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

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.

Conditions

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

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

Sponsors & Collaborators

• Kuni Foundation

  collaborator UNKNOWN

• University of Washington

  lead OTHER

Principal Investigators

• Brie Chun, MD · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-20

Primary Completion

2027-04-30

Completion

2028-06-30

FDA Drug

Yes

Countries

• United States

Study Locations