Overview

Adjuvant Therapy of Completely Resected Merkel Cell Carcinoma With Immune Checkpoint Blocking Antibodies vs Observation

Status:
Active, not recruiting

Trial end date:
2022-08-01

Target enrollment:

Participant gender:

Summary

Primary Objective: 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. Secondary Objective: 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 to the administration of nivolumab (ii) Overall survival rate at 12 months, defined as the number of patients surviving at 12 months after randomization divided by the total number of patients randomized. (iii) DFS rate at 12 months, defined as the number of patients alive and free of disease at 12 months after randomization divided by the total number of patients randomized

Phase:

Phase 2

Details

Lead Sponsor:

Prof. Dr. med. Dirk Schadendorf

Collaborator:

Bristol-Myers Squibb

Treatments:

Antibodies, Monoclonal
Nivolumab