IGNYTE-3 Study for Advanced Melanoma

This study is for people with advanced melanoma (a type of skin cancer) that has worsened after previous treatments with anti-PD-1 and anti-CTLA-4 drugs. It compares a new combination treatment, Vusolimogene Oderparepvec (a genetically modified virus) with nivolumab (an anti-PD-1 antibody), against standard treatments chosen by your doctor. These standard treatments could include nivolumab plus relatlimab, pembrolizumab (another anti-PD-1 antibody), or certain chemotherapy drugs. The study aims to see if the new combination helps people live longer. You can join if you are 12 years or older and have unresectable or metastatic Stage IIIb through IV melanoma. The study plans to enroll about 400 participants.

Study design
This is a randomized, controlled, open-label Phase 3 study, meaning participants are randomly assigned to a treatment group, and both you and your doctor will know which treatment you are receiving. Approximately 400 people will participate.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your overall survival will be assessed up to January 2029, which is approximately 55 months after the study begins.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06264180

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

Recruiting
PHASE3Ages 12+InterventionalTreatment
Replimune, Inc.
~400 participants
Updated 2026-07-15 on ClinicalTrials.gov
What's tested:Vusolimogene OderparepvecNivolumabNivolumab + RelatlimabPembrolizumabSingle-agent chemotherapy

At a glance

Recruiting sites
75 of 81 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Survival (OS)
Measured over Assessed up to January 2029, approximately 55 months
Advanced Melanoma
81 sites across 30 states
Germany10
California9
France7
Spain6
United Kingdom5
New York4
Florida3
New Jersey3
  • Jeannie Hou, MD · STUDY_DIRECTOR · Replimune, Inc.

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  • Overall Survival (OS)Assessed up to January 2029, approximately 55 months

    Time from the date of randomization to death due to any cause