MB11 (nivolumab biosimilar) / mAbxience - LARVOL DELTA

LEON study: A PK-driven biosimilarity study of MB11 to nivolumab in advanced melanoma (ESMO 2026) - No abstract available

Metastases • Melanoma • Oncology • Solid Tumor

MB11-C-01-25: Randomised, Multicentre, Multinational, Double-Blind Integrated Study to Compare the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB11 (Proposed Nivolumab Biosimilar) Versus EU-/US-Opdivon in Subjects With Previously Untreated Advanced (Unresectable or Metastatic) Melanoma (LEON Study) (clinicaltrialsregister.eu) - P2/3 | N=119 | Recruiting | Sponsor: Mabxience Research S.L.

New P2/3 trial • Melanoma • Oncology • Solid Tumor • BRAF • PD-L1

Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB11 Versus EU-/US-Opdivo® in Subjects With Previously Untreated Advanced [Unresectable or Metastatic] Melanoma (clinicaltrials.gov) - P3 | N=632 | Recruiting | Sponsor: mAbxience Research S.L. | Not yet recruiting ➔ Recruiting

Enrollment open • Mucosal Melanoma • Oncology • Solid Tumor • BRAF

Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB11 Versus EU-/US-Opdivo® in Subjects With Previously Untreated Advanced [Unresectable or Metastatic] Melanoma (clinicaltrials.gov) - P3 | N=632 | Not yet recruiting | Sponsor: mAbxience Research S.L.

New P3 trial • Melanoma • Oncology • Solid Tumor