{"groups":[{"description":"Nivolumab and dose escalation of Cetuximab.\n\nLead-in Day -14 before Cycle 1 only: Cetuximab 500 mg/m\\^2; Nivolumab - none. Cycle 1 Day 1 and all subsequent doses every 2 weeks (Q2W): Cetuximab 500 mg/m\\^2; Nivolumab 240 mg.\n\nNivolumab: Nivolumab intravenously (IV) at 240 mg as outlined in the treatment arms.\n\nCetuximab: Cetuximab intravenously (IV) at 500 mg/m\\^2.","id":"FG000","title":"Phase I - Lead in"},{"description":"Patients who had progressed on at least one prior line of treatment for their recurrent and/or metastatic HNSCC\n\nParticipants were treated with Nivolumab and Cetuximab at recommended Phase II dose (RP2D). Nivolumab: Nivolumab intravenously (IV) at 240 mg as outlined in the treatment arms. Cetuximab: Cetuximab intravenously (IV) at 500 mg/m\\^2.","id":"FG001","title":"Phase II- Cohort A"},{"description":"Patients who have not had any prior treatment for their recurrent and/or metastatic HNSCC\n\nParticipants were treated with Nivolumab and Cetuximab at recommended Phase II dose (RP2D). Nivolumab: Nivolumab intravenously (IV) at 240 mg as outlined in the treatment arms. Cetuximab: Cetuximab intravenously (IV) at 500 mg/m\\^2.","id":"FG002","title":"Phase II - Cohort B"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"5"}],"type":"Death"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"44"},{"groupId":"FG002","numSubjects":"48"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"42"},{"groupId":"FG002","numSubjects":"43"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"5"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Participants in lead-in were included in Cohort A for outcome measure data."}