Recruiting
Phase 3

Cemiplimab

Sponsor:

Regeneron Pharmaceuticals

Code:

NCT06585410

Conditions

Cutaneous Squamous Cell Carcinoma (CSCC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cemiplimab

Standard of care

Study Details

Brief summary:

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

Conditions

Cutaneous Squamous Cell Carcinoma (CSCC)

Study ID

NCT06585410

Start date

Jan 2, 2025

Status verified date

Aug, 2026

Completion date

May 3, 2030

Anticipated

Primary completion date

May 3, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

369 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental Arm

other: Control Arm

Interventions

Cemiplimab

Administered per protocol

Standard of care

Primary surgery

Primary outcome measure

  • Event-Free Survival (EFS) as assessed by the investigator [ Time Frame: Up to 1 year ]
  • EFS as assessed by the investigator [ Time Frame: Up to 3 years ]

Central Contacts and Locations

Central contacts

Clinical Trials Administrator

844-734-6643clinicaltrials@regeneron.com

Locations

Medical Dermatology Specialists - Phoenix

Recruiting

Phoenix, Arizona, United States, 85006

Mayo Clinic - Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

University of Arizona Cancer Center

Recruiting

Tucson, Arizona, United States, 85719

Arkansas Research Trials

Recruiting

North Little Rock, Arkansas, United States, 72117

UC San Diego Moores Cancer Center

Recruiting

La Jolla, California, United States, 92093

Profound Research, Dermatology Medical Group - Oceanside

Recruiting

Oceanside, California, United States, 92056

Stanford University

Recruiting

Redwood City, California, United States, 94063

Peak Dermatology, Aesthetics and Wellness

Recruiting

Visalia, California, United States, 93291

George Washington University Medical Faculty Associates

Recruiting

Washington D.C., District of Columbia, United States, 20037

Life Clinical Trials

Recruiting

Coral Springs, Florida, United States, 33071

Dermatology Associates of the Palm Beaches, Integri Research at Dermatology Associates

Recruiting

Delray Beach, Florida, United States, 33445

University of South Florida

Recruiting

Tampa, Florida, United States, 33612

University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637

Oak Dermatology

Recruiting

Naperville, Illinois, United States, 60563

US Dermatology Partners DBA DermAssociates, PC

Recruiting

Rockville, Maryland, United States, 20850

Northeast Dermatology Associates

Recruiting

Beverly, Massachusetts, United States, 01915

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

MyMichigan Dermatologic Oncology

Recruiting

Midland, Michigan, United States, 48640

Somerset Skin Centre

Recruiting

Troy, Michigan, United States, 48084

Dermatology and Skin Cancer Center

Recruiting

Lee's Summit, Missouri, United States, 64064

Washington University in St. Louis - Center for Dermatologic and Cosmetic Surgery

Recruiting

St Louis, Missouri, United States, 63141

Las Vegas Dermatology

Recruiting

Las Vegas, Nevada, United States, 89144

StracSkin, PLLC

Recruiting

Portsmouth, New Hampshire, United States, 03801

University of New Mexico

Recruiting

Albuquerque, New Mexico, United States, 87102

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10021

Columbia University Medical Center - Herbert Irving Center for Dermatology and Skin Cancer - Herbert Irving Pavilion

Recruiting

New York, New York, United States, 10032

Rochester Dermatologic Surgery, P.C.

Recruiting

Victor, New York, United States, 14564

UNC Hospitals Dermatology and Skin Cancer Center at Southern Village

Recruiting

Chapel Hill, North Carolina, United States, 27516

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Buckeye Dermatology - Springfield Office

Recruiting

Springfield, Ohio, United States, 45505

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Dermatology Health Specialists

Recruiting

Bend, Oregon, United States, 97702

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Penn State Hershey Medical Center

Recruiting

Hershey, Pennsylvania, United States, 17033

Penn Medicine, Perelman Center For Advanced Medicine

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Clinical Research Center of the Carolinas

Recruiting

Charleston, South Carolina, United States, 29407

The University of Texas at Austin Dell Medical School Ascension Medical Group

Recruiting

Austin, Texas, United States, 78701

Reveal Research Institute

Recruiting

Dallas, Texas, United States, 75235

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Epiphany Dermatology

Recruiting

Lewisville, Texas, United States, 75056

Texas Dermatology and Laser Specialists

Recruiting

San Antonio, Texas, United States, 78218

Center for Clinical Studies at Webster Clear Lake

Recruiting

Webster, Texas, United States, 77598

University of Utah Hospital

Recruiting

Salt Lake City, Utah, United States, 84132

Vcu Massey Cancer Center

Recruiting

Richmond, Virginia, United States, 23298

More Information

Sponsor

Regeneron Pharmaceuticals

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Keywords

  • Dermato-Oncology
  • Cemiplimab
  • Early Stage
  • Skin Cancer
  • Non-Melanoma Skin Cancer
  • UV Skin Damage
  • Chronic Sun Exposure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Regeneron Pharmaceuticals on 2026-08-17.