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NCT06585410PHASE3Recruiting

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

Regeneron Pharmaceuticals

Start Date

1/2/2025

Completion Date

5/3/2030

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

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Cemiplimab

PROCEDURE

Standard of care

Interested in This Trial?

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Conditions

Cutaneous Squamous Cell Carcinoma (CSCC)

Locations

Medical Dermatology Specialists - Phoenix

Phoenix, Arizona 85006

United States

Mayo Clinic - Arizona

Scottsdale, Arizona 85259

United States

University of Arizona Cancer Center

Tucson, Arizona 85719

United States

Arkansas Research Trials

North Little Rock, Arkansas 72117

United States

UC San Diego Moores Cancer Center

La Jolla, California 92093

United States

Profound Research, Dermatology Medical Group - Oceanside

Oceanside, California 92056

United States

Stanford University

Redwood City, California 94063

United States

Peak Dermatology, Aesthetics and Wellness

Visalia, California 93291

United States

George Washington University Medical Faculty Associates

Washington D.C., District of Columbia 20037

United States

Life Clinical Trials

Coral Springs, Florida 33071

United States

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

Delray Beach, Florida 33445

United States

University of South Florida

Tampa, Florida 33612

United States

University of Chicago Medical Center

Chicago, Illinois 60637

United States

Oak Dermatology

Naperville, Illinois 60563

United States

Dawes Fretzin Clinical Research - Shadeland Ave.

Indianapolis, Indiana 46250

United States

Equity Medical, LLC

Bowling Green, Kentucky 42104

United States

US Dermatology Partners DBA DermAssociates, PC

Rockville, Maryland 20850

United States

Northeast Dermatology Associates

Beverly, Massachusetts 01915

United States

Dana-Farber Cancer Institute

Boston, Massachusetts 02215

United States

MyMichigan Dermatologic Oncology

Midland, Michigan 48640

United States

Somerset Skin Centre

Troy, Michigan 48084

United States

Dermatology and Skin Cancer Center

Lee's Summit, Missouri 64064

United States

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

St Louis, Missouri 63141

United States

Las Vegas Dermatology

Las Vegas, Nevada 89144

United States

StracSkin, PLLC

Portsmouth, New Hampshire 03801

United States

Metropolitan Dermatology

Clark, New Jersey 07066

United States

University of New Mexico

Albuquerque, New Mexico 87102

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10021

United States

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

New York, New York 10032

United States

Rochester Dermatologic Surgery, P.C.

Victor, New York 14564

United States

UNC Hospitals Dermatology and Skin Cancer Center at Southern Village

Chapel Hill, North Carolina 27516

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

Buckeye Dermatology - Springfield Office

Springfield, Ohio 45505

United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma 73104

United States

Dermatology Health Specialists

Bend, Oregon 97702

United States

Oregon Health & Science University

Portland, Oregon 97239

United States

Penn State Hershey Medical Center

Hershey, Pennsylvania 17033

United States

Penn Medicine, Perelman Center For Advanced Medicine

Philadelphia, Pennsylvania 19104

United States

Clinical Research Center of the Carolinas

Charleston, South Carolina 29407

United States

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

Austin, Texas 78701

United States

Reveal Research Institute

Dallas, Texas 75235

United States

The University of Texas MD Anderson Cancer Center

Houston, Texas 77030

United States

Epiphany Dermatology

Lewisville, Texas 75056

United States

Texas Dermatology and Laser Specialists

San Antonio, Texas 78218

United States

Center for Clinical Studies at Webster Clear Lake

Webster, Texas 77598

United States

University of Utah Hospital

Salt Lake City, Utah 84132

United States

Vcu Massey Cancer Center

Richmond, Virginia 23298

United States

The Skin Hospital

Darlinghurst, New South Wales 2010

Australia

Westmead Hospital

Westmead, New South Wales 2145

Australia

Princess Alexandra Hospital

Woolloongabba, Queensland 4102

Australia

Dermatology Institute of Victoria (DIV)

South Yarra, Victoria 3141

Australia

Fremantle Dermatology

Fremantle, Western Australia 6160

Australia