TriangleNCT01693562 · OUTCOME
ORR 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
- NUMBER
- Unit
- Percentage of participants
- 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 ORR assessed by BICR in UC cohort is reported. The ORR is defined as confirmed CR or confirmed PR based on RECIST v1.1. The CR is defined as disappearance of all target and non-target lesions and no new lesions. A confirmed CR is defined as two CRs that were separated by at least 28 days with no evidence of progression in-between. The PR is defined as \>= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new nontarget lesion. A confirmed PR is defined as two PRs 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.
Analysis population: The UC cohort participants with PD-L1 status as 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 the FAS population were analyzed. FAS population included all participnats who received any dose of study drug, had measurable disease at baseline (Day 1) per BICR and were followed for at least 24 weeks by 16Oct2017.
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 | 85 |
| Expansion UC Total Cohort | 199 |
| Expansion UC PD-L1 High Cohort | 101 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Expansion UC PD-L1 Low/Negative Cohort | 5.9 | Not reported | 1.9 | 13.2 | Not reported |
| Expansion UC Total Cohort | 17.6 | Not reported | 12.6 | 23.6 | Not reported |
| Expansion UC PD-L1 High Cohort | 27.7 | Not reported | 19.3 | 37.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.9
- upper Limit
- 13.2
- value
- 5.9
- group Id
- OG001
- lower Limit
- 12.6
- upper Limit
- 23.6
- value
- 17.6
- group Id
- OG002
- lower Limit
- 19.3
- upper Limit
- 37.5
- value
- 27.7
- denoms
- counts
- group Id
- OG000
- value
- 85
- group Id
- OG001
- value
- 199
- group Id
- OG002
- value
- 101
- units
- Participants
- description
- The ORR assessed by BICR in UC cohort is reported. The ORR is defined as confirmed CR or confirmed PR based on RECIST v1.1. The CR is defined as disappearance of all target and non-target lesions and no new lesions. A confirmed CR is defined as two CRs that were separated by at least 28 days with no evidence of progression in-between. The PR is defined as \>= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new nontarget lesion. A confirmed PR is defined as two PRs 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.
- 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
- NUMBER
- population Description
- The UC cohort participants with PD-L1 status as 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 the FAS population were analyzed. FAS population included all participnats who received any dose of study drug, had measurable disease at baseline (Day 1) per BICR and were followed for at least 24 weeks by 16Oct2017.
- 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
- ORR 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
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice