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MDX-010 monoclonal antibody · 1 trial · 2 indications
OS was defined as the time from randomization until death from any cause. If a participant did not expire, the subject was censored at the time of last contact (last known alive date). 95% confidence intervals (CI) for median were computed using Brookmeyer and Crowley method.
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | Melanoma Peptide Vaccine (MDX-1379) (gp100) + Placebo |
| 2 | EXPERIMENTAL | MDX-010 (ipilimumab) + MDX-1379 (gp100) (Melanoma Peptide Vaccine) |
| 3 | ACTIVE_COMPARATOR | MDX-010 (ipilimumab) + Placebo |
| Name | Type | Description |
|---|---|---|
| MDX-010 (anti-CTLA4) monoclonal antibody | DRUG | 3mg/kg (intravenous \[iv\] infusion over 90 minutes), every 3 weeks for 4 doses |
| MDX-1379 (gp100) Melanoma Peptide Vaccine | BIOLOGICAL | 2mL (2 subcutaneous injections of 2 mL each, 1 to each thigh), every 3 weeks for 4 doses. |
Inclusion Criteria: * Diagnosed with malignant melanoma * Measurable unresectable Stage III or IV melanoma * HLA-A\*0201 positive * Previous treatment with \& failure/relapse/inability to tolerate IL-2, dacarbazine and/or temozolomide * At least 4 weeks since prior treatment * Negative pregnancy * ...
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MDX-010 monoclonal antibody is an investigational therapy being studied for the treatment of melanoma, specifically in patients with unresectable or metastatic melanoma. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
MDX-010 monoclonal antibody is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in melanoma.
MDX-010 monoclonal antibody is in Phase 3 clinical development for melanoma. It is an investigational drug, meaning it has not yet been approved by regulatory agencies. The Phase 3 trial has been completed, and the drug remains under evaluation.
MDX-010 monoclonal antibody has been studied in a completed Phase 3 clinical trial registered as NCT00094653. This trial evaluated the drug alone, in combination with MDX-1379 melanoma vaccine, or the vaccine alone in patients with unresectable or metastatic melanoma, enrolling 1,783 participants across multiple countries.
MDX-010 monoclonal antibody is also known as ipilimumab, a fully human monoclonal antibody that targets CTLA-4. In clinical trials, it has been studied under the name MDX-010, and it is being developed by Bristol-Myers Squibb for the treatment of melanoma.