{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.9"},{"groupId":"OG001","value":"4.4"}]}],"title":"Complete Response"},{"categories":[{"measurements":[{"groupId":"OG000","value":"17.0"},{"groupId":"OG001","value":"13.3"}]}],"title":"Partial Response"},{"categories":[{"measurements":[{"groupId":"OG000","value":"15.1"},{"groupId":"OG001","value":"11.1"}]}],"title":"Stable Disease"},{"categories":[{"measurements":[{"groupId":"OG000","value":"54.7"},{"groupId":"OG001","value":"55.6"}]}],"title":"Progressive Disease"},{"categories":[{"measurements":[{"groupId":"OG000","value":"11.3"},{"groupId":"OG001","value":"13.3"}]}],"title":"Not Evaluable"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0.0"},{"groupId":"OG001","value":"2.2"}]}],"title":"No Assessment"}],"denoms":[{"counts":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"45"}],"units":"Participants"}],"description":"The BOR was assessed using RECIST 1.1 and was recorded from the start of the second line of study drug (pembrolizumab) until the last imaging assessment in this period. Response categories included: Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions; and Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. For the switch-to-pembrolizumab treatment groups, BOR was based on independent review committee (IRC) assessment. The BOR for switched-to pembrolizumab treatment groups is presented.","groups":[{"description":"Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to \\~66 months)","id":"OG000","title":"ICC→Pembrolizumab 2 mg/kg"},{"description":"Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to \\~66 months)","id":"OG001","title":"ICC→Pembrolizumab 10 mg/kg"}],"paramType":"NUMBER","populationDescription":"The analysis population consisted of all randomized participants in ICC who switched to receiving pembrolizumab. Participants were included in the treatment group to which they were re-randomized (switched) for this efficacy analysis.","reportingStatus":"POSTED","timeFrame":"Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015)","title":"Best Overall Response (BOR) - Switch-to-Pembrolizumab Treatment Period","type":"SECONDARY","unitOfMeasure":"Percentage of Participants"}