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Regeneron R2810-ONC-1901

Trial Overview

Official Title

A Phase 2 Study of Neoadjuvant Cemiplimab For Stage II To IV (M0) Cutaneous Squamous Cell Carcinoma

Study Purpose

To see if cemiplimab can eliminate or reduce the number of living cancer cells in tumor(s) if taken before surgery.

Diagnosis

The study doctor has recommended surgery to treat this type of skin cancer (CSCC)

Eligibility

Patients with diagnosed Stage II to IV (M0)

Candidates for surgery who have an increased risk of recurrence and/or risk of disfigurement or loss of function.

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Intervention

  • Part 1 will take place before surgery.  Patients will have a treatment period of up to 12 weeks and two assessments scans to see how the cancer is responding to cemiplimab.
  • Part 2 will take place after surgery.  The treatment received will depend on the outcome of surgery.  Patients may receive either cemiplimab, or radiation therapy, or may enter a period of observation without treatment. 

After Part 2 is finished, patients are followed up every 4 to 6 months for 3 years, and then every 3 months thereafter.

For more information, visit ClinicalTrials.gov

Key Participation Requirements
Gender
Male or Female
Age
19 years and older
Phase
Phase II
Methodist Health System Trial Code
R2810-ONC-1901
Related Specialties