{"analyses":[{"ciLowerLimit":"7.3","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"32.8","estimateComment":"Clopper-Pearson (Exact) Confidence Interval. Excluded from rate due to no response evaluation: Soft Tissue: 2; Bone: 2; Expansion: 7 patients","groupDescription":"An objective response rate of 25% will be considered clinically meaningful and a response rate less than 10% will be considered lack of efficacy. The treatment will be considered a success if 8 or more of 40 enrolled patients have a PR or better by RECIST 1.1.","groupIds":["OG000"],"nonInferiorityComment":"An objective response rate of 25% will be considered clinically meaningful and a response rate less than 10% will be considered lack of efficacy. The treatment will be considered a success if 8 or more of 40 enrolled patients have a PR or better by RECIST 1.1.","nonInferiorityType":"SUPERIORITY","paramType":"Binomial estimate of response rate of PR","paramValue":"17.5"},{"ciLowerLimit":"1.0","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"16.9","estimateComment":"Clopper-Pearson exact confidence interval; Excluded from rate due to no response evaluation: Soft Tissue: 2; Bone: 2; Expansion: 7 patients","groupDescription":"An objective response rate of 25% will be considered clinically meaningful and a response rate less than 10% will be considered lack of efficacy. The treatment will be considered a success if 8 or more of 40 enrolled patients have a PR or better by RECIST 1.1.","groupIds":["OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Binomial estimate of response rate of PR","paramValue":"5.0"},{"ciLowerLimit":"5.5","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"25.3","estimateComment":"Clopper-Pearson (Exact) Confidence Interval Excluded from rate due to no response evaluation: Soft Tissue: 2; Bone: 2; Expansion: 7 patients","groupDescription":"An objective response rate of 25% will be considered clinically meaningful and a response rate less than 10% will be considered lack of efficacy. The treatment will be considered a success if 8 or more of 40 enrolled patients have a PR or better by RECIST 1.1.","groupIds":["OG002"],"nonInferiorityType":"SUPERIORITY","paramType":"Binomial estimate of response rate of PR","paramValue":"13.0"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"40"},{"groupId":"OG002","value":"53"}],"units":"Participants"}],"description":"The Objective Response Rate (ORR) is the percentage of patient's tumor that shrinks or disappears after treatment. ORR will be evaluated according to RECIST (Response Evaluation Criteria In Solid Tumors) 1.1, whereby Complete Response is defined as the disappearance of all target lesions and Partial Response is defined as at least a 30% decrease in the sum of the diameters of target lesions in reference to the baseline diameters. Overall Response (OR) = CR + PR.","groups":[{"description":"Patients with the following types of soft tissue sarcoma: leiomyosarcoma, poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma/MFH, MPNST and synovial sarcoma). Pembrolizumab was administered at 200 mg intravenously every 3 weeks\n\nPembrolizumab","id":"OG000","title":"Soft Tissue Sarcoma"},{"description":"Patients with the following types of bone sarcoma: Ewing sarcoma, osteosarcoma, and chondrosarcoma \\[de-differentiated or mesenchymal\\]. Pembrolizumab was administered at 200 mg intravenously every 3 weeks\n\nPembrolizumab","id":"OG001","title":"Bone Sarcoma"},{"description":"Patients with the following types of soft tissue sarcoma: poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma. Pembrolizumab was administered at 200 mg intravenously every 3 weeks","id":"OG002","title":"Expansion Cohort"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"There were 40 of 42 patients in the soft tissue sarcoma cohort who were evaluable for response. There were 40 of 42 patients in the bone sarcoma cohort who were evaluable for response. There were 53 of 60 patients in the expansion cohort who were evaluable for response.","reportingStatus":"POSTED","timeFrame":"Assessments will be conducted at 8 weeks, up to 5 years","title":"Objective Response Rate","type":"PRIMARY","unitOfMeasure":"Participants"}