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RECRUITING
NCT07078604
PHASE2

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

Sponsor: University of Washington

View on ClinicalTrials.gov

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). 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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-03-20

Completion Date

2028-06-30

Last Updated

2026-04-07

Healthy Volunteers

No

Interventions

BIOLOGICAL

CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine

Given ID

DRUG

Chemotherapy

Given standard of care chemotherapy

PROCEDURE

Computed Tomography

Undergo CT scans

PROCEDURE

Computed Tomography Assisted Biopsy

Undergo CT-guided biopsy

BIOLOGICAL

Sargramostim

Given ID

PROCEDURE

Ultrasound-Guided Biopsy

Undergo ultrasound-guided biopsy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Positron Emission Tomography (PET)

Undergo PET scan

Locations (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States