Neoadjuvant Study of PD-1 Inhibitor Pembrolizumab in PD-1 Naive Cutaneous Squamous Cell Carcinoma (cSCC)
Status:
Recruiting
Trial end date:
2028-10-01
Target enrollment:
Participant gender:
Summary
This phase II single-arm two-stage neoadjuvant study of pembrolizumab in patients with PD-1
naïve high-risk resectable cutaneous squamous cell carcinoma (cSCC) will be conducted over a
52-week period. The study will include patients who have not undergone surgery to remove
disease, to formally evaluate whether both biologically and clinically high-risk disease may
benefit from neoadjuvant anti-PD-1 therapy. Response to neoadjuvant anti-PD-1 therapy will be
evaluated for association with improved landmark Relapse-free Survival (RFS).