Phase 2 cemiplimab PD-1 checkpoint inhibitor with standardized immunosuppression in KTR advanced cSCC

Washington University School of Medicine’s CONTRAC-2 is a Phase 2, multicenter, open-label, single-arm trial using Simon’s optimal two-stage design to test whether cemiplimab (Regeneron Pharmaceuticals/Sanofi; a PD-1/CD279–blocking monoclonal antibody that reinvigorates antitumor T-cell activity) can produce meaningful tumor responses in kidney transplant recipients with locally advanced/unresectable or recurrent/metastatic cutaneous squamous cell carcinoma while minimizing allograft rejection risk. The intervention deliberately pairs PD-1 blockade with a standardized immunosuppression strategy (sirolimus, an mTOR inhibitor, plus prednisone, a glucocorticoid) with a short lead-in before cemiplimab dosing every 21 days for up to 24 months. If disease progresses, cetuximab (Eli Lilly; an EGFR-blocking monoclonal antibody) can be added as optional salvage at investigator discretion. The key scientific angle is operationalizing immunotherapy in a population often excluded from PD-1 trials, where retrospective experience suggests rejection risk can be high, and the commercial angle is defining a workable “immunotherapy + transplant-safe immunosuppression” playbook for a high-risk skin cancer niche. Today’s care for advanced cSCC in transplant recipients is surgery and/or radiation when feasible, with systemic options such as EGFR inhibition (cetuximab) or chemotherapy when immunotherapy is considered too risky for the graft.