TriangleNCT02460198 · OUTCOME
Objective Response Rate (ORR) - Response Evaluation Criteria in Solid Tumors 1.1 (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
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to approximately 48 months
What was measured
Objective response rate was defined as the percentage of the participants in the analysis population who had a complete response (CR) or partial response (PR). Complete Response: disappearance of all target lesions. Partial Response: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Responses were based upon blinded central imaging vendor per RECIST 1.1. The point estimate and 95% confidence interval for the ORR, were provided using an exact binomial distribution (Clopper and Pearson method). Participants without response data were counted as nonresponders. The data cutoff date was 09-SEPT-2019.
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 | 32.8 | Not reported | 21.3 | 46.0 | Not reported |
| Cohort B - Pembrolizumab 200 mg | 34.9 | Not reported | 23.3 | 48.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 21.3
- upper Limit
- 46.0
- value
- 32.8
- group Id
- OG001
- lower Limit
- 23.3
- upper Limit
- 48.0
- value
- 34.9
- denoms
- counts
- group Id
- OG000
- value
- 61
- group Id
- OG001
- value
- 63
- units
- Participants
- description
- Objective response rate was defined as the percentage of the participants in the analysis population who had a complete response (CR) or partial response (PR). Complete Response: disappearance of all target lesions. Partial Response: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Responses were based upon blinded central imaging vendor per RECIST 1.1. The point estimate and 95% confidence interval for the ORR, were provided using an exact binomial distribution (Clopper and Pearson method). Participants without response data were counted as nonresponders. The data cutoff date was 09-SEPT-2019.
- 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
- NUMBER
- 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 48 months
- title
- Objective Response Rate (ORR) - Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) Assessed by Central Imaging Vendor
- type
- PRIMARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice