Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06264180
Status:
RECRUITING
Last Update Posted:
2024-02-16
First Post:
2024-01-29
Brief Title:
VO and Nivolumab vs Physicians Choice in Advanced Melanoma That Progressed on Anti-PD-1 Anti-CTLA-4 Drugs IGNYTE-3
Sponsor:
Replimune Inc
Organization:
Replimune Inc
Study Overview
Official Title:
Randomized Ph3 Clinical Study Comparing Vusolimogene Oderparepvec in Combination With Nivolumab Vs Treatment of Physicians Choice in Patients With Advanced Melanoma That Progressed on Anti-PD-1 and Anti-CTLA-4 Containing Treatment
Status:
RECRUITING
Status Verified Date:
2024-10
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:
None
Brief Summary:
This is a randomized controlled multicenter open-label Phase 3 clinical study comparing VO in combination with nivolumab versus Physicians Choice treatment for patients with unresectable Stage IIIb-IV cutaneous melanoma whose disease progressed on an anti PD-1 and an anti-CTLA-4 containing regimen administered either as a combination regimen or in sequence or who are not candidates for treatment with an anti-CTLA-4 therapy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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?:
None