Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs [IGNYTE-3]
NCT06264180 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- BIOLOGICAL Pembrolizumab
- BIOLOGICAL Nivolumab
- BIOLOGICAL Vusolimogene Oderparepvec
- BIOLOGICAL Nivolumab + Relatlimab
- DRUG Single-agent chemotherapy
Study Locations (20)
California
- UC San Diego Moores Cancer Center — La Jolla
- The Angeles Clinic and Research Institute — Los Angeles
- USC Norris Comprehensive Cancer Center — Los Angeles
- UCLA Department of Medicine - Hematology/Oncology — Los Angeles
- UC Irvine Health, Chao Family Comprehensive Cancer Center — Orange
- Stanford Cancer Institute — Palo Alto
- Sutter Medical Group — Sacramento
- San Francisco Oncology Associates — San Francisco
- UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco
Colorado
- University of Colorado Hospital - Anschutz Cancer Pavilion — Aurora
- The Melanoma and Skin Cancer Institute — Englewood
Florida
- Memorial Cancer Institute at Memorial Regional Hospital — Hollywood
- Moffitt Cancer Center — Tampa
Illinois
- Northwestern Memorial Hospital — Chicago
- Advocate Lutheran General Hospital — Park Ridge
Arizona
- Banner MD Anderson Cancer Center — Gilbert
District of Columbia
- MedStar Washington Hospital Center — Washington D.C.
Georgia
- Winship Cancer Institute, Emory University — Atlanta
Iowa
- University of Iowa — Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2024-07-11 |
| Est. Completion | 2034-08-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06264180
The ClinicalTrials.gov registry entry for NCT06264180 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Replimune, which has 8 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Advanced Melanoma appearing as the primary indexed condition, and to 5 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06264180 reports 20 study locations spanning 9 distinct geographic areas — top geographies include California, Colorado, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06264180 about?
NCT06264180 is a clinical study titled "VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs [IGNYTE-3]". 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 regim...
What is the current status of trial NCT06264180?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 400 participants. The study started on 2024-07-11. Estimated completion is 2034-08-31.
What conditions does trial NCT06264180 study?
This clinical trial studies the following conditions: Advanced Melanoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06264180?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Nivolumab (BIOLOGICAL), Vusolimogene Oderparepvec (BIOLOGICAL), Nivolumab + Relatlimab (BIOLOGICAL), Single-agent chemotherapy (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06264180?
This trial is sponsored by Replimune, which has 8 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06264180 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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