NCT03126630 · OUTCOME
Phase 2 Duration of Response
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 2 years
What was measured
Will be defined as evaluable patients who achieved noted to be a partial response or complete response based Response Evaluation Criteria in Solid Tumors version 1.1 criteria. Will be estimated using the method of Kaplan-Meier. The comparison of duration of response between two treatment arms will be based on the log-rank test. This calculation will start with the date of start of treatment.
Analysis population: Data were not collected and the outcome cannot be reported.
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) | 0 |
| Group II (Anetumab Ravtansine, 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
- Will be defined as evaluable patients who achieved noted to be a partial response or complete response based Response Evaluation Criteria in Solid Tumors version 1.1 criteria. Will be estimated using the method of Kaplan-Meier. The comparison of duration of response between two treatment arms will be based on the log-rank test. This calculation will start with the date of start of treatment.
- 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)
- population Description
- Data were not collected and the outcome cannot be reported.
- reporting Status
- POSTED
- time Frame
- Up to 2 years
- title
- Phase 2 Duration of Response
- type
- SECONDARY
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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