drugset / Trial / NCT01629758
Safety Study of IL-21/Anti-PD-1 Combination in the Treatment of Solid Tumors
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to determine whether the combination of the 2 drugs being investigated (IL-21 and anti-PD-1) is safe, and provide preliminary information on the clinical benefits of two different schedules of the combination.
Timeline
- Start
- 2012-06
- Primary completion
- 2014-12
- Completion
- 2014-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nivolumab | Monoclonal antibody | 3 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 | 75 ug/kg | Intravenous |
| Subject | Recombinant Human Interleukin-21 | Protein / enzyme biologic | 100 ug/kg | Intravenous |