TriangleNCT01693562 · OUTCOME
DoR Assessed by BICR in UC Cohort (PD-L1 Low/Negative, Total, and PD-L1 High) in the Dose-expansion Phase
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
- From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)
What was measured
The DoR assessed by BICR in UC cohort is reported. The DoR is defined as the duration from the first documentation of OR (confirmed CR or confirmed PR) to the first documented disease progression based on RECIST v1.1 or death due to any cause, whichever occurred first. A confirmed CR is defined as two CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 28 days with no evidence of progression in-between. A confirmed PR is defined as two PRs (\>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion) or an un-confirmed PR and an un-confirmed CR that were separated by at least 4 weeks with no evidence of progression in-between. The DoR was estimated using Kaplan-Meier method.
Analysis population: The UC cohort participants with PD-L1 status low/negative (\<25% tumor cell membrane and \<25% immune cell staining), total (PD-L1 high, PD-L1 low/negative, and PD-L1 unknown), and high (\>= 25% tumor cell membrane or \>=25% immune cell staining) included in FAS population (all participants who received any dose of study drug, had measurable disease at baseline (Day 1) per BICR and were followed for at least 24 wks by 16Oct2017) were analyzed. DoR was analyzed for those participants who achieved OR.
Groups in this outcome
Expansion UC PD-L1 Low/Negative Cohort
Participants with UC (PD-L1 status low/Negative) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
Expansion UC Total Cohort
Participants with UC (Total PD-L1 status - high, low/Negative, and unknown) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
Expansion UC PD-L1 High Cohort
Participants with UC (PD-L1 status high) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
| Group | Source count |
|---|---|
| Expansion UC PD-L1 Low/Negative Cohort | 5 |
| Expansion UC Total Cohort | 35 |
| Expansion UC PD-L1 High Cohort | 28 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Expansion UC PD-L1 Low/Negative Cohort | 12.25 | Not reported | 8.6 | NA | Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis. |
| Expansion UC Total Cohort | NA | Not reported | 16.0 | NA | Median and Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis. |
| Expansion UC PD-L1 High Cohort | NA | Not reported | 16.0 | NA | Median and Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis. |
Complete source fields
- classes
- categories
- measurements
- comment
- Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.
- group Id
- OG000
- lower Limit
- 8.6
- upper Limit
- NA
- value
- 12.25
- comment
- Median and Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.
- group Id
- OG001
- lower Limit
- 16.0
- upper Limit
- NA
- value
- NA
- comment
- Median and Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.
- group Id
- OG002
- lower Limit
- 16.0
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 35
- group Id
- OG002
- value
- 28
- units
- Participants
- description
- The DoR assessed by BICR in UC cohort is reported. The DoR is defined as the duration from the first documentation of OR (confirmed CR or confirmed PR) to the first documented disease progression based on RECIST v1.1 or death due to any cause, whichever occurred first. A confirmed CR is defined as two CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 28 days with no evidence of progression in-between. A confirmed PR is defined as two PRs (\>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion) or an un-confirmed PR and an un-confirmed CR that were separated by at least 4 weeks with no evidence of progression in-between. The DoR was estimated using Kaplan-Meier method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with UC (PD-L1 status low/Negative) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
- id
- OG000
- title
- Expansion UC PD-L1 Low/Negative Cohort
- description
- Participants with UC (Total PD-L1 status - high, low/Negative, and unknown) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
- id
- OG001
- title
- Expansion UC Total Cohort
- description
- Participants with UC (PD-L1 status high) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
- id
- OG002
- title
- Expansion UC PD-L1 High Cohort
- param Type
- MEDIAN
- population Description
- The UC cohort participants with PD-L1 status low/negative (\<25% tumor cell membrane and \<25% immune cell staining), total (PD-L1 high, PD-L1 low/negative, and PD-L1 unknown), and high (\>= 25% tumor cell membrane or \>=25% immune cell staining) included in FAS population (all participants who received any dose of study drug, had measurable disease at baseline (Day 1) per BICR and were followed for at least 24 wks by 16Oct2017) were analyzed. DoR was analyzed for those participants who achieved OR.
- reporting Status
- POSTED
- time Frame
- From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)
- title
- DoR Assessed by BICR in UC Cohort (PD-L1 Low/Negative, Total, and PD-L1 High) in the Dose-expansion Phase
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice