Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 3interventionalRules rewrite

Phase 3: testing MB11 (Proposed Nivolumab Biosimilar) for Advanced (Unresectable or Metastatic) Melanoma

This is a randomly assigned, multicentre, multinational, neither you nor the study doctors know who gets the real treatment, integrated study to sompare the pharmacokinetics, how well it works, safety, and immunogenicity of MB11 versus Opdivo® in subjects with previously untreated advanced (unresectable or Metastatic) Melanoma

Official registry: https://clinicaltrials.gov/study/NCT07221734 · mAbxience Research S.L. · enrollment listed as 632

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are MB11 (Proposed Nivolumab Biosimilar), EU-Opdivo®, or US- sourced Opdivo®. The registry lists allocation as randomized. This is a randomly assigned, multicentre, multinational, neither you nor the study doctors know who gets the real treatment, integrated study to sompare the pharmacokinetics, how well it works, safety, and immunogenicity of MB11 versus Opdivo® in subjects with previously untreated advanced (unresectable or Metastatic) Melanoma

They plan to enroll about 632 people at 86 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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)

Interventions: MB11 (Proposed Nivolumab Biosimilar), EU-Opdivo®, US- sourced Opdivo®

Primary outcome (registry wording): To demonstrate the Pharmacokinetic (PK) bioequivalence between MB11 and EU/ US-Opdivo.

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Body weight ≥50 kg at baseline
  • how well you can do daily activities (ECOG score) of 0 or 1
  • Life expectancy for at least 3 months

Public study contact (from the registry)

Susana Millán, PhD

+34917711500

Susana.Millan@mabxience.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

86 listed

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FAQ about this NCT record

Is NCT07221734 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07221734?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07221734?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary