Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2026-01-02 @ 11:46 AM
Study NCT ID:
NCT07078604
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-15
First Post:
2025-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Cancer Vaccine (STEMVAC) in Combination With Chemotherapy for the Treatment of PD-L1 Negative Metastatic Triple-Negative Breast Cancer
Sponsor:
University of Washington
Organization:
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
OUTLINE:
Patients receive one of the following chemotherapy regimens, per the treating physician's discretion, in the absence of disease progression or unacceptable toxicity: 1) Paclitaxel every 21 days; paclitaxel on days 1, 8, and 15 every 28 days; paclitaxel on days 1 and 8 every 21 days; or docetaxel every 21 days; 2) Carboplatin every 21 days; carboplatin every 28 days; carboplatin on days 1 and 8 every 21 days; or cisplatin every 21 days; 3) Doxorubicin every 21 days; or liposomal doxorubicin every 28 days; OR 4) Eribulin on days 1 and 8 every 21 days. Patients receive 3 priming doses of STEMVAC with sargramostim intradermally (ID) every 21-28 days (7-10 days after each chemotherapy administration or during the off week of weekly chemotherapy), 2 booster STEMVAC/sargramostim doses at 4 and 7 months after 3rd priming dose, and then every 6 months in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) or ultrasound-guided biopsy, for research purposes, on study, as well as CT or positron emission tomography (PET) scans and blood sample collection throughout the study. In addition, patients may also undergo CT or ultrasound-guided biopsy, for research purposes, during screening.
After completion of study treatment, patients are followed up at 21 or 28 days and then every 6 months for 3 years.
Patients receive one of the following chemotherapy regimens, per the treating physician's discretion, in the absence of disease progression or unacceptable toxicity: 1) Paclitaxel every 21 days; paclitaxel on days 1, 8, and 15 every 28 days; paclitaxel on days 1 and 8 every 21 days; or docetaxel every 21 days; 2) Carboplatin every 21 days; carboplatin every 28 days; carboplatin on days 1 and 8 every 21 days; or cisplatin every 21 days; 3) Doxorubicin every 21 days; or liposomal doxorubicin every 28 days; OR 4) Eribulin on days 1 and 8 every 21 days. Patients receive 3 priming doses of STEMVAC with sargramostim intradermally (ID) every 21-28 days (7-10 days after each chemotherapy administration or during the off week of weekly chemotherapy), 2 booster STEMVAC/sargramostim doses at 4 and 7 months after 3rd priming dose, and then every 6 months in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) or ultrasound-guided biopsy, for research purposes, on study, as well as CT or positron emission tomography (PET) scans and blood sample collection throughout the study. In addition, patients may also undergo CT or ultrasound-guided biopsy, for research purposes, during screening.
After completion of study treatment, patients are followed up at 21 or 28 days and then every 6 months for 3 years.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: