NCT06640530

Clinical Study of the Efficacy and Safety of BCD-263 and Opdivo® as Monotherapy in Subjects With Advanced Melanoma of the Skin

A Double-Blind, Randomized Clinical Study of the Efficacy and Safety of BCD-263 and Opdivo® as Monotherapy in Subjects With Advanced Melanoma of the Skin

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 392 (estimated)
• Sponsor: Biocad · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study BCD-263-2/UNIVERSE is to demonstrate comparable efficacy and similar safety and immunogenicity profile of BCD-263 and Opdivo after repeated intravenous doses in subjects with advanced unresectable or metastatic melanoma of the skin.

Detailed description

Following screening, subjects will be randomized to receive either BCD-263 or Opdivo in a 1:1 ratio and enter the main study period. During the main study period, subjects will receive therapy with BCD-263 or Opdivo, which will be administered intravenously until disease progression or signs of unacceptable toxicity develop (whichever occurs earlier). At Week 25, after completion of all scheduled procedures subjects in both groups will continue to receive open-label BCD-263 for up to a total of 2 years of therapy, or disease progression, or signs of unacceptable toxicity (whichever occurs first). Following discontinuation of the study therapy, the subjects will enter a follow-up period, during which data on overall survival will be collected through telephone contacts.

Conditions

• Advanced Melanoma
• Melanoma (Skin)

Interventions

Type	Name	Description
DRUG	BCD-263	BCD-263 at a dose 480 mg administered intravenously every 4 weeks up to 6 cycles
DRUG	Opdivo	Opdivo at a dose 480 mg administered intravenously every 4 weeks up to 6 cycles

Timeline

• Start date: 2024-03-21
• Primary completion: 2025-12-01
• Completion: 2027-03-01
• First posted: 2024-10-15
• Last updated: 2025-07-08

Locations

44 sites across 3 countries: Belarus, Pakistan, Russia