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

StatusActive, Not Recruiting
PhasePhase 1
SponsorBiocad
Started2023-05-29
View on ClinicalTrials.gov ↗

Amendment history

2025-07-03
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v2
Trial statusRecruiting→Active, Not Recruiting
Primary completion dateestimated 2024-09→confirmed 2024-01-31
Study sitesdetails revised at 30 of 30 sites
2023-11-02
Study Identification, Study Status, Arms and Interventions v1
Study title-25 characters
A Double-Blind, Randomized Clinical Study of the Pharmacokinetics and Safety of BCD-26 [...]
2023-10-27
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-263-1 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.
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