CheckMate 9ER is a phase 3, randomized, openlabel trial of nivolumab combined with cabozantinib as compared with sunitinib monotherapy. Patients underwent randomization in a 1:1 ratio and were stratified according to IMDC prognostic risk score (0 [favorable] vs. 1 or 2 [intermediate] vs. 3 to 6 [poor]),18 (link),19 (link) geographic region (United States and Europe vs. the rest of the world), and tumor expression of the PD-1 ligand PD-L1 (≥1% vs. <1% or indeterminate). Specific risk factors that make up the IMDC score are included in the Supplementary Appendix, available at NEJM.org. Nivolumab was administered intravenously at a dose of 240 mg every 2 weeks, and cabozantinib was administered orally at a dose of 40 mg once daily. Sunitinib was administered orally at a dose of 50 mg once daily for 4 weeks, followed by 2 weeks off (6-week cycle). All trial treatment continued until disease progression or unacceptable toxic effects, with a maximum 2-year duration of nivolumab treatment. Crossover between groups was not permitted. Dose reductions were not allowed for nivolumab but were permitted for cabozantinib and sunitinib, according to the protocol. Dose delays for adverse events were permitted for all trial drugs. Discontinuation assessments for nivolumab and cabozantinib were made separately for each drug; if discontinuation criteria were met for only one drug, treatment could continue with the other drug that was not related to the observed toxic effect, according to the protocol. Dose-reduction specifications and discontinuation criteria for both groups are detailed in the trial protocol.