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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)

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Trial Profile

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)

Status: Not yet recruiting
Phase of Trial: Phase III

Latest Information Update: 31 Oct 2025

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At a glance

  • Drugs Nivolumab (Primary)
  • Indications Malignant melanoma
  • Focus Pharmacokinetics; Therapeutic Use
  • Acronyms LEON Study
  • Sponsors mAbxience

Most Recent Events

  • 31 Oct 2025 New trial record

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