Adjuvant Therapy of Completely Resected Merkel Cell Carcinoma With Immune Checkpoint Blocking Antibodies vs Observation
To estimate the efficacy of adjuvant nivolumab monotherapy in completely resected Merkel cell
carcinoma (MCC) patients; i.e. the primary endpoint is disease-free survival (DFS) in arm A
at 12 months, defined as the number of patients alive and free of disease at 12 months after
randomization compared to DFS in arm B.
To assess safety and additional efficacy parameters of the nivolumab treatment in MCC, as
well as to characterize potential biomarkers; secondary endpoints are:
(i) Adverse events according to CTCAE, Version 4.0 criteria, that are definitely, probably,
or possibly related...