Clinical Trial

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

Active, Not Recruiting Phase 1
View on ClinicalTrials.gov →
Summary
The aim of the study BCD-263-1 is to prove the comparability of the pharmacokinetics and similarity of the safety, immunogenicity and pharmacodynamic profiles of BCD-263 and Opdivo following intravenous administration to subjects with advanced unresectable or metastatic melanoma of the skin. The study will have randomized, double-blind design with parallel assignment.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-10-27; most recent amendment 2025-07-03.
Status change: Recruiting → Active, Not Recruiting 2025-07-03
Trial Details
NCT Number NCT06112808
Lead Sponsor Biocad
Conditions Advanced Melanoma
Enrollment 300 participants
Start Date 2023-05-29
Primary Completion 2024-01-31 (estimated)
Study Completion 2027-01 (estimated)
Updated on ClinicalTrials.gov 2025-07-08