Response Rate
Name: Azacitidine
Type: DrugArm D Arm E Arm F
Name: Entinostat
Type: DrugArm D Arm E Arm F
Name: Nivolumab
Type: DrugArm C Arm D Arm E Arm F
Description: Percentage of participants with response to combination Nivolumab and epigenetic therapy. Response will be assessed by RECIST 1.1 criteria, where complete response (CR)= disappearance of all target lesions, partial response (PR) is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions.
Measure: Objective Response Time: 2 yearsDescription: Number of months from the time of randomization until radiologic (per RECIST 1.1) or clinical progression or death, whichever comes first.
Measure: Progression free survival Time: 2 yearsDescription: Number of months from the time nivolumab begins until radiologic (per RECIST 1.1) or clinical progression is noted.
Measure: Time to Progression Time: 2 yearsDescription: Number of months from the time of randomization until death. Estimation will be by the Kaplan-Meier method.
Measure: Overall survival Time: 2 yearsDescription: Number of participants who experience adverse events as defined by CTCAE v4.0.
Measure: Safety and tolerability as assessed by number of participants with adverse events Time: 2 yearsAllocation: Randomized
Parallel Assignment
There is one SNP
- All adenocarcinoma patients must be tested for ALK rearrangements and EGFR (Exon 19 Deletion and Exon 21 L8585R Substitution) mutations and must have been treated with EGFR or ALK TKI therapy if found to have an actionable alteration. --- L8585R ---