drugset / Trial / NCT06153238
A PK Study to Compare GME751 (Proposed Pembrolizumab Biosimilar) and US-licensed and EU-authorized Keytruda® in Participants With Stage II and III Melanoma
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to investigate the pharmacokinetic (PK) similarity and efficacy, safety, and immunogenicity of GME751 compared with Keytruda® (pembrolizumab) in subjects with resected advanced melanoma requiring adjuvant treatment with pembrolizumab.
Timeline
- Start
- 2024-05-15
- Primary completion
- 2026-05-05
- Completion
- 2026-05-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GME751 | Protein / enzyme biologic | 400 mg | Intravenous |
| Comparator | Pembrolizumab | Monoclonal antibody | 400 mg | Intravenous |