Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB11 Versus EU-/US-Opdivo® in Subjects With Previously Untreated Advanced [Unresectable or Metastatic] Melanoma
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)
Other study identifiers
Sponsor study identifier
interventional
632
16 countries
87
Study Start
December 29, 2025
Actual (reported)Primary Completion
April 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
- Recruitment status
- recruiting
- Estimated enrollment
- 632 participants
- Study completion date
February 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
- Listed locations
- 16 countries · 87 sites
Trial Relationships
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Some registry-reported names shown below are not yet linked in this graph.
Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
First Submitted
October 6, 2025
Actual (reported)First Posted
October 28, 2025
Actual (reported)Study Start
December 29, 2025
Actual (reported)Primary Completion
April 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
- Last Updated
- October 29, 2026
- Status Verified
- October 2026
- Last Update Submitted
- October 28, 2026