drugset / Trial / NCT01489059
Safety Study of IL-21/Ipilimumab Combination in the Treatment of Melanoma
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to determine whether the combination of interleukin-21 (IL-21) and Ipilimumab in subjects with melanoma is safe, and provide preliminary information on the clinical benefits of the combination compared with Ipilimumab alone
Timeline
- Start
- 2011-12
- Primary completion
- 2014-06
- Completion
- 2014-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ipilimumab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Comparator | Ipilimumab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Comparator | Ipilimumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Recombinant Human Interleukin-21 | Protein / enzyme biologic | 10 ug/kg | Intravenous |
| Subject | Recombinant Human Interleukin-21 | Protein / enzyme biologic | 30 ug/kg | Intravenous |
| Subject | Recombinant Human Interleukin-21 | Protein / enzyme biologic | 50 ug/kg | Intravenous |
| Subject | Recombinant Human Interleukin-21 | Protein / enzyme biologic | 100 ug/kg | Intravenous |
| Subject | Recombinant Human Interleukin-21 | Protein / enzyme biologic | 150 ug/kg | Intravenous |