Clinical Trials Directory

Trials / Terminated

TerminatedNCT03199040

Neoantigen DNA Vaccine Alone vs. Neoantigen DNA Vaccine Plus Durvalumab in Triple Negative Breast Cancer Patients Following Standard of Care Therapy

A Randomized Phase 1 Trial of Neoantigen DNA Vaccine Alone vs. Neoantigen DNA Vaccine Plus Durvalumab in Triple Negative Breast Cancer Patients Following Standard of Care Therapy

Status
Terminated
Phase
Phase 1
Study type
Interventional
Enrollment
18 (actual)
Sponsor
Washington University School of Medicine · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGDurvalumab-Human monoclonal antibody
BIOLOGICALNeoantigen DNA vaccine-The vaccine will be given by the TDS-IM system
DEVICETDS-IM system (Inchor Medical Systems)-At each vaccination time point, patients will receive two injections at separate sites.
PROCEDUREPeripheral blood draw-Baseline, following completion of standard of care therapy, Day 1, Day 57, Day 113, Day 159, and 1 year after initiation of neoantigen DNA vaccine therapy

Timeline

Start date
2019-07-23
Primary completion
2022-11-21
Completion
2023-05-01
First posted
2017-06-26
Last updated
2024-05-28
Results posted
2023-12-14

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT03199040. Inclusion in this directory is not an endorsement.