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 Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Experimental Arm |
Investigational treatment |
|
|
Other Control Arm |
Standard of care treatment |
|
Recruiting Locations
Medical Dermatology Specialists
Phoenix, Arizona 85006
Phoenix, Arizona 85006
Dermatology Associates of the Palm Beaches
Delray Beach, Florida 33445
Delray Beach, Florida 33445
University Skin Oncologists Inc
Beverly, Massachusetts 01915
Beverly, Massachusetts 01915
Rochester Dermatologic Surgery, P.C.
Victor, New York 14564
Victor, New York 14564
Reveal Research Institute
Dallas, Texas 75235
Dallas, Texas 75235
More Details
- NCT ID
- NCT06585410
- Status
- Recruiting
- Sponsor
- Regeneron Pharmaceuticals