{"groups":[{"description":"Participants received nivolumab 3 mg/kg IV over 30 minutes every 2 weeks for up to 3 doses (ie, 6 weeks of treatment; each cycle is 14 days). In Cycle 1 Day 1 only, nivolumab will be followed by a single dose of ipilimumab 1 mg/kg IV over 30 minutes.\n\nFollowing definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.","id":"FG000","title":"Arm A: Nivo 3 mg/kg + Ipi 1 mg/kg"},{"description":"Participants receive investigator-choice of platinum doublet chemotherapy regimens in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).\n\nFollowing definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.","id":"FG001","title":"Arm B: Platinum Doublet Chemo"},{"description":"Participants receive nivolumab 360 mg IV + platinum doublet chemotherapy in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).\n\nFollowing definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.","id":"FG002","title":"Arm C: Nivo 360 mg + Platinum Doublet Chemo"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}],"type":"Adverse event unrelated to study drug"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"0"}],"type":"Participant withdrew consent"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"2"}],"type":"Participant no longer meets study criteria"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"113"},{"groupId":"FG001","numSubjects":"213"},{"groupId":"FG002","numSubjects":"179"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"179"},{"groupId":"FG002","numSubjects":"179"}],"comment":"The primary population for efficacy analyses","type":"All Concurrently Randomized Participants in Arms B and C"},{"achievements":[{"comment":"One participant reassigned to Arm B as received the wrong treatment","groupId":"FG000","numSubjects":"112"},{"groupId":"FG001","numSubjects":"207"},{"groupId":"FG002","numSubjects":"176"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"3"}],"type":"NOT COMPLETED"}],"title":"Randomization Period"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"0"}],"type":"Participant request to discontinue study treatment"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"0"}],"type":"Participant withdrew consent"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Participant no longer meets study criteria"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"1"}],"type":"Disease progression"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"14"},{"groupId":"FG002","numSubjects":"10"}],"type":"Study drug toxicity"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"0"}],"type":"Adverse event unrelated to study treatment"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"111"},{"groupId":"FG001","numSubjects":"208"},{"groupId":"FG002","numSubjects":"176"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"176"},{"groupId":"FG002","numSubjects":"176"}],"comment":"The primary population for safety analyses","type":"All Treated Participants From Concurrently Randomized Arms B and C"},{"achievements":[{"groupId":"FG000","numSubjects":"101"},{"groupId":"FG001","numSubjects":"177"},{"groupId":"FG002","numSubjects":"165"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"31"},{"groupId":"FG002","numSubjects":"11"}],"type":"NOT COMPLETED"}],"title":"Neoadjuvant Treatment Period"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"Disease progression"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"1"}],"type":"Study drug toxicity"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}],"type":"Adverse event unrelated to study drug"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"}],"type":"Participant request to discontinue treatment"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}],"type":"Other reasons"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"37"},{"groupId":"FG001","numSubjects":"47"},{"groupId":"FG002","numSubjects":"26"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"28"},{"groupId":"FG001","numSubjects":"41"},{"groupId":"FG002","numSubjects":"22"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"4"}],"type":"NOT COMPLETED"}],"title":"Systemic Adjuvant Treatment Period"}],"preAssignmentDetails":"One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm A for baseline and efficacy analyses (analyses based on the randomized population) and is counted in Arm B (chemo) for exposure and safety analyses (based on the treated population). This participant was randomized prior to Revised Protocol 02 and is not included in the All Treated Participants from the Concurrently Randomized Arms B and C population."}