TriangleNCT02657889 · OUTCOME
Phase 2: Overall Response Rate (ORR) as Measured by Immune-related RECIST (irRECIST)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- Not reported
- Unit
- Not reported
- Interval / dispersion
- Not reported
- Time frame
- Up to a maximum of 54 months
What was measured
ORR by irRECIST is defined as the percentage of participants with a confirmed best overall response of CR or PR using irRECIST. Immune related complete response (irCR) is defined as at least two radiographic determinations of CR, at least 4 weeks apart and before Immune related progressive disease (irPD - defined as at least two consecutive radiographic determinations of progressive disease \[PD\] at least 4 weeks apart) at least 4 weeks apart. Immune related partial response (irPR) defined as at least two radiographic determinations of PR or better at least 4 weeks apart and before irPD (and not qualifying for an irCR).
Analysis population: Full Analysis Set. IrRECIST data were invalid due to errors in the collection approach. Hence, data for this outcome measure were not reported. This decision was documented in the final Statistical Analysis Plan (SAP) (Version 2, 21-March-2019) and approved before database lock which occurred on 22-October-2021.
Groups in this outcome
Phase 2 OC: Niraparib 200mg + Pembrolizumab
Participants with Ovarian Cancer (OC) received recommended phase 2 dose (RP2D) of Niraparib 200 mg orally once daily and Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle.
Phase 2 TNBC: Niraparib 200mg + Pembrolizumab
Participants with Triple Negative Breast Cancer (TNBC) received RP2D of Niraparib 200 mg orally once daily and Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle.
| Group | Source count |
|---|---|
| Phase 2 OC: Niraparib 200mg + Pembrolizumab | 0 |
| Phase 2 TNBC: Niraparib 200mg + Pembrolizumab | 0 |
Reported measurements
No numerical measurement classes were posted for this outcome. Missing is not zero.
Complete source fields
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- units
- Participants
- description
- ORR by irRECIST is defined as the percentage of participants with a confirmed best overall response of CR or PR using irRECIST. Immune related complete response (irCR) is defined as at least two radiographic determinations of CR, at least 4 weeks apart and before Immune related progressive disease (irPD - defined as at least two consecutive radiographic determinations of progressive disease \[PD\] at least 4 weeks apart) at least 4 weeks apart. Immune related partial response (irPR) defined as at least two radiographic determinations of PR or better at least 4 weeks apart and before irPD (and not qualifying for an irCR).
- groups
- description
- Participants with Ovarian Cancer (OC) received recommended phase 2 dose (RP2D) of Niraparib 200 mg orally once daily and Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle.
- id
- OG000
- title
- Phase 2 OC: Niraparib 200mg + Pembrolizumab
- description
- Participants with Triple Negative Breast Cancer (TNBC) received RP2D of Niraparib 200 mg orally once daily and Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle.
- id
- OG001
- title
- Phase 2 TNBC: Niraparib 200mg + Pembrolizumab
- population Description
- Full Analysis Set. IrRECIST data were invalid due to errors in the collection approach. Hence, data for this outcome measure were not reported. This decision was documented in the final Statistical Analysis Plan (SAP) (Version 2, 21-March-2019) and approved before database lock which occurred on 22-October-2021.
- reporting Status
- POSTED
- time Frame
- Up to a maximum of 54 months
- title
- Phase 2: Overall Response Rate (ORR) as Measured by Immune-related RECIST (irRECIST)
- type
- SECONDARY
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice