TriangleNCT05551117 · OUTCOME
Part 1: Six-month Radiographic Progression Free Survival (rPFS) as Determined by the Investigator
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- proportion of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Assessed every 8 weeks for six months. Six month data reported.
What was measured
The landmark analysis for 6 month rPFS rate will occur when all participants on Part 1 have been on study for at least 6 months.
Analysis population: All participants according to the study treatment assigned (Intent to Treat Population) for participants with mCRPC in Part 1 only. This outcome measure applies to Part 1 only. Per protocol, participants in Part 2 did not have mCRPC and were not part of this analysis.
Groups in this outcome
Part 1: MGC018 2.0 mg (Arm A)
vobramitamab duocarmazine 2.0 mg/kg, IV, every 4 weeks
Part 1: MGC018 2.7 mg (Arm B)
vobramitamab duocarmazine 2.7 mg/kg, IV, every 4 weeks
Part 1: Control Arm
abiraterone 1000 mg once daily or enzalutamide 160 mg once daily.
Part 2
vobramitamab duocarmazine 2.7 mg.kg, IV, every 4 weeks
| Group | Source count |
|---|---|
| Part 1: MGC018 2.0 mg (Arm A) | 91 |
| Part 1: MGC018 2.7 mg (Arm B) | 90 |
| Part 1: Control Arm | 7 |
| Part 2 | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: MGC018 2.0 mg (Arm A) | 0.69 | Not reported | 0.57 | 0.78 | Not reported |
| Part 1: MGC018 2.7 mg (Arm B) | 0.70 | Not reported | 0.46 | 0.79 | Not reported |
| Part 1: Control Arm | 0.47 | Not reported | 0.021 | NA | upper limit could not be estimated due to insufficient number of events. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.57
- upper Limit
- 0.78
- value
- 0.69
- group Id
- OG001
- lower Limit
- 0.46
- upper Limit
- 0.79
- value
- 0.70
- comment
- upper limit could not be estimated due to insufficient number of events.
- group Id
- OG002
- lower Limit
- 0.021
- upper Limit
- NA
- value
- 0.47
- denoms
- counts
- group Id
- OG000
- value
- 91
- group Id
- OG001
- value
- 90
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 0
- units
- Participants
- description
- The landmark analysis for 6 month rPFS rate will occur when all participants on Part 1 have been on study for at least 6 months.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- vobramitamab duocarmazine 2.0 mg/kg, IV, every 4 weeks
- id
- OG000
- title
- Part 1: MGC018 2.0 mg (Arm A)
- description
- vobramitamab duocarmazine 2.7 mg/kg, IV, every 4 weeks
- id
- OG001
- title
- Part 1: MGC018 2.7 mg (Arm B)
- description
- abiraterone 1000 mg once daily or enzalutamide 160 mg once daily.
- id
- OG002
- title
- Part 1: Control Arm
- description
- vobramitamab duocarmazine 2.7 mg.kg, IV, every 4 weeks
- id
- OG003
- title
- Part 2
- param Type
- NUMBER
- population Description
- All participants according to the study treatment assigned (Intent to Treat Population) for participants with mCRPC in Part 1 only. This outcome measure applies to Part 1 only. Per protocol, participants in Part 2 did not have mCRPC and were not part of this analysis.
- reporting Status
- POSTED
- time Frame
- Assessed every 8 weeks for six months. Six month data reported.
- title
- Part 1: Six-month Radiographic Progression Free Survival (rPFS) as Determined by the Investigator
- type
- PRIMARY
- unit Of Measure
- proportion of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice