{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"18.32","upperLimit":"60.64","value":"33"},{"comment":"All Arm C patients experienced progression","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"5"}],"units":"Participants"}],"description":"The Kaplan-Meier method will be used to estimate 1-year PFS, defined as the time from randomization to disease progression or death due to any cause. 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":"Progression Free Survival (PFS)","type":"PRIMARY","unitOfMeasure":"percentage of participants"}