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

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

Study Overview

• Status: Recruiting
• Conditions: Cutaneous Squamous Cell Carcinoma (CSCC)
• Intervention / Treatment: Drug: Cemiplimab; Procedure: Standard of care

• Study Type: Interventional
• Enrollment (Estimated): 369
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Clinical Trials Administrator; Phone Number: 844-734-6643; Email: clinicaltrials@regeneron.com

Study Locations

• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • Recruiting
      • The Skin Hospital
    • Westmead, New South Wales, Australia, 2145
      • Recruiting
      • Westmead Hospital
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Recruiting
      • Princess Alexandra Hospital
  • Victoria
    • South Yarra, Victoria, Australia, 3141
      • Recruiting
      • Dermatology Institute of Victoria (DIV)
  • Western Australia
    • Fremantle, Western Australia, Australia, 6160
      • Recruiting
      • Fremantle Dermatology
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Recruiting
      • Medical Dermatology Specialists - Phoenix
    • Scottsdale, Arizona, United States, 85259
      • Recruiting
      • Mayo Clinic - Arizona
    • Tucson, Arizona, United States, 85719
      • Recruiting
      • University of Arizona Cancer Center
  • Arkansas
    • North Little Rock, Arkansas, United States, 72117
      • Recruiting
      • Arkansas Research Trials
  • California
    • La Jolla, California, United States, 92093
      • Recruiting
      • UC San Diego Moores Cancer Center
    • Oceanside, California, United States, 92056
      • Recruiting
      • Profound Research, Dermatology Medical Group - Oceanside
    • Redwood City, California, United States, 94063
      • Recruiting
      • Stanford University
    • Visalia, California, United States, 93291
      • Recruiting
      • Peak Dermatology, Aesthetics and Wellness
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20037
      • Recruiting
      • George Washington University Medical Faculty Associates
  • Florida
    • Coral Springs, Florida, United States, 33071
      • Recruiting
      • Life Clinical Trials
    • Delray Beach, Florida, United States, 33445
      • Recruiting
      • Dermatology Associates of the Palm Beaches
    • Tampa, Florida, United States, 33612
      • Recruiting
      • University of South Florida
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University of Chicago Medical Center
    • Naperville, Illinois, United States, 60563
      • Recruiting
      • Oak Dermatology
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Withdrawn
      • Dawes Fretzin Clinical Research - Shadeland Ave.
  • Kentucky
    • Bowling Green, Kentucky, United States, 42104
      • Recruiting
      • Equity Medical, LLC
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Recruiting
      • US Dermatology Partners DBA DermAssociates, PC
  • Massachusetts
    • Beverly, Massachusetts, United States, 01915
      • Recruiting
      • Northeast Dermatology Associates
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana-Farber Cancer Institute
  • Michigan
    • Midland, Michigan, United States, 48640
      • Recruiting
      • MyMichigan Dermatologic Oncology
    • Troy, Michigan, United States, 48084
      • Recruiting
      • Somerset Skin Centre
  • Missouri
    • Lee's Summit, Missouri, United States, 64064
      • Recruiting
      • Dermatology and Skin Cancer Center
    • St Louis, Missouri, United States, 63141
      • Recruiting
      • Washington University in St. Louis - Center for Dermatologic and Cosmetic Surgery
  • Nevada
    • Las Vegas, Nevada, United States, 89144
      • Recruiting
      • Las Vegas Dermatology
  • New Jersey
    • Clark, New Jersey, United States, 07066
      • Recruiting
      • Metropolitan Dermatology
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Recruiting
      • University of New Mexico
  • New York
    • New York, New York, United States, 10021
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Medical Center - Herbert Irving Center for Dermatology and Skin Cancer - Herbert Irving Pavilion
    • Victor, New York, United States, 14564
      • Recruiting
      • Rochester Dermatologic Surgery, P.C.
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27516
      • Recruiting
      • UNC Hospitals Dermatology and Skin Cancer Center at Southern Village
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
    • Springfield, Ohio, United States, 45505
      • Recruiting
      • Buckeye Dermatology - Springfield Office
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Recruiting
      • University of Oklahoma Health Sciences Center
  • Oregon
    • Bend, Oregon, United States, 97702
      • Recruiting
      • Dermatology Health Specialists
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health & Science University
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Recruiting
      • Penn State Hershey Medical Center
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Hospital of the University of Pennsylvania
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Recruiting
      • Clinical Research Center of the Carolinas
  • Texas
    • Austin, Texas, United States, 78701
      • Recruiting
      • The University of Texas at Austin Dell Medical School Ascension Medical Group
    • Dallas, Texas, United States, 75235
      • Recruiting
      • Reveal Research Institute
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas MD Anderson Cancer Center
    • Lewisville, Texas, United States, 75056
      • Recruiting
      • Epiphany Dermatology
    • San Antonio, Texas, United States, 78218
      • Recruiting
      • Texas Dermatology and Laser Specialists
    • Webster, Texas, United States, 77598
      • Recruiting
      • Center for Clinical Studies at Webster Clear Lake
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • Recruiting
      • University of Utah Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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, 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Arm	Drug: Cemiplimab; Administered per protocol; Other Names: Libtayo
Other: Control Arm	Procedure: Standard of care; Primary surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Event-Free Survival (EFS) as assessed by the investigator	Up to 1 year
EFS as assessed by the investigator	Up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite Complete Response (CCR) for Target Lesion (TL)	Experimental Arm	At week 13
Non-Target Lesions (NTLs) in the Region of the Target Lesion (ROTL)	Experimental Arm	Baseline and at week 13
Severity of TEAEs		Up to 3 years
Size of surgical defect		At week 13
Size of biopsy defect		At week 13
Occurrence of Treatment Emergent Adverse Events (TEAEs)		Up to 3 years

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Investigators: Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Publications and helpful links

Helpful Links

• Clear

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2025
• Primary Completion (Estimated): May 3, 2030
• Study Completion (Estimated): May 3, 2030

Study Registration Dates

• First Submitted: September 3, 2024
• First Submitted That Met QC Criteria: September 3, 2024
• First Posted (Actual): September 5, 2024

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Skin Cancer; Non-Melanoma Skin Cancer; Cemiplimab; Early Stage; Dermato-Oncology; UV Skin Damage; Chronic Sun Exposure
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Skin Neoplasms; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care; cemiplimab
• Other Study ID Numbers: R2810-ONC-2251; 2024-511812-26-00 (Registry Identifier: EUCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

IPD Sharing Time Frame

When Regeneron has:

• received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
• made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
• the legal authority to share the data, and
• ensured the ability to protect participant privacy

• IPD Sharing Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No