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Anatomic Stage IV Breast Cancer AJCC v8Phase 2NCT07078604

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

A Phase 2 study testing CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine, Chemotherapy and Computed Tomography in people with Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Triple-Negative Breast Carcinoma, run by University of Washington at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine, Chemotherapy and Computed Tomography
Type of treatment
Vaccines, Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
24 Mar 2026to 30 Jun 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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"
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Research Coordinator(s) contact

1-866-932-8588

cvitrial@uw.edu

United States1 site, 1 recruiting

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109

    Research Coordinator(s), 866-932-8588, cvitrial@uw.edu

    Brie Chun, MD

    Recruiting

Other trials in United States

About this study

Official title: A Phase II Trial of the Immunogenicity of a DNA Plasmid-Based Vaccine (STEMVAC) Encoding Th1 Selective Epitopes From Five Antigens Associated With Breast Cancer Stem Cells (MDM2, YB1, SOX2, CDH3, CD105) in Patients With Metastatic Triple-Negative Breast Cancer

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.

Read the detailed description

OUTLINE:

Patients receive systemic standard of care chemotherapy as determined by their attending medical oncologist. Patients receive 3 priming doses of STEMVAC with sargramostim intradermally (ID) every 21-28 days (7-13 days after each chemotherapy administration or during the off week of weekly chemotherapy), 2 booster STEMVAC/sargramostim doses at 4 and 7 months after 3rd priming dose, and then every 6 months in the absence of disease progression or unacceptable toxicity. Patients also undergo image-guided biopsy, for research purposes, on study, as well as computed tomography (CT) or positron emission tomography (PET) scans and blood sample collection throughout the study. In addition, patients may also undergo image-guided biopsy, for research purposes, during screening.

After completion of study treatment, patients are followed up at 21 or 28 days and then every 6 months for 3 years.

Being tested
CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine, Chemotherapy, Computed Tomography, Sargramostim, Biospecimen Collection
Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA VaccineBiological

    Also called CD105/Yb-1/SOX2/CDH3/MDM2 Plasmid Vaccine, STEMVAC, STEMVAC Th1 Polyepitope Plasmid-based Vaccine

    Given ID

  • ChemotherapyDrug

    Given standard of care chemotherapy

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT scans

  • SargramostimBiological

    Also called 23-L-Leucinecolony-Stimulating Factor 2, DRG-0012, Leukine, Prokine

    Given ID

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection

    Undergo blood sample collection

  • Positron Emission Tomography (PET)Procedure or surgery

    Also called Medical Imaging, PET scan, PT

    Undergo PET scan

  • Image Guided BiopsyProcedure or surgery

    Also called Image-Guided Biopsy, Imaging for Biopsy, Imaging Guided Biopsy

    Undergo image-guided biopsy

Study groups in NCT07078604
Study groupRoleWhat they receive
Treatment (chemotherapy, STEMVAC, GM-CSF)ExperimentalPatients receive systemic standard of care chemotherapy as determined by their attending medical oncologist. Patients receive 3 priming doses of STEMVAC with sargramostim ID every 21-28 days (7-13 days after each chemotherapy administration or during the off week of weekly chemotherapy), 2 booster STEMVAC/sargramostim doses at 4 and 7 months after 3rd priming dose, and then every 6 months in the absence of disease progression or unacceptable toxicity. Patients also undergo image-guided biopsy, for research purposes, on study, as well as CT or PET scans and blood sample collection throughout the study. In addition, patients may also undergo image-guided biopsy, for research purposes, during screening.
Receives: Biological: CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine; Drug: Chemotherapy; Procedure: Computed Tomography; Biological: Sargramostim; Procedure: Biospecimen Collection; Procedure: Positron Emission Tomography (PET); Procedure: Image Guided Biopsy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    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.

    Measured: Baseline up to 7 months after STEMVAC priming dose #3

  2. Incidence of adverse events

    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.

    Measured: Up to 21 or 28 days after completion of study treatment

Secondary outcomes (4)

  1. 6-month overall response rate

    Will evaluate the clinical response to treatment following the first booster dose of STEMVAC using standard of care imaging and RECIST 1.1.

    Measured: At 6 months

  2. Progression-free survival (PFS)

    Will evaluate the real-world progression-free survival to first subsequent therapy, defined as the date of first subsequent therapy after STEMVAC immunization and chemotherapy to disease progression, initiation of hospice or death as extracted from clinical notes.

    Measured: From the start of treatment to the worsening of cancer or death whichever occurs first, assessed up to 3 years after completion of study treatment

  3. Overall survival (OS)

    Overall survival will be defined by patient survival or death from the start of treatment.

    Measured: Up to 3 years after completion of study treatment

  4. Magnitude of immunogenicity of CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope plasmid deoxyribonucleic acid vaccine (STEMVAC)

    Defined as the sum of the interferon gamma enzyme-linked immunosorbent spot of all STEMVAC antigens on blood samples collected pre-vaccine as compared to 1-month post dose #3 of the STEMVAC vaccine and again after 2 booster doses of STEMVAC vaccine. The magnitude of immunity will be calculated as the sum of antigen-specific immune responses across the five vaccine antigens. The mean and maximum post-vaccine immune responses will be summarized and compared with pre-treatment levels. If substantial outliers are present or the data are non-normally distributed, the Wilcoxon signed-rank test will be used to assess differences between pre-treatment and post-vaccine priming samples.

    Measured: Baseline up to 7 months after STEMVAC priming dose #3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2025
  2. Study start24 Mar 2026
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07078604
Sponsor's protocol ID
RG1125414
Other IDs
NCI-2025-04327, 20925
Status last verified
Jul 2026
First submitted
11 Jul 2025
Last updated
4 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine, Chemotherapy and Computed Tomography in people with Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Triple-Negative Breast Carcinoma, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Research Coordinator(s) (1-866-932-8588, cvitrial@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Baseline up to 7 months after STEMVAC priming dose #3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07078604.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.

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