Sequential or Up-front Triple Treatment With Durvalumab, Tremelimumab and Bevacizumab for Non-resectable Hepatocellular Carcinoma (HCC) Patients

Summary

This is a randomized, open-label, multi-center, international, Phase II study to assess the efficacy and safety of sequential or up-front triple treatment with durvalumab, tremelimumab and bevacizumab for non-resectable hepatocellular carcinoma. Patients will be randomized in a 1:1 ratio to one of the following arms: Arm A: initial treatment with durvalumab plus tremelimumab followed by treatment escalation with the addition of bevacizumab upon radiological progression or in the absence of objective response Arm B: up-front treatment with durvalumab, tremelimumab and bevacizumab Patients will be stratified according to macrovascular invasion and etiology of liver disease (viral etiologies versus others).

Timeline

Start

2023-04-06

Primary completion

2026-12-31

Completion

2026-12-31

Publications

• Background De Toni EN, Mayerle J, Oehrle B, Seidensticker M, Rimassa L, Philipp A, Roessler D, Khaled NB. Letter: Presence of progression or absence of response? Alternative trial designs for immunotherapy of advanced hepatocellular carcinoma. Aliment Pharmacol Ther. 2024 Jun;59(11):1462-1464. doi: 10.1111/apt.17985. Epub 2024 Apr 21. No abstract available.
• Ben Khaled N, Ehmer U, Kubisch I, Gonzalez-Carmona MA, Philipp A, Seidensticker M, Altenhofer J, Basch M, Huwer T, Oehrle B, Geier A, Solda C, Auriemma A, Bauer U, Zhou T, Perkhofer L, Chater J, Weinmann A, von Felden J, De Rosa A, Vivaldi C, Piseddu I, Schwald I, Enssle S, Karin M, Schneider JS, Groper MN, Ondrejkova K, Weiss L, Beyer G, Schulze K, Antonuzzo L, Masi G, Daniele B, Ricke J, Mayerle J, Foerster F, Reiter FP, Ettrich TJ, De Toni EN. Sequential or upfront triple combination with durvalumab, tremelimumab, and bevacizumab for patients with unresectable hepatocellular carcinoma: the MONTBLANC trial protocol (AIO-HEP-0325/ass). Ther Adv Med Oncol. 2026 Feb 20;18:17588359261417640. doi: 10.1177/17588359261417640. eCollection 2026.

Drugs

Indications