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Clinical Trial Summary

The is 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 is structured as a master protocol for the investigation of SAR444245 with other anticancer therapies. Substudy 1-Cohort A1 aims 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 are treatment-naïve for recurrent and/or metastatic (R/M) disease. Substudy 2 - Cohort A2 aims to establish proof-of-concept that SAR444245 combined with both the anti-PD1 antibody pembrolizumab and cetuximab will result in a significant increase in the observed number of objective responses in trial participants with HNSCC who are treatment-naïve for recurrent and/or metastatic (R/M) disease Substudy 4-Cohort B1 aims 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 aims 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-naïve after failure of no more than 2 regimens for recurrent and/or metastatic (R/M) disease.


Clinical Trial Description

Up to 6 years (screening period [28 days], treatment period [max 35 cycles {cohort A1 and B1} = 735 days or until PD {cohort B2}]; max 35 cycles for SAR444245 and pembrolizumab, and until PD for cetixumab (cohort A2)] and follow-up period [approximately 3 years]) ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05061420
Study type Interventional
Source Sanofi
Contact email recommended (Toll free number for US & Canada)
Phone 800-633-1610
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date October 25, 2021
Completion date December 22, 2023

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