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NCT06585410 | RECRUITING | Cutaneous Squamous Cell Carcinoma (CSCC)

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

Regeneron Pharmaceuticals

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

Condition or disease

Cutaneous Squamous Cell Carcinoma (CSCC)

Intervention/treatment

Cemiplimab

Standard of care

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 369 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 3 Randomized Study of Intralesional Cemiplimab Versus Primary Surgery in Participants With Early Stage Cutaneous Squamous Cell Carcinoma (CSCC)
Actual Study Start Date : 2025-01-02
Estimated Primary Completion Date : 2030-05-03
Estimated Study Completion Date : 2030-05-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Study of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell Carcinoma

Location Details

NCT06585410

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arizona

Medical Dermatology Specialists

Phoenix, Arizona, United States, 85006

RECRUITING

United States, Florida

Dermatology Associates of the Palm Beaches

Delray Beach, Florida, United States, 33445

RECRUITING

United States, Illinois

Oak Dermatology

Naperville, Illinois, United States, 60563

RECRUITING

United States, Indiana

Dawes Fretzin Clinical Research - Shadeland Ave.

Indianapolis, Indiana, United States, 46250

RECRUITING

United States, Massachusetts

University Skin Oncologists Inc

Beverly, Massachusetts, United States, 01915

RECRUITING

United States, Massachusetts

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

RECRUITING

United States, New Mexico

University of New Mexico

Albuquerque, New Mexico, United States, 87102

RECRUITING

United States, New York

Rochester Dermatologic Surgery, P.C.

Victor, New York, United States, 14564

RECRUITING

United States, Oregon

Dermatology Health Specialists

Bend, Oregon, United States, 97702

RECRUITING

United States, South Carolina

Clinical Research Center of the Carolinas

Charleston, South Carolina, United States, 29407

RECRUITING

United States, Texas

Reveal Research Institute

Dallas, Texas, United States, 75235

RECRUITING

United States, Texas

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030