Status:
RECRUITING
Study of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell Carcinoma
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Cutaneous Squamous Cell Carcinoma (CSCC)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 syst...
Eligibility Criteria
Inclusion
- Key
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
January 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 3 2030
Estimated Enrollment :
369 Patients enrolled
Trial Details
Trial ID
NCT06585410
Start Date
January 2 2025
End Date
May 3 2030
Last Update
December 18 2025
Active Locations (41)
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1
Medical Dermatology Specialists
Phoenix, Arizona, United States, 85006
2
Mayo Clinic - Arizona
Scottsdale, Arizona, United States, 85259
3
Arkansas Research Trials
North Little Rock, Arkansas, United States, 72117
4
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093