drugset / Trial / NCT07715734
Cemiplimab for Kidney Transplant Recipients With Advanced Cutaneous Squamous Cell Carcinoma
Phase 2
Not yet recruiting
22 enrolled
Washington University School of Medicine
Regeneron Pharmaceuticals · collab
NaSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2026-09-30
- Primary completion
- 2031-03-31
- Completion
- 2031-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cemiplimab | Monoclonal antibody | 350 mg | Intravenous |
| Background | Cetuximab | Monoclonal antibody | — | — |
| Background | Prednisone | Other / unclassified | 10 mg | Oral |
| Background | Sirolimus | Small molecule | — | Oral |