TriangleNCT03239145 · OUTCOME
Progression Free Survival at 6 Months (PFS6)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage probability
- Interval / dispersion
- 90% Confidence Interval
- Time frame
- 6 months
What was measured
PFS6 is the percent probability estimate at 6 months based on the Kaplan-Meier method. PFS is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Participants alive without PD were censored at the earliest of the date of the last disease evaluation or start of new anticancer therapy. 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) | 13 | Not reported | 5 | 25 | Not reported |
| [Dose Level II] Pembrolizumab + Trebananib (Ovarian) | 9 | Not reported | 1 | 33 | Not reported |
| [Dose Level II] Pembrolizumab + Trebananib (Renal Cell Carcinoma) | 50 | Not reported | 6 | 84 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5
- upper Limit
- 25
- value
- 13
- group Id
- OG001
- lower Limit
- 1
- upper Limit
- 33
- value
- 9
- group Id
- OG002
- lower Limit
- 6
- upper Limit
- 84
- value
- 50
- denoms
- counts
- group Id
- OG000
- value
- 40
- group Id
- OG001
- value
- 11
- group Id
- OG002
- value
- 4
- units
- Participants
- description
- PFS6 is the percent probability estimate at 6 months based on the Kaplan-Meier method. PFS is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Participants alive without PD were censored at the earliest of the date of the last disease evaluation or start of new anticancer therapy. 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
- NUMBER
- 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
- 6 months
- title
- Progression Free Survival at 6 Months (PFS6)
- type
- SECONDARY
- unit Of Measure
- percentage probability
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice