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]
Replimune, Inc.
400 participants
Jul 11, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
Genetically modified Herpes Simplex Type 1 Virus.
Anti-PD-1 Monoclonal Antibody
Nivolumab: Anti-PD-1 Monoclonal antibody. Relatlimab: A lymphocyte activation gene-3 (LAG-3) blocking antibody.
A programmed death receptor-1 (PD-1)-blocking antibody indicated.
Dacarbazine, temozolomide, or paclitaxel/albumin-bound paclitaxel.
Locations(73)
View Full Details on ClinicalTrials.gov
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NCT06264180