RecruitingPhase 2NCT07078604

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

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


Sponsor

University of Washington

Enrollment

20 participants

Start Date

Mar 20, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a cancer vaccine called STEMVAC combined with standard chemotherapy for people with a hard-to-treat form of advanced breast cancer called triple-negative breast cancer (TNBC) that does not have a specific immune marker called PD-L1. The goal is to see if adding this vaccine helps the immune system attack the cancer. **You may be eligible if...** - You are 18 or older with confirmed triple-negative breast cancer that has spread to other parts of the body - Your tumor tests negative for PD-L1 - You have not received immunotherapy in the metastatic (spread) setting - You are otherwise healthy enough to receive chemotherapy - You are willing to have up to two biopsies during the study **You may NOT be eligible if...** - You have already received more than one line of treatment for metastatic disease - You have a serious heart condition or active autoimmune disease - You are pregnant, breastfeeding, or have HIV, hepatitis B, or hepatitis C - You have had major surgery in the past 4 weeks - You are enrolled in another treatment-based clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine

Given ID

DRUGChemotherapy

Given standard of care chemotherapy

PROCEDUREComputed Tomography

Undergo CT scans

PROCEDUREComputed Tomography Assisted Biopsy

Undergo CT-guided biopsy

BIOLOGICALSargramostim

Given ID

PROCEDUREUltrasound-Guided Biopsy

Undergo ultrasound-guided biopsy

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREPositron Emission Tomography (PET)

Undergo PET scan


Locations(1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT07078604


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