NCT06585410

Study of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell Carcinoma

A Phase 3 Randomized Study of Intralesional Cemiplimab Versus Primary Surgery in Participants With Early Stage Cutaneous Squamous Cell Carcinoma (CSCC)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 369 (estimated)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will test a study drug called cemiplimab to see if it can help treat early-stage cutaneous squamous cell carcinoma (CSCC), a type of skin cancer. Cemiplimab works by helping the immune system to kill cancer cells. It binds to a protein called programmed cell death-1 (PD-1) on the surface of certain immune cells. The main purpose of this study is to compare how well cemiplimab works compared to surgery, when injected into the lesion. The study is looking at: * The side effects cemiplimab might cause * How well cemiplimab works

Conditions

• Cutaneous Squamous Cell Carcinoma (CSCC)

Interventions

Type	Name	Description
DRUG	Cemiplimab	Administered per protocol
PROCEDURE	Standard of care	Primary surgery

Timeline

• Start date: 2025-01-02
• Primary completion: 2030-05-03
• Completion: 2030-05-03
• First posted: 2024-09-05
• Last updated: 2026-04-08

Locations

49 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study