{"entity":{"id":"nct07221734","kind":"trial","name":"Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB11 Versus EU-/US-Opdivo® in Subjects With Previously Untreated Advanced [Unresectable or Metastatic] Melanoma","aka":[],"tldr":"A phase 3 trial of Nivolumab in melanoma, run by mAbxience Research S.L., now recruiting.","summary":"Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB11 Versus EU-/US-Opdivo® in Subjects With Previously Untreated Advanced [Unresectable or Metastatic] Melanoma is a phase 3 interventional study registered as NCT07221734 by mAbxience Research S.L., with 632 participants planned, started 2025-12-29 and due to reach its primary completion in 2027-04. Interventions recorded: MB11 (Proposed Nivolumab Biosimilar), EU-Opdivo® and US- sourced Opdivo®.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07221734","url":"https://clinicaltrials.gov/study/NCT07221734"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":["nivolumab"],"companies":["mabxience-research-s-l"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"notes":[],"nct":"NCT07221734","phase":"3","setting":"Randomised, Multicentre, Multinational, Double-Blind Integrated Study to Compare the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB11 (Proposed Nivolumab Biosimilar) Versus EU-/US-Opdivo® in Subjects With Previously Untreated Advanced (Unresectable or Metastatic) Melanoma (LEON Study)","sponsor":"mAbxience Research S.L.","enrolled":632,"outcomes":[]},"route":"/trials/nct07221734/","neighbours":{"cancer":[{"id":"melanoma","kind":"cancer","name":"Melanoma","route":"/cancers/melanoma/"}],"drug":[{"id":"nivolumab","kind":"drug","name":"Nivolumab","route":"/drugs/nivolumab/"}],"company":[{"id":"mabxience-research-s-l","kind":"company","name":"mAbxience Research S.L.","route":"/companies/mabxience-research-s-l/"}]}}