Using cemiplimab to treat early-stage skin cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of cemiplimab, an immune checkpoint inhibitor, in treating early-stage cutaneous squamous cell carcinoma (CSCC) by injecting it directly into the tumor. The primary goal is to compare the outcomes of cemiplimab treatment with standard surgical options. Researchers will also monitor the side effects associated with cemiplimab. Participants must have specific tumor characteristics and be eligible for surgical resection.

Why it matters

Who can join: the full rules

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) prior to biopsy and \>0.7 cm to ≤2.0 cm after biopsy, 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, sarcomatoid 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.

Where it's running

• Medical Dermatology Specialists - Phoenix
  Phoenix, Arizona, United States Recruiting
• Mayo Clinic - Arizona
  Scottsdale, Arizona, United States Recruiting
• University of Arizona Cancer Center
  Tucson, Arizona, United States Recruiting
• Arkansas Research Trials
  North Little Rock, Arkansas, United States Recruiting
• UC San Diego Moores Cancer Center
  La Jolla, California, United States Recruiting
• Profound Research, Dermatology Medical Group - Oceanside
  Oceanside, California, United States Recruiting

+3 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Clinical Trials Administrator
• Email: clinicaltrials@regeneron.com
• Phone: 844-734-6643

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  This project will test whether advanced blood and tumor immune profiling can help predict who with advanced cutaneous squamous cell carcinoma will benefit from cemiplimab and who may develop side effects.

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• Seeing if the first lymph node helps detect skin cancer spread earlier

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• REGN15505 Alone or With Cemiplimab or REGN4336 in Advanced Prostate Cancer and Kidney Cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.