{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.47","upperLimit":".87","value":"0.71"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"18"}],"units":"Participants"}],"description":"Clinical Benefit Rate (CBR) is defined as the percentage of patients with Complete Response (CR), Partial Response (PR), and Stable Disease (SD) and will be assessed by RECIST 1.1 in patients with adenoid cystic carcinoma (ACC). Per RECIST v. 1.1, CR is defined as, \"Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10mm.\" PR is defined as, \"At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.\" SD is defined as, \"Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.\"","dispersionType":"95% Confidence Interval","groups":[{"description":"Nivolumab and ipilimumab combination will be administered intravenously until disease progression or intolerable toxicity.\n\nNivolumab: Given at 240mg over 30 minutes (-5 / +15 minutes) every 2 weeks starting with Cycle 1 Day 1 for the first 16 weeks (1 cycle = 12 weeks). Starting with Cycle 2 Day 29, nivolumab will be given at 480mg IV over 60 minutes (-10 / +15 minutes) every 4 weeks.\n\nIpilimumab: Given at 1mg/Kg every 6 weeks starting with Cycle 1 Day 1 over approximately 90 minutes (-5 / +15 minutes).\n\nOn days when both nivolumab and ipilimumab are administered, nivolumab should be given first, followed by ipilimumab about 30 minutes after completion of nivolumab.\n\nPatients will be assessed for response every 12 weeks (±7 days).","id":"OG000","title":"Nivolumab + Ipilimumab"}],"paramType":"NUMBER","populationDescription":"Patients with Adenoid cystic carcinoma only.","reportingStatus":"POSTED","timeFrame":"On Cycle 2 Day 1, and every cycle thereafter (1 cycle = 12 weeks), about 27 months","title":"Clinical Benefit Rate (CBR)","type":"SECONDARY","unitOfMeasure":"percent of participants"}