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

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

  • Cutaneous Squamous Cell Carcinoma (CSCC)

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 5308655, Arizona 5551752 85006

Mayo Clinic - Arizona
Scottsdale 5313457, Arizona 5551752 85259

University of Arizona Cancer Center
Tucson 5318313, Arizona 5551752 85719

Arkansas Research Trials
North Little Rock 4124112, Arkansas 4099753 72117

UC San Diego Moores Cancer Center
La Jolla 5363943, California 5332921 92093

Stanford University
Redwood City 5386834, California 5332921 94063

Peak Dermatology, Aesthetics and Wellness
Visalia 5406567, California 5332921 93291

George Washington University Medical Faculty Associates
Washington D.C. 4140963, District of Columbia 4138106 20037

Life Clinical Trials
Coral Springs 4151909, Florida 4155751 33071

Dermatology Associates of the Palm Beaches
Delray Beach 4153132, Florida 4155751 33445

University of South Florida
St. Petersburg 4171563, Florida 4155751 33701

University of Chicago Medical Center
Chicago 4887398, Illinois 4896861 60637

Oak Dermatology
Naperville 4903279, Illinois 4896861 60563

Dawes Fretzin Clinical Research - Shadeland Ave.
Indianapolis 4259418, Indiana 4921868 46250

Equity Medical, LLC
Bowling Green 4285268, Kentucky 6254925 42104

US Dermatology Partners DBA DermAssociates, PC
Rockville 4367175, Maryland 4361885 20850

Northeast Dermatology Associates
Beverly 4930505, Massachusetts 6254926 01915

Dana-Farber Cancer Institute
Boston 4930956, Massachusetts 6254926 02215

MyMichigan Dermatologic Oncology
Midland 5001929, Michigan 5001836 48640

Somerset Skin Centre
Troy 5012639, Michigan 5001836 48084

Dermatology and Skin Cancer Center
Lee's Summit 4394870, Missouri 4398678 64064

Washington University in St. Louis - Center for Dermatologic and Cosmetic Surgery
St Louis 4407066, Missouri 4398678 63141

Las Vegas Dermatology
Las Vegas 5506956, Nevada 5509151 89144

Metropolitan Dermatology
Clark 5096655, New Jersey 5101760 07066

University of New Mexico
Albuquerque 5454711, New Mexico 5481136 87102

Memorial Sloan Kettering Cancer Center
New York 5128581, New York 5128638 10021

Columbia University Medical Center - Herbert Irving Center for Dermatology and Skin Cancer - Herbert Irving Pavilion
New York 5128581, New York 5128638 10032

Rochester Dermatologic Surgery, P.C.
Victor 5142315, New York 5128638 14564

UNC Hospitals Dermatology and Skin Cancer Center at Southern Village
Chapel Hill 4460162, North Carolina 4482348 27516

Cleveland Clinic
Cleveland 5150529, Ohio 5165418 44195

Buckeye Dermatology - Springfield Office
Springfield 4525353, Ohio 5165418 45505

University of Oklahoma Health Sciences Center
Oklahoma City 4544349, Oklahoma 4544379 73104

Dermatology Health Specialists
Bend 5713587, Oregon 5744337 97702

Oregon Health & Science University
Portland 5746545, Oregon 5744337 97239

Penn State Hershey Medical Center
Hershey 5193342, Pennsylvania 6254927 17033

Hospital of the University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19104

Clinical Research Center of the Carolinas
Charleston 4574324, South Carolina 4597040 29407

The University of Texas at Austin Dell Medical School Ascension Medical Group
Austin 4671654, Texas 4736286 78701

Reveal Research Institute
Dallas 4684888, Texas 4736286 75235

The University of Texas MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030

Epiphany Dermatology
Lewisville 4706057, Texas 4736286 75056

Texas Dermatology and Laser Specialists
San Antonio 4726206, Texas 4736286 78218

University of Utah Hospital
Salt Lake City 5780993, Utah 5549030 84132

More Details

NCT ID
NCT06585410
Status
Recruiting
Sponsor
Regeneron Pharmaceuticals

Study Contact

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

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center