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Taking people in United StatesPhase 3

Tests cemiplimab injected into early skin squamous cell carcinoma against surgery

Compares an injected immune drug with surgery in adults with early skin cancer.

Plain-language title generated from the registry record
Registry title: Study of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell Carcinoma

Key facts

Where
Albuquerque, Austin, Bend, Beverly, Boston, Bowling Green, Cedar Park, Chapel Hill, Charleston, Chicago, Clark, Cleveland, Coral Springs, Dallas, Delray Beach, Hershey, Houston, Indianapolis, La Jolla, Las Vegas, Lee's Summit, Lewisville, Midland, Naperville, New York, North Little Rock, Oceanside, Oklahoma City, Philadelphia, Phoenix, Portland, Portsmouth, Redwood City, Richmond, Rockville, Salt Lake City, San Antonio, Scottsdale, Springfield, St Louis, Tampa, Troy, Tucson, Victor, Visalia, Washington D.C., and Webster, United StatesSee the 48 sites
Phase
Phase 3

Where in United States

  • University of New MexicoAlbuquerque, United StatesTaking people
  • The University of Texas at Austin Dell Medical School Ascension Medical GroupAustin, United StatesTaking people
  • Dermatology Health SpecialistsBend, United StatesTaking people
  • Northeast Dermatology AssociatesBeverly, United StatesTaking people
  • Dana-Farber Cancer InstituteBoston, United StatesTaking people
  • Equity Medical, LLCBowling Green, United StatesNo longer taking part
  • U.S. Dermatology PartnersCedar Park, United StatesTaking people
  • UNC Hospitals Dermatology and Skin Cancer Center at Southern VillageChapel Hill, United StatesTaking people
  • Clinical Research Center of the CarolinasCharleston, United StatesTaking people
  • University of Chicago Medical CenterChicago, United StatesTaking people
  • Metropolitan DermatologyClark, United StatesNo longer taking part
  • Cleveland ClinicCleveland, United StatesTaking people
  • Life Clinical TrialsCoral Springs, United StatesTaking people
  • Reveal Research InstituteDallas, United StatesTaking people
  • Dermatology Associates of the Palm Beaches, Integri Research at Dermatology AssociatesDelray Beach, United StatesTaking people
  • Penn State Hershey Medical CenterHershey, United StatesTaking people
  • The University of Texas MD Anderson Cancer CenterHouston, United StatesTaking people
  • Dawes Fretzin Clinical Research - Shadeland Ave.Indianapolis, United StatesNo longer taking part
  • UC San Diego Moores Cancer CenterLa Jolla, United StatesTaking people
  • Las Vegas DermatologyLas Vegas, United StatesTaking people
  • Dermatology and Skin Cancer CenterLee's Summit, United StatesTaking people
  • Epiphany DermatologyLewisville, United StatesTaking people
  • MyMichigan Dermatologic OncologyMidland, United StatesTaking people
  • Oak DermatologyNaperville, United StatesTaking people
  • Columbia University Medical Center - Herbert Irving Center for Dermatology and Skin Cancer - Herbert Irving PavilionNew York, United StatesTaking people
  • Memorial Sloan-Kettering Cancer CenterNew York, United StatesTaking people
  • Arkansas Research TrialsNorth Little Rock, United StatesTaking people
  • Profound Research, Dermatology Medical Group - OceansideOceanside, United StatesTaking people
  • University of Oklahoma Health Sciences CenterOklahoma City, United StatesTaking people
  • Penn Medicine - Perelman Center for Advanced MedicinePhiladelphia, United StatesTaking people
  • Medical Dermatology Specialists PhoenixPhoenix, United StatesTaking people
  • Oregon Health Science UniversityPortland, United StatesTaking people
  • StracSkin, PLLCPortsmouth, United StatesTaking people
  • Stanford UniversityRedwood City, United StatesTaking people
  • VCU Massey Cancer CenterRichmond, United StatesTaking people
  • US Dermatology Partners DBA DermAssociates, PCRockville, United StatesTaking people
  • University of Utah HospitalSalt Lake City, United StatesTaking people
  • Texas Dermatology and Laser SpecialistsSan Antonio, United StatesTaking people
  • Mayo Clinic - ArizonaScottsdale, United StatesTaking people
  • Buckeye Dermatology - Springfield OfficeSpringfield, United StatesTaking people
  • Washington University in St. Louis - Center for Dermatologic and Cosmetic SurgerySt Louis, United StatesTaking people
  • University of South FloridaTampa, United StatesTaking people
  • Somerset Skin CentreTroy, United StatesTaking people
  • University of Arizona Cancer CenterTucson, United StatesTaking people
  • Rochester Dermatologic Surgery, P.C.Victor, United StatesTaking people
  • Peak Dermatology, Aesthetics and WellnessVisalia, United StatesTaking people
  • George Washington University- Medical Faculty AssociatesWashington D.C., United StatesTaking people
  • Center for Clinical Studies at Webster Clear LakeWebster, United StatesTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Regeneron Pharmaceuticals
Trial code
NCT06585410
Record updated
16 September 2026
Original description
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.Read full original descriptionShow less

A Phase 3 Randomized Study of Intralesional Cemiplimab Versus Primary Surgery in Participants With Early Stage Cutaneous Squamous Cell Carcinoma (CSCC)

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 compared to surgery

Inclusion: Participants who have a histologically confirmed invasive CSCC TL, as described in the protocol; Participants who have CSCC TL ≥1 cm and ≤2.0 cm (longest diameter) prior to biopsy and >0.7 cm to ≤2.0 cm after biopsy, located in either the Head or Neck (HN), hand, or pre-tibial surface, as described in the protocol; 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; Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1; Adequate hepatic, renal and bone marrow functions, as described in the protocol.

Exclusion: 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; 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; Participant in which the TL is a keratoacanthoma (KA), adenosquamous carcinoma, desmoplastic carcinoma, sarcomatoid 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.); History of non-infectious pneumonitis within the last 5 years.

ClinicalTrials.gov NCT06585410