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

Launched by REGENERON PHARMACEUTICALS · Sep 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called cemiplimab to see if it can effectively treat early-stage cutaneous squamous cell carcinoma (CSCC), which is a type of skin cancer. Cemiplimab helps the body's immune system recognize and attack cancer cells. The main goal of the trial is to compare how well cemiplimab works when injected directly into the cancerous area, versus traditional surgical methods to remove the cancer.

To participate in the trial, you must have been diagnosed with a specific type of invasive CSCC that is between 1 and 2 centimeters in size, located on your head, neck, hand, or lower leg. You should also be eligible for surgery that allows for careful examination of the surgical margins, meaning doctors can check to ensure all cancer has been removed. Throughout the study, participants will be monitored for any side effects from the medication and how well it works. If you qualify, you will receive more information about what to expect during the trial, including any necessary tests and follow-up appointments.

Gender

ALL

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.