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

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

NCT ID: NCT06585410

Condition: Cutaneous Squamous Cell Carcinoma (CSCC)

Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Cemiplimab

Conditions: Keywords:
Dermato-Oncology
Cemiplimab
Early Stage
Skin Cancer
Non-Melanoma Skin Cancer
UV Skin Damage
Chronic Sun Exposure

Study type: Interventional

Study phase: Phase 3

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Cemiplimab
Description: Administered per protocol
Arm group label: Experimental Arm

Other name: Libtayo

Intervention type: Procedure
Intervention name: Standard of care
Description: Primary surgery
Arm group label: Control Arm

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

Criteria for eligibility:
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: January 28, 2025

Completion date: June 3, 2029

Lead sponsor:
Agency: Regeneron Pharmaceuticals
Agency class: Industry

Source: Regeneron Pharmaceuticals

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06585410