Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer

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 tremelimum

Trial Details

NCT ID
NCT03606967
Phase
PHASE2
Sponsor
National Cancer Institute (NCI)
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • Biopsy Procedure
  • Biospecimen Collection
  • Carboplatin
  • Computed Tomography
  • Durvalumab
  • Gemcitabine Hydrochloride
Locations (sample)
  • Orange, California, United States|33.78779,-117.85311
  • Sacramento, California, United States|38.58157,-121.4944
  • Aurora, Colorado, United States|39.72943,-104.83192
  • Hartford, Connecticut, United States|41.76371,-72.68509
  • New Haven, Connecticut, United States|41.30815,-72.92816

Key Eligibility Criteria

  • Patients must have a histologically confirmed diagnosis of metastatic invasive triple negative breast cancer. Patients with clinical and/or radiolo…
  • Estrogen receptor (ER) and progesterone receptor (PR) less than Allred score of 3 OR less than 1% positive staining cells in the invasive component…
  • HER2 negative by fluorescence in situ hybridization (FISH) or immunohistochemistry (IHC) staining 0 or 1+.
  • PD-L1 negative by a Clinical Laboratory Improvement Act (CLIA) approved laboratory using compatible assays appropriate for treatment decisions.

For full eligibility, visit ClinicalTrials.gov.

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