TriangleNCT04234113 · OUTCOME
Objective Response Rate
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- Day 1 up to approximately 5 years 5 months
What was measured
Based on investigator review of radiographic images according to Response Evaluation Criteria In Solid Tumors for immune-based therapeutics (iRECIST). Objective response rate according to iRECIST was defined as the percentage of participants with complete response according to iRECIST or partial 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. 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) | 3.8 | Not reported | Not reported | Not reported | Not reported |
| Part A1 (Nanrilkefusp Alfa Divided Dosing, Monotherapy) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B (Nanrilkefusp Alfa Combined With Pembrolizumab) | 26.3 | Not reported | Not reported | Not reported | Not reported |
| Part D (Nanrilkefusp Alfa Monotherapy, Expansion at the RP2D Identified in Part A) | 4.35 | Not reported | Not reported | Not reported | Not reported |
| Part B1 (Nanrilkefusp Alfa Twice Daily With Pembrolizumab, Expansion at RP2D Identified in Part A) | 25.0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3.8
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 26.3
- group Id
- OG003
- value
- 4.35
- group Id
- OG004
- value
- 25.0
- 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
- Based on investigator review of radiographic images according to Response Evaluation Criteria In Solid Tumors for immune-based therapeutics (iRECIST). Objective response rate according to iRECIST was defined as the percentage of participants with complete response according to iRECIST or partial response according to iRECIST for target lesions and assessed by CT/MRI.
- 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
- NUMBER
- 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
- Objective Response Rate
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice