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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 is a Phase 1 study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 18 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03199040
The ClinicalTrials.gov registry entry for NCT03199040 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 18 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 4 interventions - of which Durvalumab is the first listed.
NCT03199040 reports 0 study locations.
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.
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