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New treatment option for Anatomic Stage IV Breast Cancer AJCC v8
Official title A Cancer Vaccine (STEMVAC) in Combination With Chemotherapy for the Treatment of PD-L1 Negative Metastatic Triple-Negative Breast Cancer
ClinicalTrials.gov ID: NCT07078604
What this study is testing
What is CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine?
CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine is an investigational medicine, given as an once-weekly, being studied as a potential treatment for anatomic stage iv breast cancer ajcc v8.
Also referred to as CD105/Yb-1/SOX2/CDH3/MDM2 Plasmid Vaccine, STEMVAC.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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
You likely can't join if
- Patient has received more than one line of prior therapy in metastatic setting
- Patients with tumors that are PD-L1-positive per standard of care immunohistochemistry 22C3 pharmDx assay
- Enrollment in a concurrent treatment clinical trial. Biomarker or tissue collection or any other non-treatment clinical trial enrollment is allowed
- Patients with any of the following cardiac conditions:
- Symptomatic restrictive cardiomyopathy
- Dilated cardiomyopathy
See the full eligibility criteria
Who can join
- 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...
- 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 defined 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"...
- Tumor is negative for PD-L1 marker testing per standard of care immunohistochemistry 22C3 pharmDx assay
- Metastatic disease that is measurable based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Target lesions situated in a previously irradiated area are considered measurable if progression has been...
- 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 how well it works purposes...
- 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
- 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
- Treatment with a bisphosphate or denosumab concurrently with protocol-specific therapy is allowed while on study (it is not exclusionary)
- Patients must be at least 28 days post systemic steroids prior to enrollment, unless this is a steroid administered concurrently with chemotherapy or used as part of prophylaxis to prevent intravenous (IV) contrast...
- Must have recovered from major infections and/or surgical procedures; and in the opinion of the investigator, not have any significant active concurrent medical illnesses or condition precluding protocol treatment
- Willing to undergo up to two serial biopsies while on study
- White blood cell (WBC) ≥ 2500/mm\^3 (Within 28 days of receiving first study vaccine)
- Lymphocyte count ≥ 500/mm\^3 (Within 28 days of receiving first study vaccine)
- Absolute neutrophil count (ANC) ≥ 1000/μL (Within 28 days of receiving first study vaccine)
- Hemoglobin (Hgb) ≥ 9 g/dL (Within 28 days of receiving first study vaccine)
- Platelets ≥ 75,000/μL (Within 28 days of receiving first study vaccine)
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN), except patients with Gilbert's syndrome in whom total bilirubin must be \< 3.0 mg/dL (Within 28 days of receiving first study vaccine)
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 1.5 x institutional ULN (Within 28 days of receiving first study vaccine)
- Creatinine ≤ 1.5 x ULN mg/dL or creatinine clearance \> 60 mL/min (Within 28 days of receiving first study vaccine)
- Patients of child-bearing potential must agree to use dual methods of contraception and have a negative urine pregnancy test at screening, and male patients must use an effective barrier method of contraception if...
What rules you out
- Patient has received more than one line of prior therapy in metastatic setting
- Patients with tumors that are PD-L1-positive per standard of care immunohistochemistry 22C3 pharmDx assay
- Enrollment in a concurrent treatment clinical trial. Biomarker or tissue collection or any other non-treatment 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 that require chronic systemic steroids or immunosuppressants. Patients with conditions requiring inhaled, intranasal or topical steroids are permitted
- 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 or any B-cell malignancy (e.g., chronic lymphocytic leukemia or follicular lymphoma) under active surveillance
- 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]...
- Major surgery within the 4 weeks prior to initiation of study vaccine
- Must be 14 days between a non-study vaccine, including live attenuated and non-live vaccines and any STEMVAC vaccination
- Note: The minimum of 14 days does not apply to the tetanus and diphtheria (Td) vaccine
- Any condition that may interfere with the patient's participation in the study per treating physician
The study team makes the final eligibility decision.
Where it's taking place
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.