{"entity":{"id":"relativity-098","kind":"trial","name":"RELATIVITY-098","aka":[],"tldr":"Adding relatlimab to adjuvant nivolumab did not reduce recurrence, so the LAG-3 combination stays a treatment for measurable disease.","summary":"RELATIVITY-098, trial NCT05002569 sponsored by Bristol Myers Squibb and published in 2025, found that adding the LAG-3 antibody relatlimab to adjuvant nivolumab did not reduce recurrence in resected stage III and IV melanoma, so the combination stays a treatment for measurable disease. It randomised 1,093 patients and showed no difference in recurrence-free survival, with overall survival not formally tested. OnCo links it to LAG-3 as a target, the relatlimab plus nivolumab and nivolumab records, Hussein A. Tawbi and a caution pairing about LAG-3 blockade outside active disease. Whether LAG-3 blockade needs an antigen-rich tumour to act on, echoing why neoadjuvant designs outperform adjuvant ones, is the question it raises.","status":"negative","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT05002569","url":"https://clinicaltrials.gov/study/NCT05002569"},{"label":"RELATIVITY-098 publication","url":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12705465/"}],"tags":["failure","lesson:adjuvant-vs-active-disease"],"related":[],"cancers":["melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["lag3"],"drugs":["relatlimab-nivolumab","nivolumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["hussein-tawbi"],"bottlenecks":[],"keyPapers":["paper-relativity-098-nat-med-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05002569","phase":"3","setting":"Resected stage III/IV melanoma: adjuvant nivolumab + relatlimab vs nivolumab","sponsor":"BMS","result":"RFS not improved.","started":"2021-10-19","startedType":"actual","yearReported":2025,"enrolled":1093,"enrolledBasis":"registry","outcomes":[{"endpoint":"Recurrence-free survival","primary":true,"unit":"months","arms":[{"name":"Nivolumab + relatlimab","n":547,"note":"No difference; OS not formally tested"},{"name":"Nivolumab","n":546}],"hr":1.01,"ci":[0.83,1.22],"p":"0.928","source":"https://doi.org/10.1038/s41591-025-04032-8"}],"replication":"Failed to extend the RELATIVITY-047 advanced-disease benefit into the adjuvant setting; translational data attribute this to low peripheral LAG-3+ T cells without macroscopic tumour."},"route":"/trials/relativity-098/","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":"lag3","kind":"target","name":"LAG-3","route":"/targets/lag3/"}],"drug":[{"id":"nivolumab","kind":"drug","name":"Nivolumab","route":"/drugs/nivolumab/"},{"id":"relatlimab-nivolumab","kind":"drug","name":"Relatlimab + nivolumab","route":"/drugs/relatlimab-nivolumab/"}],"person":[{"id":"hussein-tawbi","kind":"person","name":"Hussein A. Tawbi","route":"/people/hussein-tawbi/"}],"paper":[{"id":"paper-relativity-098-nat-med-2025","kind":"paper","name":"Adjuvant nivolumab and relatlimab in stage III/IV melanoma: the randomized phase 3 RELATIVITY-098 trial","route":"/key-papers/paper-relativity-098-nat-med-2025/"}],"pairing":[{"id":"lag3-adjuvant-caution","kind":"pairing","name":"Caution: LAG-3 blockade outside active disease","route":"/pairings/lag3-adjuvant-caution/"}],"idea":[{"id":"idea-tr1-extended-interval-checkpoint-dosing","kind":"idea","name":"Extended-interval immunotherapy: give checkpoint inhibitors every 8-12 weeks once stable","route":"/ideas/idea-tr1-extended-interval-checkpoint-dosing/"},{"id":"idea-chronotherapy-immunotherapy","kind":"idea","name":"Give immunotherapy in the morning","route":"/ideas/idea-chronotherapy-immunotherapy/"},{"id":"idea-microbiome-io-fmt","kind":"idea","name":"Microbiome transplant as a routine immunotherapy adjunct","route":"/ideas/idea-microbiome-io-fmt/"},{"id":"idea-tr1-immunotherapy-stop-trials","kind":"idea","name":"Randomised trials of stopping immunotherapy after one year versus continuing","route":"/ideas/idea-tr1-immunotherapy-stop-trials/"}]}}