This was a randomized, open-label, phase 3 study of nivolumab compared with everolimus. Stratified randomization (1:1 ratio) with block size of 4 was implemented. Stratification factors were region (US/Canada or Western Europe or rest of world), Memorial Sloan Kettering Cancer Center (MSKCC) prognostic risk group (favorable, intermediate, or poor risk based on the presence of 0, 1 or 2, or 3 prognostic factors, respectively [anemia, hypercalcemia, poor performance status]),18 (link) and number of prior antiangiogenic therapy regimens (one or two) for advanced renal cell carcinoma.
Nivolumab and everolimus were provided by the Sponsor, except in cases when everolimus was procured as a local commercial product in certain countries. Nivolumab was administered at a dose of 3 mg/kg as a 60-minute intravenous infusion every 2 weeks. Everolimus was administered as a daily oral dose of 10 mg. Dose modifications were not permitted for nivolumab but were permitted for everolimus.
This study was approved by the institutional review board/independent ethics committee for each center and conducted in accordance with Good Clinical Practice guidelines defined by the International Conference on Harmonisation. All patients provided written informed consent to participate based on the principles of the Declaration of Helsinki. A data monitoring committee reviewed efficacy and safety during the study.
The authors vouch for the accuracy and completeness of analyses reported and for the fidelity of the study to the protocol. Development of the manuscript first draft was led by the lead author. All authors contributed to drafting the manuscript and provided final approval to submit for publication. Medical writing support, funded by the sponsor, was provided by PPSI. The study protocol is available with the full text of this article atwww.nejm.org .
Nivolumab and everolimus were provided by the Sponsor, except in cases when everolimus was procured as a local commercial product in certain countries. Nivolumab was administered at a dose of 3 mg/kg as a 60-minute intravenous infusion every 2 weeks. Everolimus was administered as a daily oral dose of 10 mg. Dose modifications were not permitted for nivolumab but were permitted for everolimus.
This study was approved by the institutional review board/independent ethics committee for each center and conducted in accordance with Good Clinical Practice guidelines defined by the International Conference on Harmonisation. All patients provided written informed consent to participate based on the principles of the Declaration of Helsinki. A data monitoring committee reviewed efficacy and safety during the study.
The authors vouch for the accuracy and completeness of analyses reported and for the fidelity of the study to the protocol. Development of the manuscript first draft was led by the lead author. All authors contributed to drafting the manuscript and provided final approval to submit for publication. Medical writing support, funded by the sponsor, was provided by PPSI. The study protocol is available with the full text of this article at
