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Study of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell Carcinoma
NCT06585410 · Regeneron Pharmaceuticals
In plain English
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Official title
A Phase 3 Randomized Study of Intralesional Cemiplimab Versus Primary Surgery in Participants With Early Stage Cutaneous Squamous Cell Carcinoma (CSCC)
About this study
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
Eligibility criteria
Key Inclusion Criteria:
1. Participants who have a histologically confirmed invasive CSCC TL, as described in the protocol
2. Participants who have CSCC TL ≥1 cm and ≤2.0 cm (longest diameter) located in either the Head or Neck (HN), hand, or pre-tibial surface, as described in the protocol
3. Participants who are judged to be eligible for surgical resection of their CSCC TL and the method of planned surgical resection would be Micrographically oriented histographic surgery (Mohs) or other surgical method of Complete Margin Assessment (CMA). Participants for whom the planned surgery is surgical excision without margin control are not eligible
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1
5. Adequate hepatic, renal and bone marrow functions, as described in the protocol
Key Exclusion Criteria:
1. Participant in which the TL is a keratoacanthoma (KA), adenosquamous carcinoma, desmoplastic carcinoma, basal cell carcinoma, basosquamous.carcinoma, Bowen's disease, or CSCC in situ without an invasive component. (Note: For participants with invasive CSCC with a minor basaloid component, the patient may be eligible after discussion with the sponsor medical director.)
2. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for Immune-mediated Adverse Events (imAEs), as described in the protocol
3. History of non-infectious pneumonitis within the last 5 years
4. TL (lesion planned for intralesional therapy) or other non-target CSCC lesion in dry red lip (vermillion), oral cavity, or nasal mucosa
NOTE: Other protocol defined inclusion / exclusion criteria apply.
Study design
Enrollment target: 369 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-01-02
Estimated completion: 2030-05-03
Last updated: 2026-04-08
Interventions
Drug: CemiplimabProcedure: Standard of care
Primary outcomes
- • Event-Free Survival (EFS) as assessed by the investigator (Up to 1 year)
- • EFS as assessed by the investigator (Up to 3 years)
Sponsor
Regeneron Pharmaceuticals · industry
Contacts & investigators
ContactClinical Trials Administrator · contact · clinicaltrials@regeneron.com · 844-734-6643
InvestigatorClinical Trial Management · study_director, Regeneron Pharmaceuticals
All locations (49)
Medical Dermatology SpecialistsRecruiting
Phoenix, Arizona, United States
Mayo Clinic - ArizonaRecruiting
Scottsdale, Arizona, United States
University of Arizona Cancer CenterRecruiting
Tucson, Arizona, United States
Arkansas Research TrialsRecruiting
North Little Rock, Arkansas, United States
UC San Diego Moores Cancer CenterRecruiting
La Jolla, California, United States
Stanford UniversityRecruiting
Redwood City, California, United States
Peak Dermatology, Aesthetics and WellnessRecruiting
Visalia, California, United States
George Washington University Medical Faculty AssociatesRecruiting
Washington D.C., District of Columbia, United States
Life Clinical TrialsRecruiting
Coral Springs, Florida, United States
Dermatology Associates of the Palm BeachesRecruiting
Delray Beach, Florida, United States
University of South FloridaRecruiting
St. Petersburg, Florida, United States
University of Chicago Medical CenterRecruiting
Chicago, Illinois, United States
Oak DermatologyRecruiting
Naperville, Illinois, United States
Dawes Fretzin Clinical Research - Shadeland Ave.Withdrawn
Indianapolis, Indiana, United States
Equity Medical, LLCRecruiting
Bowling Green, Kentucky, United States
US Dermatology Partners DBA DermAssociates, PCRecruiting
Rockville, Maryland, United States
Northeast Dermatology AssociatesRecruiting
Beverly, Massachusetts, United States
Dana-Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
MyMichigan Dermatologic OncologyRecruiting
Midland, Michigan, United States
Somerset Skin CentreRecruiting
Troy, Michigan, United States
Dermatology and Skin Cancer CenterRecruiting
Lee's Summit, Missouri, United States
Washington University in St. Louis - Center for Dermatologic and Cosmetic SurgeryRecruiting
St Louis, Missouri, United States
Las Vegas DermatologyRecruiting
Las Vegas, Nevada, United States
Metropolitan DermatologyRecruiting
Clark, New Jersey, United States
University of New MexicoRecruiting
Albuquerque, New Mexico, United States
Memorial Sloan Kettering Cancer CenterRecruiting
New York, New York, United States
Columbia University Medical Center - Herbert Irving Center for Dermatology and Skin Cancer - Herbert Irving PavilionRecruiting
New York, New York, United States
Rochester Dermatologic Surgery, P.C.Recruiting
Victor, New York, United States
UNC Hospitals Dermatology and Skin Cancer Center at Southern VillageRecruiting
Chapel Hill, North Carolina, United States
Cleveland ClinicRecruiting
Cleveland, Ohio, United States
Buckeye Dermatology - Springfield OfficeRecruiting
Springfield, Ohio, United States
University of Oklahoma Health Sciences CenterRecruiting
Oklahoma City, Oklahoma, United States
Dermatology Health SpecialistsRecruiting
Bend, Oregon, United States
Oregon Health & Science UniversityRecruiting
Portland, Oregon, United States
Penn State Hershey Medical CenterRecruiting
Hershey, Pennsylvania, United States
Hospital of the University of PennsylvaniaRecruiting
Philadelphia, Pennsylvania, United States
Clinical Research Center of the CarolinasRecruiting
Charleston, South Carolina, United States
The University of Texas at Austin Dell Medical School Ascension Medical GroupRecruiting
Austin, Texas, United States
Reveal Research InstituteRecruiting
Dallas, Texas, United States
The University of Texas MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
Epiphany DermatologyRecruiting
Lewisville, Texas, United States
Texas Dermatology and Laser SpecialistsRecruiting
San Antonio, Texas, United States
Center for Clinical Studies at Webster Clear LakeRecruiting
Webster, Texas, United States
University of Utah HospitalRecruiting
Salt Lake City, Utah, United States
The Skin HospitalRecruiting
Darlinghurst, New South Wales, Australia
Westmead HospitalRecruiting
Westmead, New South Wales, Australia
Princess Alexandra HospitalRecruiting
Woolloongabba, Queensland, Australia
Dermatology Institute of Victoria (DIV)Recruiting
South Yarra, Victoria, Australia
Fremantle DermatologyRecruiting
Fremantle, Western Australia, Australia