{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityComment":"The null hypothesis that there are no differences between the classes in the population. The purpose of the test is to evaluate how likely the observed frequencies would be assuming the null hypothesis is true.","nonInferiorityType":"EQUIVALENCE","pValue":"0.27541","statisticalMethod":"Chi-squared"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"4"}]}],"title":"NE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"2"}]}],"title":"PD (Preliminary)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"}]}],"title":"PD (Confirmed)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"9"}]}],"title":"SD"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"}]}],"title":"PR (Confirmed)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"18"}],"units":"Participants"}],"description":"Will be assessed using Response Evaluation Criteria in Solid Tumors version 1.1 criteria. The proportion of successes will be estimated in each group by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated in each arm. Comparison of confirmed response rates between the two treatment groups will be performed using a one-sided z-test with pooled variance at significance level 0.10. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.","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":"Up to 2 years","title":"Phase 2 Confirmed Tumor Response Rate (Phase II)","type":"PRIMARY","unitOfMeasure":"Participants"}