Study of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell Carcinoma

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT06585410
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Cutaneous Squamous Cell Carcinoma (CSCC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cemiplimab — DRUG
    Administered per protocol
  • Standard of care — PROCEDURE
    Primary surgery

Study Details

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

Key Dates

Start date
Jan 2, 2025
Status verified
May 2026
Primary completion
May 3, 2030
Completion
May 3, 2030

Study Design

Enrollment
369 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Arm
  • Other: Control Arm

Primary Outcome Measure

Event-Free Survival (EFS) as assessed by the investigator [ Time Frame: Up to 1 year ]

Central Contacts

Locations (45)

FacilityCityStateZIPSite coordinators
Medical Dermatology Specialists - PhoenixPhoenixArizona85006-
Mayo Clinic - ArizonaScottsdaleArizona85259-
University of Arizona Cancer CenterTucsonArizona85719-
Arkansas Research TrialsNorth Little RockArkansas72117-
UC San Diego Moores Cancer CenterLa JollaCalifornia92093-
Profound Research, Dermatology Medical Group - OceansideOceansideCalifornia92056-
Stanford UniversityRedwood CityCalifornia94063-
Peak Dermatology, Aesthetics and WellnessVisaliaCalifornia93291-
George Washington University Medical Faculty AssociatesWashington D.C.District of Columbia20037-
Life Clinical TrialsCoral SpringsFlorida33071-
Dermatology Associates of the Palm BeachesDelray BeachFlorida33445-
University of South FloridaTampaFlorida33612-
University of Chicago Medical CenterChicagoIllinois60637-
Oak DermatologyNapervilleIllinois60563-
Dawes Fretzin Clinical Research - Shadeland Ave.IndianapolisIndiana46250-
Equity Medical, LLCBowling GreenKentucky42104-
US Dermatology Partners DBA DermAssociates, PCRockvilleMaryland20850-
Northeast Dermatology AssociatesBeverlyMassachusetts01915-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
MyMichigan Dermatologic OncologyMidlandMichigan48640-
Somerset Skin CentreTroyMichigan48084-
Dermatology and Skin Cancer CenterLee's SummitMissouri64064-
Washington University in St. Louis - Center for Dermatologic and Cosmetic SurgerySt LouisMissouri63141-
Las Vegas DermatologyLas VegasNevada89144-
Metropolitan DermatologyClarkNew Jersey07066-
University of New MexicoAlbuquerqueNew Mexico87102-
Columbia University Medical Center - Herbert Irving Center for Dermatology and Skin Cancer - Herbert Irving PavilionNew YorkNew York10032-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10021-
Rochester Dermatologic Surgery, P.C.VictorNew York14564-
UNC Hospitals Dermatology and Skin Cancer Center at Southern VillageChapel HillNorth Carolina27516-
Cleveland ClinicClevelandOhio44195-
Buckeye Dermatology - Springfield OfficeSpringfieldOhio45505-
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-
Dermatology Health SpecialistsBendOregon97702-
Oregon Health & Science UniversityPortlandOregon97239-
Penn State Hershey Medical CenterHersheyPennsylvania17033-
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104-
Clinical Research Center of the CarolinasCharlestonSouth Carolina29407-
The University of Texas at Austin Dell Medical School Ascension Medical GroupAustinTexas78701-
Reveal Research InstituteDallasTexas75235-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-
Epiphany DermatologyLewisvilleTexas75056-
Texas Dermatology and Laser SpecialistsSan AntonioTexas78218-
Center for Clinical Studies at Webster Clear LakeWebsterTexas77598-
University of Utah HospitalSalt Lake CityUtah84132-

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By research site
Medical Dermatology Specialists - Phoenix· Phoenix, AZMayo Clinic - Arizona· Scottsdale, AZUniversity of Arizona Cancer Center· Tucson, AZArkansas Research Trials· North Little Rock, ARUC San Diego Moores Cancer Center· La Jolla, CAProfound Research, Dermatology Medical Group - Oceanside· Oceanside, CA

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