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A Study of SAR444245 Combined With Cemiplimab for the Treatment of Participants With Various Advanced Skin Cancers (Pegathor Skin 201)

Malignant Melanoma Clinical Trial

Official title:
A Phase 1/2 Non-randomized, Open-label, Multi-cohort, Multi-center Study Assessing the Clinical Benefit of SAR444245 (THOR- 707) Combined With Cemiplimab for the Treatment of Participants With Advanced Unresectable or Metastatic Skin Cancers

Clinical Trial Summary

Primary Objective: -To determine the antitumor activity of SAR444245 in combination with cemiplimab. Secondary Objectives: - To determine the recommended phase 2 dose and to assess the safety profile of SAR444245 when combined with cemiplimab - To assess other indicators of antitumor activity - To assess the concentrations of SAR444245 when given in combination with cemiplimab - To assess the immunogenicity of SAR444245 - To assess active concentrations of cemiplimab when given in combination with SAR444245

Clinical Trial Description

The duration of the study for an individual patient will start from the signature of the main informed consent and include a screening period of up to 28 days, a treatment period [max 35 cycles or until PD], an end-of-treatment visit 30 days + 7 days following the last administration of study drug (or until the patient receives another anticancer therapy, whichever is earlier), and a follow-up visit 3 months after treatment discontinuation and every 3 months following, until disease progression, or initiation of another antitumor treatment, or final cohort cut-off, whichever is earlier ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04913220
Study type Interventional
Source Sanofi
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date July 15, 2021
Completion date February 11, 2025
View Details
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