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

• Status: Active, not recruiting
• Trial end date: 2022-12-03

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.

• Phase: Phase 1

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborators: MedImmune LLC; National Cancer Institute (NCI); National Institutes of Health (NIH)
• Treatments: Antibodies, Monoclonal; Durvalumab; Vaccines