MB11 (nivolumab biosimilar)
/ Insud Pharma
- LARVOL DELTA
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February 18, 2026
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
January 13, 2026
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
October 29, 2025
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
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