drugset / Trial / NCT03597282
A Personal Cancer Vaccine (NEO-PV-01) and APX005M or Ipilimumab With Nivolumab in Patients With Advanced Melanoma
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The primary purpose of this study is to demonstrate that the NEO-PV-01 vaccine, either with APX005M or ipilimumab, and nivolumab is safe for the treatment of patients with advanced or metastatic melanoma. The study will also investigate an alternative schedule for the administration of the NEO-PV-01 vaccine. Study interventions will be assessed by both clinical and immune responses to treatment.
Timeline
- Start
- 2018-10-08
- Primary completion
- 2020-05-05
- Completion
- 2020-08-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ipilimumab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | NEO-PV-01 | Vaccine | — | Subcutaneous |
| Subject | Nivolumab | Monoclonal antibody | 240 mg | Intravenous |
| Subject | sotigalimab | Monoclonal antibody | 0.1 mg/kg | Intravenous |