Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
completion around
Principal Investigator
by Ritesh Parajuli

Description

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.

Official Title

Randomized Phase 2 Clinical Trial of Nab-Paclitaxel + Durvalumab (MEDI4736) + Tremelimumab + Neoantigen Vaccine Vs. Nab-Paclitaxel + Durvalumab (MEDI4736) + Tremelimumab in Patients With Metastatic Triple Negative Breast Cancer

Details

Keywords

Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Carcinoma, Metastatic Triple-Negative Breast Carcinoma, Carcinoma, Breast Neoplasms, Triple Negative Breast Neoplasms, Poly I-C, Paclitaxel, Camptothecin, Albumin-Bound Paclitaxel, Carboplatin, Gemcitabine, Durvalumab, Tremelimumab, Ipilimumab, Irinotecan, Carboxymethylcellulose Sodium, Vaccines, Antibodies, Immunoglobulins, Monoclonal Antibodies, Immunoglobulin G, Poly ICLC, Sacituzumab govitecan, Immunoconjugates, Biopsy, Biospecimen Collection, Computed Tomography, Gemcitabine Hydrochloride, Magnetic Resonance Imaging, Nab-paclitaxel, Personalized Synthetic Long Peptide Vaccine, neoantigen vaccine, durvalumab, nab-paclitaxel, durvalumab, nab-paclitaxel

Eligibility

Locations

  • UC Irvine Health/Chao Family Comprehensive Cancer Center accepting new patients
    Orange California 92868 United States
  • University of California Davis Comprehensive Cancer Center accepting new patients
    Sacramento California 95817 United States

Lead Scientist at UC Irvine

  • Ritesh Parajuli
    Associate Clinical Professor, Medicine, School of Medicine. Authored (or co-authored) 18 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
National Cancer Institute (NCI)
ID
NCT03606967
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 70 study participants
Last Updated