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Anatomic Stage IB Breast Cancer AJCC v8Phase 2NCT05455658

STEMVAC in Patients With Early Stage Triple Negative Breast Cancer

A Phase 2 study testing CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine and Sargramostim in people with Anatomic Stage IB Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by University of Washington at 3 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This phase II trial studies the effect of DNA plasmid based vaccine (STEMVAC) in treating patients with patients with stage IB-III triple negative breast cancer. STEMVAC may wake up the immune system in patients who have had a diagnosis of triple negative breast cancer and have been treated. 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 and Sargramostim
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
3 sitesUnited States
Study dates
17 Nov 2022to 16 Jul 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

  • Participants with triple negative breast cancer, stages IB, II or III. Estrogen receptor (ER)-negative and progesterone receptor (PR)-negative is defined as breast cancer with less than 10% of ER or PR expression. HER2 negative is defined as:
  • 0-1+ HER2 expression by immunohistochemistry (IHC) OR
  • Fluorescence in situ hybridization (FISH) negative OR
  • HER2 2+ and FISH negative
  • Note: Participants with low ER positivity (≤10%) who are already on adjuvant hormonal therapy will be allowed on study and can continue their adjuvant hormonal treatment during study participation.
  • Participants must have completed all standard of care (or investigational) systemic therapy (including immune modulating agents) and radiotherapy if used between 28 and 365 days prior to enrollment
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  • Note: Treatment with a bisphosphonate or denosumab to prevent bone loss is not considered to be systemic therapy for breast cancer and its use within the 28 day pre-enrollment period or while on study is not exclusionary. Treatment with adjuvant olaparib within the 28 day pre-enrollment period or while on study is not exclusionary.
  • Participants must agree to avoid systemic steroids for the duration of the treatment period and until completion of the 1 month post 2nd booster vaccine visit (end of treatment)
  • Participants 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 participants < 18 years of age, children and adolescents are excluded from this study but will be eligible for future pediatric trials, if applicable.
  • Participants must have Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1
  • White blood cell (WBC) >= 3000/mm^3 (within 60 days of enrollment and at least 28 days post standard of care [SOC] treatment)
  • Lymphocyte count >= 800/mm^3 (within 60 days of enrollment and at least 28 days post standard of care [SOC] treatment)
  • Platelet count >= 100,000/mm^3 (within 60 days of enrollment and at least 28 days post standard of care [SOC] treatment)
  • Hemoglobin (Hgb) >= 10 g/dl (within 60 days of enrollment and at least 28 days post standard of care [SOC] treatment)
  • Serum creatinine =< 1.2 mg/dl OR creatinine clearance > 60 ml/min (within 60 days of enrollment and at least 28 days post standard of care [SOC] treatment)
  • Total bilirubin =< 1.5 X upper limit of institutional normal (ULN) (within 60 days of enrollment and at least 28 days post standard of care [SOC] treatment)
  • AST (aspartate aminotransferase)/serum glutamic-oxaloacetic transaminase (SGOT) =< 1.5 X upper limit of institutional normal (ULN) (within 60 days of enrollment and at least 28 days post standard of care [SOC] treatment)
  • 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
  • The effects of STEMVAC on the developing human fetus are unknown. For this reason,
  • Female participant agrees to use adequate contraception (examples include: estrogen and/or progestogen containing hormonal contraception, barrier method (condom, cervical cap) or abstinence) while on the study and until 1 month after the 2nd booster vaccination when/if engaging in sex that could lead to pregnancy. Exceptions: Females who have had a hysterectomy, tubal ligation or bilateral oophorectomy OR meet one of the following criteria for postmenopausal: Age > 60 or age < 60 with >= 12 months amenorrhea and follicle-stimulating hormone (FSH) within the testing facility's postmenopausal range
  • Female participant agrees to inform her study physician immediately should she become pregnant or suspect she is pregnant while participating in this study
  • Male participants who are having sex that can lead to pregnancy must use an acceptable form of contraception (vasectomy with the absence of sperm, sexual abstinence, condoms) throughout the course of the study
  • Must be 14 days between a vaccine (i.e. COVID19, Flu, shingrix, Tdap, etc.) and any STEMVAC vaccination. **Note: This does not apply to the Td vaccine.
  • Patients must be willing to not undergo major elective surgical procedures with general anesthesia or conscious sedation through the end of treatment visit. (Note: port removal is allowable)
  • Ability to understand and the willingness to sign a written informed consent document

Who cannot join

  • Contraindication or known hypersensitivity to receiving sargramostim (rhuGM-CSF) or other products
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to STEMVAC
  • Participants receiving any other investigational agents
  • Chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs) is prohibited during the treatment period of the study, except when taken as low-dose (81 mg) aspirin therapy. Prohibited chronic use is defined as daily use for more than 7 days
  • Participants with any clinically significant autoimmune disease uncontrolled with treatment
  • Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements
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  • Pregnant and breastfeeding women are excluded from this study
  • Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C
  • Note: These individuals are excluded in order to avoid confounding an existing condition with an immune response to STEMVAC
  • Chronic usage of immunosuppressants and glucocorticoids (methotrexate for RA, etc.)
  • History of invasive breast cancer prior to TNBC diagnosis * Note: Prior DCIS is allowable

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21287

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 53792

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109

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, CDC25B, CD105) in Participants With Early Stage Triple Negative Breast Cancer

This phase II trial studies the effect of DNA plasmid based vaccine (STEMVAC) in treating patients with patients with stage IB-III triple negative breast cancer. STEMVAC may wake up the immune system in patients who have had a diagnosis of triple negative breast cancer and have been treated. STEMVAC targets proteins that are expressed on breast cancer cells and works by boosting the immune system to recognize and destroy the invader cancer cell proteins that are causing the disease. The purpose of this trial is to test the immune system's response to STEMVAC.

Read the detailed description

OUTLINE:

Patients receive STEMVAC vaccine with sargramostim intradermally (ID) every month for 3 months in the absence of disease progression or unacceptable toxicity. Patients then receive STEMVAC vaccine with sargramostim ID booster injections 3 months after the 3rd vaccination and 6 months after the 1st booster vaccination.

After completion of study treatment, patients are followed up at 28 days, and then annually for 5 years.

Being tested
CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine, Sargramostim
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 IV

  • SargramostimBiological

    Also called 123774-72-1, 23-L-Leucinecolony-Stimulating Factor 2, DRG-0012, Leukine

    Given ID

Study groups in NCT05455658
Study groupRoleWhat they receive
Prevention (STEMVAC vaccine, sargramostim)ExperimentalPatients receive STEMVAC vaccine with sargramostim ID every month for 3 months in the absence of disease progression or unacceptable toxicity. Patients then receive STEMVAC vaccine with sargramostim ID booster injections 3 months after the 3rd vaccination and 6 months after the 1st booster vaccination.
Receives: Biological: CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine; Biological: Sargramostim

What is being measured

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

  1. Cellular immune response: incidence

    Defined by the incidence of development of the Th1 (IFN-gamma [g]) antigen specific immune response against STEMVAC antigens using enzyme-linked immunosorbent spot assay (ELISPOT).

    Measured: At 1 month after 3rd vaccination

  2. Cellular immune response: incidence

    Defined by the incidence of development of the Th1 (IFN-gamma [g]) antigen specific immune response against STEMVAC antigens using enzyme-linked immunosorbent spot assay (ELISPOT).

    Measured: At 10 months after 3rd vaccination

  3. Cellular immune response: magnitude

    Defined by the magnitude of development of the Th1 (IFN-gamma [g]) antigen specific immune response against STEMVAC antigens using enzyme-linked immunosorbent spot assay (ELISPOT). The magnitude of immune response is defined as the sum of the corrected spots/well values calculated at each time point.

    Measured: At 1 month after 3rd vaccination

  4. Cellular immune response: magnitude

    Defined by the magnitude of development of the Th1 (IFN-gamma [g]) antigen specific immune response against STEMVAC antigens using enzyme-linked immunosorbent spot assay (ELISPOT). The magnitude of immune response is defined as the sum of the corrected spots/well values calculated at each time point.

    Measured: At 3 months after 3rd vaccination

  5. Cellular immune response: magnitude

    Defined by the magnitude of development of the Th1 (IFN-gamma [g]) antigen specific immune response against STEMVAC antigens using enzyme-linked immunosorbent spot assay (ELISPOT). The magnitude of immune response is defined as the sum of the corrected spots/well values calculated at each time point.

    Measured: At 9 months after 3rd vaccination

  6. Cellular immune response: magnitude

    Defined by the magnitude of development of the Th1 (IFN-gamma [g]) antigen specific immune response against STEMVAC antigens using enzyme-linked immunosorbent spot assay (ELISPOT). The magnitude of immune response is defined as the sum of the corrected spots/well values calculated at each time point.

    Measured: At 10 months after 3rd vaccination

Secondary outcomes (4)

  1. Kinetics of the magnitude of antigen specific IFN-gamma ELISPOT counts

    Will be assessed over time from pre to post immunization to determine if pre-existent immunity affects magnitude of response.

    Measured: 13 months

  2. Incidence of adverse events

    Safety and systemic toxicity 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 5.0 and monitoring of adverse events will be done per Food and Drug Administration and NCI guidelines.

    Measured: 1 month after last booster vaccine

  3. Activation status and repertoire diversity of peripheral blood T-cells

    The peripheral T cell repertoire diversity will be determined by high-throughput deoxyribonucleic acid (DNA) sequencing of the recombined V(D)J region of the T cell receptor beta-chain (TCRB) using the immunoSEQ platform (Adaptive Biotechnologies) on antigen-specific T-cells from a short-term in vitro culture. The activation, exhaustion and memory status of the peripheral T cells will be determined by flow cytometry using fluorochrome linked antibodies to PD-1, CD4, CD3, LAG3, CD137, CD8, KLGR1, CD44, CD69, CD62L and OX40. Transcription factors for Th1 (Tbet), Th2 (GATA3) and Treg (FOXP3) will also be evaluated. All results will be summarized using simple descriptive statistics.

    Measured: Prior to and after STEMVAC vaccination

  4. Relapse free survival (RFS)

    Will explore if adjuvant vaccination with STEMVAC improves relapse free survival as compared to historical controls. Local and distant recurrence at year 5 will be reported as proportion with confidence intervals, and RFS will be estimated using Kaplan-Meier method with the 5-year RFS rate estimated from the Kaplan-Meier estimate of the survival distribution along with a 95% confidence interval. Comparison of the local and distant recurrence and 5-year RFS against the historical control will be based on a binomial test.

    Measured: Up to 5 years

Timeline

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

  1. First posted13 Jul 2022
  2. Study start17 Nov 2022
  3. Primary completion1 Jun 2026
  4. Study completion16 Jul 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
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05455658
Sponsor's protocol ID
RG1122380
Other IDs
NCI-2021-07734, UG1CA242635, UWI20-00-01
Status last verified
Jul 2026
First submitted
30 Jun 2022
Last updated
23 Jul 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 and Sargramostim in people with Anatomic Stage IB Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by University of Washington at 3 sites 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 26 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cellular immune response: incidence (time frame: At 1 month after 3rd vaccination). The study lists 6 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 NCT05455658.

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 23 Jul 2026.

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