Randomized, Ph3 Clinical Study Comparing Vusolimogene Oderparepvec in Combination With Nivolumab Vs Treatment of Physician's Choice in Patients With Advanced Melanoma That Progressed on Anti-PD-1 and Anti-CTLA-4 Containing Treatment [IGNYTE-3]

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.

Eligibility

Age range

12+ years

Sex

All

Healthy volunteers

No

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.

Locations (73)