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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: Completed Phase 1 study, sponsored by Washington University School of Medicine.
NCT03532217 is a Phase 1 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
-Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0
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 |
What the finished NCT03532217 record still lists
NCT03532217 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 5 interventions - of which Nivolumab is the first listed.
NCT03532217 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03532217's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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