TriangleNCT02256436 · OUTCOME
PFS Per mRECIST - Participants With PD-L1 Positive Tumors
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
- Through final analysis database cut-off date of 26-Oct-2017 (Up to approximately 34 months)
What was measured
PFS was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. Per mRECIST, PD was defined was defined as at least 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered PD. Per mRECIST, confirmation by a repeat, consecutive assessment no less than 4 weeks from the date first documented was required for participants remaining on treatment following PD per RECIST 1.1. PFS per mRECIST was assessed by BICR in participants with PD-L1 positive tumors (CPS ≥1%) up through the final analysis database cut-off date of 26-Oct-2017.
Analysis population: The analysis population consisted of all randomized PD-L1 positive participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.
Groups in this outcome
Control
Participants received paclitaxel 175 mg/m\^2 intravenously (IV) or docetaxel 75 mg/m\^2 IV or vinflunine 320 mg/m\^2 IV, on Day 1 of each 3-week cycle (Q3W). Eligible participants who experienced disease progression may have been able to switch over to receive pembrolizumab 200 mg IV Q3W for up to 35 treatment administrations (up to approximately 2 years).
Pembrolizumab
Participants received pembrolizumab 200 mg IV on Day 1 Q3W. Eligible participants who stopped pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab 200 mg IV Q3W for up to 17 cycles (up to approximately 1 additional year).
| Group | Source count |
|---|---|
| Control | 120 |
| Pembrolizumab | 110 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Control | 3.3 | Not reported | 2.6 | 3.6 | Not reported |
| Pembrolizumab | 2.1 | Not reported | 2.0 | 3.7 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.60
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.10
- group Description
- PFS per mRECIST - PD-L1 Positive Participants
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.08745
- p Value Comment
- One-sided p-value based on stratified log-rank test
- param Type
- Hazard Ratio (HR)
- param Value
- 0.82
- statistical Comment
- Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy
- statistical Method
- Regression, Cox
Complete source fields
- analyses
- ci Lower Limit
- 0.60
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.10
- group Description
- PFS per mRECIST - PD-L1 Positive Participants
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.08745
- p Value Comment
- One-sided p-value based on stratified log-rank test
- param Type
- Hazard Ratio (HR)
- param Value
- 0.82
- statistical Comment
- Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy
- statistical Method
- Regression, Cox
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.6
- upper Limit
- 3.6
- value
- 3.3
- group Id
- OG001
- lower Limit
- 2.0
- upper Limit
- 3.7
- value
- 2.1
- denoms
- counts
- group Id
- OG000
- value
- 120
- group Id
- OG001
- value
- 110
- units
- Participants
- description
- PFS was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. Per mRECIST, PD was defined was defined as at least 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered PD. Per mRECIST, confirmation by a repeat, consecutive assessment no less than 4 weeks from the date first documented was required for participants remaining on treatment following PD per RECIST 1.1. PFS per mRECIST was assessed by BICR in participants with PD-L1 positive tumors (CPS ≥1%) up through the final analysis database cut-off date of 26-Oct-2017.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received paclitaxel 175 mg/m\^2 intravenously (IV) or docetaxel 75 mg/m\^2 IV or vinflunine 320 mg/m\^2 IV, on Day 1 of each 3-week cycle (Q3W). Eligible participants who experienced disease progression may have been able to switch over to receive pembrolizumab 200 mg IV Q3W for up to 35 treatment administrations (up to approximately 2 years).
- id
- OG000
- title
- Control
- description
- Participants received pembrolizumab 200 mg IV on Day 1 Q3W. Eligible participants who stopped pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab 200 mg IV Q3W for up to 17 cycles (up to approximately 1 additional year).
- id
- OG001
- title
- Pembrolizumab
- param Type
- MEDIAN
- population Description
- The analysis population consisted of all randomized PD-L1 positive participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.
- reporting Status
- POSTED
- time Frame
- Through final analysis database cut-off date of 26-Oct-2017 (Up to approximately 34 months)
- title
- PFS Per mRECIST - Participants With PD-L1 Positive Tumors
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice