Actively Recruiting
A Cancer Vaccine (STEMVAC) in Combination With Chemotherapy for the Treatment of PD-L1 Negative Metastatic Triple-Negative Breast Cancer
Led by University of Washington · Updated on 2026-04-07
20
Participants Needed
1
Research Sites
119 weeks
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
K
Kuni Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Cancer Vaccine (STEMVAC) in Combination With Chemotherapy for the Treatment of PD-L1 Negative Metastatic Triple-Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be at least 18 years of age
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 2 or less
- Histologically confirmed triple-negative breast cancer (ER and PR 64 5% or negative; HER2-negative or HER2-low)
- Tumor tested negative for PD-L1 marker by immunohistochemistry 22C3 pharmDx assay
- Measurable metastatic disease according to RECIST 1.1 criteria
- At least one biopsy-accessible disease site not used to determine measurable disease
- No prior cancer immunotherapy in the metastatic setting
- Prior FDA-approved antibody drug conjugates allowed
- Suitable for standard of care chemotherapy as determined by treating oncologist
- Prior neoadjuvant or adjuvant chemotherapy allowed
- Minimum 14 days washout since last systemic therapy or palliative radiotherapy
- Treatment with bisphosphonate or denosumab allowed during study
- At least 28 days post systemic steroids unless given with chemotherapy or for IV contrast prophylaxis
- Recovered from major infections and surgeries; no significant active illnesses preventing treatment
- Willing to undergo up to two biopsies during study
- Adequate blood counts and liver/kidney function within 28 days before first vaccine dose
- Female patients of child-bearing potential must use dual contraception and have negative pregnancy test; male patients must use barrier contraception if sexually active with someone of child-bearing potential
- Effective contraception used throughout study until end of treatment
You will not qualify if you...
- More than one prior line of therapy in metastatic setting
- Tumors positive for PD-L1 by immunohistochemistry 22C3 pharmDx assay
- Enrollment in another interventional clinical trial (non-interventional trials allowed)
- Cardiac conditions: symptomatic restrictive or dilated cardiomyopathy, unstable angina within 4 months, NYHA class III-IV heart failure on active treatment, symptomatic pericardial effusion
- Autoimmune diseases requiring chronic systemic steroids or immunosuppressants (inhaled, intranasal, or topical steroids allowed)
- Known hypersensitivity or contraindication to GM-CSF
- Non-breast malignancy requiring recent radiation or systemic therapy within 5 years, or active B-cell malignancy under surveillance
- Pregnant or breastfeeding individuals
- Known HIV, hepatitis B, or hepatitis C infection
- Major surgery within 4 weeks prior to study vaccine start
- Less than 14 days between any non-study vaccine and STEMVAC vaccination (except tetanus and diphtheria vaccines)
- Any condition interfering with study participation as judged by treating physician
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
R
Research Coordinator(s)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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