drugset / Trial / NCT06640530

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

NCT06640530 ↗

Phase 3 Active not recruiting 392 enrolled Biocad
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2024-03-21
Primary completion
2025-12
Completion
2027-03

Drugs

EvaluationDrugModalityDoseRoute
Subject BCD-263 Unknown 480 mg Intravenous

Indications