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

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT07078604
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine — BIOLOGICAL
    Given ID
  • Chemotherapy — DRUG
    Given standard of care chemotherapy
  • Computed Tomography — PROCEDURE
    Undergo CT scans
  • Computed Tomography Assisted Biopsy — PROCEDURE
    Undergo CT-guided biopsy
  • Sargramostim — BIOLOGICAL
    Given ID
  • Ultrasound-Guided Biopsy — PROCEDURE
    Undergo ultrasound-guided biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Positron Emission Tomography (PET) — PROCEDURE
    Undergo PET scan

Study Details

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.

Key Dates

Start date
Mar 20, 2026
Status verified
Mar 2026
Primary completion
Apr 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (chemotherapy, STEMVAC, GM-CSF)
    Patients 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 CT or ultrasound-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 CT or ultrasound-guided biopsy, for research purposes, during screening.

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109
Research Coordinator(s)
[email protected]
866-932-8588
Brie Chun, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Seattle, WA

By research site
Fred Hutch/University of Washington Cancer Consortium· Seattle, WA

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