Metronomic Oral Vinorelbine Plus Anti-PD-L1/Anti-CTLA4 ImmunothErapy in Patients With Advanced Solid Tumours

Phase 1/2 Completed 126 enrolled UNICANCER AstraZeneca · collab National Cancer Institute, France · collab Pierre Fabre Laboratories · collab

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a phase I/II national, multicentre, multiple cohort, prospective open-label, non-randomised and non-comparative study, to evaluate the safety and activity of metronomic oral vinorelbine associated with durvalumab + tremelimumab combination immunotherapy for the treatment of advanced solid tumours.

Timeline

Start: 2018-06-20
Primary completion: 2022-04-01
Completion: 2024-12-19

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

paper Mean estimated CBR (95 % credible interval) using a non-informative prior was 15.6 % (5.5-29.8). PMID 40795480 ↗

Publications

De La Motte Rouge T, Frenel JS, Cropet C, Borcoman E, Hervieu A, Emile G, Augereau P, Charafe E, Legrand F, Dasse E, Goncalves A. Tremelimumab plus durvalumab combined to metronomic oral vinorelbine: Results from the breast cancer cohort of the phase II MOVIE study. Breast. 2025 Oct;83:104549. doi: 10.1016/j.breast.2025.104549. Epub 2025 Aug 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Durvalumab	Monoclonal antibody	1500 mg	—
Subject	Tremelimumab	Monoclonal antibody	75 mg	—
Subject	Vinorelbine	Small molecule	40 mg	Oral