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

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Nov 12, 2025 to Dec 31, 2026
    • Study completion date: Jun 17, 2027 to Dec 31, 2027
    v9
  2. Trial status: Suspended to Active, Not Recruiting
    • Enrollment target: estimated 34 to confirmed 35
    • Primary completion date changed from estimate of Jun 17, 2026 to Nov 12, 2025
    v8
  3. Trial status: Recruiting to Suspended Sponsor's reason: Analysis
    • Primary completion date: Jun 17, 2025 to Jun 17, 2026
    • Study completion date: Jun 17, 2026 to Jun 17, 2027
    • Site details revised at 5 of 5 sites
    v7
  4. Primary completion date: Jun 17, 2024 to Jun 17, 2025
    • Study sites: 4 to 5
    • Study completion date: Jun 17, 2025 to Jun 17, 2026
    v6
  5. Primary completion date: Jun 17, 2023 to Jun 17, 2024
    • Study sites: 3 to 4
    • Study completion date: Jan 17, 2024 to Jun 17, 2025
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Primary completion date: Jun 17, 2022 to Jun 17, 2023
    • Study completion date: Jan 17, 2023 to Jan 17, 2024
    v4
  2. Re-verified, no change to tracked fieldsv3
  3. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Apr 1, 2022 to Jun 17, 2022
    • Study completion date: Oct 31, 2022 to Jan 17, 2023
    • Start date changed from estimate of Apr 1, 2020 to Jun 17, 2020
    • Site details revised at 3 of 3 sites
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04315701
Lead Sponsor University of Southern California
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Recurrent Skin Squamous Cell Carcinoma, Resectable Skin Squamous Cell Carcinoma, Stage I Skin Cancer, Stage II Skin Cancer, Stage III Skin Cancer
Related terms Skin Neoplasms
Enrollment 35 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov