drugset / Trial / 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
RandomizedParallel-groupTriple-blindTreatment
Summary
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
Timeline
- Start
- 2025-12-29
- Primary completion
- 2027-04
- Completion
- 2029-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MB11 | Unknown | 3 mg/kg | Intravenous |
| Subject | MB11 | Unknown | 240 mg | Intravenous |
| Comparator | Nivolumab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Comparator | Nivolumab | Monoclonal antibody | 240 mg | Intravenous |