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Adjuvant nivolumab plus ipilimumab or nivolumab monotherapy versus placebo in patients with resected stage IV melanoma with no evidence of disease (IMMUNED): a randomised, double-blind, placebo-controlled, phase 2 trial

Zimmer, Lisa ; Livingstone, Elisabeth ; Hassel, Jessica C. ; Fluck, Michael ; Eigentler, Thomas ; Loquai, Carmen ; Haferkamp, Sebastian ; Gutzmer, Ralf ; Meier, Friedegund ; Mohr, Peter ; Hauschild, Axel ; Schilling, Bastian ; Menzer, Christian ; Kieker, Felix ; Dippel, Edgar ; Rösch, Alexander ; Simon, Jan-Christoph ; Conrad, Beate ; Körner, Silvia ; Windemuth-Kieselbach, Christine ; Schwarz, Leonora ; Garbe, Claus ; Becker, Jürgen C. ; Schadendorf, Dirk ; Berking, Carola ; Herbst, Rudolf A. ; Martens, Uwe M. ; Sell, Sabine ; Stadler, Rudolf ; Terheyden, Patrick ; Utikal, Jochen


Background Nivolumab and ipilimumab, alone or in combination, are widely used immunotherapeutic treatment options for patients with advanced-ie, unresectable or metastatic-melanoma. This criterion, however, excludes patients with stage IV melanoma with no evidence of disease. We therefore aimed to evaluate the safety and efficacy of adjuvant nivolumab plus ipilimumab or nivolumab monotherapy ...


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