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A Phase 1b Study of Safety and Immune Response to PVX-410 Vaccine Alone and in Combination with an Antibody Targeting the PD-1/PD-L1 Pathway in HLA-A2+ Subjects Who Have Completed Initial Standard Treatment of Stage II or III Triple Negative Breast Cancer (TNBC)
The purpose of this research study is to evaluate Immunotherapy with a peptide vaccine and Programmed Death Ligand 1 (PD-L1) inhibitor as a possible adjuvant treatment for Stage II or III Triple Negative Breast Cancer. This research study is studying the safety, tolerability, and immune response of these treatments. The names of the study interventions involved in this study are: PVX-410 Vaccine Durvalumab (MEDI4736)
Primary Objective The primary objective of this study is: - to assess and explore the safety and tolerability of 3 injections of PVX-410 alone followed by 3 doses of PVX-410 in combination with 2 infusions of durvalumab. Secondary Objectives The secondary objectives of this study are: - to perform a pair-wise comparison of the immune response to PVX-410 and PVX-410 plus durvalumab using patients as their own controls. - to assess disease-free survival. - to evaluate correlative immune response indicators. - to compare the safety profile of PVX-410 vaccine regimen alone versus PVX-410 vaccine regimen plus durvalumab.