A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With HNSCC (Master Protocol)

Official Title

A Phase 2 Non-randomized, Open-label, Multi-cohort, Multi-centre Study Assessing the Clinical Benefit of SAR444245 (THOR-707) Combined With Other Anticancer Therapies for the Treatment of Participants With Head and Neck Squamous Cell Carcinoma (HNSCC)

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.

Trial Description

Primary Outcome:

  • Objective response rate (ORR)
Secondary Outcome:
  • To assess the safety profile of SAR444245 when combined with other anti-cancer therapies (TEAEs)
  • To assess the safety profile of SAR444245 when combined with other anti-cancer therapies (SAEs)
  • Time to response
  • Duration of response (DoR)
  • Clinical benefit rate (CBR)
  • Progression free survival (PFS)
  • To assess the concentrations of SAR444245
  • To assess the immunogenicity of SAR444245
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])

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society