A Clinical Study of BCD-217 (Nurulimab + Prolgolimab) Followed by Anti-PD-1 Compared to Anti-PD-1 Monotherapy as First-Line Treatment in Subjects With Unresectable/Metastatic Melanoma

Phase 3 Active not recruiting 270 enrolled Biocad

RandomizedParallel-groupDouble-blindTreatment

Summary

The aim of study is to investigate the efficacy, safety, immunogenicity, pharmacokinetics, and pharmacodynamics of BCD-217 followed by prolgolimab monotherapy versus prolgolimab monotherapy as first-line therapy in subjects with unresectable or metastatic melanoma.

Timeline

Start: 2022-08-02
Primary completion: 2024-06-20
Completion: 2025-07

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Prolgolimab	Monoclonal antibody	1 mg/kg	Intravenous
Subject	nurulimab	Monoclonal antibody	1 mg/kg	Intravenous

A Clinical Study of BCD-217 (Nurulimab + Prolgolimab) Followed by Anti-PD-1 Compared to Anti-PD-1 Monotherapy as First-Line Treatment in Subjects With Unresectable/Metastatic Melanoma

Summary

Timeline

Drugs

Indications