Neoadjuvant Cemiplimab in Newly Diagnosed or Recurrent Stage I-II Merkel Cell Carcinoma and Locoregionally Advanced Cutaneous Squamous Cell Carcinoma: Safety and Biomarker Analysis
The goal of this clinical research study is to determine if Cemiplimab-rwlc (called Cemiplimab in this document) given prior to tumor resection surgery is safe and effective in treating (1) Merkel Cell Carcinoma or (2) Cutaneous Squamous Cell Carcinoma (CSCC).
• Histologically proven diagnosis of Merkel cell carcinoma (MCC).
• Clinical stage I-II MCC (AJCC 8th edition) either newly diagnosed or previously diagnosed with recent disease recurrence. This includes patients with a previous diagnosis of clinical Stage I-II who present with local or regional disease recurrence.
• Patients must be considered candidates for wide local surgical excision and may be candidates for sentinel lymph node biopsy. If sentinel biopsy is determined to not be clinically indicated then it would not be required to be completed and only the tumor excision would be required.
• Patients with stage III to stage IV (M0) CSCC of the head/neck, extremity, or trunk, and selected patients with stage II CSCC (≥3 cm longest diameter lesion in an aesthetically-sensitive region), for whom surgery is planned.
• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged at least 18 years
• ECOG performance Status of 0, 1, or 2
• Adequate baseline laboratory assessments within 28 days of study registration:
‣ Adequate hepatic function: i. Total bilirubin ≤1.5 x upper limit of normal (ULN) (NOTE: For patients with Gilbert's syndrome, total bilirubin ≤3 x ULN) ii. Transaminases (aspartate aminotransferase \[AST\] and alanine aminotransferase \[ALT\]) ≤3 x ULN iii. Alkaline phosphatase (ALP) ≤2.5 x ULN
⁃ Adequate renal function: Serum creatinine ≤1.5 x ULN or estimated creatinine clearance (CrCl) \>30 mL/min according to the method of Cockcroft and Gault.
⁃ Adequate bone marrow function: i. Hemoglobin ≥9.0 g/dL ii. Absolute neutrophil count (ANC) ≥1.0 x 109/L iii. Platelet count ≥75 x 109/L
• Patients who are HIV+ with undetectable HIV viral load are eligible.
• For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 6 months after the end of cemiplimab administration.
• For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner