Clinical Trial

A PD-1 Checkpoint Inhibitor (Cemiplimab) for High-Risk Localized, Locally Recurrent, or Regionally Advanced Skin Cancer

Active, Not Recruiting Phase 2
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Summary
This phase II trial studies how well cemiplimab before surgery works in treating patients with skin cancer that is high-risk and has not spread to other parts of the body (localized), has come back locally (locally recurrent), or has spread regionally (regionally advanced), and can be removed by surgery (resectable). Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2020-03-17; most recent amendment 2026-05-29.
Status change: Suspended → Active, Not Recruiting 2025-11-17
Status change: Recruiting → Suspended 2025-07-10
Status change: Not Yet Recruiting → Recruiting 2020-09-30
Trial Details
NCT Number NCT04315701
Lead Sponsor University of Southern California
Collaborators: National Cancer Institute (NCI)
Conditions Recurrent Skin Squamous Cell Carcinoma, Resectable Skin Squamous Cell Carcinoma, Stage I Skin Cancer, Stage II Skin Cancer, Stage III Skin Cancer
Enrollment 35 participants
Start Date 2020-06-17
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-01