{"classes":[{"categories":[{"measurements":[{"comment":"The upper limit for the confidence interval on median PFS is unknown because the upper confidence limit for the PFS curve never reached 0.50 hence no upper limit for the median PFS exists.","groupId":"OG000","lowerLimit":"0.8","upperLimit":"NA","value":"1.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"12"}],"units":"Participants"}],"description":"A null hypothesis of 20% and an alternative hypothesis of 40% at 12 weeks will be investigated. Patients lost to follow-up or deaths within 12 weeks will be counted as failures. The overall power for overall progression-free rate at 12 weeks is 87%, using the exact binomial distribution. The operating characteristics of this design are calculated using a one-sided exact test with 10% type I error.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients receive nivolumab IV over approximately 60 minutes once every 2 weeks for up to 46 doses in the absence of disease progression or unacceptable toxicity.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nNivolumab: Given IV","id":"OG000","title":"Cohort A (Nivolumab - Closed to Accrual on 21-Oct-2015)"}],"paramType":"MEDIAN","populationDescription":"Progression is defined as using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.","reportingStatus":"POSTED","timeFrame":"Time from start of treatment to time of progression or death, whichever occurs first, assessed at 12 weeks","title":"Rate of Progression-free Survival (Cohort A)","type":"SECONDARY","unitOfMeasure":"months"}