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

Trial Details

NCT ID

NCT07221734

Phase

PHASE3

Sponsor

mAbxience Research S.L.

Status

RECRUITING

Cancer Type

Melanoma

Interventions

• MB11 (Proposed Nivolumab Biosimilar)
• EU-Opdivo®
• US- sourced Opdivo®

Locations (sample)

• Banja Luka, Bosnia and Herzegovina|44.77879,17.20629
• Sarajevo, Bosnia and Herzegovina|43.84864,18.35644
• Zenica, Bosnia and Herzegovina|44.20169,17.90397
• Barretos, Brazil|-20.55722,-48.56778
• Belo Horizonte, Brazil|-19.92083,-43.93778

Key Eligibility Criteria

• Age ≥18 years at the time of signing the informed consent (or adulthood where the legalage of majority in the country is established \>18 years).
• Body weight ≥50 kg at baseline.
• Signed informed consent must be obtained before initiation of any study-specific procedures or treatment.
• ECOG performance status of 0 or 1.

For full eligibility, visit ClinicalTrials.gov.

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