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

NCT03199040 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-05-28

Study results available
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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

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

Sponsors & Collaborators

  • MedImmune LLC

    collaborator INDUSTRY

  • National Cancer Institute (NCI)

    collaborator NIH

  • National Institutes of Health (NIH)

    collaborator NIH

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • William Gillanders, M.D. · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-23
Primary Completion
2022-11-21
Completion
2023-05-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03199040 on ClinicalTrials.gov