clinical trial · NCT07221734
Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB11 Versus EU-/US-Opdivo® in Subjects With Previously Untreated Advanced [Unresectable or Metastatic] Melanoma
mAbxience Research S.L.·phase3·recruiting·n = 632
Advanced (Unresectable or Metastatic) MelanomaMB11 (Proposed Nivolumab Biosimilar)EU-Opdivo®US- sourced Opdivo®
brief summary
This is a randomised, multicentre, multinational, double-blind, integrated study to sompare the pharmacokinetics, efficacy, safety, and immunogenicity of MB11 versus Opdivo® in subjects with previously untreated advanced (unresectable or Metastatic) Melanoma
started
Dec 29, 2025
primary completion
Apr 1, 2027
completion
Feb 1, 2029
last updated
Jan 21, 2026
official title
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)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol