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

> **NCT07221734** · PHASE3 · RECRUITING · sponsor: **mAbxience Research S.L.** · enrollment: 632 (estimated)

## Conditions studied

- Advanced (Unresectable or Metastatic) Melanoma

## Interventions

- **DRUG:** MB11 (Proposed Nivolumab Biosimilar)
- **DRUG:** EU-Opdivo®
- **DRUG:** US- sourced Opdivo®

## Key facts

- **NCT ID:** NCT07221734
- **Lead sponsor:** mAbxience Research S.L.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2025-12-29
- **Primary completion:** 2027-04
- **Final completion:** 2029-02
- **Target enrollment:** 632 (ESTIMATED)
- **Last updated:** 2026-01-21


## Primary source

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

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT07221734, "Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB11 Versus EU-/US-Opdivo® in Subjects With Previously Untreated Advanced [Unresectable or Metastatic] Melanoma". Retrieved via AI Analytics 2026-07-05 from https://api.ai-analytics.org/clinical/NCT07221734. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*