drugset / Trial / NCT05986331

Clinical Study of the Efficacy and Safety of BCD-201 and Keytruda in Subjects With Advanced Melanoma

NCT05986331 ↗

Phase 3 Unknown 366 enrolled Biocad
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This clinical study is designed as a randomized, double-blind trial. Subjects with unresectable, metastatic, or recurrent skin melanoma will be randomized to one of the two study groups (BCD-201 group and Keytruda group) at a 1:1 ratio. The goal of this study is to compare the efficacy and safety of BCD-201 and Keytruda as first-line therapy in subjects with unresectable, metastatic, or recurrent skin melanoma.

Timeline

Start
2022-07-18
Primary completion
2023-12-31
Completion
2024-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject BCD-201 Unknown 200 mg Intravenous

Indications