TriangleNCT04234113 · OUTCOME
Overall Activation Levels of Ki-67+ NK Cells on Day 6 of Cycle 1
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- percentage of cells with activation
- Interval / dispersion
- Full Range
- Time frame
- Cycle 1 Day 6
What was measured
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: • Ki-67+ Cells of CD3-CD56+ (NK) Cells (10\^9/L) = Ki-67+ Cells of CD3-CD56+ (NK) 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.
Analysis population: 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.
Groups in this outcome
Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 0.25 μg/kg
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.
Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 0.75 μg/kg
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.
Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 1.5 μg/kg
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.
Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 3 μg/kg
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.
Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 6 μg/kg
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.
Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 9 μg/kg
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.
Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 12 μg/kg
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.
Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 15 μg/kg
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.
Part A1 (Nanrilkefusp Alfa Divided Dosing, Monotherapy), Nanrilkefusp Alfa 9 μg/kg
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.
Part A1 (Nanrilkefusp Alfa Divided Dosing, Monotherapy), Nanrilkefusp Alfa 12 μg/kg
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.
Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 1.5 μg/kg
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. Pembrolizumab 200 mg was administered intravenously on day 1 of the 21-day treatment cycle.
Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 3 μg/kg
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. Pembrolizumab 200 mg was administered intravenously on day 1 of the 21-day treatment cycle.
Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 6 μg/kg
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. Pembrolizumab 200 mg was administered intravenously on day 1 of the 21-day treatment cycle.
Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 9 μg/kg
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. Pembrolizumab 200 mg was administered intravenously on day 1 of the 21-day treatment cycle.
Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 12 μg/kg
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. Pembrolizumab 200 mg was administered intravenously on day 1 of the 21-day treatment cycle.
Part D (Nanrilkefusp Alfa Monotherapy, Expansion at the RP2D), Nanrilkefusp Alfa 12 μg/kg
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.
Part B1 (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 9 μg/kg
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.
| Group | Source count |
|---|---|
| Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 0.25 μg/kg | 2 |
| Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 0.75 μg/kg | 3 |
| Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 1.5 μg/kg | 3 |
| Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 3 μg/kg | 4 |
| Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 6 μg/kg | 2 |
| Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 9 μg/kg | 4 |
| Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 12 μg/kg | 4 |
| Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 15 μg/kg | 1 |
| Part A1 (Nanrilkefusp Alfa Divided Dosing, Monotherapy), Nanrilkefusp Alfa 9 μg/kg | 4 |
| Part A1 (Nanrilkefusp Alfa Divided Dosing, Monotherapy), Nanrilkefusp Alfa 12 μg/kg | 2 |
| Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 1.5 μg/kg | 3 |
| Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 3 μg/kg | 3 |
| Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 6 μg/kg | 4 |
| Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 9 μg/kg | 2 |
| Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 12 μg/kg | 4 |
| Part D (Nanrilkefusp Alfa Monotherapy, Expansion at the RP2D), Nanrilkefusp Alfa 12 μg/kg | 15 |
| Part B1 (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 9 μg/kg | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 0.25 μg/kg | 53.25 | Not reported | 43.8 | 62.7 | Not reported |
| Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 0.75 μg/kg | 59.00 | Not reported | 56.2 | 62.2 | Not reported |
| Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 1.5 μg/kg | 80.00 | Not reported | 69.6 | 94.4 | Not reported |
| Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 3 μg/kg | 79.20 | Not reported | 56.2 | 90.0 | Not reported |
| Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 6 μg/kg | 46.45 | Not reported | 30.6 | 62.3 | Not reported |
| Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 9 μg/kg | 44.95 | Not reported | 33.0 | 82.3 | Not reported |
| Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 12 μg/kg | 70.20 | Not reported | 62.8 | 94.2 | Not reported |
| Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 15 μg/kg | 81.70 | Not reported | 81.7 | 81.7 | Not reported |
| Part A1 (Nanrilkefusp Alfa Divided Dosing, Monotherapy), Nanrilkefusp Alfa 9 μg/kg | 45.94 | Not reported | 0.9 | 94.3 | Not reported |
| Part A1 (Nanrilkefusp Alfa Divided Dosing, Monotherapy), Nanrilkefusp Alfa 12 μg/kg | 77.60 | Not reported | 56.8 | 98.4 | Not reported |
| Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 1.5 μg/kg | 34.70 | Not reported | 18.0 | 93.3 | Not reported |
| Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 3 μg/kg | 60.20 | Not reported | 30.7 | 63.9 | Not reported |
| Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 6 μg/kg | 81.10 | Not reported | 10.3 | 91.6 | Not reported |
| Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 9 μg/kg | 69.30 | Not reported | 59.4 | 79.2 | Not reported |
| Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 12 μg/kg | 50.87 | Not reported | 8.6 | 94.1 | Not reported |
| Part D (Nanrilkefusp Alfa Monotherapy, Expansion at the RP2D), Nanrilkefusp Alfa 12 μg/kg | 50.60 | Not reported | 3.2 | 98.4 | Not reported |
| Part B1 (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 9 μg/kg | 82.6 | Not reported | 65.7 | 93.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 43.8
- upper Limit
- 62.7
- value
- 53.25
- group Id
- OG001
- lower Limit
- 56.2
- upper Limit
- 62.2
- value
- 59.00
- group Id
- OG002
- lower Limit
- 69.6
- upper Limit
- 94.4
- value
- 80.00
- group Id
- OG003
- lower Limit
- 56.2
- upper Limit
- 90.0
- value
- 79.20
- group Id
- OG004
- lower Limit
- 30.6
- upper Limit
- 62.3
- value
- 46.45
- group Id
- OG005
- lower Limit
- 33.0
- upper Limit
- 82.3
- value
- 44.95
- group Id
- OG006
- lower Limit
- 62.8
- upper Limit
- 94.2
- value
- 70.20
- group Id
- OG007
- lower Limit
- 81.7
- upper Limit
- 81.7
- value
- 81.70
- group Id
- OG008
- lower Limit
- 0.9
- upper Limit
- 94.3
- value
- 45.94
- group Id
- OG009
- lower Limit
- 56.8
- upper Limit
- 98.4
- value
- 77.60
- group Id
- OG010
- lower Limit
- 18.0
- upper Limit
- 93.3
- value
- 34.70
- group Id
- OG011
- lower Limit
- 30.7
- upper Limit
- 63.9
- value
- 60.20
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 4
- group Id
- OG009
- value
- 2
- group Id
- OG010
- value
- 3
- group Id
- OG011
- value
- 3
- 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: • Ki-67+ Cells of CD3-CD56+ (NK) Cells (10\^9/L) = Ki-67+ Cells of CD3-CD56+ (NK) 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.
- dispersion Type
- 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. Pembrolizumab 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. Pembrolizumab 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
- param Type
- MEDIAN
- population Description
- 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.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day 6
- title
- Overall Activation Levels of Ki-67+ NK Cells on Day 6 of Cycle 1
- type
- SECONDARY
- unit Of Measure
- percentage of cells with activation
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Preserved source evidence · Not medical advice