TriangleNCT03239145 · OUTCOME
Objective Response Rate (ORR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 90% Confidence Interval
- Time frame
- Median follow-up was 29.3 months (range 0.9 - 42.0 months).
What was measured
ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) on treatment based on RECIST 1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
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) | 7.5 | Not reported | 2.1 | 18.3 | Not reported |
| [Dose Level II] Pembrolizumab + Trebananib (Ovarian) | 9.1 | Not reported | 0.1 | 36.4 | Not reported |
| [Dose Level II] Pembrolizumab + Trebananib (Renal Cell Carcinoma) | 0 | Not reported | 0 | 52.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.1
- upper Limit
- 18.3
- value
- 7.5
- group Id
- OG001
- lower Limit
- 0.1
- upper Limit
- 36.4
- value
- 9.1
- group Id
- OG002
- lower Limit
- 0
- upper Limit
- 52.7
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 40
- group Id
- OG001
- value
- 11
- group Id
- OG002
- value
- 4
- units
- Participants
- description
- ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) on treatment based on RECIST 1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
- 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
- Median follow-up was 29.3 months (range 0.9 - 42.0 months).
- title
- Objective Response Rate (ORR)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice