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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
369
Administered per protocol
Primary surgery
Medical Dermatology Specialists
Phoenix, Arizona, United States
RECRUITINGMayo Clinic - Arizona
Scottsdale, Arizona, United States
RECRUITINGUniversity of Arizona Cancer Center
Tucson, Arizona, United States
RECRUITINGArkansas Research Trials
North Little Rock, Arkansas, United States
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
Composite Complete Response (CCR) for Target Lesion (TL)
Experimental Arm
Time frame: At week 13
Non-Target Lesions (NTLs) in the Region of the Target Lesion (ROTL)
Experimental Arm
Time frame: Baseline and at week 13
Incidence 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
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UC San Diego Moores Cancer Center
La Jolla, California, United States
RECRUITINGStanford University
Redwood City, California, United States
RECRUITINGPeak Dermatology, Aesthetics and Wellness
Visalia, California, United States
RECRUITINGGeorge Washington University Medical Faculty Associates
Washington D.C., District of Columbia, United States
RECRUITINGLife Clinical Trials
Coral Springs, Florida, United States
RECRUITINGDermatology Associates of the Palm Beaches
Delray Beach, Florida, United States
RECRUITING...and 38 more locations