drugset / Trial / NCT06320353
Study сomparing the Efficacy and Safety of RPH-075 and Keytruda® in Patients With Unresectable or Metastatic Skin Melanoma
Phase 3
Completed
266 enrolled
R-Pharm
Data Management 365 · collabExacte Labs LLC · collabFederal State Budgetary Institution of the Central Research Institute of Epidemiology of Rospotrebnadzor · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The goal of this double-blind, randomized study is to establish the equivalence of the efficacy, safety and immunogenicity of the drugs RPH-075 (international nonproprietary name (INN) is pembrolizumab) and Keytruda® (INN is pembrolizumab) when used in patients with unresectable or metastatic skin melanoma first or second line therapy in a monotherapy regimen. The main task is to evaluate and compare the effectiveness of RPH-075 and Keytruda® drugs when used in patients with unresectable or metastatic skin melanoma as a 1 or 2 line therapy in monotherapy regimen, according to the objective response rate (ORR) parameter for up to 24 weeks of therapy.
Timeline
- Start
- 2023-09-27
- Primary completion
- 2024-08-07
- Completion
- 2026-03-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | RPH-075 | Unknown | 200 mg | Intravenous |