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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Regeneron Pharmaceuticals • ClinicalTrials.gov ID: NCT06585410

Registry updated: 2026-09-16
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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. 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

Interventions

  • Cemiplimab (Drug)
    Administered per protocol
  • Standard of care (Procedure)
    Primary surgery

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) 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 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, 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.) 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.

Conditions

Cutaneous Squamous Cell Carcinoma (CSCC)

Locations

  • Medical Dermatology Specialists - Phoenix — 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
  • Profound Research, Dermatology Medical Group - Oceanside — Oceanside, 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, Integri Research at Dermatology Associates — Delray Beach, Florida, United States
  • University of South Florida — Tampa, 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
  • StracSkin, PLLC — Portsmouth, New Hampshire, 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
  • Penn Medicine, Perelman Center For Advanced Medicine — 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
  • U.S. Dermatology Partners — Cedar Park, 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
  • Vcu Massey Cancer Center — Richmond, Virginia, 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
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record