Cemiplimab for Kidney Transplant Recipients With Advanced Cutaneous Squamous Cell Carcinoma

This is a phase II, multicenter, open label, single arm, non-randomized trial using Simon's optimal two-stage design to evaluate the efficacy of cemiplimab in kidney transplant recipients with advanced cutaneous squamous cell carcinoma. The hypothesis being tested is that cemiplimab alongside standardized immune suppression will generate anti-tumor activity without triggering allograft rejection.

NCT Number	NCT07715734
Lead Sponsor	Washington University School of Medicine Collaborators: Regeneron Pharmaceuticals
Conditions	Kidney Transplant Recipient, Cutaneous Squamous Cell Carcinoma (CSCC), Advanced Cutaneous Squamous Cell Carcinoma, Kidney Transplant
Enrollment	22 participants
Start Date	2026-09-30
Primary Completion	2031-03-31 (estimated)
Study Completion	2031-03-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-20