Study of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell Carcinoma
- Conditions
- Cutaneous Squamous Cell Carcinoma (CSCC)
- Interventions
- Procedure: Standard of care
- Registration Number
- NCT06585410
- Lead 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 369
- 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
Key
- 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
NOTE: Other protocol defined inclusion / exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Arm Standard of care Standard of care treatment Experimental Arm Cemiplimab Investigational treatment
- Primary Outcome Measures
Name Time Method Event-Free Survival (EFS) as assessed by the investigator Up to 1 year EFS as assessed by the investigator Up to 3 years
- Secondary Outcome Measures
Name Time Method Size of surgical defect At week 13 Severity of TEAEs Up to 3 years Composite Complete Response (CCR) for Target Lesion (TL) At week 13 Experimental Arm
Non-Target Lesions (NTLs) in the Region of the Target Lesion (ROTL) Baseline and at week 13 Experimental Arm
Incidence of Treatment Emergent Adverse Events (TEAEs) Up to 3 years Size of biopsy defect At week 13
Trial Locations
- Locations (12)
Oak Dermatology
🇺🇸Naperville, Illinois, United States
Dawes Fretzin Clinical Research - Shadeland Ave.
🇺🇸Indianapolis, Indiana, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
University of New Mexico
🇺🇸Albuquerque, New Mexico, United States
Dermatology Health Specialists
🇺🇸Bend, Oregon, United States
Clinical Research Center of the Carolinas
🇺🇸Charleston, South Carolina, United States
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Medical Dermatology Specialists
🇺🇸Phoenix, Arizona, United States
Dermatology Associates of the Palm Beaches
🇺🇸Delray Beach, Florida, United States
University Skin Oncologists Inc
🇺🇸Beverly, Massachusetts, United States
Rochester Dermatologic Surgery, P.C.
🇺🇸Victor, New York, United States
Reveal Research Institute
🇺🇸Dallas, Texas, United States