{"entity":{"id":"checkmate-274","kind":"trial","name":"CheckMate 274","aka":[],"tldr":"A year of nivolumab after bladder or upper-tract surgery reduces recurrence and, with long follow-up, extends life.","summary":"CheckMate 274, trial NCT02632409 sponsored by Bristol Myers Squibb and reported in 2021, showed that a year of adjuvant nivolumab after radical surgery for high-risk muscle-invasive urothelial carcinoma of the bladder or upper tract reduces recurrence and, with long follow-up, extends life. It randomised 709 patients to nivolumab or placebo, met its primary disease-free survival endpoint, and later showed an overall survival benefit that was larger in the bladder subset and durable at five years, leading to FDA approval in August 2021. OnCo links it to bladder cancer, nivolumab and Dean F. Bajorin. It now competes with perioperative approaches from NIAGARA and EV-303 and EV-304 and with ctDNA-guided adjuvant therapy, and where adjuvant nivolumab fits among them is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02632409","url":"https://clinicaltrials.gov/study/NCT02632409"},{"label":"5-year data","url":"https://www.urologytimes.com/view/checkmate-274-5-year-data-confirm-durable-benefit-with-nivolumab"}],"tags":[],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["dean-bajorin"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02632409","phase":"3","setting":"High-risk muscle-invasive urothelial carcinoma after radical surgery: adjuvant nivolumab 1 year vs placebo","sponsor":"BMS","result":"DFS HR 0.70; OS HR 0.83 (ITT), median 75 vs 50.1 months.","started":"2016-03-22","startedType":"actual","yearReported":2021,"enrolled":709,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-free survival","primary":true,"unit":"months","arms":[{"name":"Nivolumab","n":353,"value":22},{"name":"Placebo","n":356,"value":10.9}],"hr":0.7,"ci":[0.57,0.85],"source":"https://ascopubs.org/doi/10.1200/JCO.24.00340"},{"endpoint":"Overall survival (ITT)","unit":"months","arms":[{"name":"Nivolumab","value":75},{"name":"Placebo","value":50.1}],"hr":0.83,"source":"https://doi.org/10.1056/NEJMoa2034442"}],"replication":"IMvigor010 (adjuvant atezolizumab, all-comers) was negative, but its ctDNA-positive subgroup led to IMvigor011, which was positive; AMBASSADOR (adjuvant pembrolizumab) improved DFS."},"route":"/trials/checkmate-274/","neighbours":{"cancer":[{"id":"urothelial","kind":"cancer","name":"Bladder & urothelial cancer","route":"/cancers/urothelial/"},{"id":"muscle-invasive-bladder-cancer","kind":"cancer","name":"Muscle-invasive and advanced bladder cancer","route":"/cancers/muscle-invasive-bladder-cancer/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"drug":[{"id":"nivolumab","kind":"drug","name":"Nivolumab","route":"/drugs/nivolumab/"}],"person":[{"id":"dean-bajorin","kind":"person","name":"Dean F. Bajorin","route":"/people/dean-bajorin/"}]}}