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.
Parallel
Cemiplimab 350 mg i.v. on day 1 of every 21 days cycle for 2 cycles
DrugPatients will receive Cemiplimab 350 mg i.v. on day 1 of every 21 days cycle for 2 cycles
Placebo NaCl 0.9% solution i.v. on day 1 of every 21 days cycle for 2 cycles.
DrugPatients will receive NaCl 0.9% solution i.v. on day 1 of every 21 days cycle for 2 cycles.
Nodal micrometastases-free rate
rate of patients without nodal micrometastases after 2 cycles of treatment, determined by sentinel lymph node biopsy
Recurrence-free survival
time from randomization until date of the first of the following events: MCC progression, MCC recurrence, and MCC-related death
Overall survival
time from randomization until date of death from any cause
Disease specific survival
time from randomization until date of MCC-related death
Quality of life using FCRI-SF questionnaire
Quality of life determined using the FCRI-SF questionnaire
Investigation of prognostic and predictive biomarkers to estimate the risk of lymph node metastases and signs of immune activation in the sentinel lymph nodes
Biosamples will be used to determine the correlation of identified biomarkers with clinical outcome, i.e., nodal metastases-free rate, RFS, OS
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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
