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Study of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell Carcinoma
Sponsor: Regeneron Pharmaceuticals
Summary
This study will test a study drug called cemiplimab to see if it can help treat early-stage cutaneous squamous cell carcinoma (CSCC), a type of skin cancer. Cemiplimab works by helping the immune system to kill cancer cells. It binds to a protein called programmed cell death-1 (PD-1) on the surface of certain immune cells. The main purpose of this study is to compare how well cemiplimab works compared to surgery, when injected into the lesion. The study is looking at: * The side effects cemiplimab might cause * How well cemiplimab works
Official title: A Phase 3 Randomized Study of Intralesional Cemiplimab Versus Primary Surgery in Participants With Early Stage Cutaneous Squamous Cell Carcinoma (CSCC)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
369
Start Date
2025-01-02
Completion Date
2030-05-03
Last Updated
2026-04-08
Healthy Volunteers
No
Conditions
Interventions
Cemiplimab
Administered per protocol
Standard of care
Primary surgery
Locations (49)
Medical Dermatology Specialists
Phoenix, Arizona, United States
Mayo Clinic - Arizona
Scottsdale, Arizona, United States
University of Arizona Cancer Center
Tucson, Arizona, United States
Arkansas Research Trials
North Little Rock, Arkansas, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
Stanford University
Redwood City, California, United States
Peak Dermatology, Aesthetics and Wellness
Visalia, California, United States
George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, United States
Life Clinical Trials
Coral Springs, Florida, United States
Dermatology Associates of the Palm Beaches
Delray Beach, Florida, United States
University of South Florida
St. Petersburg, Florida, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Oak Dermatology
Naperville, Illinois, United States
Dawes Fretzin Clinical Research - Shadeland Ave.
Indianapolis, Indiana, United States
Equity Medical, LLC
Bowling Green, Kentucky, United States
US Dermatology Partners DBA DermAssociates, PC
Rockville, Maryland, United States
Northeast Dermatology Associates
Beverly, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
MyMichigan Dermatologic Oncology
Midland, Michigan, United States
Somerset Skin Centre
Troy, Michigan, United States
Dermatology and Skin Cancer Center
Lee's Summit, Missouri, United States
Washington University in St. Louis - Center for Dermatologic and Cosmetic Surgery
St Louis, Missouri, United States
Las Vegas Dermatology
Las Vegas, Nevada, United States
Metropolitan Dermatology
Clark, New Jersey, United States
University of New Mexico
Albuquerque, New Mexico, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Columbia University Medical Center - Herbert Irving Center for Dermatology and Skin Cancer - Herbert Irving Pavilion
New York, New York, United States
Rochester Dermatologic Surgery, P.C.
Victor, New York, United States
UNC Hospitals Dermatology and Skin Cancer Center at Southern Village
Chapel Hill, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Buckeye Dermatology - Springfield Office
Springfield, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Dermatology Health Specialists
Bend, Oregon, United States
Oregon Health & Science University
Portland, Oregon, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Clinical Research Center of the Carolinas
Charleston, South Carolina, United States
The University of Texas at Austin Dell Medical School Ascension Medical Group
Austin, Texas, United States
Reveal Research Institute
Dallas, Texas, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Epiphany Dermatology
Lewisville, Texas, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States
Center for Clinical Studies at Webster Clear Lake
Webster, Texas, United States
University of Utah Hospital
Salt Lake City, Utah, United States
The Skin Hospital
Darlinghurst, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Dermatology Institute of Victoria (DIV)
South Yarra, Victoria, Australia
Fremantle Dermatology
Fremantle, Western Australia, Australia