TriangleNCT02460198 · OUTCOME
Progression-Free Survival (PFS) Per RECIST 1.1 Assessed by Central Imaging Vendor.
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to approximately 66 months
What was measured
PFS is defined as the time from first day of study treatment to the first documented disease progression or death due to any cause, whichever occurs first. Progressive Disease: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions was also considered progression). PFS was summarized by Kaplan-Meier (KM) methods. The data cutoff date was 19-FEB-2021.
Analysis population: The analysis population consisted of all participants who received at least one dose of study treatment.
Groups in this outcome
Cohort A - Pembrolizumab 200 mg
Participants were previously treated with standard therapies, which must include fluoropyrimidine, oxaliplatin, and irinotecan. Cohort A participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to approximately 35 cycles (up to approximately 2 years).
Cohort B - Pembrolizumab 200 mg
Participants were previously treated with at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan +/ - anti vascular endothelial growth factor (VEGF)/ epidermal growth factor regulator (EGFR) monoclonal antibody. Cohort B participants received pembrolizumab 200 mg IV on Day 1 Q3W for up to approximately 35 cycles (up to approximately 2 years).
| Group | Source count |
|---|---|
| Cohort A - Pembrolizumab 200 mg | 61 |
| Cohort B - Pembrolizumab 200 mg | 63 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A - Pembrolizumab 200 mg | 2.3 | Not reported | 2.1 | 8.1 | Not reported |
| Cohort B - Pembrolizumab 200 mg | 4.1 | Not reported | 2.1 | 18.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.1
- upper Limit
- 8.1
- value
- 2.3
- group Id
- OG001
- lower Limit
- 2.1
- upper Limit
- 18.9
- value
- 4.1
- denoms
- counts
- group Id
- OG000
- value
- 61
- group Id
- OG001
- value
- 63
- units
- Participants
- description
- PFS is defined as the time from first day of study treatment to the first documented disease progression or death due to any cause, whichever occurs first. Progressive Disease: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions was also considered progression). PFS was summarized by Kaplan-Meier (KM) methods. The data cutoff date was 19-FEB-2021.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants were previously treated with standard therapies, which must include fluoropyrimidine, oxaliplatin, and irinotecan. Cohort A participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to approximately 35 cycles (up to approximately 2 years).
- id
- OG000
- title
- Cohort A - Pembrolizumab 200 mg
- description
- Participants were previously treated with at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan +/ - anti vascular endothelial growth factor (VEGF)/ epidermal growth factor regulator (EGFR) monoclonal antibody. Cohort B participants received pembrolizumab 200 mg IV on Day 1 Q3W for up to approximately 35 cycles (up to approximately 2 years).
- id
- OG001
- title
- Cohort B - Pembrolizumab 200 mg
- param Type
- MEDIAN
- population Description
- The analysis population consisted of all participants who received at least one dose of study treatment.
- reporting Status
- POSTED
- time Frame
- Up to approximately 66 months
- title
- Progression-Free Survival (PFS) Per RECIST 1.1 Assessed by Central Imaging Vendor.
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice