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A Phase 1 Study Evaluating Safety, Tolerability, and Preliminary Antitumor Activity of Entinostat and Nivolumab with or without Ipilimumab in Advanced Solid Tumors (NCI# 9844)
Protocol Number:
Phase I
Roisin Connolly
Johns Hopkins Kimmel Cancer Center in Baltimore
To evaluate the safety and tolerability of the combination of entinostat and nivolumab with or without ipilimumab in subjects with advanced solid tumors.To determine the dose of the combination of entinostat and nivolumab with ipilimumab in subjects with advanced solid tumors and to further confirm the safety of the combination therapy in subjects with advanced HER2-negative breast cancer.
Good performance status.Life expectancy of greater than 12 weeks.Normal organ and marrow function.Must have measurable or evaluable disease per RECIST 1.1. Patients with bone only disease are not eligible.Adequate pulmonary function as assessed by oxygen saturation equal to or greater than 90% when ambulating and not requiring supplemental oxygen.Must have an accessible non-bone tumor lesion from which serial core biopsy specimens can be obtained. Patients will undergo 3 biopsies.
Eligible patients will receive treatment on an outpatient basis. A safety run-in of entinostat will be given once a week for the two weeks prior to proceeding to the dose level assignment. Patients will receive entinostat orally on days 1, 8, 15, and 22; Nivolumab IV on days 1 and 15. If and when Ipilimumab is added, patients will receive a total of 4 doses on day 1.Patients will continue treatment until disease progression; intercurrent illness that prevents further administration of treatment; unacceptable side effects, pregnancy, patient non-compliance; or the patient decides to withdraw consent.
Last Update
03/05/2019 05:03 AM