{"analyses":[{"ciLowerLimit":"0.73","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"4.51","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.1952","paramType":"Hazard Ratio (HR)","paramValue":"1.81","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"18"}],"units":"Participants"}],"description":"Will be estimated using the method of Kaplan-Meier. The comparison of progression-free survival between two treatment arms will be based on the log-rank test. Progression is defined 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","groups":[{"description":"Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity. Upon radiologic documentation of disease progression, patients may cross over to Group II.\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Laboratory Biomarker Analysis: Correlative studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Pembrolizumab: Given IV\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Pharmacological Study: Correlative studies","id":"OG000","title":"Group I (Pembrolizumab)"},{"description":"Patients receive anetumab ravtansine IV over 1 hour and pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 12 months for anetumab ravtansine and up to 24 months for pembrolizumab in the absence of disease progression or unacceptable toxicity.\\> \\>\\>\n\n\\>\n\n\\>\\> Anetumab Ravtansine: Given IV\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Laboratory Biomarker Analysis: Correlative studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Pembrolizumab: Given IV\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Pharmacological Study: Correlative studies","id":"OG001","title":"Group II (Anetumab Ravtansine, Pembrolizumab)"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"From the start of treatment to the earliest date of documentation of disease progression or death due to any cause, assessed up to 2 years","title":"Phase 2 Progression Free Survival","type":"SECONDARY","unitOfMeasure":"Participants"}