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

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

Timeline

Start

2021-07-15

Primary completion

2023-08-22

Completion

2025-02-18

Publications

• Rojas C, Mortier L, Park JJ, Matamala L, Baakili A, Rao S, Xu J, Andrieu L, Wang R, Wang H, Paehler T, Abbadessa G, Ascierto PA. Phase 1/2 study of pegenzileukin, a pegylated recombinant non-alpha IL-2, with cemiplimab for the treatment of advanced unresectable or metastatic skin cancers. J Immunother Cancer. 2026 May 22;14(5):e014347. doi: 10.1136/jitc-2025-014347.

Drugs

Indications