NCT03837899 · OUTCOME
Median Percent Change From Baseline of Cluster of Differentiation 4+ (CD4+), CD8+, B Cells, Natural Killer (NK) Cells, and T-cell Activation With Ki67 Durvalumab and Tremelimumab for Pediatric Malignancies · Source last updated 2026-07-07
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure MEDIAN
Unit percentage of cells per cubic millimeter
Interval / dispersion Inter-Quartile Range
Time frame Pre-dose Cycle 1 Day 8, pre-dose Cycle 2 Day 1, Cycle 2 Day 8, pre-dose Cycle 3 Day 1 (Dose-finding); Pre-dose Cycle 1 Day 1, Cycle 1 Day 8, pre-dose Cycle 2 Day 1 (Dose-expansion) What was measured Blood samples were collected at indicated timepoints for flow cytometry assessment. Cycle (C) and Day (D). Data collected for the flow cytometry analysis from the participants enrolled in both the dose finding and dose expansion phase were analyzed in the context of the dosing regimen received, to determine any potential differences in the immune response based on the durvalumab dose.
Analysis population: Participants who received the Durvalumab + tremelimumab combination who had a pre-treatment sample collected on Day 1 and a repeat sample on Day 8 were included. As the weight of the participant was not believed to impact the immune response, it was determined that aggregating the data by dosing regimen rather than by weight group, was considered acceptable for this particular analysis.
Groups in this outcome Dose Expansion: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants from cohort SARCOMA and STO, who were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5, onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
Dose Finding: Durvalumab 20 mg/kg + Tremelimumab 1mg/kg Participants who weighed \>= 35 kg in Arm A and \< 35 kg in Arm B were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6, onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
Dose Finding: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants who weighed \>= 35 kg in Arm A and \< 35 kg in Arm B were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV for Cycles 2-5 every 28 days. From Cycle 6, onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group Source count Dose Expansion: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 12 Dose Finding: Durvalumab 20 mg/kg + Tremelimumab 1mg/kg 7 Dose Finding: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 7
Reported measurements T cells CD4+ Ki67; C1D8 Analysis denominator · Participants
Group Source count Dose Expansion: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 12 Dose Finding: Durvalumab 20 mg/kg + Tremelimumab 1mg/kg 0 Dose Finding: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 0
Values in percentage of cells per cubic millimeter · Interval/dispersion: Inter-Quartile Range Group Value Spread Lower Upper Comment Dose Expansion: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 112.8 Not reported 69.2 352.5 Not reported
T cells CD4+ Ki67; C2D1 Analysis denominator · Participants
Group Source count Dose Expansion: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 8 Dose Finding: Durvalumab 20 mg/kg + Tremelimumab 1mg/kg 7 Dose Finding: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 6
Values in percentage of cells per cubic millimeter · Interval/dispersion: Inter-Quartile Range Group Value Spread Lower Upper Comment Dose Expansion: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 10.3 Not reported -45.8 57.6 Not reported Dose Finding: Durvalumab 20 mg/kg + Tremelimumab 1mg/kg 16.7 Not reported -24.0 66.7 Not reported Dose Finding: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg -25.8 Not reported -43.8 37.8 Not reported
T cells CD4+ Ki67; C2D8 Analysis denominator · Participants
Group Source count Dose Expansion: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 0 Dose Finding: Durvalumab 20 mg/kg + Tremelimumab 1mg/kg 6 Dose Finding: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 5
Values in percentage of cells per cubic millimeter · Interval/dispersion: Inter-Quartile Range Group Value Spread Lower Upper Comment Dose Finding: Durvalumab 20 mg/kg + Tremelimumab 1mg/kg 153.1 Not reported 58.0 925.0 Not reported Dose Finding: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 118.2 Not reported 65.1 215.0 Not reported
T cells CD4+ Ki67; C3D1 Analysis denominator · Participants
Group Source count Dose Expansion: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 0 Dose Finding: Durvalumab 20 mg/kg + Tremelimumab 1mg/kg 2 Dose Finding: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 3
Values in percentage of cells per cubic millimeter · Interval/dispersion: Inter-Quartile Range Group Value Spread Lower Upper Comment Dose Finding: Durvalumab 20 mg/kg + Tremelimumab 1mg/kg -33.4 Not reported -48.0 -18.8 Not reported Dose Finding: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 21.9 Not reported -31.4 81.3 Not reported
T cells CD8+ Ki67; C1D8 Analysis denominator · Participants
Group Source count Dose Expansion: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 7 Dose Finding: Durvalumab 20 mg/kg + Tremelimumab 1mg/kg 0 Dose Finding: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 0
Values in percentage of cells per cubic millimeter · Interval/dispersion: Inter-Quartile Range Group Value Spread Lower Upper Comment Dose Expansion: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 20.0 Not reported -25.0 88.9 Not reported
T cells CD8+ Ki67; C2D1 Analysis denominator · Participants
Group Source count Dose Expansion: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 5 Dose Finding: Durvalumab 20 mg/kg + Tremelimumab 1mg/kg 6 Dose Finding: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 6
Values in percentage of cells per cubic millimeter · Interval/dispersion: Inter-Quartile Range Group Value Spread Lower Upper Comment Dose Expansion: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg -20.0 Not reported -70.8 117.5 Not reported Dose Finding: Durvalumab 20 mg/kg + Tremelimumab 1mg/kg 133.3 Not reported -9.9 431.3 Not reported Dose Finding: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg -62.1 Not reported -67.5 173.3 Not reported
T cells CD8+ Ki67; C2D8 Analysis denominator · Participants
Group Source count Dose Expansion: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 0 Dose Finding: Durvalumab 20 mg/kg + Tremelimumab 1mg/kg 5 Dose Finding: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 5
Values in percentage of cells per cubic millimeter · Interval/dispersion: Inter-Quartile Range Group Value Spread Lower Upper Comment Dose Finding: Durvalumab 20 mg/kg + Tremelimumab 1mg/kg 66.7 Not reported -35.2 900.0 Not reported Dose Finding: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg -40.0 Not reported -57.0 318.3 Not reported
T cells CD8+ Ki67; C3D1 Analysis denominator · Participants
Group Source count Dose Expansion: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 0 Dose Finding: Durvalumab 20 mg/kg + Tremelimumab 1mg/kg 1 Dose Finding: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 3
Values in percentage of cells per cubic millimeter · Interval/dispersion: Inter-Quartile Range Group Value Spread Lower Upper Comment Dose Finding: Durvalumab 20 mg/kg + Tremelimumab 1mg/kg 0.0 Not reported 0.0 0.0 Not reported Dose Finding: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg -55.4 Not reported -73.0 200.0 Not reported
T cells CD4+; C1D8 Analysis denominator · Participants
Group Source count Dose Expansion: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 12 Dose Finding: Durvalumab 20 mg/kg + Tremelimumab 1mg/kg 0 Dose Finding: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 0
Values in percentage of cells per cubic millimeter · Interval/dispersion: Inter-Quartile Range Group Value Spread Lower Upper Comment Dose Expansion: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg -12.5 Not reported -20.5 2.9 Not reported
T cells CD4+; C2D1 Analysis denominator · Participants
Group Source count Dose Expansion: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 9 Dose Finding: Durvalumab 20 mg/kg + Tremelimumab 1mg/kg 7 Dose Finding: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 7
Values in percentage of cells per cubic millimeter · Interval/dispersion: Inter-Quartile Range Group Value Spread Lower Upper Comment Dose Expansion: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 10.1 Not reported -15.2 26.2 Not reported Dose Finding: Durvalumab 20 mg/kg + Tremelimumab 1mg/kg 6.1 Not reported -20.2 45.7 Not reported Dose Finding: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 9.2 Not reported -16.6 34.9 Not reported
T cells CD4+; C2D8 Analysis denominator · Participants
Group Source count Dose Expansion: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 0 Dose Finding: Durvalumab 20 mg/kg + Tremelimumab 1mg/kg 6 Dose Finding: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 6
Values in percentage of cells per cubic millimeter · Interval/dispersion: Inter-Quartile Range Group Value Spread Lower Upper Comment Dose Finding: Durvalumab 20 mg/kg + Tremelimumab 1mg/kg 12.8 Not reported -6.5 63.8 Not reported Dose Finding: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 16.1 Not reported -13.2 52.7 Not reported
T cells CD4+; C3D1 Analysis denominator · Participants
Group Source count Dose Expansion: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 0 Dose Finding: Durvalumab 20 mg/kg + Tremelimumab 1mg/kg 2 Dose Finding: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 4
Values in percentage of cells per cubic millimeter · Interval/dispersion: Inter-Quartile Range Group Value Spread Lower Upper Comment Dose Finding: Durvalumab 20 mg/kg + Tremelimumab 1mg/kg -12.3 Not reported -32.6 8.0 Not reported Dose Finding: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 23.0 Not reported 6.3 39.9 Not reported
T cells CD8+; C1D8 Analysis denominator · Participants
Group Source count Dose Expansion: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 12 Dose Finding: Durvalumab 20 mg/kg + Tremelimumab 1mg/kg 0 Dose Finding: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 0
Values in percentage of cells per cubic millimeter · Interval/dispersion: Inter-Quartile Range Group Value Spread Lower Upper Comment Dose Expansion: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg -23.3 Not reported -37.8 -10.3 Not reported
T cells CD8+; C2D1 Analysis denominator · Participants
Group Source count Dose Expansion: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 9 Dose Finding: Durvalumab 20 mg/kg + Tremelimumab 1mg/kg 7 Dose Finding: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 7
Values in percentage of cells per cubic millimeter · Interval/dispersion: Inter-Quartile Range Group Value Spread Lower Upper Comment Dose Expansion: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 3.6 Not reported -30.2 23.1 Not reported Dose Finding: Durvalumab 20 mg/kg + Tremelimumab 1mg/kg 40.4 Not reported -18.2 59.2 Not reported Dose Finding: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 10.6 Not reported -15.6 50.6 Not reported
T cells CD8+; C2D8 Analysis denominator · Participants
Group Source count Dose Expansion: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 0 Dose Finding: Durvalumab 20 mg/kg + Tremelimumab 1mg/kg 6 Dose Finding: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 6
Values in percentage of cells per cubic millimeter · Interval/dispersion: Inter-Quartile Range Group Value Spread Lower Upper Comment Dose Finding: Durvalumab 20 mg/kg + Tremelimumab 1mg/kg 30.1 Not reported -14.6 60.9 Not reported Dose Finding: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 13.8 Not reported -18.0 71.2 Not reported
T cells CD8+; C3D1 Analysis denominator · Participants
Group Source count Dose Expansion: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 0 Dose Finding: Durvalumab 20 mg/kg + Tremelimumab 1mg/kg 2 Dose Finding: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 4
Values in percentage of cells per cubic millimeter · Interval/dispersion: Inter-Quartile Range Group Value Spread Lower Upper Comment Dose Finding: Durvalumab 20 mg/kg + Tremelimumab 1mg/kg -8.3 Not reported -24.5 7.9 Not reported Dose Finding: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 0.6 Not reported -5.5 2.6 Not reported
B cells; C1D8 Analysis denominator · Participants
Group Source count Dose Expansion: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 12 Dose Finding: Durvalumab 20 mg/kg + Tremelimumab 1mg/kg 0 Dose Finding: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 0
Values in percentage of cells per cubic millimeter · Interval/dispersion: Inter-Quartile Range Group Value Spread Lower Upper Comment Dose Expansion: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg -29.2 Not reported -40.6 -24.7 Not reported
B cells; C2D1 Analysis denominator · Participants
Group Source count Dose Expansion: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 9 Dose Finding: Durvalumab 20 mg/kg + Tremelimumab 1mg/kg 7 Dose Finding: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 7
Values in percentage of cells per cubic millimeter · Interval/dispersion: Inter-Quartile Range Group Value Spread Lower Upper Comment Dose Expansion: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 6.2 Not reported -3.1 56.9 Not reported Dose Finding: Durvalumab 20 mg/kg + Tremelimumab 1mg/kg 27.2 Not reported -1.5 650.0 Not reported Dose Finding: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg -12.0 Not reported -22.0 128.0 Not reported
B cells; C2D8 Analysis denominator · Participants
Group Source count Dose Expansion: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 0 Dose Finding: Durvalumab 20 mg/kg + Tremelimumab 1mg/kg 6 Dose Finding: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 6
Values in percentage of cells per cubic millimeter · Interval/dispersion: Inter-Quartile Range Group Value Spread Lower Upper Comment Dose Finding: Durvalumab 20 mg/kg + Tremelimumab 1mg/kg 20.6 Not reported -4.8 1543.8 Not reported Dose Finding: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg -8.2 Not reported -26.2 43.1 Not reported
B cells; C3D1 Analysis denominator · Participants
Group Source count Dose Expansion: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 0 Dose Finding: Durvalumab 20 mg/kg + Tremelimumab 1mg/kg 2 Dose Finding: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 4
Values in percentage of cells per cubic millimeter · Interval/dispersion: Inter-Quartile Range Group Value Spread Lower Upper Comment Dose Finding: Durvalumab 20 mg/kg + Tremelimumab 1mg/kg -2.5 Not reported -8.6 3.6 Not reported Dose Finding: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 15.7 Not reported -24.4 42.1 Not reported
NK cells; C1D8 Analysis denominator · Participants
Group Source count Dose Expansion: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 12 Dose Finding: Durvalumab 20 mg/kg + Tremelimumab 1mg/kg 0 Dose Finding: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 0
Values in percentage of cells per cubic millimeter · Interval/dispersion: Inter-Quartile Range Group Value Spread Lower Upper Comment Dose Expansion: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg -30.1 Not reported -39.7 15.2 Not reported
NK cells; C2D1 Analysis denominator · Participants
Group Source count Dose Expansion: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 9 Dose Finding: Durvalumab 20 mg/kg + Tremelimumab 1mg/kg 7 Dose Finding: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 7
Values in percentage of cells per cubic millimeter · Interval/dispersion: Inter-Quartile Range Group Value Spread Lower Upper Comment Dose Expansion: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg -25.8 Not reported -49.2 55.3 Not reported Dose Finding: Durvalumab 20 mg/kg + Tremelimumab 1mg/kg 31.0 Not reported -1.1 59.6 Not reported Dose Finding: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 32.2 Not reported 14.3 56.8 Not reported
NK cells; C2D8 Analysis denominator · Participants
Group Source count Dose Expansion: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 0 Dose Finding: Durvalumab 20 mg/kg + Tremelimumab 1mg/kg 6 Dose Finding: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 6
Values in percentage of cells per cubic millimeter · Interval/dispersion: Inter-Quartile Range Group Value Spread Lower Upper Comment Dose Finding: Durvalumab 20 mg/kg + Tremelimumab 1mg/kg 7.4 Not reported -28.1 75.9 Not reported Dose Finding: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 47.4 Not reported 22.2 55.6 Not reported
NK cells; C3D1 Analysis denominator · Participants
Group Source count Dose Expansion: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 0 Dose Finding: Durvalumab 20 mg/kg + Tremelimumab 1mg/kg 2 Dose Finding: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 4
Values in percentage of cells per cubic millimeter · Interval/dispersion: Inter-Quartile Range Group Value Spread Lower Upper Comment Dose Finding: Durvalumab 20 mg/kg + Tremelimumab 1mg/kg 25.9 Not reported -9.6 61.4 Not reported Dose Finding: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg 43.7 Not reported -26.9 77.2 Not reported
Complete source fields classes categories measurements
group Id OG000
lower Limit 69.2
upper Limit 352.5
value 112.8 denoms counts
group Id OG000
value 12
group Id OG001
value 0
group Id OG002
value 0
units Participants
title T cells CD4+ Ki67; C1D8 categories measurements
group Id OG000
lower Limit -45.8
upper Limit 57.6
value 10.3
group Id OG001
lower Limit -24.0
upper Limit 66.7
value 16.7
group Id OG002
lower Limit -43.8
upper Limit 37.8
value -25.8 denoms counts
group Id OG000
value 8
group Id OG001
value 7
group Id OG002
value 6
units Participants
title T cells CD4+ Ki67; C2D1 categories measurements
group Id OG001
lower Limit 58.0
upper Limit 925.0
value 153.1
group Id OG002
lower Limit 65.1
upper Limit 215.0
value 118.2 denoms counts
group Id OG000
value 0
group Id OG001
value 6
group Id OG002
value 5
units Participants
title T cells CD4+ Ki67; C2D8 categories measurements
group Id OG001
lower Limit -48.0
upper Limit -18.8
value -33.4
group Id OG002
lower Limit -31.4
upper Limit 81.3
value 21.9 denoms counts
group Id OG000
value 0
group Id OG001
value 2
group Id OG002
value 3
units Participants
title T cells CD4+ Ki67; C3D1 categories measurements
group Id OG000
lower Limit -25.0
upper Limit 88.9
value 20.0 denoms counts
group Id OG000
value 7
group Id OG001
value 0
group Id OG002
value 0
units Participants
title T cells CD8+ Ki67; C1D8 categories measurements
group Id OG000
lower Limit -70.8
upper Limit 117.5
value -20.0
group Id OG001
lower Limit -9.9
upper Limit 431.3
value 133.3
group Id OG002
lower Limit -67.5
upper Limit 173.3
value -62.1 denoms counts
group Id OG000
value 5
group Id OG001
value 6
group Id OG002
value 6
units Participants
title T cells CD8+ Ki67; C2D1 categories measurements
group Id OG001
lower Limit -35.2
upper Limit 900.0
value 66.7
group Id OG002
lower Limit -57.0
upper Limit 318.3
value -40.0 denoms counts
group Id OG000
value 0
group Id OG001
value 5
group Id OG002
value 5
units Participants
title T cells CD8+ Ki67; C2D8 categories measurements
group Id OG001
lower Limit 0.0
upper Limit 0.0
value 0.0
group Id OG002
lower Limit -73.0
upper Limit 200.0
value -55.4 denoms counts
group Id OG000
value 0
group Id OG001
value 1
group Id OG002
value 3
units Participants
title T cells CD8+ Ki67; C3D1 categories measurements
group Id OG000
lower Limit -20.5
upper Limit 2.9
value -12.5 denoms counts
group Id OG000
value 12
group Id OG001
value 0
group Id OG002
value 0
units Participants
title T cells CD4+; C1D8 categories measurements
group Id OG000
lower Limit -15.2
upper Limit 26.2
value 10.1
group Id OG001
lower Limit -20.2
upper Limit 45.7
value 6.1
group Id OG002
lower Limit -16.6
upper Limit 34.9
value 9.2 denoms counts
group Id OG000
value 9
group Id OG001
value 7
group Id OG002
value 7
units Participants
title T cells CD4+; C2D1 categories measurements
group Id OG001
lower Limit -6.5
upper Limit 63.8
value 12.8
group Id OG002
lower Limit -13.2
upper Limit 52.7
value 16.1 denoms counts
group Id OG000
value 0
group Id OG001
value 6
group Id OG002
value 6
units Participants
title T cells CD4+; C2D8 categories measurements
group Id OG001
lower Limit -32.6
upper Limit 8.0
value -12.3
group Id OG002
lower Limit 6.3
upper Limit 39.9
value 23.0 denoms counts
group Id OG000
value 0
group Id OG001
value 2
group Id OG002
value 4
units Participants
title T cells CD4+; C3D1 Show more (12 of 24) denoms counts
group Id OG000
value 12
group Id OG001
value 7
group Id OG002
value 7
units Participants
description Blood samples were collected at indicated timepoints for flow cytometry assessment. Cycle (C) and Day (D). Data collected for the flow cytometry analysis from the participants enrolled in both the dose finding and dose expansion phase were analyzed in the context of the dosing regimen received, to determine any potential differences in the immune response based on the durvalumab dose.
dispersion Type Inter-Quartile Range groups
description Participants from cohort SARCOMA and STO, who were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5, onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
id OG000
title Dose Expansion: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg
description Participants who weighed \>= 35 kg in Arm A and \< 35 kg in Arm B were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6, onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
id OG001
title Dose Finding: Durvalumab 20 mg/kg + Tremelimumab 1mg/kg
description Participants who weighed \>= 35 kg in Arm A and \< 35 kg in Arm B were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV for Cycles 2-5 every 28 days. From Cycle 6, onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
id OG002
title Dose Finding: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg
param Type MEDIAN
population Description Participants who received the Durvalumab + tremelimumab combination who had a pre-treatment sample collected on Day 1 and a repeat sample on Day 8 were included. As the weight of the participant was not believed to impact the immune response, it was determined that aggregating the data by dosing regimen rather than by weight group, was considered acceptable for this particular analysis.
reporting Status POSTED
time Frame Pre-dose Cycle 1 Day 8, pre-dose Cycle 2 Day 1, Cycle 2 Day 8, pre-dose Cycle 3 Day 1 (Dose-finding); Pre-dose Cycle 1 Day 1, Cycle 1 Day 8, pre-dose Cycle 2 Day 1 (Dose-expansion)
title Median Percent Change From Baseline of Cluster of Differentiation 4+ (CD4+), CD8+, B Cells, Natural Killer (NK) Cells, and T-cell Activation With Ki67
type SECONDARY
unit Of Measure percentage of cells per cubic millimeter Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
Triangle