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NCT03199040 · ClinicalTrials.gov registry record · Phase 1
Neoantigen DNA Vaccine Alone vs. Neoantigen DNA Vaccine Plus Durvalumab in Triple Negative Breast Cancer Patients Following Standard of Care Therapy
A Phase 1 study, sponsored by Washington University School of Medicine.
- Terminated
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT03199040: Clinical Trial Phase 1 study, sponsored by Washington University School of Medicine.
NCT03199040 is a Phase 1 study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03199040, a Phase 1 study, was terminated before completion, sponsored by Washington University School of Medicine.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
This is a single institution, open-label randomized phase 1 trial of neoantigen DNA vaccine alone vs. neoantigen DNA vaccine plus durvalumab in triple negative breast cancer (TNBC) patients following standard of care therapy. Patients with newly diagnosed clinical stage II-III TNBC are eligible for enrollment. Patients will receive standard of care therapy including chemotherapy, surgery and radiation therapy as clinically indicated. Following standard of care therapy, patients will be randomized to receive either a neoantigen DNA vaccine alone, or a neoantigen DNA vaccine + durvalumab.
Primary Outcome
* Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v4.03. * Assessment of the safety of neoantigen DNA vaccines will include both clinical observation and laboratory evaluation. Safety will be closely monitored after injection with eight or more clinical and laboratory assessments in the first 24 weeks of the trial
Interventions
- DRUG Durvalumab
- PROCEDURE Peripheral blood draw
- BIOLOGICAL Neoantigen DNA vaccine
- DEVICE TDS-IM system (Inchor Medical Systems)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2019-07-23 |
| Est. Completion | 2023-05-01 |
| Phase | Phase 1 |
Why NCT03199040 stopped before completion
NCT03199040 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 4 interventions - of which Durvalumab is the first listed.
NCT03199040 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03199040 about?
NCT03199040 is a clinical study titled "Neoantigen DNA Vaccine Alone vs. Neoantigen DNA Vaccine Plus Durvalumab in Triple Negative Breast Cancer Patients Following Standard of Care Therapy". This is a single institution, open-label randomized phase 1 trial of neoantigen DNA vaccine alone vs. neoantigen DNA vaccine plus durvalumab in triple negative breast cancer (TNBC) patients following standard of care therapy. Patients with newly diagnosed clinical stage II-III TNBC are eligible for ...
What is the current status of trial NCT03199040?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2019-07-23. Estimated completion is 2023-05-01.
What interventions are being tested in trial NCT03199040?
The interventions under investigation include: Durvalumab (DRUG), Peripheral blood draw (PROCEDURE), Neoantigen DNA vaccine (BIOLOGICAL), TDS-IM system (Inchor Medical Systems) (DEVICE).
Who is sponsoring clinical trial NCT03199040?
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 NCT03199040's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 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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