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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06054555 | A Study to Evaluate ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Unresectable or Metastatic Melanoma | PHASE3 | ACTIVE NOT_RECRUITING | 633 | — | — | Nov 2, 2023 | Jan 25, 2028 | Jan 12, 2026 | 180 | United States, Argentina +29 |
| NCT05907122 | A Study to Evaluate Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Resected Melanoma | PHASE3 | COMPLETED | 256 | — | — | Jul 26, 2023 | Oct 31, 2025 | Mar 27, 2026 | 76 | United States, Argentina +20 |
The PK similarity (AUC0-28d) of ABP 206 compared with nivolumab will be demonstrated in subjects with advanced melanoma in the adjuvant setting.
The PK similarity (AUCtau\_ss) of ABP 206 compared with nivolumab will be demonstrated in subjects with advanced melanoma in the adjuvant setting.
| Arm | Type | Description |
|---|---|---|
| ABP 206 | EXPERIMENTAL | Subjects will receive Dose A of ABP 206 via intravenous (IV) infusion. |
| Nivolumab | ACTIVE_COMPARATOR | Subjects will receive Dose A of Nivolumab via IV infusion. |
| FDA-licensed Nivolumab | ACTIVE_COMPARATOR | Subjects will receive Dose A of FDA-licensed Nivolumab via IV infusion. |
| EU-authorized Nivolumab | ACTIVE_COMPARATOR | Subjects will receive Dose A of EU-authorized Nivolumab via IV infusion. |
| Name | Type | Description |
|---|---|---|
| ABP 206 | DRUG | ABP 206 will be given intravenously over a period of 30 or 60 minutes, every 4 weeks (Q4W) for a total of 24 months. |
| Nivolumab | DRUG | Nivolumab will be given intravenously over a period of 30 or 60 minutes, Q4W for a total of 24 months. |
| FDA-licensed Nivolumab | DRUG | FDA-licensed Nivolumab will be given intravenously over a period of 30 minutes, Q4W for a total of 12 months. |
| EU-authorized Nivolumab | DRUG | FDA-licensed Nivolumab will be given intravenously over a period of 30 minutes, Q4W for a total of 12 months. |
Key Inclusion Criteria: * At least 18 years of age. * Histologically confirmed unresectable or metastatic melanoma. * Subject has no prior systemic treatment for advanced disease. * Subject must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.1). ...