Trials / No Longer Available
No Longer AvailableNCT06590480
An Expanded Access Program for VO (RP1) in Combination With Nivolumab in Patients With Advanced Melanoma
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
- No Longer Available
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Replimune, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
Summary
The purpose of this EAP is to provide expanded access (i.e., 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 physician's 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | RP1 | Genetically modified Herpes Simplex Type 1 Virus |
| BIOLOGICAL | Nivolumab | Anti-PD-1 Monoclonal Antibody |
Timeline
- First posted
- 2024-09-19
- Last updated
- 2025-12-18
Source: ClinicalTrials.gov record NCT06590480. Inclusion in this directory is not an endorsement.