NCT05732805

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

A Double-Blind Placebo-Controlled Comparative Randomized Clinical Study of the Efficacy and Safety 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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 270 (estimated)
• Sponsor: Biocad · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is designed as a phase III, randomized, double-blind, placebo-controlled study. After the stratification procedure, subjects are randomized in a 1:1 ratio into 2 groups: * BCD-217 + placebo (4 doses) → prolgolimab (BCD-217 group) * Prolgolimab + placebo (4 doses) → prolgolimab (BCD-100 monotherapy group)

Conditions

• Melanoma
• Melanoma (Skin)
• Melanoma Stage III
• Melanoma Stage IV
• Melanoma Unresectable
• Melanoma Metastatic
• Melanoma Advanced

Interventions

Type	Name	Description
BIOLOGICAL	BCD-217	Subject recieves BCD-217 0.2 mL/kg, which is equivalent to 1 mg/kg nurulimab + 3 mg/kg prolgolimab, as an intravenous infusion once every 3 weeks (Q3W) simultaneously with placebo, a total of 4 intravenous infusions. Beginning with the 5th infusion, subjects are switched to prolgolimab 1 mg/kg monotherapy once every 2 weeks (Q2W).
BIOLOGICAL	BCD-100	Subject recieves prolgolimab 3 mg/kg as an intravenous infusion once every 3 weeks (Q3W) simultaneously with placebo, a total of 4 intravenous infusions. Beginning with the 5th infusion, subjects are switched to prolgolimab 1 mg/kg monotherapy once every 2 weeks (Q2W).
BIOLOGICAL	Placebo	Placebo

Timeline

• Start date: 2022-08-02
• Primary completion: 2024-06-20
• Completion: 2025-07-01
• First posted: 2023-02-17
• Last updated: 2025-02-27

Locations

63 sites across 3 countries: Belarus, India, Russia