{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"29.49","upperLimit":"76.09","value":"47.37"}]}],"title":"progression free survival (12 months)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"44.8","upperLimit":"89.04","value":"63.16"}]}],"title":"progression free survival (6 months)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"19"}],"units":"Participants"}],"description":"Progression-Free Survival assessed per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria at time of first study treatment. PFS defined as absence of death and of progressive disease. Progressive disease per RECIST v. 1.1 defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (0.5 cm). The appearance of one or more new lesions is also considered progression. Response rates and 95% confidence intervals will be calculated using exact binomial probability distributions for discrete outcomes. Efficacy will be evaluated in all patients who receive at least one dose of study treatment and have had their disease re-evaluated.","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 recurrent or metastatic Adenoid cystic carcinoma (ACC).","reportingStatus":"POSTED","timeFrame":"From the start of treatment and every 12 weeks during treatment, for up to two years, where 1 cycle =12 weeks/84 days, and range of cycles attempted was 1-11.","title":"Progression-Free Survival","type":"PRIMARY","unitOfMeasure":"percentage of participants"}