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A Cancer Vaccine (STEMVAC) with Chemotherapy for Metastatic Triple-Negative Breast Cancer

This study is looking at a cancer vaccine called STEMVAC combined with standard chemotherapy for patients with metastatic triple-negative breast cancer that is PD-L1 negative. Metastatic means the cancer has spread from its original site to other parts of the body. STEMVAC is designed to help your immune system recognize and fight cancer cells. Researchers want to see how well STEMVAC works and if it causes any side effects. They will also measure if your immune system responds to the vaccine. This study plans to enroll 20 adults aged 18 or older. To join, you must have metastatic triple-negative breast cancer that is PD-L1 negative.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 20 participants.
What's involved
You will receive STEMVAC and sargramostim injections, along with standard chemotherapy. You will also have CT scans, biopsies, and blood tests throughout the study.
Compensation
Not stated in the trial record.
Follow-up
After your study treatment is complete, you will have follow-up appointments at 21 or 28 days, and then every 6 months for 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07078604

A Cancer Vaccine (STEMVAC) in Combination With Chemotherapy for the Treatment of PD-L1 Negative Metastatic Triple-Negative Breast Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Washington
~20 participants
Updated 2026-08-04 on ClinicalTrials.gov
What's tested:CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA VaccineChemotherapyComputed TomographySargramostimBiospecimen CollectionPositron Emission Tomography (PET)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of immunogenicity of CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope plasmid deoxyribonucleic acid vaccine (STEMVAC): Incidence of patients who develop a positive immunogenic response after vaccination
Measured over Baseline up to 7 months after STEMVAC priming dose #3
+1 more outcome measured

Conditions

Anatomic Stage IV Breast Cancer AJCC v8
Metastatic Triple-Negative Breast Carcinoma

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
Washington1

Study leadership

  • Brie Chun, MD · PRINCIPAL_INVESTIGATOR · Fred Hutch/University of Washington Cancer Consortium

Who to contact

Research Coordinator(s)
[email protected]
1-866-932-8588
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
Have at least 1 site of disease confirmed by the treating oncologist that could be biopsied during treatment. Lesions that will be biopsied should not be in a previously irradiated area unless progression has been demonstrated in such lesions
Patients can not have received any prior cancer immunotherapy in the metastatic setting
Prior Food and Drug Administration (FDA)-approved antibody drug conjugates are allowed
Patients are appropriate candidates to receive standard of care chemotherapy as per treating oncologist's clinical judgement
Patients who have received prior neoadjuvant or adjuvant chemotherapy are allowed
A minimum of 14 days washout since last systemic therapy or any palliative radiotherapy is required
Treatment with a bisphosphate or denosumab concurrently with protocol-specific therapy is allowed while on study (it is not exclusionary)
Patients must be at least 28 days post systemic steroids prior to enrollment, unless this is a steroid administered concurrently with chemotherapy or used as part of prophylaxis to prevent intravenous (IV) contrast reactions
Must have recovered from major infections and/or surgical procedures; and in the opinion of the investigator, not have any significant active concurrent medical illnesses or condition precluding protocol treatment
Willing to undergo up to two serial biopsies while on study
White blood cell (WBC) ≥ 2.5 THOU/uL (Within 28 days of receiving first study vaccine)
Lymphocyte count ≥ 0.5 THOU/uL (Within 28 days of receiving first study vaccine)
Absolute neutrophil count (ANC) ≥ 1.0 THOU/uL (Within 28 days of receiving first study vaccine)
Hemoglobin (Hgb) ≥ 9 g/dL (Within 28 days of receiving first study vaccine)
Platelets ≥ 75 THOU/uL (Within 28 days of receiving first study vaccine)
Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN), except patients with Gilbert's syndrome in whom total bilirubin must be \< 3.0 mg/d (Within 28 days of receiving first study vaccine)
Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 1.5 x institutional ULN (Within 28 days of receiving first study vaccine)
Creatinine ≤ 1.5 x ULN mg/dL or creatinine clearance \> 60 mL/min (Within 28 days of receiving first study vaccine)
Patients of child-bearing potential must agree to use dual methods of contraception and have a negative urine pregnancy test at screening, and male patients must use an effective barrier method of contraception if sexually active with a person of child-bearing potential. Acceptable methods of contraception are abstinence, condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal. Effective methods of contraception must be used throughout the study until the end of treatment on study

Exclusion

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. Participation in a trial for chimeric antigen receptor (CAR)-T cell therapy may be permitted if the CAR-T cell therapy is not planned to occur until after the currently proposed treatment (i.e. no longer participating in STEMVAC and chemotherapy trial)
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
Symptomatic pericardial effusion
Patients with any autoimmune disease or comorbidities that require chronic systemic steroids or immunosuppressants. Patients with conditions requiring inhaled, intranasal or topical steroids are permitted
Known hypersensitivity reaction to the granulocyte-macrophage colony stimulating factor (GM-CSF) adjuvant; any known contra-indication to GM-CSF
A non-breast malignancy requiring radiation or systemic therapy within last 5 years or any B-cell malignancy (e.g., chronic lymphocytic leukemia or follicular lymphoma) under active surveillance
Pregnant and breastfeeding individuals
Known history of human immunodeficiency virus (HIV) infection, hepatitis B (e.g., hepatitis B virus surface antigen \[HBsAg\] reactive), or hepatitis C (e.g., hepatitis C virus \[HCV\] ribonucleic acid \[RNA\] \[qualitative\] is detected)
Major surgery within the 4 weeks prior to initiation of study vaccine
Must be 14 days between a non-study vaccine, including live attenuated and non-live vaccines and any STEMVAC vaccination
Note: The minimum of 14 days does not apply to the tetanus and diphtheria (Td) vaccine
Any condition that may interfere with the patient's participation in the study per treating physician

What this trial measures

  • Incidence of immunogenicity of CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope plasmid deoxyribonucleic acid vaccine (STEMVAC): Incidence of patients who develop a positive immunogenic response after vaccinationBaseline up to 7 months after STEMVAC priming dose #3

    The Th1 STEMVAC antigen specific immune response will be determined by IFN-gamma ELISPOT. Magnitude of Th1 response will be defined for each antigen in STEMVAC for each patient as the value of the corrected spots per well (CSPW) (CSPW= \[(mean of spots in the antigen stimulated wells) - (mean of antigens for the no-antigen negative control wells)\] for the same time point). Patients are considered to have preexisting immune response if the mean of spots in antigen wells is greater than the mean + 2 standard deviations of no-antigen wells at baseline. Patients are considered to have generated or enhanced antigen specific immunity post-vaccine if the maximal corrected IFN-gamma response post-vaccine is greater than the mean + 2 standard deviations of the baseline level (p \< 0.05). A patient will be considered an immunogenic responder if they develop an antigen-specific immune response to at least 1 of the 5 vaccine antigens.

  • Incidence of adverse eventsUp to 21 or 28 days after completion of study treatment

    Will be determined by chemical and clinical parameters evaluated at various time points. Toxicity grading will be evaluated according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 6.0 and monitoring of adverse events will be done per Food and Drug Administration and NCI guidelines. Descriptive statistics will be provided on the key demographic and clinical variables, such as mean, standard deviation, and range for continuous variables, and percent and number for categorical variables, such as toxicity grades.