drugset / Trial / NCT04357873
Efficacy of Immunotherapy Plus a Drug in Patients With Progressive Advanced Mucosal Cancer of Different Locations
Phase 2
Completed
112 enrolled
UNICANCER
ERA-NET · collabFondation ARC · collabMerck Sharp & Dohme LLC · collab
NaSingle-groupOpen-labelTreatment
Summary
Interventional study evaluating the efficacy of an immunotherapy (pembrolizumab) in combination with a targeted therapy (vorinostat) in patient with recurrent and/or metastatic squamous cell carcinoma (localisations : head and neck, lung, cervix, anus, vulva, and penis)
Timeline
- Start
- 2020-10-28
- Primary completion
- 2022-12-15
- Completion
- 2024-11-26
Publications
- Filippini DM, Cabarrou B, Dupain C, Halladjian M, Coquan E, Sablin MP, Mazzarella L, Francisco M, Servant N, Tonini MM, Hundt AF, Castel-Ajgal Z, You B, Bigot F, Ghiringhelli F, Vansteene D, Gomez-Roca C, Cousin S, Lambert A, Saada-Bouzid E, Durando X, Abdeddaim C, Borel C, Chaltiel R, Borcoman E, Legrand F, Bernhart S, Jimenez M, Bieche I, Filleron T, Le Tourneau C, Kamal M, Jeannot E. HPV circulating tumor DNA to monitor response to pembrolizumab and vorinostat combination in patients with advanced HPV-related squamous-cell carcinomas. ESMO Open. 2026 Jan;11(1):106024. doi: 10.1016/j.esmoop.2025.106024. Epub 2025 Dec 29.
- Borcoman E, Cabarrou B, Francisco M, Bigot F, Ghiringhelli F, Vansteene D, Legrand F, Halladjian M, Dupain C, Le Saux O, Coutzac C, Borel C, Chaltiel R, You B, Gomez-Roca C, Cousin S, Coquan E, Lambert A, Saada-Bouzid E, Durando X, Saint-Ghislain M, Frige G, Guerini-Rocco E, Tonini MM, Bieche I, Castel-Ajgal Z, Marret G, Sablin MP, Jeannot E, Andre F, Filleron T, Jimenez M, Mazzarella L, Servant N, Kamal M, Le Tourneau C. Efficacy of pembrolizumab and vorinostat combination in patients with recurrent and/or metastatic squamous cell carcinomas: a phase 2 basket trial. Nat Cancer. 2025 Aug;6(8):1370-1383. doi: 10.1038/s43018-025-01004-2. Epub 2025 Jun 30.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | — |
| Subject | Vorinostat | Small molecule | 400 mg | — |