{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.5","upperLimit":"6.5","value":"4.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"description":"Tissue biomarker immune response of ICOS+ CD4 T cells after combination therapy (MEDI-4736 and Tremelimumab) and after untreated patients 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"},{"description":"4 patients will not receive MEDI4736 or Tremelimumab.\n\nno other name: Neither MEDI4736 nor Tremelimumab will be used.","id":"OG001","title":"Untreated Arm (Control)"}],"paramType":"MEDIAN","populationDescription":"Percentages of ICOS(+) CD8 T cells were obtained in only two patients who have enough amount of live single cells in post-treatment tumor samples in MEDI4736+Tremelimumab group. No patients in the untreated arm had enough cells.","reportingStatus":"POSTED","timeFrame":"Untreated group (control): at day 1, MEDI-4736 and Tremelimumab group: at a surgery within one to six weeks after treatment","title":"Percentage of Inducible T-cell Co-stimulator (ICOS) + CD4 T Cells in Patients Treated With Combination Therapy (MEDI-4736 and Tremelimumab) and in Untreated Patients.","type":"SECONDARY","unitOfMeasure":"percentage of (ICOS) + CD4 T cells"}