ClinicalTrials.gov record
Testing the Addition of an Immunotherapy Drug, Cemiplimab (REGN2810), Plus Surgery to the Usual Surgery Alone for Treating Advanced Skin Cancer
ClinicalTrials.gov ID: NCT06568172
Public ClinicalTrials.gov record NCT06568172. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Randomized Phase III Trial of Neoadjuvant Immunotherapy With Response-Adapted Treatment Versus Standard-of-Care Treatment for Resectable Stage III/IV Cutaneous Squamous Cell Carcinoma (C-PRE)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06568172
- Recruitment status
- Suspended
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 420 participants
Conditions and interventions
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
- Recurrent Skin Spindle Cell Squamous Cell Carcinoma
- Recurrent Skin Squamous Cell Carcinoma With Sarcomatoid Differentiation
- Resectable Eyelid Squamous Cell Carcinoma
- Resectable Skin Acantholytic Squamous Cell Carcinoma
- Resectable Skin Clear Cell Squamous Cell Carcinoma
- Resectable Skin Lymphoepithelial Carcinoma
- Resectable Skin Spindle Cell Squamous Cell Carcinoma
- Resectable Skin Squamous Cell Carcinoma With Sarcomatoid Differentiation
- Skin Acantholytic Squamous Cell Carcinoma
- Skin Clear Cell Squamous Cell Carcinoma
- Skin Lymphoepithelial Carcinoma
- Skin Spindle Cell Squamous Cell Carcinoma
- Skin Squamous Cell Carcinoma With Sarcomatoid Differentiation
- Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
- Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
Interventions
- Biospecimen Collection Procedure
- Cemiplimab Biological
- Computed Tomography Procedure
- Image Guided Radiation Therapy Radiation
- Intensity-Modulated Radiation Therapy Radiation
- Magnetic Resonance Imaging Procedure
- Positron Emission Tomography Procedure
- Questionnaire Administration Other
- Surgical Procedure Procedure
Procedure · Biological · Radiation + 1 more
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 18, 2025 (Actual)
- Primary completion
- Aug 14, 2031 (Estimated)
- Completion
- Aug 14, 2031 (Estimated)
- Last update posted
- Oct 20, 2026
2025 – 2031
United States locations
- U.S. sites
- 196
- U.S. states
- 35
- U.S. cities
- 150
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | Birmingham | Alabama | 35233 | — |
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | — |
| Mayo Clinic Hospital in Arizona | Phoenix | Arizona | 85054 | — |
| Tower Cancer Research Foundation | Beverly Hills | California | 90211 | — |
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010 | — |
| UC San Diego Health System - Encinitas | Encinitas | California | 92024 | — |
| City of Hope at Irvine Lennar | Irvine | California | 92618 | — |
| UC San Diego Moores Cancer Center | La Jolla | California | 92093 | — |
| City of Hope Antelope Valley | Lancaster | California | 93534 | — |
| The Angeles Clinic and Research Institute - West Los Angeles Office | Los Angeles | California | 90025 | — |
| USC / Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | — |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| Kaiser Permanente-Oakland | Oakland | California | 94611 | — |
| Stanford Cancer Institute Palo Alto | Palo Alto | California | 94304 | — |
| University of California Davis Comprehensive Cancer Center | Sacramento | California | 95817 | — |
| Kaiser Permanente-South Sacramento | Sacramento | California | 95823 | — |
| UC San Diego Medical Center - Hillcrest | San Diego | California | 92103 | — |
| Kaiser Permanente-San Francisco | San Francisco | California | 94115 | — |
| City of Hope South Pasadena | South Pasadena | California | 91030 | — |
| Torrance Memorial Physician Network - Cancer Care | Torrance | California | 90505 | — |
| City of Hope Upland | Upland | California | 91786 | — |
| Kaiser Permanente-Walnut Creek | Walnut Creek | California | 94596 | — |
| UCHealth University of Colorado Hospital | Aurora | Colorado | 80045 | — |
| UCHealth Memorial Hospital Central | Colorado Springs | Colorado | 80909 | — |
| Memorial Hospital North | Colorado Springs | Colorado | 80920 | — |
| Smilow Cancer Hospital Care Center at Greenwich | Greenwich | Connecticut | 06830 | — |
| Smilow Cancer Hospital Care Center - Guilford | Guilford | Connecticut | 06437 | — |
| Yale University | New Haven | Connecticut | 06520 | — |
| Smilow Cancer Hospital Care Center-Trumbull | Trumbull | Connecticut | 06611 | — |
| Smilow Cancer Hospital-Waterbury Care Center | Waterbury | Connecticut | 06708 | — |
| Smilow Cancer Hospital Care Center - Waterford | Waterford | Connecticut | 06385 | — |
| Helen F Graham Cancer Center | Newark | Delaware | 19713 | — |
| Medical Oncology Hematology Consultants PA | Newark | Delaware | 19713 | — |
| UM Sylvester Comprehensive Cancer Center at Aventura | Aventura | Florida | 33180 | — |
| UM Sylvester Comprehensive Cancer Center at Coral Gables | Coral Gables | Florida | 33146 | — |
| UM Sylvester Comprehensive Cancer Center at Deerfield Beach | Deerfield Beach | Florida | 33442 | — |
| UM Sylvester Comprehensive Cancer Center at Doral | Doral | Florida | 33166 | — |
| Mayo Clinic in Florida | Jacksonville | Florida | 32224-9980 | — |
| University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida | 33136 | — |
| Miami Cancer Institute | Miami | Florida | 33176 | — |
| UM Sylvester Comprehensive Cancer Center at Kendall | Miami | Florida | 33176 | — |
| Sarasota Memorial Hospital-Venice | N. Venice | Florida | 34275 | — |
| UM Sylvester Comprehensive Cancer Center at Plantation | Plantation | Florida | 33324 | — |
| Florida Cancer Specialists - Sarasota | Sarasota | Florida | 34232 | — |
| First Physicians Group - Silverstein Institute at Floyd Street | Sarasota | Florida | 34239 | — |
| Florida Cancer Specialists - Sarasota Downtown | Sarasota | Florida | 34239 | — |
| Sarasota Memorial Hospital | Sarasota | Florida | 34239 | — |
| Sarasota Memorial Health Care Center at University Parkway | Sarasota | Florida | 34243 | — |
| Moffitt Cancer Center-International Plaza | Tampa | Florida | 33607 | — |
| Moffitt Cancer Center - McKinley Campus | Tampa | Florida | 33612 | — |
| Moffitt Cancer Center | Tampa | Florida | 33612 | — |
| Florida Cancer Specialists - Venice Pinebrook | Venice | Florida | 34275 | — |
| Florida Cancer Specialists - Venice Island | Venice | Florida | 34285 | — |
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | — |
| Emory University Hospital/Winship Cancer Institute | Atlanta | Georgia | 30322 | — |
| Alton Memorial Hospital | Alton | Illinois | 62002 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| Rush MD Anderson Cancer Center | Chicago | Illinois | 60612 | — |
| University of Illinois | Chicago | Illinois | 60612 | — |
| Decatur Memorial Hospital | Decatur | Illinois | 62526 | — |
| Northwestern Medicine Cancer Center Kishwaukee | DeKalb | Illinois | 60115 | — |
| Northwestern Medicine Cancer Center Delnor | Geneva | Illinois | 60134 | — |
| Northwestern Medicine Orland Park | Orland Park | Illinois | 60462 | — |
| Memorial Hospital East | Shiloh | Illinois | 62269 | — |
| Northwestern Medicine Cancer Center Warrenville | Warrenville | Illinois | 60555 | — |
| IU Health North Hospital | Carmel | Indiana | 46032 | — |
| Goshen Center for Cancer Care | Goshen | Indiana | 46526 | — |
| Indiana University/Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | — |
| Franciscan Health Indianapolis | Indianapolis | Indiana | 46237 | — |
| Heartland Oncology and Hematology LLP | Council Bluffs | Iowa | 51503 | — |
| Methodist Jennie Edmundson Hospital | Council Bluffs | Iowa | 51503 | — |
| University of Kansas Cancer Center | Kansas City | Kansas | 66160 | — |
| University of Kansas Cancer Center-Overland Park | Overland Park | Kansas | 66210 | — |
| University of Kansas Hospital-Indian Creek Campus | Overland Park | Kansas | 66211 | — |
| University of Kansas Hospital-Westwood Cancer Center | Westwood | Kansas | 66205 | — |
| University of Kentucky/Markey Cancer Center | Lexington | Kentucky | 40536 | — |
| The James Graham Brown Cancer Center at University of Louisville | Louisville | Kentucky | 40202 | — |
| UofL Health Medical Center Northeast | Louisville | Kentucky | 40245 | — |
| LSU Health Baton Rouge-North Clinic | Baton Rouge | Louisiana | 70805 | — |
| Our Lady of the Lake Physician Group | Baton Rouge | Louisiana | 70808 | — |
| University Medical Center New Orleans | New Orleans | Louisiana | 70112 | — |
| University of Michigan Rogel Cancer Center | Ann Arbor | Michigan | 48109 | — |
| University of Michigan - Brighton Center for Specialty Care | Brighton | Michigan | 48116 | — |
| Henry Ford Hospital | Detroit | Michigan | 48202 | — |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital | Grand Rapids | Michigan | 49503 | — |
| Henry Ford West Bloomfield Hospital | West Bloomfield | Michigan | 48322 | — |
| University of Michigan Health - West | Wyoming | Michigan | 49519 | — |
| University of Minnesota/Masonic Cancer Center | Minneapolis | Minnesota | 55455 | — |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | — |
| Siteman Cancer Center at Saint Peters Hospital | City of Saint Peters | Missouri | 63376 | — |
| MU Health - University Hospital/Ellis Fischel Cancer Center | Columbia | Missouri | 65212 | — |
| Siteman Cancer Center at West County Hospital | Creve Coeur | Missouri | 63141 | — |
| University of Kansas Cancer Center - North | Kansas City | Missouri | 64154 | — |
| University of Kansas Cancer Center - Lee's Summit | Lee's Summit | Missouri | 64064 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Siteman Cancer Center-South County | St Louis | Missouri | 63129 | — |
| Siteman Cancer Center at Christian Hospital | St Louis | Missouri | 63136 | — |
| Nebraska Medicine-Bellevue | Bellevue | Nebraska | 68123 | — |
| Nebraska Cancer Specialists/Oncology Hematology West PC - MECC | Omaha | Nebraska | 68114 | — |
| Nebraska Methodist Hospital | Omaha | Nebraska | 68114 | — |
| Nebraska Medicine-Village Pointe | Omaha | Nebraska | 68118 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center | Lebanon | New Hampshire | 03756 | — |
| Memorial Sloan Kettering Basking Ridge | Basking Ridge | New Jersey | 07920 | — |
| Memorial Sloan Kettering Monmouth | Middletown | New Jersey | 07748 | — |
| Memorial Sloan Kettering Bergen | Montvale | New Jersey | 07645 | — |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87106 | — |
| Memorial Sloan Kettering Commack | Commack | New York | 11725 | — |
| Memorial Sloan Kettering Westchester | Harrison | New York | 10604 | — |
| Northwell Health/Center for Advanced Medicine | Lake Success | New York | 11042 | — |
| NYU Langone Hospital - Long Island | Mineola | New York | 11501 | — |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York | New York | 10016 | — |
| Manhattan Eye Ear and Throat Hospital | New York | New York | 10065 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| Lenox Hill Hospital | New York | New York | 10075 | — |
| University of Rochester | Rochester | New York | 14642 | — |
| Stony Brook University Medical Center | Stony Brook | New York | 11794 | — |
| State University of New York Upstate Medical University | Syracuse | New York | 13210 | — |
| SUNY Upstate Medical Center-Community Campus | Syracuse | New York | 13215 | — |
| Montefiore Medical Center-Einstein Campus | The Bronx | New York | 10461 | — |
| Montefiore Medical Center-Weiler Hospital | The Bronx | New York | 10461 | — |
| Montefiore Medical Center - Moses Campus | The Bronx | New York | 10467 | — |
| Memorial Sloan Kettering Nassau | Uniondale | New York | 11553 | — |
| Wilmot Cancer Institute at Webster | Webster | New York | 14580 | — |
| Atrium Health Stanly/LCI-Albemarle | Albemarle | North Carolina | 28002 | — |
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | — |
| Carolinas Medical Center/Levine Cancer Institute | Charlotte | North Carolina | 28203 | — |
| Atrium Health Pineville/LCI-Pineville | Charlotte | North Carolina | 28210 | — |
| Atrium Health University City/LCI-University | Charlotte | North Carolina | 28262 | — |
| Atrium Health Cabarrus/LCI-Concord | Concord | North Carolina | 28025 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Levine Cancer Institute-Gaston | Gastonia | North Carolina | 28054 | — |
| Atrium Health Union/LCI-Union | Monroe | North Carolina | 28112 | — |
| Duke Cancer Center Raleigh | Raleigh | North Carolina | 27609 | — |
| Atrium Health Cleveland/LCI-Cleveland | Shelby | North Carolina | 28150 | — |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | — |
| UH Seidman Cancer Center at UH Avon Health Center | Avon | Ohio | 44011 | — |
| UHHS-Chagrin Highlands Medical Center | Beachwood | Ohio | 44122 | — |
| Miami Valley Hospital South | Centerville | Ohio | 45459 | — |
| University of Cincinnati Cancer Center-UC Medical Center | Cincinnati | Ohio | 45219 | — |
| Case Western Reserve University | Cleveland | Ohio | 44106 | — |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | — |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | — |
| Miami Valley Hospital North | Dayton | Ohio | 45415 | — |
| Atrium Medical Center-Middletown Regional Hospital | Franklin | Ohio | 45005-1066 | — |
| Miami Valley Cancer Care and Infusion | Greenville | Ohio | 45331 | — |
| UH Seidman Cancer Center at Lake Health Mentor Campus | Mentor | Ohio | 44060 | — |
| Upper Valley Medical Center | Troy | Ohio | 45373 | — |
| University of Cincinnati Cancer Center-West Chester | West Chester | Ohio | 45069 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Providence Portland Medical Center | Portland | Oregon | 97213 | — |
| Christiana Care Health System-Concord Health Center | Chadds Ford | Pennsylvania | 19317 | — |
| UPMC Hillman Cancer Center Erie | Erie | Pennsylvania | 16505 | — |
| Saint Vincent Hospital | Erie | Pennsylvania | 16544 | — |
| Penn State Milton S Hershey Medical Center | Hershey | Pennsylvania | 17033-0850 | — |
| UPMC-Johnstown/John P. Murtha Regional Cancer Center | Johnstown | Pennsylvania | 15901 | — |
| Forbes Hospital | Monroeville | Pennsylvania | 15146 | — |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | — |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | — |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | — |
| West Penn Hospital | Pittsburgh | Pennsylvania | 15224 | — |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | — |
| Wexford Health and Wellness Pavilion | Wexford | Pennsylvania | 15090 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Rock Hill Radiation Therapy Center | Rock Hill | South Carolina | 29730 | — |
| Levine Cancer Institute-Rock Hill | Rock Hill | South Carolina | 29732 | — |
| Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | 37232 | — |
| UT MD Anderson - The Woodlands | Conroe | Texas | 77384 | — |
| UT Southwestern Simmons Cancer Center - RedBird | Dallas | Texas | 75237 | — |
| UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | 75390 | — |
| UT Southwestern/Simmons Cancer Center-Fort Worth | Fort Worth | Texas | 76104 | — |
| UT MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| UT MD Anderson - West Houston | Houston | Texas | 77079 | — |
| UT MD Anderson - League City | League City | Texas | 77573 | — |
| UT Southwestern Clinical Center at Richardson/Plano | Richardson | Texas | 75080 | — |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | — |
| UT MD Anderson - Sugar Land | Sugar Land | Texas | 77478 | — |
| Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah | 84112 | — |
| Central Vermont Medical Center/National Life Cancer Treatment | Berlin Corners | Vermont | 05602 | — |
| University of Vermont Medical Center | Burlington | Vermont | 05401 | — |
| University of Vermont and State Agricultural College | Burlington | Vermont | 05405 | — |
| Dartmouth Cancer Center - North | Saint Johnsbury | Vermont | 05819 | — |
| University of Virginia Cancer Center | Charlottesville | Virginia | 22908 | — |
| Inova Schar Cancer Institute | Fairfax | Virginia | 22031 | — |
| VCU Massey Comprehensive Cancer Center | Richmond | Virginia | 23298 | — |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | — |
| Gundersen Lutheran Medical Center | La Crosse | Wisconsin | 54601 | — |
| William S Middleton VA Medical Center | Madison | Wisconsin | 53705 | — |
| University of Wisconsin Carbone Cancer Center - Eastpark Medical Center | Madison | Wisconsin | 53718 | — |
| University of Wisconsin Carbone Cancer Center - University Hospital | Madison | Wisconsin | 53792 | — |
| Marshfield Medical Center-Marshfield | Marshfield | Wisconsin | 54449 | — |
| Froedtert Menomonee Falls Hospital | Menomonee Falls | Wisconsin | 53051 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
| Drexel Town Square Health Center | Oak Creek | Wisconsin | 53154 | — |
| Froedtert West Bend Hospital/Kraemer Cancer Center | West Bend | Wisconsin | 53095 | — |
| Marshfield Medical Center - Weston | Weston | Wisconsin | 54476 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 10 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06568172, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 20, 2026 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06568172 live on ClinicalTrials.gov.