TriangleNCT02252042 · OUTCOME
PFS Per RECIST 1.1 in Participants With PD-L1 ≥1% CPS
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 2 years
What was measured
PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded central imaging vendor review or death due to any cause, whichever occurred first. Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered progression. The PFS per RECIST 1.1 for all participants with PD-L1 expression ≥1% CPS is presented. These efficacy results were reported after complete acquisition of all outstanding survival data using a 15-May-2017 data cut-off date with a database update date of 13-Oct-2017.
Analysis population: The efficacy population consisted of all randomized participants with PD-L1 ≥1% CPS. Participants are included in the treatment group to which they were randomized.
Groups in this outcome
Pembrolizumab
Participants received pembrolizumab 200 mg intravenous (IV) on Day 1 of each 3-week cycle. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
Standard Treatment
Participants received standard treatment of either methotrexate 40 mg/m\^2 IV (could be escalated to 60 mg/m\^2 maximum dose) on Days 1, 8, and 15 of each 3-week cycle; or docetaxel 75 mg/m\^2 IV on Day 1 of each 3- week cycle; or cetuximab 400 mg/m\^2 IV loading dose on Day 1 and 250 mg/m\^2 IV on Days 8 and 15 of Cycle 1, followed by cetuximab 250 mg/m\^2 on Days 1, 8, and 15 of each subsequent 3-week cycle.
| Group | Source count |
|---|---|
| Pembrolizumab | 196 |
| Standard Treatment | 191 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab | 2.2 | Not reported | 2.1 | 3.0 | Not reported |
| Standard Treatment | 2.3 | Not reported | 2.1 | 3.0 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.69
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.06
- estimate Comment
- Cox regression model with treatment as a single covariate
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.07736
- param Type
- Hazard Ratio (HR)
- param Value
- 0.86
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.69
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.06
- estimate Comment
- Cox regression model with treatment as a single covariate
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.07736
- param Type
- Hazard Ratio (HR)
- param Value
- 0.86
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.1
- upper Limit
- 3.0
- value
- 2.2
- group Id
- OG001
- lower Limit
- 2.1
- upper Limit
- 3.0
- value
- 2.3
- denoms
- counts
- group Id
- OG000
- value
- 196
- group Id
- OG001
- value
- 191
- units
- Participants
- description
- PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded central imaging vendor review or death due to any cause, whichever occurred first. Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered progression. The PFS per RECIST 1.1 for all participants with PD-L1 expression ≥1% CPS is presented. These efficacy results were reported after complete acquisition of all outstanding survival data using a 15-May-2017 data cut-off date with a database update date of 13-Oct-2017.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received pembrolizumab 200 mg intravenous (IV) on Day 1 of each 3-week cycle. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
- id
- OG000
- title
- Pembrolizumab
- description
- Participants received standard treatment of either methotrexate 40 mg/m\^2 IV (could be escalated to 60 mg/m\^2 maximum dose) on Days 1, 8, and 15 of each 3-week cycle; or docetaxel 75 mg/m\^2 IV on Day 1 of each 3- week cycle; or cetuximab 400 mg/m\^2 IV loading dose on Day 1 and 250 mg/m\^2 IV on Days 8 and 15 of Cycle 1, followed by cetuximab 250 mg/m\^2 on Days 1, 8, and 15 of each subsequent 3-week cycle.
- id
- OG001
- title
- Standard Treatment
- param Type
- MEDIAN
- population Description
- The efficacy population consisted of all randomized participants with PD-L1 ≥1% CPS. Participants are included in the treatment group to which they were randomized.
- reporting Status
- POSTED
- time Frame
- Up to approximately 2 years
- title
- PFS Per RECIST 1.1 in Participants With PD-L1 ≥1% CPS
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice