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

NCT06585410 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: R2810-ONC-22512024-511812-26-00
• Study Type: interventional
• Target: 369
• Locations: 2 countries
• Sites: 49

Brief 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

Conditions

Cutaneous Squamous Cell Carcinoma (CSCC)

Keywords

Dermato-Oncology; Cemiplimab; Early Stage; Skin Cancer; Non-Melanoma Skin Cancer; UV Skin Damage; Chronic Sun Exposure

Outcome Measures

Primary Outcomes (2)

• Event-Free Survival (EFS) as assessed by the investigator

  Up to 1 year

• EFS as assessed by the investigator

  Up to 3 years

Secondary Outcomes (6)

• Composite Complete Response (CCR) for Target Lesion (TL)

  At week 13

• Non-Target Lesions (NTLs) in the Region of the Target Lesion (ROTL)

  Baseline and at week 13

• Incidence of Treatment Emergent Adverse Events (TEAEs)

  Up to 3 years

• Severity of TEAEs

  Up to 3 years

• Size of surgical defect

  At week 13

Study Arms (2)

Experimental Arm

EXPERIMENTAL

Investigational treatment

Drug: Cemiplimab

Control Arm

OTHER

Standard of care treatment

Procedure: Standard of care

Interventions

Cemiplimab DRUG

Administered per protocol

Also known as: Libtayo

Experimental Arm

Standard of care PROCEDURE

Primary surgery

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who have a histologically confirmed invasive CSCC TL, as described in the protocol
• 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
• 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
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1
• Adequate hepatic, renal and bone marrow functions, as described in the protocol

You may not qualify if:

• 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.)
• 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
• History of non-infectious pneumonitis within the last 5 years
• TL (lesion planned for intralesional therapy) or other non-target CSCC lesion in dry red lip (vermillion), oral cavity, or nasal mucosa

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (49)

Medical Dermatology Specialists

Phoenix, Arizona, 85006, United States

RECRUITING

Mayo Clinic - Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

University of Arizona Cancer Center

Tucson, Arizona, 85719, United States

RECRUITING

Arkansas Research Trials

North Little Rock, Arkansas, 72117, United States

RECRUITING

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

RECRUITING

Stanford University

Redwood City, California, 94063, United States

RECRUITING

Peak Dermatology, Aesthetics and Wellness

Visalia, California, 93291, United States

RECRUITING

George Washington University Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States

RECRUITING

Life Clinical Trials

Coral Springs, Florida, 33071, United States

RECRUITING

Dermatology Associates of the Palm Beaches

Delray Beach, Florida, 33445, United States

RECRUITING

University of South Florida

Tampa, Florida, 33612, United States

RECRUITING

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

RECRUITING

Oak Dermatology

Naperville, Illinois, 60563, United States

RECRUITING

Dawes Fretzin Clinical Research - Shadeland Ave.

Indianapolis, Indiana, 46250, United States

WITHDRAWN

Equity Medical, LLC

Bowling Green, Kentucky, 42104, United States

RECRUITING

US Dermatology Partners DBA DermAssociates, PC

Rockville, Maryland, 20850, United States

RECRUITING

Northeast Dermatology Associates

Beverly, Massachusetts, 01915, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

MyMichigan Dermatologic Oncology

Midland, Michigan, 48640, United States

RECRUITING

Somerset Skin Centre

Troy, Michigan, 48084, United States

RECRUITING

Dermatology and Skin Cancer Center

Lee's Summit, Missouri, 64064, United States

RECRUITING

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

St Louis, Missouri, 63141, United States

RECRUITING

Las Vegas Dermatology

Las Vegas, Nevada, 89144, United States

RECRUITING

Metropolitan Dermatology

Clark, New Jersey, 07066, United States

RECRUITING

University of New Mexico

Albuquerque, New Mexico, 87102, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

RECRUITING

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

New York, New York, 10032, United States

RECRUITING

Rochester Dermatologic Surgery, P.C.

Victor, New York, 14564, United States

RECRUITING

UNC Hospitals Dermatology and Skin Cancer Center at Southern Village

Chapel Hill, North Carolina, 27516, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Buckeye Dermatology - Springfield Office

Springfield, Ohio, 45505, United States

RECRUITING

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Dermatology Health Specialists

Bend, Oregon, 97702, United States

RECRUITING

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

RECRUITING

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Clinical Research Center of the Carolinas

Charleston, South Carolina, 29407, United States

RECRUITING

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

Austin, Texas, 78701, United States

RECRUITING

Reveal Research Institute

Dallas, Texas, 75235, United States

RECRUITING

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Epiphany Dermatology

Lewisville, Texas, 75056, United States

RECRUITING

Texas Dermatology and Laser Specialists

San Antonio, Texas, 78218, United States

RECRUITING

Center for Clinical Studies at Webster Clear Lake

Webster, Texas, 77598, United States

RECRUITING

University of Utah Hospital

Salt Lake City, Utah, 84132, United States

RECRUITING

The Skin Hospital

Darlinghurst, New South Wales, 2010, Australia

RECRUITING

Westmead Hospital

Westmead, New South Wales, 2145, Australia

RECRUITING

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

RECRUITING

Dermatology Institute of Victoria (DIV)

South Yarra, Victoria, 3141, Australia

RECRUITING

Fremantle Dermatology

Fremantle, Western Australia, 6160, Australia

RECRUITING

Related Links

• Clear

MeSH Terms

Conditions

Skin Neoplasms

Interventions

cemiplimab; Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials Administrator

CONTACT

844-734-6643; clinicaltrials@regeneron.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 5, 2024
• Study Start: January 2, 2025
• Primary Completion (Estimated): May 3, 2030
• Study Completion (Estimated): May 3, 2030
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has : * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * has the legal authority to share the data, and * has ensured the ability to protect participant privacy.
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Locations

US (44); AU (5)