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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01489059 | Safety Study of IL-21/Ipilimumab Combination in the Treatment of Melanoma | PHASE1 | COMPLETED | 42 | — | — | Dec 1, 2011 | Jun 1, 2014 | Aug 29, 2014 | 9 | United States, Puerto Rico |
Based on the dose-limiting toxicity (DLT) rate
Based on medical review of AE reports and the results of vital sign measurements, physical examinations, medical history, and clinical laboratory tests
| Arm | Type | Description |
|---|---|---|
| Part 1 - Arm 1: BMS-982470 (Daily x 5) + Ipilimumab | EXPERIMENTAL | Dose Escalation |
| Part 1 - Arm 2: BMS-982470 (Weekly) + Ipilimumab | EXPERIMENTAL | Dose Escalation |
| Part 2 - Arm 1: BMS-982470 (Daily x 5) + Ipilimumab | EXPERIMENTAL | Cohort Expansion |
| Part 2 - Arm 2: BMS-982470 (Weekly) + Ipilimumab | EXPERIMENTAL | Cohort Expansion |
| Part 2 - Arm 3: Ipilimumab monotherapy | ACTIVE_COMPARATOR | Cohort Expansion |
| Name | Type | Description |
|---|---|---|
| BMS-982470 (recombinant interleukin-21) | BIOLOGICAL | Solution, Intravenous, 10,30,50 μg/kg, daily for 5 days every 3 weeks (daily x 5), 16-20 weeks depending on response |
| Ipilimumab | BIOLOGICAL | Solution, Intravenous, 1,3,10 mg/kg, every 3 weeks, 16-20 weeks depending on response |
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: * Unresectable Stage III or Stage IV melanoma * Part 1 Dose Escalation: Prior melanoma treatment allowed except for the following: ipilimumab, BMS-982470 (rIL-21), anti-Progra...