{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-1","upperLimit":"1.8","value":"0.5"},{"groupId":"OG001","lowerLimit":"-1.4","upperLimit":"0.65","value":"-0.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"0"}],"units":"Participants"}],"title":"Pre-Kynurenine Responders"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-1.3","upperLimit":"1","value":"-0.2"},{"groupId":"OG001","lowerLimit":"-1.2","upperLimit":"0.8","value":"0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"0"}],"units":"Participants"}],"title":"Pre-Kynurenine Non-Responders"}],"denoms":[{"counts":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"11"},{"groupId":"OG002","value":"0"}],"units":"Participants"}],"description":"Tryptophan and kynurenine concentrations were measured in plasma samples using validated assays. The outcome is expressed as the ratio of tryptophan to kynurenine, a marker of IDO1 activity. Results are reported as median values with full range (minimum to maximum) across participants","dispersionType":"Full Range","groups":[{"description":"Patients receive IDO1 inhibitor BMS-986205 PO QD. Beginning week 2, patients also receive nivolumab IV over 30 minutes on day 1. Treatment repeats for up to 5 weeks in the absence of disease progression or unacceptable toxicity. Patients showing a treatment response receive IDO1 inhibitor BMS-986205 PO QD for 4 additional weeks and receive nivolumab IV over 30 minutes on day 1, then undergo surgery at week 10. Those without a treatment response after 5 weeks undergo surgery within 7 days.\n\nNivolumab: Given IV\n\nIDO1 Inhibitor BMS-986205: Given PO\n\nTherapeutic Conventional Surgery: Undergo Surgery\n\nQuestionnaire Administration: Ancillary studies","id":"OG000","title":"Arm A: BMS986205 + Nivolumab"},{"description":"Patients receive nivolumab IV over 30 minutes on day 1 in the absence of disease progression or unacceptable toxicity. Patients showing treatment response after 4 weeks receive nivolumab IV over 30 minutes on day 1, then undergo surgery at week 9. Those without a treatment response after 4 weeks undergo surgery within 7 days.\n\nNivolumab: Given IV\n\nTherapeutic Conventional Surgery: Undergo Surgery\n\nQuestionnaire Administration: Ancillary studies","id":"OG001","title":"Arm B: Group I - Nivolumab Only"},{"description":"Data from Contemporaneous Study 10237 (NCT03238365) participants who received Nivolumab alone prior to surgery is used as a historical controls under the current window of treatment (WOT), to bolster the control group.","id":"OG002","title":"Arm C: Group II - Nivolumab Only"}],"paramType":"MEDIAN","populationDescription":"This outcome measure was not analyzed for Arm C because, per protocol, the contemporaneous cohort was only used to support specific objectives such as the primary endpoint. Data collection and procedures for other measures were not conducted in this arm.","reportingStatus":"POSTED","timeFrame":"Up to 12 months","title":"Ratio of Tryptophan to Kynurenine","type":"SECONDARY","unitOfMeasure":"Ratio of Tryptophan to Kynurenine"}