{"groups":[{"description":"Patients will proceed to surgical resection with no nivolumab/ipilimumab given prior to surgery.","id":"FG000","title":"Standard of Care (no Neoadjuvant Immunotherapy)"},{"description":"Patients will receive a single dose of neoadjuvant nivolumab and ipilimumab 7 days (± 3 days) prior to surgical resection.\n\nNivolumab: Nivolumab will be given at the FDA-approved dose of 3 mg/kg.\n\nIpilimumab: Ipilimumab will be given at the FDA-approved dose of 1 mg/kg.","id":"FG001","title":"Neoadjuvant Immunotherapy"}],"periods":[{"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"In a Memo to File dated March 4, 2021, the removal of randomization in favor of a single-arm study in which all patients will receive neoadjuvant immunotherapy prior to their resection and SRS was proposed. One patient had already been randomized to receive standard of care surgery and SRS without neoadjuvant immunotherapy. This patient is not part of the analyses for the primary or secondary outcomes, as after the protocol amendment all patients were to receive neoadjuvant immunotherapy."}