{"entity":{"id":"checkmate-238","kind":"trial","name":"CheckMate 238","aka":[],"tldr":"CheckMate 238 showed that a year of nivolumab after melanoma surgery prevents more relapses than the older drug ipilimumab, with far fewer serious side effects, and it made PD-1 blockade the standard adjuvant treatment.","summary":"CheckMate 238 randomised 906 patients with completely resected stage IIIB, IIIC or IV melanoma to one year of nivolumab or of high-dose ipilimumab, the adjuvant standard set by EORTC 18071. It was designed to show that PD-1 blockade could match or beat ipilimumab's relapse-free survival benefit with less toxicity.\n\nTwelve-month recurrence-free survival was 70.5 percent with nivolumab against 60.8 percent with ipilimumab (hazard ratio 0.65), and grade 3 or 4 treatment-related adverse events occurred in 14 percent against 46 percent. At four years recurrence-free survival was 51.7 percent against 41.2 percent, while overall survival did not differ, partly because most relapsing patients in both arms went on to effective immunotherapy.\n\nNivolumab was approved as adjuvant therapy in December 2017 on this trial. With KEYNOTE-054 it established a year of anti-PD-1 antibody as the adjuvant standard for stage III melanoma, later extended to stage II by KEYNOTE-716 and CheckMate 76K and challenged by the neoadjuvant results of SWOG S1801 and NADINA.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02388906","url":"https://clinicaltrials.gov/study/NCT02388906"},{"label":"NEJM 2017","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa1709030"},{"label":"4-year follow-up, Lancet Oncology 2020","url":"https://doi.org/10.1016/S1470-2045(20)30494-0"}],"tags":[],"related":[],"cancers":["stage-iii-melanoma","melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1","ctla4"],"drugs":["nivolumab","ipilimumab"],"companies":["bms"],"institutions":[],"pathways":[],"terms":["neoadjuvant-adjuvant","efs"],"trials":[],"people":["jeffrey-weber","james-larkin","paolo-ascierto"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02388906","phase":"3","setting":"Resected stage IIIB, IIIC or IV melanoma: one year of adjuvant nivolumab versus ipilimumab 10 mg/kg","sponsor":"BMS","result":"12-month recurrence-free survival 70.5% vs 60.8% (HR 0.65); 4-year recurrence-free survival 51.7% vs 41.2%; no overall survival difference.","yearReported":2017,"enrolled":906,"outcomes":[{"endpoint":"Recurrence-free survival at 12 months","primary":true,"unit":"%","arms":[{"name":"Nivolumab","n":453,"value":70.5},{"name":"Ipilimumab 10 mg/kg","n":453,"value":60.8}],"hr":0.65,"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1709030"},{"endpoint":"Recurrence-free survival at 4 years","unit":"%","arms":[{"name":"Nivolumab","n":453,"value":51.7},{"name":"Ipilimumab 10 mg/kg","n":453,"value":41.2}],"source":"https://doi.org/10.1016/S1470-2045(20)30494-0"}],"replication":"KEYNOTE-054 (pembrolizumab versus placebo) found a relapse-free survival benefit of the same size for PD-1 blockade after surgery."},"route":"/trials/checkmate-238/","neighbours":{"cancer":[{"id":"melanoma","kind":"cancer","name":"Melanoma","route":"/cancers/melanoma/"},{"id":"stage-iii-melanoma","kind":"cancer","name":"Stage III melanoma (after surgery)","route":"/cancers/stage-iii-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":"nivolumab","kind":"drug","name":"Nivolumab","route":"/drugs/nivolumab/"}],"company":[{"id":"bms","kind":"company","name":"Bristol Myers Squibb","route":"/companies/bms/"}],"term":[{"id":"efs","kind":"term","name":"Event-free / disease-free survival (EFS, DFS, iDFS, RFS)","route":"/terms/efs/"},{"id":"neoadjuvant-adjuvant","kind":"term","name":"Neoadjuvant / adjuvant / perioperative","route":"/terms/neoadjuvant-adjuvant/"}],"person":[{"id":"james-larkin","kind":"person","name":"James Larkin","route":"/people/james-larkin/"},{"id":"jeffrey-weber","kind":"person","name":"Jeffrey S. Weber","route":"/people/jeffrey-weber/"},{"id":"paolo-ascierto","kind":"person","name":"Paolo A. Ascierto","route":"/people/paolo-ascierto/"}]}}