drugset / Trial / NCT01176461
Multiple Class I Peptides & Montanide ISA 51 VG w Escalating Doses of Anti-PD-1 ab BMS936558
Phase 1
Completed
127 enrolled
H. Lee Moffitt Cancer Center and Research Institute
Bristol-Myers Squibb · collabMedarex · collabNational Cancer Institute (NCI) · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a pilot phase 1, open-label, single center, multi-dose, dose-escalation study of BMS-936558 in combination with or without a peptide vaccine. The purpose of this study is to test the side effects of an investigational vaccine with an immune booster. Investigators also wish to find out its effects on the patient's immune system and whether it will shrink their melanoma.
Timeline
- Start
- 2010-08-04
- Primary completion
- 2016-12-12
- Completion
- 2016-12-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MART-1 | Peptide | — | — |
| Subject | NY-ESO-1 | Protein / enzyme biologic | — | — |
| Subject | Nivolumab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | gp100:209-217(210M) | Peptide | — | — |
| Subject | gp100:280-288(288V) | Vaccine | — | — |
| Background | incomplete Freund's adjuvant | Other / unclassified | — | Subcutaneous |