TOPNIVO - A safety study of Nivolumab in Patients with Recurrent and/or Metastatic Platinum-refractory Squamous Cell Carcinoma of the Head and Neck (R/M SCCHN): first results on behalf of the Unicancer H&N group and the GORTEC.

Congress : ESMO

Authors : C. Even, A. Daste, E. Saada, J. Fayette, MC. Kaminsky, S. Zanetta, A. Prevost, G. Lefebvre, C. Borel, D. Cupissol, F. Huguet, J.-P. Delord, N.Basté-Rottlan, I. Jallut, J. Delaye, N. Vintonenko, J.Bourhis, J. Guigay, M. Texier, A. Auperin.

Experts group or program : Groupe Head & Neck

In the randomized phase III Study CA209141, Nivolumab (N) demonstrated significant overall survival benefit as treatment for platinum refractory R/M SCCHN and is now approved for these patients. N has demonstrated a manageable safety profile compared to chemotherapies commonly used in patients with platinum-refractory R/M SCCHN. The main objective of the study is to provide additional insight into the frequency of high-grade AEs related to N and their outcome.

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