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

NCT06264180 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-05-15

No results posted yet for this 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

Interventions

BIOLOGICAL

Vusolimogene Oderparepvec

Genetically modified Herpes Simplex Type 1 Virus.

BIOLOGICAL

Nivolumab

Anti-PD-1 Monoclonal Antibody

BIOLOGICAL

Nivolumab + Relatlimab

Nivolumab: Anti-PD-1 Monoclonal antibody. Relatlimab: A lymphocyte activation gene-3 (LAG-3) blocking antibody.

BIOLOGICAL

Pembrolizumab

A programmed death receptor-1 (PD-1)-blocking antibody indicated.

DRUG

Single-agent chemotherapy

Dacarbazine, temozolomide, or paclitaxel/albumin-bound paclitaxel.

Sponsors & Collaborators

  • Replimune, Inc.

    lead INDUSTRY

Principal Investigators

  • Jeannie Hou, MD · Replimune, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-11
Primary Completion
2029-01-01
Completion
2034-08-31
FDA Drug
Yes

Countries

  • United States
  • France
  • Germany
  • Greece
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06264180 on ClinicalTrials.gov