Status: Recruiting
Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB11 Versus EU-/US-Opdivo® in Subjects With Previously Untreated Advanced [Unresectable or Metastatic] Melanoma
This is a randomised, multicentre, multinational, double-blind, integrated study to sompare the pharmacokinetics, efficacy, safety, and immunogenicity of MB11 versus Opdivo® in subjects with previously untreated advanced (unresectable or Metastatic) Melanoma
Participants needed: 632
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: mAbxience Research S.L.Updated: Jan 21, 2026Locations: 19
Eligibility criteria
Age ≥18 years at the time of signing the informed consent (or adulthood where th... [+5]
At least 1 measurable disease lesion by CT or MRI per RECIST v1.1 criteria. [+31]