OncoMatch/Clinical Trials/NCT03606967
Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer
Is NCT03606967 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for anatomic stage iv breast cancer ajcc v8.
Treatment: Carboplatin · Durvalumab · Gemcitabine Hydrochloride · Nab-paclitaxel · Personalized Synthetic Long Peptide Vaccine · Poly ICLC · Sacituzumab Govitecan · Tremelimumab — This phase II trial studies how well nab-paclitaxel, durvalumab, and tremelimumab with or without personalized synthetic long peptide vaccine (neoantigen vaccine) works in treating patients with triple negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Chemotherapy drugs, such as nab-paclitaxel, 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. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. It is not yet known whether giving nab-paclitaxel, durvalumab, and tremelimumab with or without neoantigen vaccine will work better in treating patients with triple negative breast cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Triple-Negative Breast Cancer
Biomarker criteria
Required: ESR1 expression < Allred score of 3 OR <1% positive staining cells (< Allred score of 3 OR <1% positive staining cells)
Estrogen receptor (ER) and progesterone receptor (PR) less than Allred score of 3 OR less than 1% positive staining cells in the invasive component of the tumor.
Required: PR (PGR) expression < Allred score of 3 OR <1% positive staining cells (< Allred score of 3 OR <1% positive staining cells)
Estrogen receptor (ER) and progesterone receptor (PR) less than Allred score of 3 OR less than 1% positive staining cells in the invasive component of the tumor.
Required: HER2 (ERBB2) negative by FISH or IHC 0 or 1+ (IHC 0 or 1+ or FISH negative)
HER2 negative by fluorescence in situ hybridization (FISH) or immunohistochemistry (IHC) staining 0 or 1+.
Required: PD-L1 (CD274) negative (negative)
PD-L1 negative by a Clinical Laboratory Improvement Act (CLIA) approved laboratory using compatible assays appropriate for treatment decisions.
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
Exception: taxane-based adjuvant therapy allowed if disease-free interval ≥ 12 months after completion
No prior therapy for metastatic TNBC. Patients who have received taxane-based adjuvant therapy are required to have a disease-free interval of at least 12 months after completion of taxane therapy.
Cannot have received: immunotherapy
Patients who have received prior immunotherapy for metastatic disease.
Cannot have received: radiotherapy
Exception: to more than 30% of the bone marrow within 30 days prior to entering the study
Patients who have had chemotherapy, radiotherapy (to more than 30% of the bone marrow), or biologic therapy within 30 days (42 days for nitrosoureas or mitomycin C) prior to entering the study.
Cannot have received: biologic therapy
Patients who have had chemotherapy, radiotherapy (to more than 30% of the bone marrow), or biologic therapy within 30 days (42 days for nitrosoureas or mitomycin C) prior to entering the study.
Cannot have received: investigational agent
Exception: none within 30 days
Patients who are receiving any other investigational agents or who have received an investigational agent within the last 30 days.
Lab requirements
Blood counts
Absolute neutrophil count >= 1,500/mcL. Platelets >= 100,000/mcL. Hemoglobin >= 9.0 g/dL.
Kidney function
Calculated creatinine clearance > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection.
Liver function
Serum bilirubin <= 1.5 x institutional upper limit of normal. AST/ALT <= 2.5 x institutional upper limit of normal unless liver metastases are present, in which case <= 5 x institutional upper limit of normal.
Cardiac function
Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) < 470 ms calculated from 3 ECGs.
Absolute neutrophil count >= 1,500/mcL. Platelets >= 100,000/mcL. Hemoglobin >= 9.0 g/dL. Serum bilirubin <= 1.5 x institutional upper limit of normal. AST/ALT <= 2.5 x institutional upper limit of normal unless liver metastases are present, in which case <= 5 x institutional upper limit of normal. Calculated creatinine clearance > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) < 470 ms calculated from 3 electrocardiograms (ECGs) (within 15 minutes at 5 minutes apart).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UC Irvine Health/Chao Family Comprehensive Cancer Center · Orange, California
- University of California Davis Comprehensive Cancer Center · Sacramento, California
- UCHealth University of Colorado Hospital · Aurora, Colorado
- Smilow Cancer Hospital Care Center at Saint Francis · Hartford, Connecticut
- Yale University · New Haven, Connecticut
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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