{"groups":[{"description":"Nivolumab 3 mg/kg IV every 2 weeks + Ipilimumab 1 mg/kg IV every 6 weeks until progression, unacceptable toxicity, or a maximum of 24 months from first nivolumab treatment.","id":"FG000","title":"Nivolumab + Ipilimumab"},{"description":"Cetuximab 400 mg/m2 IV for the initial dose only, then 250 mg/m2 weekly + cisplatin (100mg/m2) or carboplatin (AUC of 5 mg per milliliter per minute) on Day 1 and fluorouracil (1000 mg/m2 per day for 4 days) every 3 weeks for maximum of 6 cycles followed by maintenance cetuximab at 250 mg/m2 weekly (or every 2 weeks, per local prescribing information) until disease progression or unacceptable toxicity; the choice of cisplatin or carboplatin is at the discretion of the investigator.","id":"FG001","title":"EXTREME Regimen"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"}],"type":"Other reasons"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"6"}],"type":"Participant no longer meets study criteria"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Poor/non-compliance"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"18"}],"type":"Participant withdrew consent"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}],"type":"Participant request to discontinue study treatment"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Adverse event unrelated to study drug"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Disease progression"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"472"},{"groupId":"FG001","numSubjects":"475"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"468"},{"groupId":"FG001","numSubjects":"441"}],"comment":"Continuing into treatment period","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"34"}],"type":"NOT COMPLETED"}],"title":"Pre-Treatment Period"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"47"},{"groupId":"FG001","numSubjects":"12"}],"type":"Other reasons"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}],"type":"Poor/non-compliance"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"6"}],"type":"Maximum clinical benefit"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"3"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"13"}],"type":"Participant withdrew consent"},{"reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"23"}],"type":"Participant request to discontinue treatment"},{"reasons":[{"groupId":"FG000","numSubjects":"41"},{"groupId":"FG001","numSubjects":"26"}],"type":"Adverse event unrelated to study drug"},{"reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"7"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"55"},{"groupId":"FG001","numSubjects":"47"}],"type":"Study drug toxicity"},{"reasons":[{"groupId":"FG000","numSubjects":"294"},{"groupId":"FG001","numSubjects":"301"}],"type":"Disease progression"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Administrative reason by sponsor"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"468"},{"groupId":"FG001","numSubjects":"441"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"comment":"Participants continuing in the treatment period","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"468"},{"groupId":"FG001","numSubjects":"441"}],"type":"NOT COMPLETED"}],"title":"Treatment Period"}],"preAssignmentDetails":"947 participants randomized to receive study treatment. 909 participants received study treatment."}