TriangleNCT01693562 · OUTCOME
PFS Assessed by Investigator 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 PFS assessed by the investigator in UC cohort is reported. The PFS is defined as the time from the start of study treatment until the first documentation of disease progression based on RECIST v1.1 or death due to any cause, whichever occurred first. The PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study; the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The PFS was estimated using Kaplan-Meier method.
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 As-treated population were analyzed. As-treated population included all participants who received any dose of study drug. The "Number of participants Analyzed" denotes the number of participants evaluated for this outcome measure.
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 | 86 |
| Expansion UC Total Cohort | 201 |
| Expansion UC PD-L1 High Cohort | 102 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Expansion UC PD-L1 Low/Negative Cohort | 1.4 | Not reported | 1.4 | 1.7 | Not reported |
| Expansion UC Total Cohort | 1.8 | Not reported | 1.4 | 2.6 | Not reported |
| Expansion UC PD-L1 High Cohort | 2.8 | Not reported | 1.8 | 3.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.4
- upper Limit
- 1.7
- value
- 1.4
- group Id
- OG001
- lower Limit
- 1.4
- upper Limit
- 2.6
- value
- 1.8
- group Id
- OG002
- lower Limit
- 1.8
- upper Limit
- 3.7
- value
- 2.8
- denoms
- counts
- group Id
- OG000
- value
- 86
- group Id
- OG001
- value
- 201
- group Id
- OG002
- value
- 102
- units
- Participants
- description
- The PFS assessed by the investigator in UC cohort is reported. The PFS is defined as the time from the start of study treatment until the first documentation of disease progression based on RECIST v1.1 or death due to any cause, whichever occurred first. The PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study; the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The PFS 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 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 As-treated population were analyzed. As-treated population included all participants who received any dose of study drug. The "Number of participants Analyzed" denotes the number of participants evaluated for this outcome measure.
- 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
- PFS Assessed by Investigator 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