{"entity":{"id":"nct05625399","kind":"trial","name":"A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma","aka":["RELATIVITY-127"],"tldr":"A phase 3 trial of Nivolumab, Relatlimab + nivolumab in melanoma, run by Bristol-Myers Squibb, active and no longer recruiting.","summary":"A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma is a phase 3 interventional study registered as NCT05625399 by Bristol-Myers Squibb, with 579 participants enrolled, started 2023-03-06 and due to reach its primary completion in 2025-08-04. Interventions recorded: Nivolumab + Relatlimab, rHuPH20. Conditions listed: Melanoma. Results were posted on ClinicalTrials.gov in 2026; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05625399","url":"https://clinicaltrials.gov/study/NCT05625399"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab","relatlimab-nivolumab"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05625399","phase":"3","setting":"A Phase 3, Randomized, Open-label, Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination Versus Intravenous Nivolumab + Relatlimab Fixed-dose Combination in Participants With Previously Untreated Metastatic or Unresectable Melanoma","sponsor":"Bristol-Myers Squibb","started":"2023-03-06","startedType":"actual","yearReported":2026,"enrolled":579,"enrolledBasis":"registry","outcomes":[{"endpoint":"Adjusted Time-Averaged Nivolumab Serum Concentration Over the First 28 Days (Cavgd28-Nivo) on Natural Logarithmic Scale","primary":true,"unit":"ug/ml","arms":[{"name":"Nivo + Rela FDC SC","n":283,"value":4.141,"note":"SE 0.0167; Figures from the ClinicalTrials.gov results section (first posted 2026-08-26), not from a publication"},{"name":"Nivo + Rela FDC IV","n":291,"value":3.901,"note":"SE 0.0164"}],"source":"https://clinicaltrials.gov/study/NCT05625399?tab=results"},{"endpoint":"Progression Free Survival Per BICR","unit":"months","arms":[{"name":"Nivo + Rela FDC SC","n":286,"value":12.65,"note":"95% CI 8.08 to NA; Figures from the ClinicalTrials.gov results section (first posted 2026-08-26), not from a publication"},{"name":"Nivo + Rela FDC IV","n":292,"value":14.98,"note":"95% CI 12.12 to NA"}],"source":"https://clinicaltrials.gov/study/NCT05625399?tab=results"},{"endpoint":"Disease Control Rate (ORR) Per BICR","unit":"%","arms":[{"name":"Nivo + Rela FDC SC","n":286,"value":62.2,"note":"95% CI 56.3 to 67.9; Figures from the ClinicalTrials.gov results section (first posted 2026-08-26), not from a publication"},{"name":"Nivo + Rela FDC IV","n":292,"value":72.3,"note":"95% CI 66.7 to 77.3"}],"source":"https://clinicaltrials.gov/study/NCT05625399?tab=results"}]},"route":"/trials/nct05625399/","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/"}],"drug":[{"id":"nivolumab","kind":"drug","name":"Nivolumab","route":"/drugs/nivolumab/"},{"id":"relatlimab-nivolumab","kind":"drug","name":"Relatlimab + nivolumab","route":"/drugs/relatlimab-nivolumab/"}],"company":[{"id":"bms","kind":"company","name":"Bristol Myers Squibb","route":"/companies/bms/"}]}}