A Cancer Vaccine (STEMVAC) in Combination With Chemotherapy for the Treatment of PD-L1 Negative Metastatic Triple-Negative Breast Cancer
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: University of Washington
You may qualify if…
- ✓ 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
- ✓ Tumors with estrogen receptor (ER)-low (≤ 5%) or negative and progesterone receptor (PR)-low (≤ 5%) or negative will be included
- ✓ HER2-negative or HER2-low will be defined by the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) 2023 "Human Epidermal Growth Factor Receptor 2 (HER2) Breast Testing Guideline Update" which reaffirms the 2018 "HER2 Breast Testing Guideline Focused Update"
- ✓ Tumor is negative for PD-L1 marker testing per standard of care immunohistochemistry 22C3 pharmDx assay
- ✓ Metastatic disease that is measurable based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
You may not qualify if…
- ✕ 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
- ✕ Patients with any of the following cardiac conditions:
- ✕ Symptomatic restrictive cardiomyopathy
- ✕ Dilated cardiomyopathy
- ✕ Unstable angina within 4 months prior to enrollment
- ✕ New York Heart Association functional class III-IV heart failure on active treatment
Where it's recruiting
Seattle
Source: ClinicalTrials.gov · NCT07078604 · last updated 2026-04-07