{"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}],"units":"Participants"}],"description":"Will be analyzed and compared using multiplex cytokine analysis collected before and after exposure to nivolumab +/- IDO1 inhibitor BMS-986205 (BMS986205). If there is at least one significant difference between groups among the primary outcomes, the two randomization arms will be compared with respect to each secondary outcome using two-sample t-tests. P-values for comparisons of changes in secondary outcomes will be adjusted using the method of Benjamini and Hochberg to control the FDR among the secondary outcomes at 5%.","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"}],"populationDescription":"This outcome was not performed. Following early termination of the study by the Sponsor due to toxicity concerns, the planned analysis for this outcome was not pursued. Therefore, no participants were analyzed for this outcome. No additional analyses are planned, and data for this outcome will not be collected or reported in the future.","reportingStatus":"POSTED","timeFrame":"Baseline up to 12 months","title":"Change in Immune Cell Polarization (Th1/Th2; M1/M2) in Peripheral Blood and Tumor Specimens","type":"SECONDARY"}