{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"6"}],"title":"Responders"},{"measurements":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"5"}],"title":"Non-Responders"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"11"},{"groupId":"OG002","value":"0"}],"units":"Participants"}],"description":"Pathologic specimens were independently graded by two pathologists as outlined in our previous publication (2). The entire mass or surgical specimen (in the event of a partial/ complete response) was sectioned to calculate the pTR. Criteria for response included evidence of macrophage reaction, multinucleated giant cells and granulomas, fibrosis adjacent to residual tumor nests. In complete responders where no more viable tumor was identified, alteration of the normal tissue architecture by fibrosis and macrophage reaction was used to identify areas of previously viable malignancy. Tumors with pTR of ≥20% were defined as responders (R), while those with pTR \\<20% were defined as minimal or non-responders (NR) at the primary site and Lymph Nodes (LNs).","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":"This outcome measure was not analyzed for Arm C because patients from the other study did not receive a second dose if they met pathologic criteria after the first. As such, pathologic response could not be uniformly assessed or carried over for this arm.","reportingStatus":"POSTED","timeFrame":"At time of surgery","title":"Objective Pathologic Response at Time of Surgery","type":"SECONDARY","unitOfMeasure":"Participants"}