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

• Published in: The Lancet (British edition) 2023-09, Vol.402 (10404), p.798-808
• Main Authors: Becker, Jürgen C, Ugurel, Selma, Leiter, Ulrike, Meier, Friedegund, Gutzmer, Ralf, Haferkamp, Sebastian, Zimmer, Lisa, Livingstone, Elisabeth, Eigentler, Thomas K, Hauschild, Axel, Kiecker, Felix, Hassel, Jessica C, Mohr, Peter, Fluck, Michael, Thomas, Ioannis, Garzarolli, Marlene, Grimmelmann, Imke, Drexler, Konstantin, Spillner, Alexandra N, Eckhardt, Sebastian, Schadendorf, Dirk, van Akkoi, Alexander, van Houdt, Winan, Wilhelm, Tabea, Farmer, Kimberly, Ulrich, Claas, Gambichler, Thilo, Bluhm, Leonie, Schinagl, Heidemarie, Kellner, Ivonne, Herbst, Rudolf, Meiß, Frank, Rafei-Shamsabadi, David, Sell, Sabine, Kaatz, Martin, Wulfken, Lena, Hartmann, Martin, Kähler, Katharina, Ziemer, Mirjana, Simon, Jan, Terheyden, Patrick, Thaci, Diamant, Loquai, Carmen, Mitzel-Rink, Heidrun, Grabbe, Stephan, Stege, Henner, Gaiser, Maria, Utikal, Jochen, Berking, Carola, Heinzerling, Lucie, Schlaak, Max, Tomsitz, Dirk, Dyballa, Jörg, Magnolo, Nina, Weishaupt, Carsten, Berneburg, Mark, Garbe, Claus, Flatz, Lukas, Gesierich, Anja, Schilling, Bastian
• Format: Article
• Language: English
• Subjects: Adjuvants; Adjuvants, Immunologic - therapeutic use; Age; Aged; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Cancer; Cancer therapies; Carcinoma; Carcinoma, Merkel Cell - chemically induced; Carcinoma, Merkel Cell - drug therapy; Clinical trials; Disease; Disease-Free Survival; Female; Health care facilities; Health services; Hepatitis; Humans; Immune checkpoint inhibitors; Immunogenicity; Immunotherapy; Ipilimumab; Lymphatic system; Male; Melanoma; Metastasis; Monoclonal antibodies; Neoplasm Recurrence, Local - drug therapy; Nivolumab; Patients; PD-1 protein; PD-L1 protein; Radiation therapy; Response rates; Risk management; Safety; Sex; Skin cancer; Skin Neoplasms - drug therapy; Skin Neoplasms - etiology; Survival; Targeted cancer therapy
• ISSN: 0140-6736; 1474-547X
• DOI: 10.1016/S0140-6736(23)00769-9

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 (