{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"11.50","upperLimit":"62.18","value":"33"},{"groupId":"OG001","lowerLimit":"0","upperLimit":"31.54","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"5"}],"units":"Participants"}],"description":"The ORR will be defined as the proportion of patients that achieve a complete or partial response according to RECIST version 1.1 among patients who initiated protocol therapy and completed at least one subsequent imaging assessment. The 70% confidence interval was chosen to match the one-sided significance level of alpha = 0.15 specified in the protocol analysis plan.","dispersionType":"70% Confidence Interval","groups":[{"description":"Patients receive axitinib PO BID on days 1-28 and nivolumab intravenously (IV) over 30 minutes, or per institutional guidelines, on days 1 and 15 (if \\< 18 years old) or on day 1 (if \\>= 18 years old). Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity.","id":"OG000","title":"Arm A (Axitinib, Nivolumab)"},{"description":"Patients receive nivolumab IV over 30 minutes, or per institutional guidelines, on days 1 and 15 (if \\< 18 years old) or on day 1 (if \\>= 18 years old). Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity.","id":"OG001","title":"Arm C (Nivolumab)"}],"paramType":"NUMBER","populationDescription":"The data was analyzed with revised intention-to-treat approach. The following patients were excluded: Three (3) Arm B patients (as of Amendment 2A, the arm permanently closed to accrual and patients were randomly assigned to Arms A and C), One (1) Arm A patient who is ineligible for the study. 11 total patients were analyzed.","reportingStatus":"POSTED","timeFrame":"Up to 1 year from study entry","title":"Overall Response Rate (ORR)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}