TriangleNCT04234113 · OUTCOME
Overall Activation Levels of Ki-67+ NKT 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: • CD3+CD56+ (NKT) Cells of CD45+ Live Cells (10\^9/L) = CD3+CD56+ (NKT) Cells of CD45+ Live Cells (%) x 0.01 x WBC Absolute count of Ki-67+ Cells was calculated as percentage of those cells out of Live Cells 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 | 10.12 | Not reported | 9.8 | 10.4 | Not reported |
| Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 0.75 μg/kg | 30.70 | Not reported | 16.7 | 39.6 | Not reported |
| Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 1.5 μg/kg | 35.50 | Not reported | 30.2 | 40.5 | Not reported |
| Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 3 μg/kg | 50.75 | Not reported | 36.3 | 65.3 | Not reported |
| Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 6 μg/kg | 58.75 | Not reported | 44.6 | 72.9 | Not reported |
| Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 9 μg/kg | 22.85 | Not reported | 21.9 | 64.1 | Not reported |
| Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 12 μg/kg | 65.15 | Not reported | 50.0 | 83.7 | Not reported |
| Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 15 μg/kg | 66.00 | Not reported | 66.0 | 66.0 | Not reported |
| Part A1 (Nanrilkefusp Alfa Divided Dosing, Monotherapy), Nanrilkefusp Alfa 9 μg/kg | 36.85 | Not reported | 1.0 | 81.4 | Not reported |
| Part A1 (Nanrilkefusp Alfa Divided Dosing, Monotherapy), Nanrilkefusp Alfa 12 μg/kg | 66.00 | Not reported | 45.1 | 86.9 | Not reported |
| Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 1.5 μg/kg | 21.60 | Not reported | 15.6 | 32.7 | Not reported |
| Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 3 μg/kg | 37.50 | Not reported | 27.6 | 52.0 | Not reported |
| Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 6 μg/kg | 70.00 | Not reported | 15.2 | 81.7 | Not reported |
| Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 9 μg/kg | 60.95 | Not reported | 48.6 | 73.3 | Not reported |
| Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 12 μg/kg | 54.65 | Not reported | 16.6 | 91.2 | Not reported |
| Part D (Nanrilkefusp Alfa Monotherapy, Expansion at the RP2D), Nanrilkefusp Alfa 12 μg/kg | 47.80 | Not reported | 2.8 | 84.1 | Not reported |
| Part B1 (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 9 μg/kg | 57.25 | Not reported | 49.4 | 76.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.8
- upper Limit
- 10.4
- value
- 10.12
- group Id
- OG001
- lower Limit
- 16.7
- upper Limit
- 39.6
- value
- 30.70
- group Id
- OG002
- lower Limit
- 30.2
- upper Limit
- 40.5
- value
- 35.50
- group Id
- OG003
- lower Limit
- 36.3
- upper Limit
- 65.3
- value
- 50.75
- group Id
- OG004
- lower Limit
- 44.6
- upper Limit
- 72.9
- value
- 58.75
- group Id
- OG005
- lower Limit
- 21.9
- upper Limit
- 64.1
- value
- 22.85
- group Id
- OG006
- lower Limit
- 50.0
- upper Limit
- 83.7
- value
- 65.15
- group Id
- OG007
- lower Limit
- 66.0
- upper Limit
- 66.0
- value
- 66.00
- group Id
- OG008
- lower Limit
- 1.0
- upper Limit
- 81.4
- value
- 36.85
- group Id
- OG009
- lower Limit
- 45.1
- upper Limit
- 86.9
- value
- 66.00
- group Id
- OG010
- lower Limit
- 15.6
- upper Limit
- 32.7
- value
- 21.60
- group Id
- OG011
- lower Limit
- 27.6
- upper Limit
- 52.0
- value
- 37.50
- 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: • CD3+CD56+ (NKT) Cells of CD45+ Live Cells (10\^9/L) = CD3+CD56+ (NKT) Cells of CD45+ Live Cells (%) x 0.01 x WBC Absolute count of Ki-67+ Cells was calculated as percentage of those cells out of Live Cells 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+ NKT 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