drugset / Trial / NCT06264180
VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs [IGNYTE-3]
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2024-07-11
- Primary completion
- 2030-09-30
- Completion
- 2031-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dacarbazine | Small molecule | — | — |
| Subject | Nivolumab | Monoclonal antibody | — | — |
| Comparator | Paclitaxel | Small molecule | — | — |
| Comparator | Pembrolizumab | Monoclonal antibody | — | — |
| Comparator | Relatlimab | Monoclonal antibody | — | — |
| Comparator | Temozolomide | Small molecule | — | — |
| Subject | Vusolimogene Oderparepvec | Unknown | — | — |