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NCT06264180 · ClinicalTrials.gov record · last posted 2026-07-15

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

StatusRecruiting
PhasePhase 3
Started2024-07-11
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Protocol amendment history 4 changes detected by DataLookout

2026-07-16
Primary completion pushed: 2029-01-01 → 2030-09-30
2026-07-16
Completion moved earlier: 2034-08-31 → 2031-03-31
2026-05-16
Trial sites expanded: 73 → 81 locations
2026-04-19
Sponsor changed: Replimune Inc. → Replimune, Inc.
WasReplimune Inc.
NowReplimune, Inc.
Trial Details
NCT Number NCT06264180
Lead Sponsor Replimune, Inc.
Conditions Advanced Melanoma
Enrollment 400 participants
Start Date 2024-07-11
Primary Completion 2030-09-30 (estimated)
Study Completion 2031-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-15