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.
Patient has prior sentinel lymph node removal for the current MCC.
Patients received prior treatment with immunotherapy (such as PD-1/PD-L1 or CTL4) or any other systemic anti-tumor (MCC) therapy (incl. investigational therapies)
Patient has active or a history of hematological neoplasms including chronic lymphocytic leukemia (CLL), irrespective if these require treatment or not.
Patient had prior organ transplantation including allogenic stem-cell transplantation.
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Lead sponsor
Prof. Gutzmer, Skin Cancer Center Minden, Johannes-Wesling-Klinikum Minden, Germany
Collaborator
Universität Duisburg-Essen
Collaborator
Regeneron Pharmaceuticals
Collaborator