Calendario›SNY›Pembrolizumab
Pembrolizumab
A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With HNSCC (Master Protocol) (Pegathor Head and Neck 204)
Ensayo de Sanofi en Carcinoma escamoso de cabeza y cuello.
Más ensayos de: Carcinoma escamoso de cabeza y cuello.
- Fase
- Fase 2
- Estado
- Interrumpido
- Participantes
- 59
- Centros
- 27
- Fin del objetivo primario
- jul 2023
Qué significa cada fase y cada estado.
Estudio de intervención, no aleatorizado, abierto. Comenzó en oct 2021.
Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Early discontinuation based on strategic sponsor decision not driven by any safety concerns.».
Qué mide
Cohort A1: Objective Response Rate (ORR) (From first dose of study treatment administration (Day 1) up to approximately 21 months) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe study was a phase 2 multi-cohort, non-randomized, open-label, multi-center study assessing the clinical benefit of SAR444245 combined with other anticancer therapies for the treatment of participants aged 18 years and older with HNSCC. This study was structured as a master protocol for the investigation of SAR444245 with other anticancer therapies. Substudy 1-Cohort A1 aimed to establish proof-of-concept that SAR444245 combined with the anti-PD1 antibody pembrolizumab, will result in a significant increase in the observed number of objective responses in trial participants with HNSCC who were treatment-naïve for recurrent and/or metastatic (R/M) disease. Substudy 4-Cohort B1 aimed to establish proof-of-concept that SAR444245 combined with the anti-PD1 antibody pembrolizumab, will result in a significant increase in the observed number of objective responses in trial participants with HNSCC who have received treatment with PD1/PD-L1 and platinum-based regimen. Substudy 5-Cohort B2 aimed to establish proof-of-concept that SAR444245 combined with cetuximab will result in a significant increase in the observed number of objective responses in trial participants with HNSCC previously treated with platinum-based regimen \& cetuximab-naive after failure of no more than 2 regimens for recurrent and/or metastatic (R/M) disease.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT05061420), actualizada en sep 2025.