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NCT03532217 · ClinicalTrials.gov registry record · Phase 1
Neoantigen DNA Vaccine in Combination With Nivolumab/Ipilimumab and PROSTVAC in Metastatic Hormone-Sensitive Prostate Cancer
A Phase 1 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT03532217 is a Phase 1 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 19 participants.
The verdict
NCT03532217, a Phase 1 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study 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.
Interventions
- DRUG Nivolumab
- DRUG Ipilimumab
- BIOLOGICAL Neoantigen DNA vaccine
- BIOLOGICAL PROSTVAC-V
- BIOLOGICAL PROSTVAC-F
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2018-09-14 |
| Est. Completion | 2022-07-25 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03532217
The ClinicalTrials.gov registry entry for NCT03532217 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Nivolumab is the first listed.
NCT03532217 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03532217 about?
NCT03532217 is a clinical study titled "Neoantigen DNA Vaccine in Combination With Nivolumab/Ipilimumab and PROSTVAC in Metastatic Hormone-Sensitive Prostate Cancer". 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...
What is the current status of trial NCT03532217?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2018-09-14. Estimated completion is 2022-07-25.
What interventions are being tested in trial NCT03532217?
The interventions under investigation include: Nivolumab (DRUG), Ipilimumab (DRUG), Neoantigen DNA vaccine (BIOLOGICAL), PROSTVAC-V (BIOLOGICAL), PROSTVAC-F (BIOLOGICAL).
Who is sponsoring clinical trial NCT03532217?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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