Clinical Trial

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

Study acronym: UNIVERSE
Active, Not Recruiting Phase 3
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Record status
This record was last updated July 8, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-10-11.
Status change: Recruiting → Active, Not Recruiting 2025-07-03
Trial Details
NCT Number NCT06640530
Lead Sponsor Biocad
Conditions Advanced Melanoma, Melanoma (Skin)
Enrollment 392 participants
Start Date 2024-03-21
Primary Completion 2025-12 (estimated)
Study Completion 2027-03 (estimated)
Updated on ClinicalTrials.gov 2025-07-08