OncoMatch/Clinical Trials/NCT07078604
A Cancer Vaccine (STEMVAC) in Combination With Chemotherapy for the Treatment of PD-L1 Negative Metastatic Triple-Negative Breast Cancer
Is NCT07078604 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies multiple treatments including CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine and Sargramostim for anatomic stage iv breast cancer ajcc v8.
Treatment: CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine · Chemotherapy · Sargramostim — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Breast Carcinoma
Triple-Negative Breast Cancer
Biomarker criteria
Required: PD-L1 (CD274) wild-type (absence)
Tumor is negative for PD-L1 marker testing per standard of care immunohistochemistry 22C3 pharmDx assay
Excluded: PD-L1 (CD274) expression
Patients with tumors that are PD-L1-positive per standard of care immunohistochemistry 22C3 pharmDx assay
Disease stage
Required: Stage IV (other)
Metastatic disease required
Anatomic Stage IV Breast Cancer AJCC v8; Metastatic disease that is measurable based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: cancer immunotherapy in the metastatic setting
Lab requirements
Blood counts
WBC ≥ 2.5 THOU/uL; Lymphocyte count ≥ 0.5 THOU/uL; ANC ≥ 1.0 THOU/uL; Hemoglobin (Hgb) ≥ 9 g/dL; Platelets ≥ 75 THOU/uL
Kidney function
Creatinine ≤ 1.5 x ULN mg/dL or creatinine clearance > 60 mL/min
Liver function
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; AST/ALT ≤ 1.5 x institutional ULN
Cardiac function
No symptomatic restrictive or dilated cardiomyopathy, unstable angina within 4 months, NYHA class III-IV heart failure on active treatment, or symptomatic pericardial effusion
WBC ≥ 2.5 THOU/uL; Lymphocyte count ≥ 0.5 THOU/uL; ANC ≥ 1.0 THOU/uL; Hemoglobin (Hgb) ≥ 9 g/dL; Platelets ≥ 75 THOU/uL; 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; AST/ALT ≤ 1.5 x institutional ULN; Creatinine ≤ 1.5 x ULN mg/dL or creatinine clearance > 60 mL/min; No symptomatic restrictive or dilated cardiomyopathy, unstable angina within 4 months, NYHA class III-IV heart failure on active treatment, or symptomatic pericardial effusion
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Fred Hutch/University of Washington Cancer Consortium · Seattle, Washington
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07078604 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior cancer immunotherapy in the metastatic setting disqualifies patients from enrollment.
Does this trial require CD274?
Yes, CD274 wild-type is a required biomarker for enrollment.
Are patients with CD274 alterations eligible?
No. CD274 expression is an exclusion criterion.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify