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Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Experimental Arm 		Investigational treatment
  • Drug: Cemiplimab
    Administered per protocol
    Other names:
    • Libtayo
Other
Control Arm 		Standard of care treatment
  • Procedure: Standard of care
    Primary surgery

Recruiting Locations

Medical Dermatology Specialists
Phoenix, Arizona 85006

Mayo Clinic - Arizona
Scottsdale, Arizona 85259

University of Arizona Cancer Center
Tucson, Arizona 85719

Arkansas Research Trials
North Little Rock, Arkansas 72117

UC San Diego Moores Cancer Center
La Jolla, California 92093

Stanford University
Redwood City, California 94063

Peak Dermatology, Aesthetics and Wellness
Visalia, California 93291

George Washington University Medical Faculty Associates
Washington D.C., District of Columbia 20037

Life Clinical Trials
Coral Springs, Florida 33071

Dermatology Associates of the Palm Beaches
Delray Beach, Florida 33445

University of South Florida
Tampa, Florida 33612

University of Chicago Medical Center
Chicago, Illinois 60637

Oak Dermatology
Naperville, Illinois 60563

Equity Medical, LLC
Bowling Green, Kentucky 42104

US Dermatology Partners DBA DermAssociates, PC
Rockville, Maryland 20850

Northeast Dermatology Associates
Beverly, Massachusetts 01915

Dana-Farber Cancer Institute
Boston, Massachusetts 02215

MyMichigan Dermatologic Oncology
Midland, Michigan 48640

Somerset Skin Centre
Troy, Michigan 48084

Dermatology and Skin Cancer Center
Lee's Summit, Missouri 64064

Washington University in St. Louis - Center for Dermatologic and Cosmetic Surgery
St Louis, Missouri 63141

Las Vegas Dermatology
Las Vegas, Nevada 89144

Metropolitan Dermatology
Clark, New Jersey 07066

University of New Mexico
Albuquerque, New Mexico 87102

Memorial Sloan Kettering Cancer Center
New York, New York 10021

Columbia University Medical Center - Herbert Irving Center for Dermatology and Skin Cancer - Herbert Irving Pavilion
New York, New York 10032

Rochester Dermatologic Surgery, P.C.
Victor, New York 14564

UNC Hospitals Dermatology and Skin Cancer Center at Southern Village
Chapel Hill, North Carolina 27516

Cleveland Clinic
Cleveland, Ohio 44195

Buckeye Dermatology - Springfield Office
Springfield, Ohio 45505

University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104

Dermatology Health Specialists
Bend, Oregon 97702

Oregon Health & Science University
Portland, Oregon 97239

Penn State Hershey Medical Center
Hershey, Pennsylvania 17033

Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104

Clinical Research Center of the Carolinas
Charleston, South Carolina 29407

The University of Texas at Austin Dell Medical School Ascension Medical Group
Austin, Texas 78701

Reveal Research Institute
Dallas, Texas 75235

The University of Texas MD Anderson Cancer Center
Houston, Texas 77030

Epiphany Dermatology
Lewisville, Texas 75056

Texas Dermatology and Laser Specialists
San Antonio, Texas 78218

Center for Clinical Studies at Webster Clear Lake
Webster, Texas 77598

University of Utah Hospital
Salt Lake City, Utah 84132

More Details

NCT ID
NCT06585410
Status
Recruiting
Sponsor
Regeneron Pharmaceuticals

Study Contact

Clinical Trials Administrator
844-734-6643
clinicaltrials@regeneron.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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