drugset / Trial / NCT01008527
Phase I Oncovir Poly IC:LC and NY-ESO-1/gp100
Phase 1
Completed
22 enrolled
H. Lee Moffitt Cancer Center and Research Institute
National Cancer Institute (NCI) · collabOncovir, Inc. · collabPfizer · collab
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to determine what side effects CP 870,893 may cause when given with an immune stimulant called Oncovir poly IC:LC along with a melanoma vaccine. The CP 870,893, the Oncovir poly IC:LC and the melanoma vaccine are investigational drugs that have not been combined in patients before, and that have not been approved for sale by the Food and Drug Administration. The Oncovir poly IC:LC is intended to stimulate the body's immune system.
Timeline
- Start
- 2009-10
- Primary completion
- 2013-09
- Completion
- 2015-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Selicrelumab | Monoclonal antibody | 0.01 mg/kg | Intravenous |
| Subject | Selicrelumab | Monoclonal antibody | 0.025 mg/kg | Intravenous |
| Subject | Selicrelumab | Monoclonal antibody | 0.05 mg/kg | Intravenous |
| Subject | Selicrelumab | Monoclonal antibody | 0.1 mg/kg | Intravenous |
| Subject | Selicrelumab | Monoclonal antibody | 0.2 mg/kg | Intravenous |
| Background | Hiltonol | Other / unclassified | 1000 ug | Subcutaneous |
| Background | NY-ESO-l 157-165 (165V) | Peptide | 0.5 mg | Subcutaneous |
| Background | gpl002 80-288 (288V) | Peptide | 0.5 mg | Subcutaneous |