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

Official Summary

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 is in a class of drugs called histone deacetylase (HDAC) inhibitors. It may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth (locally advanced/metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving entinostat and nivolumab together with ipilimumab may work better in treating in patients with solid tumors.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NA
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 57 participants

Interventions

• PROCEDURE: Biopsy Procedure — Undergo tissue biopsy
• OTHER: Blood Sample — Undergo blood sample collection
• PROCEDURE: Bone Scan — Undergo bone scan
• PROCEDURE: Computed Tomography — Undergo CT or PET/CT
• DRUG: Entinostat — Given PO

Primary Outcomes

• Incidence of adverse events of entinostat and nivolumab in combination with ipilimumab (Up to 100 days after last dose of nivolumab)

Secondary Outcomes

• Changes in ratio of effector T cell (Teff) to regulatory T cell (Treg) in tumor biopsies (Baseline to up to 2 weeks post-entinostat)
• Objective response rate (Up to 5 years)
• Disease control rate (expansion cohort of patients with advanced breast cancer) (Up to 5 years)
• Progression-free survival (PFS) (Time from start of treatment to time of disease progression or death, whichever occurs first, assessed at 6 months)
• Duration of overall response (expansion cohort of patients with advanced breast cancer) (Time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented or death, assessed up to 5 years)

Trial Locations

• City of Hope Comprehensive Cancer Center, Duarte, California, United States
• Smilow Cancer Center/Yale-New Haven Hospital, New Haven, Connecticut, United States
• Yale University, New Haven, Connecticut, United States
• Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
• University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States

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