RecruitingInterventionalPhase 3

A Phase 3 Randomized Study of Intralesional Cemiplimab Versus Primary Surgery in Participants With Early Stage Cutaneous Squamous Cell Carcinoma (CSCC)

NCT ID: NCT06585410Sponsor: Regeneron PharmaceuticalsLast updated: 2026-06-08

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

Arms & interventions

DrugCemiplimab
Administered per protocol
ProcedureStandard of care
Primary surgery

Outcome measures

Primary

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

Secondary

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

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

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 locations (45)

Medical Dermatology Specialists - Phoenix

Phoenix, Arizona, 85006

Recruiting

Mayo Clinic - Arizona

Scottsdale, Arizona, 85259

Recruiting

University of Arizona Cancer Center

Tucson, Arizona, 85719

Recruiting

Arkansas Research Trials

North Little Rock, Arkansas, 72117

Recruiting

UC San Diego Moores Cancer Center

La Jolla, California, 92093

Recruiting

Profound Research, Dermatology Medical Group - Oceanside

Oceanside, California, 92056

Recruiting

Stanford University

Redwood City, California, 94063

Recruiting

Peak Dermatology, Aesthetics and Wellness

Visalia, California, 93291

Recruiting

George Washington University Medical Faculty Associates

Washington D.C., District of Columbia, 20037

Recruiting

Life Clinical Trials

Coral Springs, Florida, 33071

Recruiting

Dermatology Associates of the Palm Beaches

Delray Beach, Florida, 33445

Recruiting

University of South Florida

Tampa, Florida, 33612

Recruiting

University of Chicago Medical Center

Chicago, Illinois, 60637

Recruiting

Oak Dermatology

Naperville, Illinois, 60563

Recruiting

Dawes Fretzin Clinical Research - Shadeland Ave.

Indianapolis, Indiana, 46250

Withdrawn

Equity Medical, LLC

Bowling Green, Kentucky, 42104

Recruiting

US Dermatology Partners DBA DermAssociates, PC

Rockville, Maryland, 20850

Recruiting

Northeast Dermatology Associates

Beverly, Massachusetts, 01915

Recruiting

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

Recruiting

MyMichigan Dermatologic Oncology

Midland, Michigan, 48640

Recruiting

Somerset Skin Centre

Troy, Michigan, 48084

Recruiting

Dermatology and Skin Cancer Center

Lee's Summit, Missouri, 64064

Recruiting

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

St Louis, Missouri, 63141

Recruiting

Las Vegas Dermatology

Las Vegas, Nevada, 89144

Recruiting

Metropolitan Dermatology

Clark, New Jersey, 07066

Recruiting

University of New Mexico

Albuquerque, New Mexico, 87102

Recruiting

Memorial Sloan Kettering Cancer Center

New York, New York, 10021

Recruiting

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

New York, New York, 10032

Recruiting

Rochester Dermatologic Surgery, P.C.

Victor, New York, 14564

Recruiting

UNC Hospitals Dermatology and Skin Cancer Center at Southern Village

Chapel Hill, North Carolina, 27516

Recruiting

Cleveland Clinic

Cleveland, Ohio, 44195

Recruiting

Buckeye Dermatology - Springfield Office

Springfield, Ohio, 45505

Recruiting

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

Recruiting

Dermatology Health Specialists

Bend, Oregon, 97702

Recruiting

Oregon Health & Science University

Portland, Oregon, 97239

Recruiting

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033

Recruiting

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Recruiting

Clinical Research Center of the Carolinas

Charleston, South Carolina, 29407

Recruiting

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

Austin, Texas, 78701

Recruiting

Reveal Research Institute

Dallas, Texas, 75235

Recruiting

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

Recruiting

Epiphany Dermatology

Lewisville, Texas, 75056

Recruiting

Texas Dermatology and Laser Specialists

San Antonio, Texas, 78218

Recruiting

Center for Clinical Studies at Webster Clear Lake

Webster, Texas, 77598

Recruiting

University of Utah Hospital

Salt Lake City, Utah, 84132

Recruiting