NCT03126630 · OUTCOME
Phase 2 Overall Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From the start of treatment to death due to any cause, assessed up to 2 years
What was measured
Will be estimated using the method of Kaplan-Meier. The comparison of overall survival in event of death between two treatment arms will be based on the log-rank test.
Groups in this outcome
Group I (Pembrolizumab)
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity. Upon radiologic documentation of disease progression, patients may cross over to Group II.\> \>\> \> \>\> Laboratory Biomarker Analysis: Correlative studies\> \>\> \> \>\> Pembrolizumab: Given IV\> \>\> \> \>\> Pharmacological Study: Correlative studies
Group II (Anetumab Ravtansine, Pembrolizumab)
Patients receive anetumab ravtansine IV over 1 hour and pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 12 months for anetumab ravtansine and up to 24 months for pembrolizumab in the absence of disease progression or unacceptable toxicity.\> \>\> \> \>\> Anetumab Ravtansine: Given IV\> \>\> \> \>\> Laboratory Biomarker Analysis: Correlative studies\> \>\> \> \>\> Pembrolizumab: Given IV\> \>\> \> \>\> Pharmacological Study: Correlative studies
| Group | Source count |
|---|---|
| Group I (Pembrolizumab) | 17 |
| Group II (Anetumab Ravtansine, Pembrolizumab) | 18 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group I (Pembrolizumab) | 0 | Not reported | Not reported | Not reported | Not reported |
| Group II (Anetumab Ravtansine, Pembrolizumab) | 2 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.0
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit Comment
- Not enough events
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.1936
- param Type
- Hazard Ratio (HR)
- param Value
- 0.0
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.0
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit Comment
- Not enough events
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.1936
- param Type
- Hazard Ratio (HR)
- param Value
- 0.0
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 18
- units
- Participants
- description
- Will be estimated using the method of Kaplan-Meier. The comparison of overall survival in event of death between two treatment arms will be based on the log-rank test.
- groups
- description
- Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity. Upon radiologic documentation of disease progression, patients may cross over to Group II.\> \>\> \> \>\> Laboratory Biomarker Analysis: Correlative studies\> \>\> \> \>\> Pembrolizumab: Given IV\> \>\> \> \>\> Pharmacological Study: Correlative studies
- id
- OG000
- title
- Group I (Pembrolizumab)
- description
- Patients receive anetumab ravtansine IV over 1 hour and pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 12 months for anetumab ravtansine and up to 24 months for pembrolizumab in the absence of disease progression or unacceptable toxicity.\> \>\> \> \>\> Anetumab Ravtansine: Given IV\> \>\> \> \>\> Laboratory Biomarker Analysis: Correlative studies\> \>\> \> \>\> Pembrolizumab: Given IV\> \>\> \> \>\> Pharmacological Study: Correlative studies
- id
- OG001
- title
- Group II (Anetumab Ravtansine, Pembrolizumab)
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- From the start of treatment to death due to any cause, assessed up to 2 years
- title
- Phase 2 Overall Survival
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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