Sequential or upfront triple combination with durvalumab, tremelimumab, and bevacizumab for patients with unresectable hepatocellular carcinoma: the MONTBLANC trial protocol (AIO-HEP-0325/ass) - PubMe
4 hours ago
- #immunotherapy
- #hepatocellular carcinoma
- #clinical trial
- The MONTBLANC trial investigates a triple combination therapy for unresectable hepatocellular carcinoma (HCC) using durvalumab, tremelimumab, and bevacizumab.
- This phase II, randomized, open-label study compares upfront triple-agent therapy versus sequential doublet therapy (durvalumab + tremelimumab) followed by bevacizumab upon progression.
- Primary endpoint is overall response rate; secondary endpoints include overall survival, progression-free survival, safety, and patient-reported outcomes.
- The study aims to enhance efficacy in advanced HCC, where current immune checkpoint inhibitor therapies benefit only a subset of patients.
- Ethical approval has been obtained, and the trial adheres to Declaration of Helsinki and Good Clinical Practice standards.
- Trial registered at ClinicalTrials.gov (NCT05844046) and EU Clinical Trials Register (2022-001201-48).