Ignite Creation Date:
2024-10-25 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06590480
Status:
AVAILABLE
Last Update Posted:
None
First Post:
2024-09-06
Brief Title:
An Expanded Access Program for VO RP1 in Combination With Nivolumab in Patients With Advanced Melanoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Expanded Access Program - Real-world Data Collection for VO in Combination With Nivolumab in Patients With Advanced Melanoma That Has Progressed on an Anti-PD-1 Containing Treatment Regimen
Status:
AVAILABLE
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RPL-EAP-001
Brief Summary:
The purpose of this EAP is to provide expanded access ie before marketing authorization to vusolimogene oderparepvec VO herein referred to as VO plus standard-of-care SOC nivolumab for eligible patients diagnosed with advanced melanoma who in their treating physicians opinion could benefit from this treatment
Detailed Description:
The objective of treating with VO is to directly reduce or eliminate tumors by lytic virus replication and to induce a systemic anti-tumor immune response leading to tumor immunity and durable clinical responses Limited treatment options are available to those patients with advanced melanoma who have progressed while on an anti-PD-1 therapy regimen and the duration of progression-free survival PFS is less than 6 months with overall survival OS being less than 3 years The mechanism of VO complements that of anti-PD-1 therapy such that combining VO with an anti-PD-1 agent such as nivolumab will increase the number of tumor-reactive T cells through the action of VO and relieve CD8-T cell exhaustion through the action of the anti-PD-1 therapy Combining VO with nivolumab is supported by evidence in syngeneic immune-competent murine models demonstrating an increased reduction in tumor volume compared with either VO or anti-PD-1 monotherapy
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: