NCT03199040 - Neoantigen DNA Vaccine Alone vs. Neoantigen DNA Vaccine Plus Durvalumab in Triple Negative Breast Cancer Patients Following Standard of Care Therapy | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

July 23, 2019

Primary Completion Date

November 21, 2022

Study Completion Date

May 1, 2023

Conditions

Triple Negative Breast CancerTriple Negative Breast NeoplasmsTNBC - Triple-Negative Breast CancerTriple-negative Breast Carcinoma

Interventions

DRUG

Durvalumab

-Human monoclonal antibody

BIOLOGICAL

Neoantigen DNA vaccine

-The vaccine will be given by the TDS-IM system

DEVICE

TDS-IM system (Inchor Medical Systems)

-At each vaccination time point, patients will receive two injections at separate sites.

PROCEDURE

Peripheral 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

Trial Locations (1)

63110

Washington University School of Medicine, St Louis