{"groups":[{"description":"Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.","id":"FG000","title":"CC-486 and Pembrolizumab (CC-486 + PBZ)"},{"description":"Participant received placebo tablets (identically matching in appearance to CC-486) administered orally daily on Days 1-14 plus pembrolizumab 200 mg administered as a 30-minute IV infusion on Day 1 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.","id":"FG001","title":"Placebo and Pembrolizumab (PBO + PBZ)"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"22"}],"type":"Progressive Disease"},{"reasons":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"6"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"3"}],"type":"Symptomatic Deterioration"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"4"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Non-compliance with Study Drug"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Study Terminated by Sponsor"},{"reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"9"}],"type":"Miscellaneous"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"51"},{"groupId":"FG001","numSubjects":"49"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"comment":"Completed = Not applicable according to the study design","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"51"},{"groupId":"FG001","numSubjects":"49"}],"type":"NOT COMPLETED"}],"title":"Treatment Period"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"5"}],"type":"Missing Status"},{"reasons":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"12"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"13"},{"groupId":"FG001","numSubjects":"16"}],"type":"Alive"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"}],"type":"Lost to Follow-up"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"36"},{"groupId":"FG001","numSubjects":"35"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"comment":"Participants remained in follow-up until withdrawal of consent, death or lost to follow-up","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"36"},{"groupId":"FG001","numSubjects":"35"}],"type":"NOT COMPLETED"}],"title":"Survival Follow-Up Phase"}],"preAssignmentDetails":"Qualified participants were randomized in a 1:1 ratio to one of the two treatment groups. Randomization was stratified by cancer histology (non-squamous versus squamous).","recruitmentDetails":"This study was a multicenter study with 25 sites from the United States, France. Germany, Italy, and Spain."}