Clinical Trial

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

Recruiting Phase 3
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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
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-10-27; most recent amendment 2026-01-19.
Status change: Not Yet Recruiting → Recruiting 2026-01-09
Trial Details
NCT Number NCT07221734
Lead Sponsor mAbxience Research S.L.
Conditions Advanced (Unresectable or Metastatic) Melanoma
Enrollment 632 participants
Start Date 2025-12-29
Primary Completion 2027-04 (estimated)
Study Completion 2029-02 (estimated)
Updated on ClinicalTrials.gov 2026-01-21