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Also known as MDX-010 (anti-CTLA4) monoclonal antibody
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 immunotherapy that was studied in melanoma, including unresectable or metastatic disease. It is a monoclonal antibody developed by Bristol-Myers Squibb Company (ticker: BMY) and reached Phase 3 clinical development. It was evaluated in a single completed Phase 3 trial enrolling 1,783 patients.
MDX-010 monoclonal antibody was studied for the treatment of unresectable or metastatic melanoma. The Phase 3 trial also evaluated it alongside MDX-1379, a melanoma vaccine, both as separate arms and as a combination treatment. The study enrolled adults 18 years and older with melanoma or metastases.
MDX-010 monoclonal antibody targets CTLA-4, also written CTLA4, a checkpoint receptor on T cells. It is an anti-CTLA4 monoclonal antibody, a class of immunotherapy designed to act on this immune checkpoint. The Phase 3 melanoma trial was biomarker selected, meaning enrollment was tied to a biomarker-defined patient population.
MDX-010 monoclonal antibody is developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. Bristol-Myers Squibb sponsored the Phase 3 melanoma study of the antibody. The trial also tested MDX-1379, a melanoma vaccine, alone and in combination with MDX-010.
MDX-010 monoclonal antibody reached Phase 3 development. It is an investigational agent and is not described as approved. One Phase 3 trial has been completed, and no trials of MDX-010 monoclonal antibody are currently active. That completed study enrolled 1,783 patients with unresectable or metastatic melanoma.
MDX-010 monoclonal antibody was studied in the completed Phase 3 trial NCT00094653, titled MDX-010 Antibody, MDX-1379 Melanoma Vaccine, or MDX-010/MDX-1379 Combination Treatment for Patients With Unresectable or Metastatic Melanoma. The trial enrolled 1,783 patients across the United States, Argentina, Belgium, Brazil, Canada, Chile, France, Germany, Hungary, the Netherlands, South Africa, Switzerland, and the United Kingdom.
Yes. MDX-010 monoclonal antibody is also known as MDX-010 (anti-CTLA4) monoclonal antibody. Both names refer to the same anti-CTLA4 monoclonal antibody developed by Bristol-Myers Squibb Company (BMY) and studied in the Phase 3 melanoma trial NCT00094653. The parenthetical form simply names the CTLA-4 target.