drugset / Trial / NCT01176474
Vaccine Combining Multiple Class I Peptides and Montanide ISA 51VG With Escalating Doses of Anti-PD-1 Antibody Nivolumab or Ipilimumab With Nivolumab For Patients With Resected Stages IIIC/ IV Melanoma
Phase 1
Completed
73 enrolled
H. Lee Moffitt Cancer Center and Research Institute
Bristol-Myers Squibb · collabMedarex · collabNational Cancer Institute (NCI) · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to test the side effects of an investigational vaccine with an immune booster, or 2 different boosters together. Investigators also want to find out its effects on the immune system and whether it will decrease the chance that melanoma will return.
Timeline
- Start
- 2010-08-13
- Primary completion
- 2020-08
- Completion
- 2023-01-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ipilimumab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | Ipilimumab | Monoclonal antibody | 3 mg/kg | Intravenous |
| 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 | gp100:280-288(288V) | Vaccine | — | — |
| Background | Montanide ISA 51 vegetable grade (VG) | Unknown | — | Subcutaneous |