{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"500"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"}],"units":"Participants"}],"description":"Maximum Tolerated Dose (MTD).. The target Dose Limiting Toxicity (DLT) rate is \\<25%. The MTD will be defined as the dose of cetuximab and nivolumab in which \\<1 of 3 patients experience a DLT or \\<2 of 6 patients experience a DLT with the next higher dose having at least 2 patients experiencing a DLT. The MTD is the highest dose at which at most 1 of 6 patients has a DLT. This study will utilize the Cancer Therapy Evaluation Program CTCAE version 4.1 for toxicity and event reporting. Dose-limiting toxicities will be observed until patients have completed Cycle 1 (4 weeks).","groups":[{"description":"Nivolumab and dose lead in 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 or 250 mg/m\\^2 as outlined in the treatment arms.","id":"OG000","title":"Phase I - Lead in"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"Up to 12 months","title":"Phase I: Maximum Tolerated Dose","type":"PRIMARY","unitOfMeasure":"mg/m^2"}