{"entity":{"id":"checkmate-577","kind":"trial","name":"CheckMate 577","aka":[],"tldr":"A year of immunotherapy after surgery doubled the time before cancer returned in patients whose tumour had not fully responded to chemoradiation, though the survival gain did not reach significance.","summary":"CheckMate 577, trial NCT02743494 sponsored by Bristol Myers Squibb and reported in 2021, showed that a year of adjuvant nivolumab doubled the time before cancer returned in patients with oesophageal or gastro-oesophageal junction cancer whose tumour had not fully responded to neoadjuvant chemoradiation and surgery, though the survival gain did not reach significance. It randomised 794 patients with residual disease to nivolumab or placebo and met its primary disease-free survival endpoint, the basis of the 2021 FDA approval, while the final overall survival analysis at ASCO 2025 favoured nivolumab without statistical significance. It remains standard in NCCN and ESMO guidance, and whether a disease-free benefit without a survival benefit should be enough is the open question.","status":"mixed","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02743494","url":"https://clinicaltrials.gov/study/NCT02743494"},{"label":"Final OS, ASCO 2025","url":"https://ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.4000"}],"tags":[],"related":[],"cancers":["esophageal","gastric","oesophageal-squamous-cell-carcinoma","oesophageal-adenocarcinoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1"],"drugs":["nivolumab"],"companies":[],"institutions":[],"pathways":[],"terms":["neoadjuvant-adjuvant"],"trials":["cross"],"people":["ronan-kelly"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02743494","phase":"3","setting":"Resected oesophageal/GEJ cancer with residual disease after neoadjuvant chemoradiation: adjuvant nivolumab 1 year vs placebo","sponsor":"BMS","result":"DFS 22.4 vs 11.0 months (HR 0.69); OS 51.7 vs 35.3 months (HR 0.85, NS).","started":"2016-07-14","startedType":"actual","yearReported":2021,"enrolled":794,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-free survival","primary":true,"unit":"months","arms":[{"name":"Nivolumab","n":532,"value":22.4},{"name":"Placebo","n":262,"value":11}],"hr":0.69,"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2032125"},{"endpoint":"Overall survival (final)","unit":"months","arms":[{"name":"Nivolumab","n":532,"value":51.7},{"name":"Placebo","n":262,"value":35.3}],"hr":0.85,"ci":[0.7,1.04],"p":"0.1064","source":"https://ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.4000"}],"replication":"Single phase 3; real-world matched cohorts show similar OS direction."},"route":"/trials/checkmate-577/","neighbours":{"cancer":[{"id":"gastric","kind":"cancer","name":"Gastric & gastro-oesophageal junction cancer","route":"/cancers/gastric/"},{"id":"oesophageal-adenocarcinoma","kind":"cancer","name":"Oesophageal and junctional adenocarcinoma","route":"/cancers/oesophageal-adenocarcinoma/"},{"id":"esophageal","kind":"cancer","name":"Oesophageal cancer","route":"/cancers/esophageal/"},{"id":"oesophageal-squamous-cell-carcinoma","kind":"cancer","name":"Oesophageal squamous cell carcinoma","route":"/cancers/oesophageal-squamous-cell-carcinoma/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"target":[{"id":"pd1","kind":"target","name":"PD-1","route":"/targets/pd1/"}],"drug":[{"id":"nivolumab","kind":"drug","name":"Nivolumab","route":"/drugs/nivolumab/"}],"term":[{"id":"de-escalation","kind":"term","name":"De-escalation, escalation and response-adapted therapy","route":"/terms/de-escalation/"},{"id":"neoadjuvant-adjuvant","kind":"term","name":"Neoadjuvant / adjuvant / perioperative","route":"/terms/neoadjuvant-adjuvant/"}],"trial":[{"id":"cross","kind":"trial","name":"CROSS","route":"/trials/cross/"}],"person":[{"id":"ronan-kelly","kind":"person","name":"Ronan J. Kelly","route":"/people/ronan-kelly/"}],"pairing":[{"id":"cross-then-nivolumab","kind":"pairing","name":"CROSS chemoradiation → surgery → adjuvant nivolumab if residual disease","route":"/pairings/cross-then-nivolumab/"}],"paper":[{"id":"paper-checkmate-577-nejm-2021","kind":"paper","name":"CheckMate 577: adjuvant nivolumab in resected oesophageal or gastro-oesophageal junction cancer","route":"/key-papers/paper-checkmate-577-nejm-2021/"}]}}