Neoadjuvant Merkel Cell Carcinoma Therapy (Tx) With the PD-1 Inhibitor Cemiplimab - A Randomized, Double-blind, Placebo-controlled, Non-comparative Phase II Study
The study is a randomized, double blind, placebo-controlled, non-comparative phase II trial that investigates the efficacy of neoadjuvant anti-PD-1 antibody Cemiplimab treatment in patients with clinical stage I or II Merkel cell carcinoma who have have undergone primary tumour excision and are pending sentinel lymph node biopsy.
• Patient has signed informed written consent.
• Patients is 18 years and older at time of signing of written informed consent
• 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.
• Patient has ECOG performance status 0-2.
• Patients has adequate laboratory parameters particularly for the blood count, renal and liver function parameters.
‣ Absolute number of neutrophils ≥ 1.5 x 109/L
⁃ Platelets ≥ 75 x 109/L
⁃ Hemoglobin ≥ 9 g/dL
⁃ 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)
⁃ AST (SGOT) and ALT (SGPT) ≤ 3x ULN
⁃ AP ≤ 2.5x ULN
⁃ Serum creatinine ≤ 2x ULN or creatinine clearance ≥ 40 mL/min
• 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.
• Patient must be willing to allow translational work-up of tissue samples (PT, sentinel lymph node biopsy).