Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06264180 | VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs [IGNYTE-3] | PHASE3 | RECRUITING | 400 | — | — | Jul 11, 2024 | Aug 31, 2034 | May 15, 2026 | 81 | United States, France +5 |
Time from the date of randomization to death due to any cause
| Arm | Type | Description |
|---|---|---|
| VO + nivolumab | EXPERIMENTAL | - |
| Physicians Choice | ACTIVE_COMPARATOR | Choosing from 1 of the following (to be consistent with approved label and/or applicable local clinical guidelines): * Nivolumab + relatlimab (as Opdualag) * Anti-PD-1 monotherapy (nivolumab or pembrolizumab) * Single-agent chemotherapy (dacarbazine, temozolomide, or paclitaxel/albumin-bound paclitaxel) |
| Name | Type | Description |
|---|---|---|
| Vusolimogene Oderparepvec | BIOLOGICAL | Genetically modified Herpes Simplex Type 1 Virus. |
| Nivolumab | BIOLOGICAL | Anti-PD-1 Monoclonal Antibody |
| Nivolumab + Relatlimab | BIOLOGICAL | Nivolumab: Anti-PD-1 Monoclonal antibody. Relatlimab: A lymphocyte activation gene-3 (LAG-3) blocking antibody. |
| Pembrolizumab | BIOLOGICAL | A programmed death receptor-1 (PD-1)-blocking antibody indicated. |
| Single-agent chemotherapy | DRUG | Dacarbazine, temozolomide, or paclitaxel/albumin-bound paclitaxel. |
Key Inclusion 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, as per AJCC staging system, 8th edit...