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

Name: Clinical Study of the Efficacy and Safety of BCD-263 and Opdivo® as Monotherapy in Subjects With Advanced Melanoma of the Skin — clinical trial record (NCT06640530)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Study acronym: UNIVERSE

StatusActive, Not Recruiting

PhasePhase 3

SponsorBiocad

Started2024-03-21

View on ClinicalTrials.gov ↗

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.

Amendment history

2025-07-03

Recruiting→Active, Not Recruiting Study Identification, Study Status, Contacts/Locations v1

Trial statusRecruiting→Active, Not Recruiting

Study sites45→44

Study titlerevised

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

2024-10-11

Original filing

Biocad

26 trials monitored

See all monitored trials

Melanoma

1,020 trials monitored

See 45 trials at risk

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.

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