Perlmutter Cancer Center

The primary objective is to characterize the safety and tolerability of cemiplimab (also known as REGEN2810) injected intralesionally in patients with recurrent cutaneous squamous cell carcinoma (CSCC). This is a phase 1, single-arm, open-label, dose-escalation pilot study (with cohort expansions) designed to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor efficacy of weekly intralesional injections of cemiplimab in patients with resectable CSCC. Each patient will receive once weekly (QW) 250 µL intralesional injections of cemiplimab at the assigned dose level for 12 weeks prior to scheduled surgery. Three dose cohorts are planned and will follow a 3 + 3 dose-escalation design with cohort expansion at the recommended dose. Dose Escalation: Initially, 3 patients will be enrolled at the first dose level. After the first 3 evaluable patients in the cohort have been observed for at least 28 days after the first dose of cemiplimab (ie, dose limiting toxicity [DLT] observation period), a Dose Escalation Review meeting will be held and the following decision criteria will guide the enrollment of subsequent patients: For the first 3 patients: ? If 0/3 patients experience a DLT, then enroll 3 patients at the next dose level ? If 1/3 patients experience a DLT, then enroll an additional 3 patients at the current dose level For the next 3 patients (3 + 3) If = 1/6 patients experience a DLT, then enroll 3 patients at the next dose level If = 2/6 patients experience a DLT, then the maximum tolerated dose (MTD) has been exceeded at this dose level and enrollment at the current dose level will stop. ? If = 2/3 patients experience a DLT, then MTD has been exceeded at this dose level and enrollment at the current dose level will stop. Backfill Enrollment: If there are 0 DLTs among the first 3 patients at dose level “X” and the decision is made to enroll at the next dose level (X + 1), the sponsor may allow enrollment of 3 additional patients at dose level “X” to achieve a total of 6 patients at that dose level. Dose Expansion Enrollment: After 6 patients are enrolled at any dose level without exceeding MTD, the sponsor may enroll up to 6 additional patients for a total of 12 patients. No formal DLT monitoring is planned for backfill enrollment or dose expansion enrollment.