{"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"description":"Ki-67 is a nuclear protein involved in cell proliferation regulation.","groups":[{"description":"Patients will proceed to surgical resection with no nivolumab/ipilimumab given prior to surgery.","id":"OG000","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":"OG001","title":"Neoadjuvant Immunotherapy"}],"populationDescription":"Outcome measure only applies to Neoadjuvant Immunotherapy; no participants were enrolled in the Neoadjuvant Immunotherapy group.","reportingStatus":"POSTED","timeFrame":"baseline to day 1","title":"Proliferation of Circulating T-cells as Measured by Mean Fold-change Between Baseline and Day 1 in Ki67 Levels.","type":"PRIMARY"}