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Using cemiplimab to treat early-stage skin cancer

A Phase 3 Randomized Study of Intralesional Cemiplimab Versus Primary Surgery in Participants With Early Stage Cutaneous Squamous Cell Carcinoma (CSCC)

Phase 3 Interventional Regeneron Pharmaceuticals · NCT06585410

This study tests if injecting a new immune treatment called cemiplimab directly into early-stage skin cancer can work better than regular surgery.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment369 (estimated)
Ages18 Years and up
SexAll
SponsorRegeneron Pharmaceuticals Industry-sponsored
Drugs / interventionscemiplimab
Locations49 sites (Phoenix, Arizona and 48 other locations)
Trial IDNCT06585410 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults with histologically confirmed invasive CSCC tumors measuring between 1 cm and 2 cm located in specific areas such as the head, neck, hand, or pre-tibial surface.

Not a fit: Patients with tumors that are keratoacanthomas, basal cell carcinomas, or other specified skin cancers will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a non-surgical option for patients with early-stage CSCC, potentially reducing the need for invasive procedures.

How similar studies have performed: Other studies have shown promise with immune checkpoint inhibitors in treating various cancers, suggesting potential success for this approach in CSCC.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Phoenix, Arizona and 48 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Cutaneous Squamous Cell CarcinomaDermato-OncologyCemiplimabEarly StageSkin CancerNon-Melanoma Skin CancerUV Skin DamageChronic Sun Exposure
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.