A PD-1 Checkpoint Inhibitor (Cemiplimab) for High-Risk Localized, Locally Recurrent, or Regionally Advanced Skin Cancer

Inclusion Criteria: * Histologically confirmed, cutaneous squamous cell carcinoma * Patients must have disease that is deemed potentially resectable, at the time of the start of study, by the treating investigator. The decision to perform surgery on patients must be based on good clinical judgment. Eligible patients for surgical resection must have disease that, in the judgment of the surgeon, is deemed potentially resectable, resulting in free surgical margins * Patients must have measurable disease * Patients must have disease that is considered either: (1) high-risk localized CSCC, (2) locally recurrent CSCC, or (3) regionally advanced CSCC. The criteria specific to each of these populations is listed below * For patients with high-risk localized CSCC, at least two of the following clinical or pathologic high-risk features must be present to be eligible: * Clinical risk factors * Any tumor size \> 2.0 cm in diameter * Tumors \> 1.0 cm in high risk locations, including "mask areas" (central face, eyelids, eyebrow, nose, lips \[cutaneous\], periorbital, chin, mandible, preauricular and postauricular skin/sulci, genitalia, hands, feet, cheek, forehead, scalp, neck and pretibial) * Any rapidly growing and/or symptomatic tumor * Pathologic risk factors * Poorly differentiated histology * Depth \> 6 mm in thickness * Acantholytic / adenoid, adenosquamous, desmoplastic, or metaplastic / carcinosarcomatous histologic subtypes …