drugset / Trial / NCT03549715
NEoadjuvant Dose-dense MVAC In cOmbination With Durvalumab and Tremelimumab in Muscle-invasive Urothelial Carcinoma
Phase 1/2
Unknown
121 enrolled
Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
RandomizedParallel-groupOpen-labelTreatment
Summary
This is an open label, phase I/II clinical trial to evaluate the efficacy and safety of 2 cycles of durvalumab without (Arm A) or with (Arm B) tremelimumab in association with ddMVAC as neoadjuvant therapy in patients with MIUC.
Timeline
- Start
- 2018-12-06
- Primary completion
- 2024-06
- Completion
- 2025-09
Publications
- Thibault C, Bennamoun M, Flechon A, Gravis G, Pouessel D, Combe P, Borchiellini D, Loriot Y, Laguerre B, Barthelemy P, Huillard O, Gross-Goupil M, Le Roy A, Jaffrelot L, Cancel M, Audenet F, Belhouari H, Kaci G, Lepicard E, Vernerey D, Henriques J, Oudard S. Neoadjuvant Durvalumab +/- Tremelimumab in Combination With Dose-Dense Methotrexate, Vinblastine, Doxorubicin, and Cisplatin in Muscle-Invasive Bladder Carcinoma: Results of the Phase I/II NEMIO Study. J Clin Oncol. 2026 May 26:JCO2503045. doi: 10.1200/JCO-25-03045. Online ahead of print.
- Thibault C, Elaidi R, Vano YA, Rouabah M, Braychenko E, Helali I, Audenet F, Oudard S. Open-label phase II to evaluate the efficacy of NEoadjuvant dose-dense MVAC In cOmbination with durvalumab and tremelimumab in muscle-invasive urothelial carcinoma: NEMIO. Bull Cancer. 2020 Jun;107(5S):eS8-eS15. doi: 10.1016/S0007-4551(20)30281-2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Durvalumab | Monoclonal antibody | 1500 mg | Intravenous |
| Subject | Tremelimumab | Monoclonal antibody | 75 mg | Intravenous |
| Background | Cisplatin | Other / unclassified | 70 mg/m2 | Intravenous |
| Background | Doxorubicin | Other / unclassified | 30 mg/m2 | Intravenous |
| Background | Methotrexate | Small molecule | 30 mg/m2 | Intravenous |
| Background | Vinblastine | Small molecule | 3 mg/m2 | Intravenous |