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 regimen (administered either as a combination regimen or in sequence) or who are not candidates for treatment with an anti-CTLA-4 therapy.

Trial Details

NCT ID
NCT06264180
Phase
PHASE3
Sponsor
Replimune, Inc.
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • Vusolimogene Oderparepvec
  • Nivolumab
  • Nivolumab + Relatlimab
  • Pembrolizumab
  • Single-agent chemotherapy
Locations (sample)
  • Gilbert, Arizona, United States|33.35283,-111.78903
  • La Jolla, California, United States|32.84727,-117.2742
  • Los Angeles, California, United States|34.05223,-118.24368
  • Los Angeles, California, United States|34.05223,-118.24368
  • Los Angeles, California, United States|34.05223,-118.24368

Key Eligibility Criteria

  • I 1. Male or female who is 12 years of age or older at the time of signed informed consent.
  • I 2. Patients with histologically or cytologically confirmed unresectable or metastatic Stage IIIb through IV/M1a through M1d cutaneous melanoma, a…
  • I 3. Confirmed disease progression (PD) on an anti-PD-1 antibody treatment and an anti-CTLA-4 antibody treatment, administered as either a combinat…
  • Treatment with prior anti-PD-1 therapy must have continued for a minimum of 8 weeks (note: treatment with prior pembrolizumab therapy when administ…

For full eligibility, visit ClinicalTrials.gov.

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