TriangleNCT02256436 · OUTCOME
PFS Per RECIST 1.1 - Participants With Programmed Cell Death-Ligand (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 primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 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 RECIST 1.1, PD 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 demonstrate an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered PD. PFS per RECIST 1.1 was assessed by BICR in all participants who had PD-L1 positive tumors (combined positive score \[CPS\] ≥1%) up through the primary analysis database cut-off date of 07-Sep-2016.
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 | 3.2 | Not reported | 2.2 | 3.4 | Not reported |
| Pembrolizumab | 2.1 | Not reported | 2.0 | 2.4 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.68
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.24
- group Description
- PFS - PD-L1 positive participants
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.26443
- p Value Comment
- One-sided p-value based on stratified log-rank test
- param Type
- Hazard Ratio (HR)
- param Value
- 0.91
- 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
- 0.68
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.24
- group Description
- PFS - PD-L1 positive participants
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.26443
- p Value Comment
- One-sided p-value based on stratified log-rank test
- param Type
- Hazard Ratio (HR)
- param Value
- 0.91
- 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
- 2.2
- upper Limit
- 3.4
- value
- 3.2
- group Id
- OG001
- lower Limit
- 2.0
- upper Limit
- 2.4
- 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 RECIST 1.1, PD 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 demonstrate an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered PD. PFS per RECIST 1.1 was assessed by BICR in all participants who had PD-L1 positive tumors (combined positive score \[CPS\] ≥1%) up through the primary analysis database cut-off date of 07-Sep-2016.
- 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 primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months)
- title
- PFS Per RECIST 1.1 - Participants With Programmed Cell Death-Ligand (PD-L1) Positive Tumors
- type
- PRIMARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice