%0 Journal Article
%A Becker, Jürgen
%A Ugurel, Selma
%A Leiter, Ulrike
%A Meier, Friedegund
%A Gutzmer, Ralf
%A Haferkamp, Sebastian
%A Zimmer, Lisa
%A Livingstone, Elisabeth
%A Eigentler, Thomas K
%A Hauschild, Axel
%A Kiecker, Felix
%A Hassel, Jessica C
%A Mohr, Peter
%A Fluck, Michael
%A Thomas, Ioannis
%A Garzarolli, Marlene
%A Grimmelmann, Imke
%A Drexler, Konstantin
%A Spillner, Alexandra N
%A Eckhardt, Sebastian
%A Schadendorf, Dirk
%T 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.
%J The lancet 
%V 402
%N 10404
%@ 0140-6736
%C London [u.a.]
%I Elsevier
%M DKFZ-2023-01464
%P 798-808
%D 2023
%Z 2023 Sep 2;402(10404):798-808
%X Merkel cell carcinoma (MCC) is an immunogenic but aggressive skin cancer. Even after complete resection and radiation, relapse rates are high. PD-1 and PD-L1 checkpoint inhibitors showed clinical benefit in advanced MCC. We aimed to assess efficacy and safety of adjuvant immune checkpoint inhibition in completely resected MCC (ie, a setting without an established systemic standard-of-care treatment).In this multicentre phase 2 trial, patients (any stage, Eastern Cooperative Oncology Group performance status 0-1) at 20 academic medical centres in Germany and the Netherlands with completely resected MCC lesions were randomly assigned 2:1 to receive nivolumab 480 mg every 4 weeks for 1 year, or observation, stratified by stage (American Joint Committee on Cancer stages 1-2 vs stages 3-4), age (<65 vs ≥65 years), and sex. Landmark disease-free survival (DFS) at 12 and 24 months was the primary endpoint, assessed in the intention-to-treat populations. Overall survival and safety were secondary endpoints. This planned interim analysis was triggered when the last-patient-in was followed up for more than 1 year. This study is registered with ClinicalTrials.gov (NCT02196961) and with the EU Clinical Trials Register (2013-000043-78).Between Oct 1, 2014, and Aug 31, 2020, 179 patients were enrolled (116 [65
%F PUB:(DE-HGF)16
%9 Journal Article
%$ pmid:37451295
%R 10.1016/S0140-6736(23)00769-9
%U https://inrepo02.dkfz.de/record/277747