Actively Recruiting
Study of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell Carcinoma
Led by Regeneron Pharmaceuticals · Updated on 2026-04-22
369
Participants Needed
49
Research Sites
278 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Study of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed invasive cutaneous squamous cell carcinoma (CSCC) tumor lesion (TL)
- Tumor size between 1 cm and 2 cm located on head, neck, hand, or pre-tibial surface
- Eligible for surgical resection using Mohs surgery or other complete margin assessment (CMA) method
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate liver, kidney, and bone marrow function as described in the protocol
You will not qualify if you...
- Tumor lesion is keratoacanthoma, adenosquamous carcinoma, desmoplastic carcinoma, basal cell carcinoma, basosquamous carcinoma, Bowen's disease, or CSCC in situ without invasive component
- Significant autoimmune disease treated with systemic immunosuppressive drugs within past 5 years
- History of non-infectious pneumonitis within the last 5 years
- Tumor lesion or other non-target CSCC lesion located in dry red lip (vermillion), oral cavity, or nasal mucosa
- Planned surgery without margin control is not allowed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 49 locations
1
Medical Dermatology Specialists
Phoenix, Arizona, United States, 85006
Actively Recruiting
2
Mayo Clinic - Arizona
Scottsdale, Arizona, United States, 85259
Actively Recruiting
3
University of Arizona Cancer Center
Tucson, Arizona, United States, 85719
Actively Recruiting
4
Arkansas Research Trials
North Little Rock, Arkansas, United States, 72117
Actively Recruiting
5
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Actively Recruiting
6
Stanford University
Redwood City, California, United States, 94063
Actively Recruiting
7
Peak Dermatology, Aesthetics and Wellness
Visalia, California, United States, 93291
Actively Recruiting
8
George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, United States, 20037
Actively Recruiting
9
Life Clinical Trials
Coral Springs, Florida, United States, 33071
Actively Recruiting
10
Dermatology Associates of the Palm Beaches
Delray Beach, Florida, United States, 33445
Actively Recruiting
11
University of South Florida
Tampa, Florida, United States, 33612
Actively Recruiting
12
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
13
Oak Dermatology
Naperville, Illinois, United States, 60563
Actively Recruiting
14
Dawes Fretzin Clinical Research - Shadeland Ave.
Indianapolis, Indiana, United States, 46250
Withdrawn
15
Equity Medical, LLC
Bowling Green, Kentucky, United States, 42104
Actively Recruiting
16
US Dermatology Partners DBA DermAssociates, PC
Rockville, Maryland, United States, 20850
Actively Recruiting
17
Northeast Dermatology Associates
Beverly, Massachusetts, United States, 01915
Actively Recruiting
18
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
19
MyMichigan Dermatologic Oncology
Midland, Michigan, United States, 48640
Actively Recruiting
20
Somerset Skin Centre
Troy, Michigan, United States, 48084
Actively Recruiting
21
Dermatology and Skin Cancer Center
Lee's Summit, Missouri, United States, 64064
Actively Recruiting
22
Washington University in St. Louis - Center for Dermatologic and Cosmetic Surgery
St Louis, Missouri, United States, 63141
Actively Recruiting
23
Las Vegas Dermatology
Las Vegas, Nevada, United States, 89144
Actively Recruiting
24
Metropolitan Dermatology
Clark, New Jersey, United States, 07066
Actively Recruiting
25
University of New Mexico
Albuquerque, New Mexico, United States, 87102
Actively Recruiting
26
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
Actively Recruiting
27
Columbia University Medical Center - Herbert Irving Center for Dermatology and Skin Cancer - Herbert Irving Pavilion
New York, New York, United States, 10032
Actively Recruiting
28
Rochester Dermatologic Surgery, P.C.
Victor, New York, United States, 14564
Actively Recruiting
29
UNC Hospitals Dermatology and Skin Cancer Center at Southern Village
Chapel Hill, North Carolina, United States, 27516
Actively Recruiting
30
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
31
Buckeye Dermatology - Springfield Office
Springfield, Ohio, United States, 45505
Actively Recruiting
32
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
33
Dermatology Health Specialists
Bend, Oregon, United States, 97702
Actively Recruiting
34
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
35
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
36
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
37
Clinical Research Center of the Carolinas
Charleston, South Carolina, United States, 29407
Actively Recruiting
38
The University of Texas at Austin Dell Medical School Ascension Medical Group
Austin, Texas, United States, 78701
Actively Recruiting
39
Reveal Research Institute
Dallas, Texas, United States, 75235
Actively Recruiting
40
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
41
Epiphany Dermatology
Lewisville, Texas, United States, 75056
Actively Recruiting
42
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States, 78218
Actively Recruiting
43
Center for Clinical Studies at Webster Clear Lake
Webster, Texas, United States, 77598
Actively Recruiting
44
University of Utah Hospital
Salt Lake City, Utah, United States, 84132
Actively Recruiting
45
The Skin Hospital
Darlinghurst, New South Wales, Australia, 2010
Actively Recruiting
46
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Actively Recruiting
47
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Actively Recruiting
48
Dermatology Institute of Victoria (DIV)
South Yarra, Victoria, Australia, 3141
Actively Recruiting
49
Fremantle Dermatology
Fremantle, Western Australia, Australia, 6160
Actively Recruiting
Research Team
C
Clinical Trials Administrator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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