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

Summary

Primary objective: To estimate the efficacy of adjuvant nivolumab monotherapy in completely resected MCC patients Primary endpoint: Disease-free survival (DFS) rate evaluated at 12, 24 and 48 months after date of randomization Secondary Objectives: To describe the safety profile and additional efficacy parameters of the nivolumab treatment in MCC Secondary endpoints: * Adverse events according to CTCAE, Version 4.0 criteria, that are related to the administration of nivolumab * Disease-free survival (DFS) * Overall survival (OS) and OS rates at 12, 24 and 48 months after randomization Explorative Endpoints: * Distant-metastases-free survival (DMFS) and DMFS rate at 12, 24 and 48 months after randomization * Identification and validation of prognostic/predictive biomarkers * Quality of life (EORTC QLQ-C30) until 24 months after randomization

Timeline

Start

2014-06

Primary completion

2024-08-31

Completion

2024-08-31

Publications

• Becker JC, Ugurel S, Leiter U, Meier F, Gutzmer R, Haferkamp S, Zimmer L, Livingstone E, Eigentler TK, Hauschild A, Kiecker F, Hassel JC, Mohr P, Fluck M, Thomas I, Garzarolli M, Grimmelmann I, Drexler K, Spillner AN, Eckhardt S, Schadendorf D; DeCOG. Adjuvant immunotherapy with nivolumab versus observation in completely resected Merkel cell carcinoma (ADMEC-O): disease-free survival results from a randomised, open-label, phase 2 trial. Lancet. 2023 Sep 2;402(10404):798-808. doi: 10.1016/S0140-6736(23)00769-9. Epub 2023 Jul 11.

Drugs

Indications