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
Who can participate
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, 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
Cemiplimab
DRUG
Standard of care
PROCEDURE
Locations
49
Australia (5)
The Skin Hospital
Darlinghurst , New South Wales
Fremantle Dermatology
Fremantle , Western Australia
Dermatology Institute of Victoria (DIV)
South Yarra , Victoria
Westmead Hospital
Westmead , New South Wales
Princess Alexandra Hospital
Woolloongabba , Queensland
United States (44)
University of New Mexico
Albuquerque , New Mexico
The University of Texas at Austin Dell Medical School Ascension Medical Group
Austin , Texas
Dermatology Health Specialists
Bend , Oregon
Northeast Dermatology Associates
Beverly , Massachusetts
Dana-Farber Cancer Institute
Boston , Massachusetts
Equity Medical, LLC
Bowling Green , Kentucky
UNC Hospitals Dermatology and Skin Cancer Center at Southern Village
Chapel Hill , North Carolina
Clinical Research Center of the Carolinas
Charleston , South Carolina
University of Chicago Medical Center
Chicago , Illinois
Metropolitan Dermatology
Clark , New Jersey
Cleveland Clinic
Cleveland , Ohio
Life Clinical Trials
Coral Springs , Florida
Reveal Research Institute
Dallas , Texas
Dermatology Associates of the Palm Beaches
Delray Beach , Florida
Penn State Hershey Medical Center
Hershey , Pennsylvania
The University of Texas MD Anderson Cancer Center
Houston , Texas
Dawes Fretzin Clinical Research - Shadeland Ave.
Indianapolis , Indiana
WITHDRAWN
UC San Diego Moores Cancer Center
La Jolla , California
Las Vegas Dermatology
Las Vegas , Nevada
Dermatology and Skin Cancer Center
Lee's Summit , Missouri
Epiphany Dermatology
Lewisville , Texas
MyMichigan Dermatologic Oncology
Midland , Michigan
Oak Dermatology
Naperville , Illinois
Memorial Sloan Kettering Cancer Center
New York , New York
Columbia University Medical Center - Herbert Irving Center for Dermatology and Skin Cancer - Herbert Irving Pavilion
New York , New York
Arkansas Research Trials
North Little Rock , Arkansas
University of Oklahoma Health Sciences Center
Oklahoma City , Oklahoma
Hospital of the University of Pennsylvania
Philadelphia , Pennsylvania
Medical Dermatology Specialists
Phoenix , Arizona
Oregon Health & Science University
Portland , Oregon
Stanford University
Redwood City , California
US Dermatology Partners DBA DermAssociates, PC
Rockville , Maryland
University of Utah Hospital
Salt Lake City , Utah
Texas Dermatology and Laser Specialists
San Antonio , Texas
Mayo Clinic - Arizona
Scottsdale , Arizona
Buckeye Dermatology - Springfield Office
Springfield , Ohio
Washington University in St. Louis - Center for Dermatologic and Cosmetic Surgery
St Louis , Missouri
University of South Florida
Tampa , Florida
Somerset Skin Centre
Troy , Michigan
University of Arizona Cancer Center
Tucson , Arizona
Rochester Dermatologic Surgery, P.C.
Victor , New York
Peak Dermatology, Aesthetics and Wellness
Visalia , California
George Washington University Medical Faculty Associates
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