PRIMARY OBJECTIVE:
I. To establish the pathologic response rate of neoadjuvant cemiplimab in cutaneous squamous cell carcinoma (cSCC).
SECONDARY OBJECTIVES:
I. To document the local recurrence rate of high-risk cSCC treated with adjuvant cemiplimab.
II. To document the systemic recurrence rate of high-risk cSCC treated with adjuvant cemiplimab.
III. To document the 6-month, 12-month, 2-year overall survival (OS), recurrence-free survival (RFS) for patients with high risk cSCC.
TERTIARY/EXPLORATORY OBJECTIVE:
I. To evaluate the immune profile of fresh tumor tissue, blood in patients with cSCC treated with cemiplimab.
OUTLINENEOADJUVANT PHASE: Prior to standard of care surgery, patients receive cemiplimab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
ADJUVANT PHASE: Within 2-6 weeks after completion of standard of care radiation therapy (or surgery if no radiation therapy), patients receive cemiplimab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 12 weeks for 2 years, every 6 months for the next 3 years, and then annually for up to 10 years.
