{"entity":{"id":"checkmate-067","kind":"trial","name":"CheckMate 067","aka":[],"tldr":"The trial with the longest immunotherapy follow-up: about half of patients on the combination are alive at 10 years.","summary":"CheckMate 067, trial NCT01844505 sponsored by Bristol Myers Squibb and reported in 2015 with ten-year results in the New England Journal of Medicine, is the trial with the longest immunotherapy follow-up: about half of patients on nivolumab plus ipilimumab for untreated advanced melanoma are alive at ten years when melanoma-specific survival is counted. It randomised 945 patients to the combination, nivolumab alone or ipilimumab alone, met its co-primary progression-free survival endpoint, and established that immunotherapy can produce durable cures. Who needs the ipilimumab component and its toxicity remains the open question.","status":"positive","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT01844505","url":"https://clinicaltrials.gov/study/NCT01844505"}],"tags":[],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab","ipilimumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["dirk-schadendorf","jedd-wolchok","paolo-ascierto","michael-postow","f-stephen-hodi","james-larkin"],"bottlenecks":[],"keyPapers":["paper-checkmate-067-10-year-nejm-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01844505","phase":"3","setting":"Untreated advanced melanoma: nivolumab + ipilimumab vs nivolumab vs ipilimumab","sponsor":"BMS","result":"10-year OS 43% vs 37% vs 19%.","started":"2013-06-11","startedType":"actual","yearReported":2015,"enrolled":945,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival at 10 years","unit":"%","arms":[{"name":"Nivolumab + ipilimumab","n":314,"value":43},{"name":"Nivolumab","n":316,"value":37},{"name":"Ipilimumab","n":315,"value":19}],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2407417"},{"endpoint":"Median overall survival","unit":"months","arms":[{"name":"Nivolumab + ipilimumab","value":71.9},{"name":"Nivolumab","value":36.9},{"name":"Ipilimumab","value":19.9}],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2407417"},{"endpoint":"Melanoma-specific survival at 10 years","unit":"%","arms":[{"name":"Nivolumab + ipilimumab","value":52},{"name":"Nivolumab","value":44},{"name":"Ipilimumab","value":23}],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2407417"},{"endpoint":"Progression-free survival (co-primary)","primary":true,"unit":"months","arms":[{"name":"Nivolumab + ipilimumab","value":11.5,"note":"HR for combination vs ipilimumab"},{"name":"Nivolumab","value":6.9},{"name":"Ipilimumab","value":2.9}],"hr":0.42,"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1504030"}],"replication":"Replicated by CheckMate 069 (phase 2) and consistent with KEYNOTE-006 for single-agent PD-1; the longest immunotherapy follow-up in any solid tumour."},"route":"/trials/checkmate-067/","neighbours":{"cancer":[{"id":"advanced-melanoma","kind":"cancer","name":"Advanced melanoma (unresectable stage III and stage IV)","route":"/cancers/advanced-melanoma/"},{"id":"braf-v600-melanoma","kind":"cancer","name":"BRAF V600-mutant melanoma","route":"/cancers/braf-v600-melanoma/"},{"id":"melanoma","kind":"cancer","name":"Melanoma","route":"/cancers/melanoma/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"drug":[{"id":"ipilimumab","kind":"drug","name":"Ipilimumab","route":"/drugs/ipilimumab/"},{"id":"nivolumab","kind":"drug","name":"Nivolumab","route":"/drugs/nivolumab/"}],"person":[{"id":"dirk-schadendorf","kind":"person","name":"Dirk Schadendorf","route":"/people/dirk-schadendorf/"},{"id":"f-stephen-hodi","kind":"person","name":"F. Stephen Hodi","route":"/people/f-stephen-hodi/"},{"id":"james-larkin","kind":"person","name":"James Larkin","route":"/people/james-larkin/"},{"id":"jedd-wolchok","kind":"person","name":"Jedd D. Wolchok","route":"/people/jedd-wolchok/"},{"id":"michael-postow","kind":"person","name":"Michael A. Postow","route":"/people/michael-postow/"},{"id":"paolo-ascierto","kind":"person","name":"Paolo A. Ascierto","route":"/people/paolo-ascierto/"}],"paper":[{"id":"paper-checkmate-067-10-year-nejm-2025","kind":"paper","name":"CheckMate 067 at ten years: nivolumab plus ipilimumab produces long-term survival in half of patients with advanced melanoma","route":"/key-papers/paper-checkmate-067-10-year-nejm-2025/"},{"id":"paper-nivolumab-melanoma-n-engl-j-med-2015","kind":"paper","name":"Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma","route":"/key-papers/paper-nivolumab-melanoma-n-engl-j-med-2015/"},{"id":"paper-leach-allison-ctla4-blockade-science-1996","kind":"paper","name":"Leach, Krummel and Allison: releasing the CTLA-4 brake makes mice reject tumours","route":"/key-papers/paper-leach-allison-ctla4-blockade-science-1996/"},{"id":"paper-relativity-047-nejm-2022","kind":"paper","name":"RELATIVITY-047: relatlimab plus nivolumab, the first LAG-3 checkpoint combination, in untreated advanced melanoma","route":"/key-papers/paper-relativity-047-nejm-2022/"}],"trial":[{"id":"relativity-047","kind":"trial","name":"RELATIVITY-047","route":"/trials/relativity-047/"}],"term":[{"id":"hazard-ratio","kind":"term","name":"Hazard ratio (HR)","route":"/terms/hazard-ratio/"},{"id":"kaplan-meier-curve","kind":"term","name":"Kaplan-Meier curve, censoring and proportional hazards","route":"/terms/kaplan-meier-curve/"},{"id":"landmark-survival","kind":"term","name":"Landmark and milestone survival (5-year survival, median follow-up)","route":"/terms/landmark-survival/"},{"id":"os","kind":"term","name":"Overall survival (OS)","route":"/terms/os/"},{"id":"randomised-trial","kind":"term","name":"Randomised trial","route":"/terms/randomised-trial/"},{"id":"stratified-randomisation","kind":"term","name":"Stratified randomisation, allocation concealment and minimisation","route":"/terms/stratified-randomisation/"}],"roadmap":[{"id":"immunotherapy-roadmap","kind":"roadmap","name":"Immunotherapy roadmap: Coley's toxins → checkpoint inhibitors → engineered immunity","route":"/roadmaps/immunotherapy-roadmap/"}],"bottleneck":[{"id":"b-immunotherapy-response","kind":"bottleneck","name":"No one can predict who responds to immunotherapy","route":"/bottlenecks/b-immunotherapy-response/"}],"idea":[{"id":"idea-bio2-lymph-node-immune-priming","kind":"idea","name":"Treat the draining lymph node before removing it","route":"/ideas/idea-bio2-lymph-node-immune-priming/"}],"institution":[{"id":"pascale-naples","kind":"institution","name":"Istituto Nazionale Tumori IRCCS Fondazione G. Pascale","route":"/institutions/pascale-naples/"},{"id":"essen-wtz","kind":"institution","name":"West German Cancer Center (WTZ), University Hospital Essen","route":"/institutions/essen-wtz/"}]}}