Neoadjuvant Merkel Cell Carcinoma Therapy (Tx) With the PD-1 Inhibitor Cemiplimab

Inclusion Criteria

• •1. Patient has signed informed written consent.
• •2. Patients is 18 years and older at time of signing of written informed consent
• •3. Patient has diagnosis of Merkel cell carcinoma in clinical stage II, or in stage I with minimum diameter of 1 cm, with primary tumor already removed and a planned sentinel lymph nodes biopsy still pending.
• •4. Patient has ECOG performance status 0-2.
• •5. Patients has adequate laboratory parameters particularly for the blood count, renal and liver function parameters.
• •1. Absolute number of neutrophils ≥ 1.5 x 109/L
• •2. Platelets ≥ 75 x 109/L
• •3. Hemoglobin ≥ 9 g/dL
• •4. Total bilirubin ≤ 1.5 times the upper limit of normal (ULN) (patients with Gilbert´s Disease and total bilirubin up to 3x ULN may be eligible after approval from trial's medical expert)
• •5. AST (SGOT) and ALT (SGPT) ≤ 3x ULN
• •6. AP ≤ 2.5x ULN
• •7. Serum creatinine ≤ 2x ULN or creatinine clearance ≥ 40 mL/min
• •6. Female patients of childbearing potential and male patients with female partners of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \<1% per year during the treatment period and for at least 6 months after the last dose of Cemiplimab. Male patients must refrain from donating sperm during this same period. Male patients with a pregnant partner must agree to remain abstinent or to use a condom for the duration of the pregnancy.
• •7. Patient must be willing to allow translational work-up of tissue samples (PT, sentinel lymph node biopsy).
• •* Patients have controlled HIV infection with CD4 counts is \> 350 cells/μL and viral load is undetectable \[HIV RNA PCR\]. Patients with controlled HIV infection must be monitored per local standards during the trial.
• •* Patients positive for HBV surface antigen have controlled HBV infection receiving anti-viral therapy and with undetectable serum viral load \[HBV DNA PCR\]. Patients with controlled infection must undergo periodic monitoring of HBV DNA and p must remain on anti-viral therapy for at least 6 months after last dose of Cemiplimab.
• •* Patients positive for HCV antibody have controlled HCV infection with undetectable viral load \[HCV RNA PCR\].
• •11. Patent received vaccination with any live vaccine (e.g., intranasal flu vaccine) within 4 weeks before the first dose of Cemiplimab or planned vaccination with live vaccine during the trial
• •12. Female patients, who are pregnant or breast feeding or planning to become pregnant within and 6 months after the end of treatment. Female patients of childbearing potential must have a negative serum β-HCG pregnancy test result within 7 days prior to initiation of study treatment.
• •13. Patient has evidence of any other disease, neurologic or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of any of the study medications, puts the patient at higher risk for treatment-related complications or may affect the interpretation of study results.
• •14. Patient has known substance abuse or other psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
• •15. Patient is legally incapacitated or has limited legal capacity