Clinical Trial

A Clinical Study of BCD-217 (Nurulimab + Prolgolimab) Followed by Anti-PD-1 Compared to Anti-PD-1 Monotherapy as First-Line Treatment in Subjects With Unresectable/Metastatic Melanoma

Study acronym: OCTAVA
Active, Not Recruiting Phase 3
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Summary
The aim of study is to investigate the efficacy, safety, immunogenicity, pharmacokinetics, and pharmacodynamics of BCD-217 followed by prolgolimab monotherapy versus prolgolimab monotherapy as first-line therapy in subjects with unresectable or metastatic melanoma.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-02-08.
Status change: Recruiting → Active, Not Recruiting 2025-02-25
Trial Details
NCT Number NCT05732805
Lead Sponsor Biocad
Conditions Melanoma, Melanoma (Skin), Melanoma Stage III, Melanoma Stage IV, Melanoma Unresectable, Melanoma Metastatic, Melanoma Advanced
Enrollment 270 participants
Start Date 2022-08-02
Primary Completion 2024-06-20 (estimated)
Study Completion 2025-07 (estimated)
Updated on ClinicalTrials.gov 2025-02-27