Overview

Study сomparing the Efficacy and Safety of RPH-075 and Keytruda® in Patients With Unresectable or Metastatic Skin Melanoma

Status:
ACTIVE_NOT_RECRUITING

Trial end date:
2026-01-01

Target enrollment:

Participant gender:

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.

Phase:

PHASE3

Details

Lead Sponsor:

R-Pharm

Collaborators:

Data Management 365
Exacte Labs LLC
Federal State Budgetary Institution of the Central Research Institute of Epidemiology of Rospotrebnadzor

Treatments:

pembrolizumab