{"entity":{"id":"keynote-006","kind":"trial","name":"KEYNOTE-006","aka":[],"tldr":"The trial that made PD-1 blockade the first choice over the older CTLA-4 drug, with a third of patients alive at ten years.","summary":"Pembrolizumab improved PFS and OS versus ipilimumab with fewer high-grade side effects. The 10-year analysis (Annals of Oncology 2024) reported OS 34.0% versus 23.6%; patients who completed two years of pembrolizumab had durable remissions off treatment. Established anti-PD-1 monotherapy as a first-line standard and the two-year treatment duration.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT01866319","url":"https://clinicaltrials.gov/study/NCT01866319"},{"label":"10-year follow-up, Annals of Oncology 2024","url":"https://www.annalsofoncology.org/article/S0923-7534(24)03910-3/fulltext"}],"tags":[],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1","ctla4"],"drugs":["pembrolizumab","ipilimumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["caroline-robert"],"bottlenecks":[],"keyPapers":["paper-keynote-006-pembrolizumab-ipilimumab-melanoma-nejm-2015"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01866319","phase":"3","setting":"Advanced melanoma, ≤1 prior systemic therapy: pembrolizumab (two schedules) vs ipilimumab","sponsor":"Merck","result":"10-year OS 34.0% vs 23.6%.","started":"2013-08-28","startedType":"actual","yearReported":2015,"enrolled":834,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival at 10 years","unit":"%","arms":[{"name":"Pembrolizumab","value":34},{"name":"Ipilimumab","value":23.6}],"source":"https://www.annalsofoncology.org/article/S0923-7534(24)03910-3/fulltext"}],"replication":"Consistent with CheckMate 066/067 (nivolumab) and long-term KEYNOTE-001 data; PD-1 superiority over ipilimumab is replicated."},"route":"/trials/keynote-006/","neighbours":{"cancer":[{"id":"advanced-melanoma","kind":"cancer","name":"Advanced melanoma (unresectable stage III and stage IV)","route":"/cancers/advanced-melanoma/"},{"id":"melanoma","kind":"cancer","name":"Melanoma","route":"/cancers/melanoma/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"target":[{"id":"ctla4","kind":"target","name":"CTLA-4","route":"/targets/ctla4/"},{"id":"pd1","kind":"target","name":"PD-1","route":"/targets/pd1/"}],"drug":[{"id":"ipilimumab","kind":"drug","name":"Ipilimumab","route":"/drugs/ipilimumab/"},{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"}],"company":[{"id":"merck","kind":"company","name":"Merck & Co. (MSD)","route":"/companies/merck/"}],"person":[{"id":"caroline-robert","kind":"person","name":"Caroline Robert","route":"/people/caroline-robert/"}],"paper":[{"id":"paper-keynote-006-pembrolizumab-ipilimumab-melanoma-nejm-2015","kind":"paper","name":"KEYNOTE-006 (Robert 2015): pembrolizumab versus ipilimumab in advanced melanoma","route":"/key-papers/paper-keynote-006-pembrolizumab-ipilimumab-melanoma-nejm-2015/"}]}}