πŸ›οΈ Verified NIH Record β€’ Updated 2026-06-25

Neoadjuvant Study of PD-1 Inhibitor Pembrolizumab in PD-1 Naive Cutaneous Squamous Cell Carcinoma (cSCC) (NCT04808999)

Phase II Neoadjuvant Study of PD-1 Inhibitor Pembrolizumab in PD-1 Naive Cutaneous Squamous Cell Carcinoma (cSCC)

πŸ”΅ Active, Not Recruiting Phase2 πŸ’Š Investigational Drug / Biologic Sponsor: Diwakar Davar

🩺 Plain-English Summary (8th-Grade Level)

This phase II single-arm two-stage neoadjuvant study of pembrolizumab in patients with PD-1 naΓ―ve 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).

Who can join: Review the eligibility criteria below.

Location: UPMC Hillman Cancer Center β€” Pittsburgh, Pennsylvania

Age range: 18 Years

πŸ§ͺ Interventions in This Study

πŸ“‹ "Do I Qualify?" β€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria β†—

πŸ“ All Participating Trial Locations (1 Sites)

  • UPMC Hillman Cancer Center β€” Pittsburgh, Pennsylvania

πŸ’° Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

πŸ’‘ How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
πŸ›οΈ View Official NIH Record β†—