RecruitingPhase 3NCT06585410

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)

Sponsor

Regeneron Pharmaceuticals

Enrollment

369 participants

Start Date

Jan 2, 2025

Study Type

INTERVENTIONAL

Conditions

Cutaneous Squamous Cell Carcinoma (CSCC)

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether injecting an immunotherapy drug called cemiplimab directly into a skin cancer lesion (cutaneous squamous cell carcinoma) before surgery can shrink the tumor and improve outcomes, potentially allowing less invasive surgery. **You may be eligible if...** - You have a confirmed invasive squamous cell skin cancer tumor that is between 1 cm and 2 cm in diameter - The tumor is located on your head, neck, hand, or shin (pre-tibial area) - Your doctor has determined the tumor can and should be surgically removed - You are an adult and able to give informed consent **You may NOT be eligible if...** - You have active autoimmune conditions requiring immune-suppressing medication - You have previously received anti-PD-1/PD-L1 immunotherapy - Your tumor is located in an area not listed in the study criteria - You have other active cancers being treated - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCemiplimab

Administered per protocol

PROCEDUREStandard of care

Primary surgery

Locations(49)

Medical Dermatology Specialists

Phoenix, Arizona, United States

Mayo Clinic - Arizona

Scottsdale, Arizona, United States

University of Arizona Cancer Center

Tucson, Arizona, United States

Arkansas Research Trials

North Little Rock, Arkansas, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

Stanford University

Redwood City, California, United States

Peak Dermatology, Aesthetics and Wellness

Visalia, California, United States

George Washington University Medical Faculty Associates

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

Life Clinical Trials

Coral Springs, Florida, United States

Dermatology Associates of the Palm Beaches

Delray Beach, Florida, United States

University of South Florida

Tampa, Florida, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Oak Dermatology

Naperville, Illinois, United States

Dawes Fretzin Clinical Research - Shadeland Ave.

Indianapolis, Indiana, United States

Equity Medical, LLC

Bowling Green, Kentucky, United States

US Dermatology Partners DBA DermAssociates, PC

Rockville, Maryland, United States

Northeast Dermatology Associates

Beverly, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

MyMichigan Dermatologic Oncology

Midland, Michigan, United States

Somerset Skin Centre

Troy, Michigan, United States

Dermatology and Skin Cancer Center

Lee's Summit, Missouri, United States

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

St Louis, Missouri, United States

Las Vegas Dermatology

Las Vegas, Nevada, United States

Metropolitan Dermatology

Clark, New Jersey, United States

University of New Mexico

Albuquerque, New Mexico, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

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

New York, New York, United States

Rochester Dermatologic Surgery, P.C.

Victor, New York, United States

UNC Hospitals Dermatology and Skin Cancer Center at Southern Village

Chapel Hill, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Buckeye Dermatology - Springfield Office

Springfield, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Dermatology Health Specialists

Bend, Oregon, United States

Oregon Health & Science University

Portland, Oregon, United States

Penn State Hershey Medical Center

Hershey, Pennsylvania, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Clinical Research Center of the Carolinas

Charleston, South Carolina, United States

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

Austin, Texas, United States

Reveal Research Institute

Dallas, Texas, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Epiphany Dermatology

Lewisville, Texas, United States

Texas Dermatology and Laser Specialists

San Antonio, Texas, United States

Center for Clinical Studies at Webster Clear Lake

Webster, Texas, United States

University of Utah Hospital

Salt Lake City, Utah, United States

The Skin Hospital

Darlinghurst, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Dermatology Institute of Victoria (DIV)

South Yarra, Victoria, Australia

Fremantle Dermatology

Fremantle, Western Australia, Australia

View Full Details on ClinicalTrials.gov

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NCT06585410

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