Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:04 AM
Study NCT ID:
NCT05732805
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-27
First Post:
2023-02-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Biocad
Organization:
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Comparative Randomized Clinical Study of the Efficacy and Safety 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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OCTAVA
Brief 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.
Detailed Description:
This study is designed as a phase III, randomized, double-blind, placebo-controlled study.
After the stratification procedure, subjects are randomized in a 1:1 ratio into 2 groups:
* BCD-217 + placebo (4 doses) → prolgolimab (BCD-217 group)
* Prolgolimab + placebo (4 doses) → prolgolimab (BCD-100 monotherapy group)
After the stratification procedure, subjects are randomized in a 1:1 ratio into 2 groups:
* BCD-217 + placebo (4 doses) → prolgolimab (BCD-217 group)
* Prolgolimab + placebo (4 doses) → prolgolimab (BCD-100 monotherapy group)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: