Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer
Summary
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.
Timeline
- Start
- 2021-04-13
- Primary completion
- 2026-12-30
- Completion
- 2026-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Personalized Synthetic Long Peptide Vaccine | Vaccine | — | Subcutaneous |
| Background | Carboplatin | Small molecule | — | Intravenous |
| Background | Durvalumab | Monoclonal antibody | — | Intravenous |
| Background | Gemcitabine | Small molecule | — | Intravenous |
| Background | Hiltonol | Other / unclassified | — | Subcutaneous |
| Background | Paclitaxel | Small molecule | — | Intravenous |
| Background | Sacituzumab Govitecan | Monoclonal antibody | — | Intravenous |
| Background | Tremelimumab | Monoclonal antibody | — | Intravenous |