{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.9","upperLimit":"2.1","value":"2.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"8"}],"units":"Participants"}],"description":"A null hypothesis of 18% and an alternative hypothesis of 40% at 6 months will be investigated. Patients lost to follow-up or deaths within 6 months will be counted as failures. The overall power for overall progression-free rate at 6 months is 85%, 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 followed by a saline flush and ipilimumab IV over 90 minutes. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.\n\nIpilimumab: Given IV\n\nLaboratory Biomarker Analysis: Correlative studies","id":"OG000","title":"Cohort B (Nivolumab and Ipilimumab)"}],"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 6 months","title":"Rate of Progression-free Survival (Cohort B)","type":"SECONDARY","unitOfMeasure":"months"}