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NCT06264180 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Advanced Melanoma, sponsored by Replimune.

Recruiting
Registry status
Phase 3
Development phase
400
Enrollment target
20
Study locations

NCT06264180: Recruiting Phase 3 study of Advanced Melanoma, sponsored by Replimune.

NCT06264180 is a Phase 3 study of Advanced Melanoma that is actively recruiting participants, run by Replimune. The registered enrollment target is 400 participants, above the 153-participant average among 21 other Advanced Melanoma trials with a reported enrollment target (161% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06264180, a Phase 3 study of Advanced Melanoma, is actively recruiting participants, sponsored by Replimune.

RECRUITING
Registry status
Phase 3
Development phase
400 participants
Enrollment target
20
Study locations

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.

Primary Outcome

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

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

FieldValue
Enrollment Target 400 participants
Start Date 2024-07-11
Est. Completion 2034-08-31
Phase Phase 3
Replimune

9 total trials

What NCT06264180 shows while recruiting

NCT06264180 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, above the 153-participant average among 21 other Advanced Melanoma trials with a reported enrollment target (161% higher).

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.

NCT06264180 names 20 study sites across 9 states, led by California, Colorado, Florida.

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.

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).

Who is sponsoring clinical trial NCT06264180?

This trial is sponsored by Replimune, which has 9 total clinical trials registered on ClinicalTrials.gov.

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.

Similar trials for Advanced Melanoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06264180's enrollment target sits among peer trials

400 4th of 21 higher than 18 of 21 other Advanced Melanoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Advanced Melanoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06264180, the US trial registry maintained by the National Library of Medicine. NCT06264180 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.