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Cemiplimab Before and After Surgery for the Treatment of High Risk Cutaneous Squamous Cell Cancer

StatusActive, Not Recruiting
PhasePhase 1
Started2020-05-15
View on ClinicalTrials.gov ↗

Amendment history

2026-09-10
Study Status, Oversight, Study Design, Contacts/Locations v7
Enrollment closed, study ongoing
Final enrollment: 14 participants (planned 20)
Enrollment targetestimated 20→confirmed 14
Study sitesdetails revised at 1 of 1 site
2025-08-11
Study Status, Oversight v6
Completion date2030-10-01→2031-10-01
2024-08-05
2 amendments v4-v5
2 re-verifications since 2023-07-18, no change to tracked fields
2022-06-28
Study Status, Sponsor/Collaborators, Eligibility, Contacts/Locations v3
Eligibility criteria-2 characters
[...] at arises within the area of the previously resected tumor, plusor at least one of the following additional features: >= N2b d [...]
Study sitescontacts updated at 1 of 1 site
Collaborators+31 characters
National Cancer Institute (NCI)
2021-08-23
Study Status v2
Re-verified, no change to tracked fields
2020-06-29
Active, Not Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusActive, Not Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
2020-06-10
Original filing
This phase I trial studies how well cemiplimab before and after surgery works in treating patients with high risk cutaneous squamous cell cancer. 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. Giving cemiplimab before surgery may improve risk of the cancer returning in patients with high risk cutaneous squamous cell cancer.
Trial Details
NCT Number NCT04428671
Lead Sponsor Emory University
Collaborators: National Cancer Institute (NCI)
Conditions Metastatic Skin Squamous Cell Carcinoma, Recurrent Skin Squamous Cell Carcinoma
Enrollment 14 participants
Start Date 2020-05-15
Primary Completion 2030-10-01 (estimated)
Study Completion 2031-10-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-14