{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.5","upperLimit":"2.2","value":"1.87"},{"groupId":"OG001","lowerLimit":"9.7","upperLimit":"19.5","value":"15.70"},{"groupId":"OG002","lowerLimit":"22.0","upperLimit":"31.4","value":"24.80"},{"groupId":"OG003","lowerLimit":"17.3","upperLimit":"40.5","value":"25.20"},{"groupId":"OG004","lowerLimit":"41.8","upperLimit":"49.9","value":"45.85"},{"groupId":"OG005","lowerLimit":"24.7","upperLimit":"72.9","value":"31.85"},{"groupId":"OG006","lowerLimit":"69.8","upperLimit":"81.8","value":"74.40"},{"groupId":"OG007","lowerLimit":"66.5","upperLimit":"66.5","value":"66.50"},{"groupId":"OG008","lowerLimit":"1.1","upperLimit":"72.7","value":"13.58"},{"groupId":"OG009","lowerLimit":"39.1","upperLimit":"89.2","value":"64.15"},{"groupId":"OG010","lowerLimit":"10.4","upperLimit":"18.0","value":"13.20"},{"groupId":"OG011","lowerLimit":"15.8","upperLimit":"28.3","value":"17.70"},{"groupId":"OG012","lowerLimit":"13.7","upperLimit":"74.4","value":"50.40"},{"groupId":"OG013","lowerLimit":"45.6","upperLimit":"52.4","value":"49.00"},{"groupId":"OG014","lowerLimit":"4.7","upperLimit":"71.9","value":"39.40"},{"groupId":"OG015","lowerLimit":"4.0","upperLimit":"96.2","value":"52.30"},{"groupId":"OG016","lowerLimit":"39.3","upperLimit":"75.4","value":"54.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"4"},{"groupId":"OG004","value":"2"},{"groupId":"OG005","value":"4"},{"groupId":"OG006","value":"4"},{"groupId":"OG007","value":"1"},{"groupId":"OG008","value":"4"},{"groupId":"OG009","value":"2"},{"groupId":"OG010","value":"3"},{"groupId":"OG011","value":"3"},{"groupId":"OG012","value":"4"},{"groupId":"OG013","value":"2"},{"groupId":"OG014","value":"4"},{"groupId":"OG015","value":"15"},{"groupId":"OG016","value":"4"}],"units":"Participants"}],"description":"The eCRF Hematology data (specifically white blood cell count (WBC)) for each timepoint will be used to derive the Cell counts in 10\\^9/L. Once merged with the pharmacodynamic data by subject and timepoint, the following will be used as derivation:\n\n• Ki-67+ Cells of CD8+ Cells (10\\^9/L) = Ki-67+ Cells of CD8+ Cells (%CD45+) x 0.01 x WBC\" Absolute count of Ki-67+ Cells was calculated as percentage of those cells out of CD45+ multiplied by WBC and 0.01.","dispersionType":"Full Range","groups":[{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.","id":"OG000","title":"Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 0.25 μg/kg"},{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.","id":"OG001","title":"Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 0.75 μg/kg"},{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.","id":"OG002","title":"Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 1.5 μg/kg"},{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.","id":"OG003","title":"Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 3 μg/kg"},{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.","id":"OG004","title":"Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 6 μg/kg"},{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.","id":"OG005","title":"Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 9 μg/kg"},{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.","id":"OG006","title":"Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 12 μg/kg"},{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.","id":"OG007","title":"Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 15 μg/kg"},{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle twice a day as 2 divided doses (50%:50%) with the second dose on each treatment day administered 8 hours (±15 min) after the first dose.","id":"OG008","title":"Part A1 (Nanrilkefusp Alfa Divided Dosing, Monotherapy), Nanrilkefusp Alfa 9 μg/kg"},{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle twice a day as 2 divided doses (50%:50%) with the second dose on each treatment day administered 8 hours (±15 min) after the first dose.","id":"OG009","title":"Part A1 (Nanrilkefusp Alfa Divided Dosing, Monotherapy), Nanrilkefusp Alfa 12 μg/kg"},{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.\n\nPembrolizumab 200 mg was administered intravenously on day 1 of the 21-day treatment cycle.","id":"OG010","title":"Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 1.5 μg/kg"},{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.\n\nPembrolizumab 200 mg was administered intravenously on day 1 of the 21-day treatment cycle.","id":"OG011","title":"Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 3 μg/kg"},{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.\n\nPembrolizumab 200 mg was administered intravenously on day 1 of the 21-day treatment cycle.","id":"OG012","title":"Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 6 μg/kg"},{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.\n\nPembrolizumab 200 mg was administered intravenously on day 1 of the 21-day treatment cycle.","id":"OG013","title":"Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 9 μg/kg"},{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.\n\nPembrolizumab 200 mg was administered intravenously on day 1 of the 21-day treatment cycle.","id":"OG014","title":"Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 12 μg/kg"},{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.","id":"OG015","title":"Part D (Nanrilkefusp Alfa Monotherapy, Expansion at the RP2D), Nanrilkefusp Alfa 12 μg/kg"},{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle twice a day as 2 divided doses (50%:50%) with the second dose on each treatment day administered 8 hours (±15 min) after the first dose. Pembrolizumab 200 mg was administered intravenously on day 1 of the 21-day treatment cycle.","id":"OG016","title":"Part B1 (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 9 μg/kg"}],"paramType":"MEDIAN","populationDescription":"For several patients the PD profile was not evaluable: 7 patients in part A (1 in 0.25 μg/kg, 1 in 6 μg/kg, 2 in12 μg/kg and 3 in 15 μg/kg arms), 2 patients in Part A1 (1 in 9 μg/kg and 1 in 12 μg/kg arms), 5 patients in Part B (3 in 6 μg/kg, 1 in 9 μg/kg, and 1 in 12 μg/kg arm), and 37 patients in Part D.","reportingStatus":"POSTED","timeFrame":"Cycle 1 Day 6","title":"Overall Activation Levels of Ki-67+ CD8+ T Cells on Day 6 of Cycle 1","type":"SECONDARY","unitOfMeasure":"percentage of cells with activation"}