This phase II trial studies how well a cancer vaccine called STEMVAC works in combination with chemotherapy in treating patients with PD-L1 negative, triple-negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). STEMVAC is designed to target proteins that are expressed on breast cancer stem cells, and it is believed to work by boosting the immune system to recognize and destroy the invader tumor cells that are causing the disease. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving STEMVAC in combination with chemotherapy may be an effective treatment for PD-L1 negative metastatic triple-negative breast cancer.
Patients must be at least ≥ 18 years of age
Note: Because no dosing or adverse event (AE) data are currently available on the use of STEMVAC in patients < 18 years of age, children and adolescents are excluded from this study, but will be eligible for future pediatric trials, if applicable
Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status Score of ≤ 2
Histologically confirmed triple-negative breast cancer
Patient has received more than one line of prior therapy in metastatic setting
Patients with tumors that are PD-L1-positive per standard of care immunohistochemistry 22C3 pharmDx assay
Enrollment in a concurrent interventional clinical trial. Biomarker or tissue collection or any other non-interventional clinical trial enrollment is allowed
Symptomatic restrictive cardiomyopathy
University of Washington
Lead sponsor
Kuni Foundation
Collaborator