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

NCT07078604 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: RG1125414NCI-2025-0432720925
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. The allowable combination chemotherapy includes: (1) Paclitaxel is in a class of chemotherapy medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. (2) Docetaxel is in a class of chemotherapy medications called taxanes. It stops tumor cells from growing and dividing and may kill them. (3) Cisplatin is in a class of chemotherapy medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. (4) Carboplatin is in a class of chemotherapy medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. (5) Doxorubicin is in a class of chemotherapy medications called anthracyclines. Doxorubicin damages the cell's deoxyribonucleic acid (DNA) and may kill tumor cells. It also blocks a certain enzyme needed for cell division and DNA repair. (6) Liposomal doxorubicin is a form of the anticancer drug doxorubicin that is contained inside very tiny, fat-like particles. Liposomal doxorubicin may have fewer side effects and work better than other forms of the drug. (7) Eribulin is in a class of chemotherapy medications called microtubule dynamics inhibitors. It works by stopping the growth and spread of tumor cells. 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

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1/Positron Emission Tomography (PET) Response Criteria in Solid Tumors (PERCIST). Kaplan-Meier method will be used to estimate PFS and the rates at specified time point (e.g., 6 or 12 months) will be calculated and the 95% confidence intervals will be provided.

  From the start of treatment to the worsening of cancer or death whichever occurs first, assessed up to 3 years after completion of study treatment

Secondary Outcomes (3)

• Overall survival (OS)

  Up to 3 years after completion of study treatment

• Incidence of adverse events

  Up to 21 or 28 days after completion of study treatment

• Immunogenicity of CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope plasmid deoxyribonucleic acid vaccine (STEMVAC)

  Baseline up to 7 months after STEMVAC priming dose #3

Study Arms (1)

Treatment (chemotherapy, STEMVAC, GM-CSF)

EXPERIMENTAL

See Detailed Description.

Biological: CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine; Drug: Cisplatin; Procedure: Computed Tomography; Procedure: Computed Tomography Assisted Biopsy; Drug: Docetaxel; Drug: Doxorubicin; Drug: Eribulin; Drug: Paclitaxel; Drug: Pegylated Liposomal Doxorubicin Hydrochloride; Biological: Sargramostim; Procedure: Ultrasound-Guided Biopsy; Procedure: Biospecimen Collection; Drug: Carboplatin; Procedure: Positron Emission Tomography (PET)

Interventions

Cisplatin DRUG

Given cisplatin

Also known as: Abiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-diamminedichloroplatinum, Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone's Chloride, Peyrone's Salt, Placis, Plastistil, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol- AQ, Platinol-AQ, Platinol-AQ VHA Plus, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, Platosin

Treatment (chemotherapy, STEMVAC, GM-CSF)

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

Given ID

Also known as: CD105/Yb-1/SOX2/CDH3/MDM2 Plasmid Vaccine, STEMVAC, STEMVAC Th1 Polyepitope Plasmid-based Vaccine

Treatment (chemotherapy, STEMVAC, GM-CSF)

Computed Tomography PROCEDURE

Undergo CT scans

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography

Treatment (chemotherapy, STEMVAC, GM-CSF)

Computed Tomography Assisted Biopsy PROCEDURE

Undergo CT-guided biopsy

Also known as: Computed Tomography Biopsy, Computed Tomography-Guided Needle Biopsy, CT Assisted Biopsy, CT Guided Biopsy

Treatment (chemotherapy, STEMVAC, GM-CSF)

Docetaxel DRUG

Given docetaxel

Also known as: Docecad, RP 56976, RP-56976, RP56976, Taxotere, Taxotere Injection Concentrate

Treatment (chemotherapy, STEMVAC, GM-CSF)

Doxorubicin DRUG

Given doxorubicin

Also known as: Adriablastin, Hydroxydaunomycin, Hydroxyl Daunorubicin, Hydroxyldaunorubicin

Treatment (chemotherapy, STEMVAC, GM-CSF)

Eribulin DRUG

Given eribulin

Also known as: E 7389, E-7389, ER 086526, ER-086526, ER086526

Treatment (chemotherapy, STEMVAC, GM-CSF)

Paclitaxel DRUG

Given paclitaxel

Also known as: Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat

Treatment (chemotherapy, STEMVAC, GM-CSF)

Pegylated Liposomal Doxorubicin Hydrochloride DRUG

Given liposomal doxorubicin

Also known as: ATI-0918, Caelyx, Dox-SL, Doxil, Doxilen, Doxorubicin HCl Liposomal, Doxorubicin HCl Liposome, Doxorubicin Hydrochloride Liposome, Duomeisu, Evacet, LipoDox, Lipodox 50, Liposomal Adriamycin, Liposomal Doxorubicin Hydrochloride, Liposomal-Encapsulated Doxorubicin, Pegylated Doxorubicin HCl Liposome, Pegylated Liposomal Doxorubicin, S-Liposomal Doxorubicin, Stealth Liposomal Doxorubicin, TLC D-99

Treatment (chemotherapy, STEMVAC, GM-CSF)

Sargramostim BIOLOGICAL

Given ID

Also known as: 23-L-Leucinecolony-Stimulating Factor 2, DRG-0012, Leukine, Prokine, rhu GM-CFS, Sagramostim, Sargramostatin

Treatment (chemotherapy, STEMVAC, GM-CSF)

Ultrasound-Guided Biopsy PROCEDURE

Undergo ultrasound-guided biopsy

Also known as: Ultrasound Biopsy, Ultrasound Guided Biopsy

Treatment (chemotherapy, STEMVAC, GM-CSF)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection

Treatment (chemotherapy, STEMVAC, GM-CSF)

Carboplatin DRUG

Given carboplatin

Also known as: Blastocarb, Carbosin, Carbosol, CBDCA, Displata, Ercar, JM-8, JM8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo

Treatment (chemotherapy, STEMVAC, GM-CSF)

Positron Emission Tomography (PET) PROCEDURE

Undergo PET scan

Also known as: Medical Imaging, PET scan, PT

Treatment (chemotherapy, STEMVAC, GM-CSF)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 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 patients \< 18 years of age, children and adolescents are excluded from this study, but will be eligible for future pediatric trials, if applicable
• Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status Score of ≤ 2
• Histologically confirmed triple-negative breast cancer
• Tumors with estrogen receptor (ER)-low (≤ 5%) or negative and progesterone receptor (PR)-low (≤ 5%) or negative will be included
• HER2-negative or HER2-low will be fined by the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) 2023 "Human Epidermal Growth Factor Receptor 2 (HER2) Breast Testing Guideline Update" which reaffirms the 2018 "HER2 Breast Testing Guideline Focused Update"
• Tumor is negative for PD-L1 marker testing per standard of care antibodies/clones in breast cancer at time of eligibility
• Metastatic disease that is measurable based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or PET Response Criteria in Solid Tumors (PERCIST). Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
• Have at least 1 site of disease confirmed by the treating oncologist that could be biopsied during treatment. This site should not be a site that is used to determine measurable disease for efficacy purposes. Lesions that will be biopsied should not be in a previously irradiated area unless progression has been demonstrated in such lesions
• Patients should not have received any prior cancer immunotherapy in the metastatic setting
• Prior Food and Drug Administration (FDA)-approved antibody drug conjugates are allowed
• Patients are appropriate candidates to receive standard of care chemotherapy as per treating oncologist's clinical judgement
• NOTE: Only chemotherapy partners listed in the protocol are allowed to be administered in metastatic setting concurrently with STEMVAC vaccine
• Patients who have received prior neoadjuvant or adjuvant chemotherapy are allowed
• A minimum of 14 days washout since last systemic therapy or any palliative radiotherapy is required

You may not qualify if:

• Patient has received more than one line of prior therapy in metastatic setting
• Patients with tumors that are PD-L1-positive
• Enrollment in a concurrent interventional clinical trial. Biomarker or tissue collection or any other non-interventional clinical trial enrollment is allowed
• Patients with any of the following cardiac conditions:
• Symptomatic restrictive cardiomyopathy
• Dilated cardiomyopathy
• Unstable angina within 4 months prior to enrollment
• New York Heart Association functional class III-IV heart failure on active treatment
• Symptomatic pericardial effusion
• Patients with any autoimmune disease or comorbidities requiring chronic steroids or immunosuppressants
• Known hypersensitivity reaction to the granulocyte-macrophage colony stimulating factor (GM-CSF) adjuvant; any known contra-indication to GM-CSF
• A non-breast malignancy requiring radiation or systemic therapy within last 5 years
• Pregnant and breastfeeding individuals
• Known history of human immunodeficiency virus (HIV) infection, hepatitis B (e.g., hepatitis B virus surface antigen \[HBsAg\] reactive), or hepatitis C (e.g., hepatitis C virus \[HCV\] ribonucleic acid \[RNA\] \[qualitative\] is detected)
• Major surgery within the 4 weeks prior to initiation of study vaccine

Sponsors & Collaborators

• University of Washington: lead
• Kuni Foundation: collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Cisplatin; 1,2-diaminocyclohexaneplatinum II citrate; Platinum; Docetaxel; Doxorubicin; eribulin; Paclitaxel; Taxes; liposomal doxorubicin; sargramostim; Colony-Stimulating Factors; Carboplatin; Magnetic Resonance Spectroscopy; X-Rays

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Metals, Heavy; Elements; Transition Elements; Metals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Economics; Health Care Economics and Organizations; Glycoproteins; Glycoconjugates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Coordination Complexes; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Brie Chun, MD

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Coordinator(s)

CONTACT

1-866-932-8588; cvitrial@uw.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: July 22, 2025
• Study Start: April 11, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: March 12, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)