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

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: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 632 (estimated)
• Sponsor: mAbxience Research S.L. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Advanced (Unresectable or Metastatic) Melanoma

Interventions

Type	Name	Description
DRUG	MB11 (Proposed Nivolumab Biosimilar)	During fist 12 cycles: 3 mg/kg IV infusion, over 30 minutes, Q2W. On Cycle 13 onwards: 3 mg/kg IV infusion, over 30 minutes, Q2W or 240 mg flat dose Q2W dosing
DRUG	EU-Opdivo®	During fist 12 cycles: 3 mg/kg IV infusion, over 30 minutes, Q2W. On Cycle 13 onwards: 3 mg/kg IV infusion, over 30 minutes, Q2W or 240 mg flat dose Q2W dosing
DRUG	US- sourced Opdivo®	During fist 12 cycles: 3 mg/kg IV infusion, over 30 minutes, Q2W. On Cycle 13 onwards: 3 mg/kg IV infusion, over 30 minutes, Q2W or 240 mg flat dose Q2W dosing

Timeline

• Start date: 2025-12-29
• Primary completion: 2027-04-01
• Completion: 2029-02-01
• First posted: 2025-10-28
• Last updated: 2026-01-21

Locations

19 sites across 2 countries: Portugal, Ukraine

Regulatory

• FDA-regulated drug study