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Pembrolizumab for the Treatment of Locally Advanced and/or Recurrent Orbital or Periocular Cutaneous Squamous Cell Carcinoma

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 86% 22 → 3 participants
See other at-risk trials from University of Michigan Rogel Cancer Center

Record History

  1. Enrollment reduced: 22 → 3 participantsv6 Show 4 more changesShow less
    • Primary completion moved earlier from Mar 1, 2028 to Dec 2026
    • Enrollment closed, study ongoing
    • Study completion moved earlier from Mar 1, 2030 to Dec 2026
    • Site details revised
  2. Re-verified, no change to tracked fieldsv5
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 1, 2025 to Mar 5, 2025
    • Site details revised
    v4
  4. Start date: Dec 1, 2024 to Mar 1, 2025
    • Primary completion date: Dec 1, 2027 to Mar 1, 2028
    • Study completion date: Dec 1, 2029 to Mar 1, 2030
    v3
  5. Start date: Oct 1, 2024 to Dec 1, 2024
    • Primary completion date: Oct 1, 2027 to Dec 1, 2027
    • Study completion date: Oct 1, 2029 to Dec 1, 2029
    v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 pembrolizumab works in treating patients with orbital (eye socket) and/or periorbital (surrounding the eye socket) cutaneous squamous cell cancer (cSCC) that has spread to nearby tissue or lymph nodes (locally advanced) or has come back after a period of improvement (recurrent). Skin cancers that are close to the eye or on the eyelid often have more genetic (heredity) changes than other types of cancers. This means that the deoxyribonucleic acid (DNA) (the building blocks of the body that determine such things as the color of the hair) in tumor tissue has been altered compared to normal tissue. It is thought cancer cells with these DNA changes are more likely to respond to a type of drug called immunotherapy. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Pembrolizumab is approved for patients with recurrent or metastatic cSCC not amenable (responsive) to cure by surgery or radiation. Giving pembrolizumab may work better in treating patients with locally advanced or recurrent orbital and/or periorbital cSCC.
Trial Details
NCT Number NCT06580054
Lead Sponsor University of Michigan Rogel Cancer Center
Conditions
(from sponsor)		 Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck, Recurrent Cutaneous Squamous Cell Carcinoma of the Head and Neck, Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8
Enrollment 3 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov