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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00094653 | MDX-010 Antibody, MDX-1379 Melanoma Vaccine, or MDX-010/MDX-1379 Combination Treatment for Patients With Unresectable or Metastatic Melanoma | PHASE3 | COMPLETED | 1,783 | — | — | Sep 1, 2004 | Oct 1, 2009 | Jul 11, 2011 | 209 | United States, Argentina +11 |
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 * ...