{"analyses":[{"groupDescription":"Compare tissue biomarker immune response of CD8 and Treg (ratio of CD8/treg) after MEDI-4736 and Tremelimumab, and after MEDI4736 alone","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.954","statisticalMethod":"Wilcoxon (Mann-Whitney)"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"3.4","upperLimit":"9.4","value":"8"},{"groupId":"OG001","lowerLimit":"2","upperLimit":"20.9","value":"9.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"8"}],"units":"Participants"}],"description":"Tissue biomarker immune response of CD8 and Treg after MEDI-4736 and Tremelimumab, and after MEDI4736 alone will be obtained using CytoF (time-of-flight mass cytometry) and/or flow cytometry. The ratios of CD8/Treg are calculated by diving CD8 by Treg.","dispersionType":"Inter-Quartile Range","groups":[{"description":"8 patients will receive an infusion of MEDI4736 (15 mg/kg 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.","id":"OG000","title":"MEDI4736"},{"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":"OG001","title":"MEDI4736 + Tremelimumab"}],"paramType":"MEDIAN","populationDescription":"one participant who was assigned to MEDI4736 alone group completed the study procedures but the tumor sample was too small to analyze in the lab.","reportingStatus":"POSTED","timeFrame":"at a surgery within one to six weeks after treatment","title":"Ratio of Intratumoral Cytotoxic T Cells to Regulatory T Cells (CD8/Treg) in Patients Treated With Combination Therapy (MEDI-4736 and Tremelimumab) and in Patients Treated With MEDI-4736 Alone.","type":"SECONDARY","unitOfMeasure":"no unit of ratios with same units(%)"}