{"analyses":[{"groupIds":["OG000"],"nonInferiorityComment":"Compare the tissue biomarker for the immune response of ICOS+ CD4 T cells to before and after MEDI-4736 and Tremelimumab","nonInferiorityType":"OTHER","pValue":"1","statisticalMethod":"Wilcoxon signed rank test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-5.2","upperLimit":"1","value":"-2.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"8"}],"units":"Participants"}],"description":"Tissue biomarker for the immune response of ICOS+ CD4 T cells to before and after MEDI-4736 and Tremelimumab will be obtained using CytoF (time-of-flight mass cytometry) and/or flow cytometry. The percentages of ICOS+CD4 T cells are calculated by dividing by total cells.","dispersionType":"Inter-Quartile Range","groups":[{"description":"8 patients will receive an infusion of MEDI4736 (1500 mg intravenously, once) + tremelimumab (75mg intravenously, once), one to six weeks prior to surgical resection.\n\nMEDI4736: MEDI4736 is formulated at 50 mg/mL in 26 mM histidine/histidine-HCl, 275 mM trehalose dihydrate, 0.02% (w/v) polysorbate 80, pH 6.0.\n\nTremelimumab: Tremelimumab Drug Product is formulated at a nominal concentration of 20 mg/mL in 20 mM histidine/histidine hydrochloride, 222 mM trehalose dihydrate, 0.02% (weight/volume \\[w/v\\]) polysorbate 80, 0.27 mM disodium edetate dihydrate (EDTA), pH 5.5.","id":"OG000","title":"MEDI4736 + Tremelimumab"}],"paramType":"MEDIAN","populationDescription":"The objective was the comparison of percentage of inducible T-cell co-stimulator (ICOS) + CD4 T cells before and after treatment with combination MEDI-4736 and Tremelimumab group. Therefore, the analysis population was from one arm (MEDI4736+Tremelimumab).","reportingStatus":"POSTED","timeFrame":"at day 1 after screening and at a surgery within one to six weeks after treatment","title":"Change in Percentage of Inducible T-cell Co-stimulator (ICOS) + CD4 T Cells.","type":"SECONDARY","unitOfMeasure":"percentage of inducible T-cell co-stimul"}