TriangleNCT04234113 · OUTCOME
Progression-free Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Day 1 up to approximately 5 years 5 months
What was measured
Progression-free survival according to iRECIST was defined as the time from the first day of study treatment to the first date of radiological disease progression according to iRECIST or death.
Analysis population: In the trial protocol and SAP it was pre-specified that the arms in individual trial parts will be analyzed combined (A, A1, B, D, and B1).
Groups in this outcome
Part A (Nanrilkefusp Alfa Monotherapy)
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 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 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 Identified in Part A)
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 Twice Daily With Pembrolizumab, Expansion at RP2D Identified in Part A)
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) | 26 |
| Part A1 (Nanrilkefusp Alfa Divided Dosing, Monotherapy) | 7 |
| Part B (Nanrilkefusp Alfa Combined With Pembrolizumab) | 19 |
| Part D (Nanrilkefusp Alfa Monotherapy, Expansion at the RP2D Identified in Part A) | 46 |
| Part B1 (Nanrilkefusp Alfa Twice Daily With Pembrolizumab, Expansion at RP2D Identified in Part A) | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A (Nanrilkefusp Alfa Monotherapy) | 1.6 | Not reported | 1.2 | 2.6 | Not reported |
| Part A1 (Nanrilkefusp Alfa Divided Dosing, Monotherapy) | 1.2 | Not reported | 1.1 | 1.4 | Not reported |
| Part B (Nanrilkefusp Alfa Combined With Pembrolizumab) | 5.2 | Not reported | 3.0 | 9.8 | Not reported |
| Part D (Nanrilkefusp Alfa Monotherapy, Expansion at the RP2D Identified in Part A) | 2.6 | Not reported | 1.4 | 2.9 | Not reported |
| Part B1 (Nanrilkefusp Alfa Twice Daily With Pembrolizumab, Expansion at RP2D Identified in Part A) | 5.5 | Not reported | 1.1 | NA | Insufficient data to calculate upper limit of confidence interval |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.2
- upper Limit
- 2.6
- value
- 1.6
- group Id
- OG001
- lower Limit
- 1.1
- upper Limit
- 1.4
- value
- 1.2
- group Id
- OG002
- lower Limit
- 3.0
- upper Limit
- 9.8
- value
- 5.2
- group Id
- OG003
- lower Limit
- 1.4
- upper Limit
- 2.9
- value
- 2.6
- comment
- Insufficient data to calculate upper limit of confidence interval
- group Id
- OG004
- lower Limit
- 1.1
- upper Limit
- NA
- value
- 5.5
- denoms
- counts
- group Id
- OG000
- value
- 26
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 19
- group Id
- OG003
- value
- 46
- group Id
- OG004
- value
- 4
- units
- Participants
- description
- Progression-free survival according to iRECIST was defined as the time from the first day of study treatment to the first date of radiological disease progression according to iRECIST or death.
- dispersion Type
- 95% Confidence Interval
- 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)
- 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
- OG001
- title
- Part A1 (Nanrilkefusp Alfa Divided Dosing, Monotherapy)
- 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
- OG002
- title
- Part B (Nanrilkefusp Alfa Combined With Pembrolizumab)
- 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 D (Nanrilkefusp Alfa Monotherapy, Expansion at the RP2D Identified in Part A)
- 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
- OG004
- title
- Part B1 (Nanrilkefusp Alfa Twice Daily With Pembrolizumab, Expansion at RP2D Identified in Part A)
- param Type
- MEDIAN
- population Description
- In the trial protocol and SAP it was pre-specified that the arms in individual trial parts will be analyzed combined (A, A1, B, D, and B1).
- reporting Status
- POSTED
- time Frame
- Day 1 up to approximately 5 years 5 months
- title
- Progression-free Survival
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice