{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"10"}]}],"title":"Radiographic Responders"},{"categories":[{"measurements":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"9"}]}],"title":"Radiographic Non-Responders"}],"denoms":[{"counts":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"11"},{"groupId":"OG002","value":"19"}],"units":"Participants"}],"description":"Radiographic response was assessed at the primary site and involved lymph nodes. Participants with ≥10% volumetric reduction at either site and no progression received a second treatment cycle before surgery, while those with stable disease or progression proceeded to surgery at the 5-week evaluation. The study hypothesized that adding an IDO inhibitor to PD-1 blockade would improve radiographic response. The primary endpoint was the proportion of participants eligible for a second cycle. The 10% cutoff was based on prior publications showing that volumetric analysis is more sensitive than single-axis RECIST v1.1 and allows minor immune-related increases (0-9%) while defining \\>10% growth as progression.","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":"COUNT_OF_PARTICIPANTS","populationDescription":"Only 27 participants were analyzed for Arm A, 4 patients withdrew.","reportingStatus":"POSTED","timeFrame":"At 5 weeks","title":"Objective Response","type":"PRIMARY","unitOfMeasure":"Participants"}