{"groups":[{"description":"Nivolumab and ipilimumab combination will be administered intravenously until disease progression or intolerable toxicity.\n\nNivolumab: Given at 240mg over 30 minutes (-5 / +15 minutes) every 2 weeks starting with Cycle 1 Day 1 for the first 16 weeks (1 cycle = 12 weeks). Starting with Cycle 2 Day 29, nivolumab will be given at 480mg IV over 60 minutes (-10 / +15 minutes) every 4 weeks.\n\nIpilimumab: Given at 1mg/Kg every 6 weeks starting with Cycle 1 Day 1 over approximately 90 minutes (-5 / +15 minutes).\n\nOn days when both nivolumab and ipilimumab are administered, nivolumab should be given first, followed by ipilimumab about 30 minutes after completion of nivolumab.\n\nPatients will be assessed for response every 12 weeks (±7 days).","id":"FG000","title":"Nivolumab + Ipilimumab"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Did not continue to meet protocol eligibility criteria after registration."}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"25"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"24"}],"type":"Received First Dose of Study Drug"},{"achievements":[{"groupId":"FG000","numSubjects":"24"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"1"}],"type":"NOT COMPLETED"}],"title":"Registered for Study"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Adverse Event"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"24"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"23"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"1"}],"type":"NOT COMPLETED"}],"title":"Completed Cycle 1 of Treatment(Nivo+Ipi)"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"2"}],"type":"Still on treatment"},{"reasons":[{"groupId":"FG000","numSubjects":"2"}],"type":"Progressive Disease"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"23"}],"comment":"Nivolumab and ipilimumab administered intravenously until disease progression/intolerable toxicity.","type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"23"}],"type":"Reached First Response Assessment"},{"achievements":[{"groupId":"FG000","numSubjects":"21"}],"type":"Received Cycle 2 Dose of Study Drugs"},{"achievements":[{"groupId":"FG000","numSubjects":"19"}],"comment":"2 patients discontinued after completing Cycle 1 due to disease progression.","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"4"}],"type":"NOT COMPLETED"}],"title":"Continued to Cycle 2 and Beyond"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"11"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"7"}],"type":"Still in follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Lost to Follow-up"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"22"}],"comment":"Patients who received one dose of study drug and have discontinued treatment go into follow-up.","type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"3"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"19"}],"type":"NOT COMPLETED"}],"title":"2 Year Follow-up"}],"recruitmentDetails":"Opened for accrual on May 19, 2017 with goal of 63 patients. The first patient started treatment June 12, 2017. The study closed Aug. 9, 2019 without meeting the total accrual goal due to the pharma company deciding to close the study."}