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

Source: https://onco.cc/trials/nct07221734/  
OnCo record `nct07221734` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial of Nivolumab in melanoma, run by mAbxience Research S.L., now recruiting.

## Summary

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®.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-16
- Tags: pipeline; ctgov-ingest
- Registry id: NCT07221734
- Phase: 3
- Setting: 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)
- Sponsor: mAbxience Research S.L.
- Enrolled: 632

## Sources

- ClinicalTrials.gov NCT07221734: https://clinicaltrials.gov/study/NCT07221734

## Connected records

- cancers: [Melanoma](https://onco.cc/cancers/melanoma/)
- drugs: [Nivolumab](https://onco.cc/drugs/nivolumab/)
- companies: [mAbxience Research S.L.](https://onco.cc/companies/mabxience-research-s-l/)

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