A Phase 1 Study Evaluating Safety, Tolerability, and Preliminary Antitumor Activity of Entinostat and Nivolumab With or Without Ipilimumab in Advanced Solid Tumors

What is the purpose of this trial?

This phase I trial studies the side effects and best dose of entinostat and nivolumab when given together with ipilimumab in treating patients with solid tumors that have spread to other places in the body and usually cannot be cured or controlled with treatment (metastatic) or that cannot be removed by surgery (unresectable) or human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread from where it started to nearby tissue or lymph nodes or other parts of the body. Entinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth (locally advanced/metastatic). Monoclonal antibodies, such as nivolumab and ipilimumab, may block tumor growth in different ways by targeting certain cells. Giving entinostat and nivolumab together with ipilimumab may be a better treatment in patients with solid tumors.


Participation Guidelines

Ages: 18 years and older

Gender: Both


National Cancer Institute

Dates: 05/11/2016 - 06/01/2018

Last Updated: 10/26/2017

Study HIC#: 1511016794