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

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified March 2026 by Regeneron Pharmaceuticals
Sponsor
Regeneron Pharmaceuticals
Information Provided by (Responsible Party)
Regeneron Pharmaceuticals
Clinicaltrials.gov Identifier
NCT06585410
Other Study ID Numbers:
R2810-ONC-2251
First Submitted
September 2, 2024
First Posted
September 4, 2024
Last Update Posted
April 21, 2026
Last Verified
March 2026

ClinicalTrials.gov processed this data on April 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Cutaneous Squamous Cell Carcinoma (CSCC)
Drug: CemiplimabProcedure: Standard of care

Study Design

Study TypeInterventional
Actual Enrollment369 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleA Phase 3 Randomized Study of Intralesional Cemiplimab Versus Primary Surgery in Participants With Early Stage Cutaneous Squamous Cell Carcinoma (CSCC)
Study Start DateJanuary 1, 2025
Actual Primary Completion Date3yrs 11mos from now
Actual Study Completion Date3yrs 11mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Experimental Arm
Investigational treatment
Drug: Cemiplimab
Administered per protocol
Control Arm
Standard of care treatment
Procedure: Standard of care
Primary surgery

Outcome Measures

Primary Outcome Measures
  1. Event-Free Survival (EFS) as assessed by the investigator
  2. EFS as assessed by the investigator
Secondary Outcome Measures
  1. Composite Complete Response (CCR) for Target Lesion (TL)
    Experimental Arm
  2. Non-Target Lesions (NTLs) in the Region of the Target Lesion (ROTL)
    Experimental Arm
  3. Incidence of Treatment Emergent Adverse Events (TEAEs)
  4. Severity of TEAEs
  5. Size of surgical defect
  6. Size of biopsy defect

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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.

Contacts and Locations

Sponsors and CollaboratorsRegeneron Pharmaceuticals
Locations
Medical Dermatology Specialists | Phoenix Arizona, United States, 85006Mayo Clinic - Arizona | Scottsdale Arizona, United States, 85259University of Arizona Cancer Center | Tucson Arizona, United States, 85719Arkansas Research Trials | North Little Rock Arkansas, United States, 72117UC San Diego Moores Cancer Center | La Jolla California, United States, 92093Stanford University | Redwood City California, United States, 94063Peak Dermatology, Aesthetics and Wellness | Visalia California, United States, 93291George Washington University Medical Faculty Associates | Washington D.C. District of Columbia, United States, 20037Life Clinical Trials | Coral Springs Florida, United States, 33071Dermatology Associates of the Palm Beaches | Delray Beach Florida, United States, 33445University of South Florida | Tampa Florida, United States, 33612University of Chicago Medical Center | Chicago Illinois, United States, 60637Oak Dermatology | Naperville Illinois, United States, 60563Dawes Fretzin Clinical Research - Shadeland Ave. | Indianapolis Indiana, United States, 46250Equity Medical, LLC | Bowling Green Kentucky, United States, 42104US Dermatology Partners DBA DermAssociates, PC | Rockville Maryland, United States, 20850Northeast Dermatology Associates | Beverly Massachusetts, United States, 01915Dana-Farber Cancer Institute | Boston Massachusetts, United States, 02215MyMichigan Dermatologic Oncology | Midland Michigan, United States, 48640Somerset Skin Centre | Troy Michigan, United States, 48084Dermatology and Skin Cancer Center | Lee's Summit Missouri, United States, 64064Washington University in St. Louis - Center for Dermatologic and Cosmetic Surgery | St Louis Missouri, United States, 63141Las Vegas Dermatology | Las Vegas Nevada, United States, 89144Metropolitan Dermatology | Clark New Jersey, United States, 07066University of New Mexico | Albuquerque New Mexico, United States, 87102Memorial Sloan Kettering Cancer Center | New York New York, United States, 10021Columbia University Medical Center - Herbert Irving Center for Dermatology and Skin Cancer - Herbert Irving Pavilion | New York New York, United States, 10032Rochester Dermatologic Surgery, P.C. | Victor New York, United States, 14564UNC Hospitals Dermatology and Skin Cancer Center at Southern Village | Chapel Hill North Carolina, United States, 27516Cleveland Clinic | Cleveland Ohio, United States, 44195Buckeye Dermatology - Springfield Office | Springfield Ohio, United States, 45505University of Oklahoma Health Sciences Center | Oklahoma City Oklahoma, United States, 73104Dermatology Health Specialists | Bend Oregon, United States, 97702Oregon Health & Science University | Portland Oregon, United States, 97239Penn State Hershey Medical Center | Hershey Pennsylvania, United States, 17033Hospital of the University of Pennsylvania | Philadelphia Pennsylvania, United States, 19104Clinical Research Center of the Carolinas | Charleston South Carolina, United States, 29407The University of Texas at Austin Dell Medical School Ascension Medical Group | Austin Texas, United States, 78701Reveal Research Institute | Dallas Texas, United States, 75235The University of Texas MD Anderson Cancer Center | Houston Texas, United States, 77030Epiphany Dermatology | Lewisville Texas, United States, 75056Texas Dermatology and Laser Specialists | San Antonio Texas, United States, 78218Center for Clinical Studies at Webster Clear Lake | Webster Texas, United States, 77598University of Utah Hospital | Salt Lake City Utah, United States, 84132The Skin Hospital | Darlinghurst New South Wales, Australia, 2010Westmead Hospital | Westmead New South Wales, Australia, 2145Princess Alexandra Hospital | Woolloongabba Queensland, Australia, 4102Dermatology Institute of Victoria (DIV) | South Yarra Victoria, Australia, 3141Fremantle Dermatology | Fremantle Western Australia, Australia, 6160
Investigators
Study Director: Clinical Trial Management, Regeneron Pharmaceuticals