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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
StatusActive, Not Recruiting
PhasePhase 3
SponsorBiocad
Started2022-08-02
View on ClinicalTrials.gov ↗

Amendment history

2025-02-25
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v1
Trial statusRecruiting→Active, Not Recruiting
Primary completion dateestimated 2024-04→confirmed 2024-06-20
Completion date2025-04→2025-07
Study sitesdetails revised at 63 of 63 sites
2023-02-08
Original filing
Biocad
26 trials monitored
See all monitored trials
Melanoma
1,020 trials monitored
See 45 trials at risk
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.
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