years of treatment and 2 years of follow-up from their enrollment date.

Timeline

Start: 2023-03-09
Primary completion: 2025-05-12
Completion: 2025-05-12

Publications

Merle P, Blanc JF, Le Malicot K, Peron JM, Bourgeois V, Bouattour M, Touchefeu Y, Vitellius C, Akouz FK, Heurgue A, Girot P, Assenat E, Nguyen-Khac E, Bronowicki JP, Viaud J, Ben Abdelghani M, Manfredi S, Edeline J, Phelip JM; TRIPLET-HCC study investigators. Addition of ipilimumab to atezolizumab plus bevacizumab in advanced hepatocellular carcinoma (PRODIGE 81-FFCD 2101-TRIPLET HCC): phase 2 results from a randomised, multicentre, open-label, phase 2-3 trial. Lancet Gastroenterol Hepatol. 2026 Jun 22:S2468-1253(26)00115-9. doi: 10.1016/S2468-1253(26)00115-9. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ipilimumab	Monoclonal antibody	1 mg/kg	Intravenous
Background	Atezolizumab	Monoclonal antibody	1200 mg	Intravenous
Background	Bevacizumab	Monoclonal antibody	15 mg/kg	Intravenous

Study Evaluating the Benefit of Adding Ipilimumab to the Combination of Atezolizumab and Bevacizumab in Patients With Hepatocellular Carcinoma Receiving First-line Systemic Therapy

Summary

Timeline

Publications

Drugs

Indications