NCT03239145 · OUTCOME
Median Time To Progression (TTP)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 90% Confidence Interval
- Time frame
- Median follow-up was 29.3 months (range 0.9 - 42.0 months).
What was measured
TTP based on Kaplan-Meier method is defined as the time from registration to progression disease (PD), or censored at date of last disease evaluation for those without progression reported. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated.
Analysis population: The analysis population will include patients enrolled in the dose escalation and dose expansion portions of the trial. Per protocol, the dose escalation and dose expansion data may be combined for patients with the same cancer type who received the same treatment doses.
Groups in this outcome
[Dose Level II] Pembrolizumab + Trebananib (Colorectal)
Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.
[Dose Level II] Pembrolizumab + Trebananib (Ovarian)
Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.
[Dose Level II] Pembrolizumab + Trebananib (Renal Cell Carcinoma)
Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.
| Group | Source count |
|---|---|
| [Dose Level II] Pembrolizumab + Trebananib (Colorectal) | 40 |
| [Dose Level II] Pembrolizumab + Trebananib (Ovarian) | 11 |
| [Dose Level II] Pembrolizumab + Trebananib (Renal Cell Carcinoma) | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| [Dose Level II] Pembrolizumab + Trebananib (Colorectal) | 3.1 | Not reported | 2.8 | 3.2 | Not reported |
| [Dose Level II] Pembrolizumab + Trebananib (Ovarian) | 3.1 | Not reported | 3.0 | 3.8 | Not reported |
| [Dose Level II] Pembrolizumab + Trebananib (Renal Cell Carcinoma) | 4.4 | Not reported | 1.2 | NA | The upper bound of the TTP 90% confidence interval was not reached due to insufficient events at the time of analysis. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.8
- upper Limit
- 3.2
- value
- 3.1
- group Id
- OG001
- lower Limit
- 3.0
- upper Limit
- 3.8
- value
- 3.1
- comment
- The upper bound of the TTP 90% confidence interval was not reached due to insufficient events at the time of analysis.
- group Id
- OG002
- lower Limit
- 1.2
- upper Limit
- NA
- value
- 4.4
- denoms
- counts
- group Id
- OG000
- value
- 40
- group Id
- OG001
- value
- 11
- group Id
- OG002
- value
- 4
- units
- Participants
- description
- TTP based on Kaplan-Meier method is defined as the time from registration to progression disease (PD), or censored at date of last disease evaluation for those without progression reported. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated.
- dispersion Type
- 90% Confidence Interval
- groups
- description
- Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.
- id
- OG000
- title
- [Dose Level II] Pembrolizumab + Trebananib (Colorectal)
- description
- Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.
- id
- OG001
- title
- [Dose Level II] Pembrolizumab + Trebananib (Ovarian)
- description
- Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.
- id
- OG002
- title
- [Dose Level II] Pembrolizumab + Trebananib (Renal Cell Carcinoma)
- param Type
- MEDIAN
- population Description
- The analysis population will include patients enrolled in the dose escalation and dose expansion portions of the trial. Per protocol, the dose escalation and dose expansion data may be combined for patients with the same cancer type who received the same treatment doses.
- reporting Status
- POSTED
- time Frame
- Median follow-up was 29.3 months (range 0.9 - 42.0 months).
- title
- Median Time To Progression (TTP)
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice
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