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NCT06568172 · ClinicalTrials.gov registry record · Phase 3
Testing the Addition of an Immunotherapy Drug, Cemiplimab (REGN2810), Plus Surgery to the Usual Surgery Alone for Treating Advanced Skin Cancer
A Phase 3 study of Eyelid Squamous Cell Carcinoma and Recurrent Eyelid Squamous Cell Carcinoma, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 3
- Development phase
- 420
- Enrollment target
- 20
- Study locations
NCT06568172: Recruiting Phase 3 study of Eyelid Squamous Cell Carcinoma and Recurrent Eyelid Squamous Cell Carcinoma, sponsored by National Cancer Institute (NCI).
NCT06568172 is a Phase 3 study of Eyelid Squamous Cell Carcinoma and Recurrent Eyelid Squamous Cell Carcinoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 420 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% lower). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06568172, a Phase 3 study of Eyelid Squamous Cell Carcinoma and Recurrent Eyelid Squamous Cell Carcinoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 420 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial compares the effect of adding cemiplimab to standard therapy (surgery with or without radiation) versus standard therapy alone in treating patients with stage III/IV squamous cell skin cancer that is able to be removed by surgery (resectable) and that may have come back after a period of improvement (recurrent). The usual treatment for patients with resectable squamous cell skin cancer is the removal of the cancerous tissue (surgery) with or without radiation, which uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. 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. Cemiplimab has been approved for the treatment of skin cancer that has spread or that cannot be removed by surgery, but it has not been approved for the treatment of skin cancer than can be removed by surgery. Adding cemiplimab to the usual treatment of surgery with or without radiation may be more effective in treating patients with stage III/IV resectable squamous cell skin cancer than the usual treatment alone.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- BIOLOGICAL Cemiplimab
- RADIATION Intensity-Modulated Radiation Therapy
- RADIATION Image Guided Radiation Therapy
Study Locations (20)
California
- Tower Cancer Research Foundation - Beverly Hills
- City of Hope Comprehensive Cancer Center - Duarte
- UC San Diego Health System - Encinitas - Encinitas
- City of Hope at Irvine Lennar - Irvine
- UC San Diego Moores Cancer Center - La Jolla
- City of Hope Antelope Valley - Lancaster
- The Angeles Clinic and Research Institute - West Los Angeles Office - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- Cedars Sinai Medical Center - Los Angeles
- Kaiser Permanente-Oakland - Oakland
- Stanford Cancer Institute Palo Alto - Palo Alto
- University of California Davis Comprehensive Cancer Center - Sacramento
- Kaiser Permanente-South Sacramento - Sacramento
- UC San Diego Medical Center - Hillcrest - San Diego
- Kaiser Permanente-San Francisco - San Francisco
- City of Hope South Pasadena - South Pasadena
- Torrance Memorial Physician Network - Cancer Care - Torrance
Arizona
- Banner MD Anderson Cancer Center - Gilbert
- Mayo Clinic Hospital in Arizona - Phoenix
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 420 participants |
| Start Date | 2025-02-18 |
| Est. Completion | 2031-08-14 |
| Phase | Phase 3 |
What NCT06568172 shows while recruiting
NCT06568172 is an interventional study that assigns participants to a tested intervention. The registered 420 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% lower).
The record links to 10 conditions, with Eyelid Squamous Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06568172 names 20 study sites across 3 states, led by California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT06568172 about?
NCT06568172 is a clinical study titled "Testing the Addition of an Immunotherapy Drug, Cemiplimab (REGN2810), Plus Surgery to the Usual Surgery Alone for Treating Advanced Skin Cancer". This phase III trial compares the effect of adding cemiplimab to standard therapy (surgery with or without radiation) versus standard therapy alone in treating patients with stage III/IV squamous cell skin cancer that is able to be removed by surgery (resectable) and that may have come back after a ...
What is the current status of trial NCT06568172?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 420 participants. The study started on 2025-02-18. Estimated completion is 2031-08-14.
What conditions does trial NCT06568172 study?
This clinical trial studies the following conditions: Eyelid Squamous Cell Carcinoma, Recurrent Eyelid Squamous Cell Carcinoma, Recurrent Skin Acantholytic Squamous Cell Carcinoma, Recurrent Skin Clear Cell Squamous Cell Carcinoma, Recurrent Skin Lymphoepithelial Carcinoma.
What interventions are being tested in trial NCT06568172?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Cemiplimab (BIOLOGICAL), Intensity-Modulated Radiation Therapy (RADIATION), Image Guided Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT06568172?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06568172 being conducted?
This trial has 20 study locations across Alabama, Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06568172's enrollment target sits among peer trials
420 892nd of 2000 higher than 1,102 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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