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NCT06580054 · ClinicalTrials.gov registry record · Phase 2
Pembrolizumab for the Treatment of Locally Advanced and/or Recurrent Orbital or Periocular Cutaneous Squamous Cell Carcinoma
A Phase 2 study of Recurrent Cutaneous Squamous Cell Carcinoma of the Head and Neck and Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8, sponsored by University of Michigan Rogel Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
- 1
- Study location
NCT06580054: Recruiting Phase 2 study of Recurrent Cutaneous Squamous Cell Carcinoma of the Head and Neck and Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8, sponsored by University of Michigan Rogel Cancer Center.
NCT06580054 is a Phase 2 study of Recurrent Cutaneous Squamous Cell Carcinoma of the Head and Neck and Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8 that is actively recruiting participants, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 22 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06580054, a Phase 2 study of Recurrent Cutaneous Squamous Cell Carcinoma of the Head and Neck and Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8, is actively recruiting participants, sponsored by University of Michigan Rogel Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Will be calculated from the tumor partial and complete responses based on immune-related Response Evaluation Criteria In Solid Tumors. Will be reported with exact 95% binomial confidence intervals.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- OTHER Digital Photography
Study Locations (1)
Michigan
- University of Michigan Comprehensive Cancer Center - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2025-03-05 |
| Est. Completion | 2030-03-01 |
| Phase | Phase 2 |
What NCT06580054 shows while recruiting
NCT06580054 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 3 conditions, with Recurrent Cutaneous Squamous Cell Carcinoma of the Head and Neck appearing as the primary indexed condition, and to 4 interventions - of which Pembrolizumab is the first listed.
NCT06580054 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT06580054 about?
NCT06580054 is a clinical study titled "Pembrolizumab for the Treatment of Locally Advanced and/or Recurrent Orbital or Periocular Cutaneous Squamous Cell Carcinoma". 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 improvem...
What is the current status of trial NCT06580054?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2025-03-05. Estimated completion is 2030-03-01.
What conditions does trial NCT06580054 study?
This clinical trial studies the following conditions: Recurrent Cutaneous Squamous Cell Carcinoma of the Head and Neck, Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8, Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck.
What interventions are being tested in trial NCT06580054?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Digital Photography (OTHER).
Who is sponsoring clinical trial NCT06580054?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06580054 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06580054's enrollment target sits among peer trials
22 1790th of 2000 higher than 208 of 2,000 other Phase 2 trials
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