A Randomized Phase II Study of Epigenetic Therapy with Azacitidine and Entinostat with Concurrent Nivolumab versus Nivolumab Alone in Subjects with Recurrent Metastatic Non-Small Cell Lung Cancer.
Johns Hopkins Bayview Medical Center
Johns Hopkins Kimmel Cancer Center in Baltimore
Primary objective is the progression free survival to Nivolumab with and without epigenetic therapy. Secondary endpoint is objective response, progression free survival, time to progression, overall survival, safety and tolerability as well as laboratory correlation of response at different time points.
Patients greater than 18 yrs old, and in good condition, will have stage IIIB, IV or recurrent NSCLC, with measureable disease, following at least 1 platinum based chemotherapy and not more than 3 prior therapies for stage IIIB/IV disease. Patient that are EGFR or ALK mutation +, must have prior therapy for mutation, as well as platinum containing doublet. Biopsies are required for study participation. Patient cannot have history of known autoimmune disease. Patients with interstitial lung disease and those requiring continuous supplemental oxygen are excluded. Patient with conditions that require systemic treatment with corticosteroids are excluded.
Eligible patients will be randomized to Arms C: Nivolumab every 2 weeks until disease progression or Arm D: 5 Azacitidine injection Days 1-5 & 8-10 with Entinostat orally on Days 3 & 10 and Nivolumab IV every 2 weeks (D1 and D15) for 6 months and then Nivolumab alone every 2 weeks until disease progression
09/19/2017 05:03 AM