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ABP 206 · 2 trials · 1 indication
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). ...
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ABP 206 is an investigational small molecule being studied for the treatment of melanoma. It is being evaluated in patients with resected melanoma and in patients with unresectable or metastatic melanoma. The drug is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
ABP 206 is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. Amgen is conducting Phase 3 clinical trials to evaluate the safety and efficacy of ABP 206 in patients with melanoma.
ABP 206 is currently in Phase 3 clinical development. It is an investigational drug being studied for the treatment of melanoma. As of now, ABP 206 has not been approved by the FDA or other regulatory agencies and remains in clinical trials.
ABP 206 is being studied in two Phase 3 clinical trials. NCT05907122 is a completed study comparing ABP 206 with OPDIVO (nivolumab) in subjects with resected melanoma. NCT06054555 is an active, not recruiting study comparing ABP 206 with OPDIVO in subjects with unresectable or metastatic melanoma.
ABP 206 is not the same as OPDIVO (nivolumab). ABP 206 is an investigational drug being developed by Amgen, and it is being compared with OPDIVO in clinical trials to evaluate similarity. These trials are designed to assess whether ABP 206 is similar to OPDIVO in treating melanoma.
ABP 206 is a small molecule being developed for melanoma. The specific molecular target of ABP 206 has not been disclosed in available information. Clinical trials are evaluating its similarity to OPDIVO (nivolumab) in treating resected and unresectable or metastatic melanoma.