TriangleNCT04234113 · OUTCOME
Duration of Response
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
Duration of response according to iRECIST was defined as time to disease progression for participants with partial response or complete response according to iRECIST for target lesions and assessed by CT/MRI.
Analysis population: Patients who were exposed to nanrilkefusp alfa for at least 1 cycle and with at least 1 evaluable tumor assessment per iRECIST after nanrilkefusp alfa treatment start were analyzed. 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. v
| Group | Source count |
|---|---|
| Part A (Nanrilkefusp Alfa Monotherapy) | 0 |
| Part A1 (Nanrilkefusp Alfa Divided Dosing, Monotherapy) | 0 |
| Part B (Nanrilkefusp Alfa Combined With Pembrolizumab) | 2 |
| Part D (Nanrilkefusp Alfa Monotherapy, Expansion at the RP2D Identified in Part A) | 2 |
| Part B1 (Nanrilkefusp Alfa Twice Daily With Pembrolizumab, Expansion at RP2D Identified in Part A) | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part B (Nanrilkefusp Alfa Combined With Pembrolizumab) | 21.3 | Not reported | 5.3 | NA | Insufficient number of participants with events to calculate confidence interval |
| Part D (Nanrilkefusp Alfa Monotherapy, Expansion at the RP2D Identified in Part A) | 8.9 | Not reported | 8.1 | NA | Insufficient number of participants with events Insufficient number of participants with events to calculate confidence interval |
| Part B1 (Nanrilkefusp Alfa Twice Daily With Pembrolizumab, Expansion at RP2D Identified in Part A) | 5.55 | Not reported | NA | NA | Insufficient number of participants with events to calculate confidence interval |
Complete source fields
- classes
- categories
- measurements
- comment
- Insufficient number of participants with events to calculate confidence interval
- group Id
- OG002
- lower Limit
- 5.3
- upper Limit
- NA
- value
- 21.3
- comment
- Insufficient number of participants with events Insufficient number of participants with events to calculate confidence interval
- group Id
- OG003
- lower Limit
- 8.1
- upper Limit
- NA
- value
- 8.9
- comment
- Insufficient number of participants with events to calculate confidence interval
- group Id
- OG004
- lower Limit
- NA
- upper Limit
- NA
- value
- 5.55
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 1
- units
- Participants
- description
- Duration of response according to iRECIST was defined as time to disease progression for participants with partial response or complete response according to iRECIST for target lesions and assessed by CT/MRI.
- 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. v
- id
- OG004
- title
- Part B1 (Nanrilkefusp Alfa Twice Daily With Pembrolizumab, Expansion at RP2D Identified in Part A)
- param Type
- MEDIAN
- population Description
- Patients who were exposed to nanrilkefusp alfa for at least 1 cycle and with at least 1 evaluable tumor assessment per iRECIST after nanrilkefusp alfa treatment start were analyzed. 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
- Duration of Response
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice