Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB11 Versus EU-/US-Opdivo® in Subjects With Previously Untreated Advanced [Unresectable or Metastatic] Melanoma
A phase 3 trial of Nivolumab in melanoma, run by mAbxience Research S.L., now recruiting.
Overview
Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB11 Versus EU-/US-Opdivo® in Subjects With Previously Untreated Advanced [Unresectable or Metastatic] Melanoma is a phase 3 interventional study registered as NCT07221734 by mAbxience Research S.L., with 632 participants planned, started 2025-12-29 and due to reach its primary completion in 2027-04. Interventions recorded: MB11 (Proposed Nivolumab Biosimilar), EU-Opdivo® and US- sourced Opdivo®.
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