NCT06264180

VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs [IGNYTE-3]

Randomized, Ph3 Clinical Study Comparing Vusolimogene Oderparepvec in Combination With Nivolumab Vs Treatment of Physician's Choice in Patients With Advanced Melanoma That Progressed on Anti-PD-1 and Anti-CTLA-4 Containing Treatment [IGNYTE-3]

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Replimune, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, controlled, multicenter, open-label Phase 3 clinical study comparing VO in combination with nivolumab versus Physician's 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.

Conditions

• Advanced Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	Vusolimogene Oderparepvec	Genetically modified Herpes Simplex Type 1 Virus.
BIOLOGICAL	Nivolumab	Anti-PD-1 Monoclonal Antibody
BIOLOGICAL	Nivolumab + Relatlimab	Nivolumab: Anti-PD-1 Monoclonal antibody. Relatlimab: A lymphocyte activation gene-3 (LAG-3) blocking antibody.
BIOLOGICAL	Pembrolizumab	A programmed death receptor-1 (PD-1)-blocking antibody indicated.
DRUG	Single-agent chemotherapy	Dacarbazine, temozolomide, or paclitaxel/albumin-bound paclitaxel.

Timeline

• Start date: 2024-07-11
• Primary completion: 2029-01-01
• Completion: 2034-08-31
• First posted: 2024-02-16
• Last updated: 2026-03-13

Locations

73 sites across 6 countries: United States, France, Germany, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study