drugset / Trial / NCT03532217
Neoantigen DNA Vaccine in Combination With Nivolumab/Ipilimumab and PROSTVAC in Metastatic Hormone-Sensitive Prostate Cancer
Phase 1
Completed
19 enrolled
Washington University School of Medicine
Bavarian Nordic · collabBristol-Myers Squibb · collabProstate Cancer Foundation · collabThe Foundation for Barnes-Jewish Hospital · collab
NaSingle-groupOpen-labelTreatment
Summary
This study study aims to elucidate the immune responses to a shared antigen vaccine (PROSTVAC) and tumor specific antigens generated DNA vaccine in combination with checkpoint blockade using nivolumab (anti-PD-1), and ipilimumab (anti-CTLA-4). Additionally, the investigators will study the impact of the combination immunotherapy on peripheral T cell activation, as well as immune response in the tumor microenvironment. Finally, the investigators will evaluate the safety and tolerability to this novel personalized immunotherapy in combination with checkpoint blockade.
Timeline
- Start
- 2018-09-14
- Primary completion
- 2022-04-01
- Completion
- 2022-07-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ipilimumab | Monoclonal antibody | — | — |
| Subject | Neoantigen DNA vaccine | Vaccine | 4 mg | Intramuscular |
| Subject | Nivolumab | Monoclonal antibody | 480 mg | Intravenous |
| Subject | PROSTVAC-F | Vaccine | — | — |
| Subject | PROSTVAC-V | Vaccine | — | — |