Actively Recruiting
Phase 3 Study Comparing Cemiplimab Injection and Surgery for Early Stage Cutaneous Squamous Cell Carcinoma in Adults
Led by Regeneron Pharmaceuticals · Updated on 2026-07-08
369
Participants Needed
52
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating a drug called cemiplimab for treating early-stage Cutaneous Squamous Cell Carcinoma CSCC, a type of skin cancer. Cemiplimab helps the immune system attack cancer cells by targeting a protein called PD-1 on immune cells. The studys main goal is to compare how well cemiplimab works when injected directly into the lesion versus standard surgery. Participants will be randomly assigned to receive either cemiplimab injected into the lesion or undergo primary surgery using techniques like Mohs surgery or other complete margin assessment methods. The study will assess side effects and how well cemiplimab performs compared to surgery in treating the cancer. During the study, participants will be monitored for event-free survival up to 3 years. Researchers will also evaluate lesion response, treatment-related adverse events, and sizes of surgical or biopsy defects. The total participation period extends up to 3 years, with regular assessments to track safety and treatment effectiveness.
CONDITIONS
Brief Title
Study of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell Carcinoma
Research Team
C
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