Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB11 Versus EU-/US-Opdivo® in Subjects With Previously Untreated Advanced [Unresectable or Metastatic] Melanoma

Sponsor
mAbxience Research S.L.
Study ID
NCT07221734
Phase
PHASE3
Status
Recruiting
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Conditions

  • Advanced (Unresectable or Metastatic) Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MB11 (Proposed Nivolumab Biosimilar) — DRUG
    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
  • EU-Opdivo® — DRUG
    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
  • US- sourced Opdivo® — DRUG
    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

Study Details

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

Key Dates

Start date
Dec 29, 2025
Status verified
Jan 2026
Primary completion
Apr 30, 2027
Completion
Feb 28, 2029

Study Design

Enrollment
632 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MB11 (Proposed Nivolumab Biosimilar)
  • Active Comparator: EU-Opdivo®
  • Active Comparator: US- sourced Opdivo®

Primary Outcome Measure

To demonstrate the Pharmacokinetic (PK) bioequivalence between MB11 and EU/ US-Opdivo. [ Time Frame: Week 1 - Week 24 ]

Central Contacts