NeoMatryx - Neoadjuvant Merkel cell carcinoma therapy (Tx) with the PD-1 inhibitor Cemiplimab – A randomized, double-blind, placebo-controlled, non-comparative Phase II study

Condition studied

Merkel Cell Carcinoma

Investigational medicinal product(s)

Eligibility

Primary endpoint

Nodal micrometastases-free rate defined as the rate of patients without nodal micrometastases after 2 cycles of treatment, determined by sentinel lymph node biopsy

Endpoint detail

Recurrence-free survival (RFS) defined as time from randomization until the date of the first of the following events: i. MCC progression or ii. MCC-related death (DSS), Overall survival (OS), defined as time from randomization until date of death from any cause, Disease specific survival (DSS), defined as time from randomization until date of MCC-related death, Quality of life (QoL) using: (i) FCRI-SF questionnaire (ii) mFACT-M questionnaire, Descriptive comparison of neoadjuvant Cemiplimab with placebo treatment prior to sentinel lymph node biopsy regarding: nodal micrometastases-free rate, RFS, TTR, OS, DSS, QoL, Assessment of safety of the treatment as determined by the incidence, nature, causality, frequency, timing and severity of adverse events using NCI CTCAE 5, Descriptive comparison of safety between neoadjuvant Cemiplimab and placebo treatment prior to sentinel lymph node biopsy, Correlation of identified biomarker with clinical outcome, i.e., nodal metastases-free rate, RFS, OS, Time to recurrence (TTR) defined as time from randomization until date of first MCC recurrence