{"entity":{"id":"checkmate-9er","kind":"trial","name":"CheckMate 9ER","aka":[],"tldr":"Nivolumab with cabozantinib doubled progression-free survival versus sunitinib and lengthened life, with quality of life preserved.","summary":"CheckMate 9ER, trial NCT03141177 sponsored by Bristol Myers Squibb and Exelixis and reported in 2020, showed that nivolumab with cabozantinib doubled progression-free survival versus sunitinib in untreated advanced clear-cell renal cell carcinoma and lengthened life, with quality of life preserved. It randomised 651 patients, met its primary progression-free survival endpoint, improved overall survival with the effect narrowing at the final four-year analysis, and led to FDA approval in January 2021; cabozantinib's MET and AXL activity is a proposed contributor. OnCo links it to renal cell carcinoma, nivolumab, cabozantinib, sunitinib, Robert J. Motzer, Toni K. Choueiri and James Larkin. Choosing between the IO-TKI doublets without head-to-head data is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03141177","url":"https://clinicaltrials.gov/study/NCT03141177"}],"tags":[],"related":[],"cancers":["rcc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab","cabozantinib","sunitinib"],"companies":["exelixis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["robert-motzer","james-larkin","toni-choueiri"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03141177","phase":"3","setting":"Untreated advanced clear-cell RCC: nivolumab + cabozantinib vs sunitinib","sponsor":"BMS / Exelixis","result":"PFS HR 0.51; OS HR 0.77 at ~4 years (46.5 vs 36.0 months).","started":"2017-07-23","startedType":"actual","yearReported":2020,"enrolled":701,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Nivolumab + cabozantinib","n":323,"value":16.6},{"name":"Sunitinib","n":328,"value":8.3}],"hr":0.51,"ci":[0.41,0.64],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2026982"},{"endpoint":"Overall survival (final)","unit":"months","arms":[{"name":"Nivolumab + cabozantinib","value":46.5},{"name":"Sunitinib","value":36}],"hr":0.77,"ci":[0.63,0.95],"source":"https://doi.org/10.1056/NEJMoa2026982"}],"replication":"Consistent with other IO-TKI doublets; COSMIC-313 (adding cabozantinib to nivolumab-ipilimumab) improved PFS but not OS."},"route":"/trials/checkmate-9er/","neighbours":{"cancer":[{"id":"rcc","kind":"cancer","name":"Renal cell carcinoma","route":"/cancers/rcc/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"drug":[{"id":"cabozantinib","kind":"drug","name":"Cabozantinib","route":"/drugs/cabozantinib/"},{"id":"nivolumab","kind":"drug","name":"Nivolumab","route":"/drugs/nivolumab/"},{"id":"sunitinib","kind":"drug","name":"Sunitinib","route":"/drugs/sunitinib/"}],"company":[{"id":"exelixis","kind":"company","name":"Exelixis","route":"/companies/exelixis/"}],"person":[{"id":"james-larkin","kind":"person","name":"James Larkin","route":"/people/james-larkin/"},{"id":"robert-motzer","kind":"person","name":"Robert J. Motzer","route":"/people/robert-motzer/"},{"id":"toni-choueiri","kind":"person","name":"Toni K. Choueiri","route":"/people/toni-choueiri/"}],"term":[{"id":"pfs","kind":"term","name":"Progression-free survival (PFS)","route":"/terms/pfs/"},{"id":"qol-pro","kind":"term","name":"Quality of life and patient-reported outcomes (QoL, PRO)","route":"/terms/qol-pro/"},{"id":"quality-adjusted-survival","kind":"term","name":"Quality-adjusted survival (QALYs and Q-TWiST)","route":"/terms/quality-adjusted-survival/"}]}}