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Clinical trial

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)

NCT07221734 is registered in ClinicalTrials.gov with mAbxience Research S.L. as lead sponsor.

NCT NCT07221734
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Registry record

As filed in ClinicalTrials.gov.

Title
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)
Lead sponsor
mAbxience Research S.L.
Phase
Phase 3
Overall status
Recruiting
Start date
December 29, 2025
Completion date
February 28, 2029
Enrollment
632 (estimated)
Sites
19

Conditions

As the registry lists them; a condition with its own page is linked.

advanced (unresectable or metastatic) melanoma