Efficacy of Immunotherapy Plus a Drug in Patients With Progressive Advanced Mucosal Cancer of Different Locations

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

Outcome

Mixed primary results

paper The primary endpoint was the objective response rate (ORR) in each tumor cohort during treatment as per the investigators' assessment. PMID 40588522 ↗

paper The ORR was met in cervical (39%), anal (31%) and vulvar/vaginal (19%) cancer cohorts PMID 40588522 ↗

paper but not in head and neck SCC (19%) or penile (18%) cancer cohorts PMID 40588522 ↗

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

Indications