TriangleNCT02256436 · OUTCOME
ORR Per mRECIST - Participants With Strongly PD-L1 Positive Tumors
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
- Through final analysis database cut-off date of 26-Oct-2017 (Up to approximately 34 months)
What was measured
ORR per mRECIST was defined as the percentage of participants in the analysis population who had a CR (complete disappearance of all lesions (and no new lesions), with confirmation by a repeat, consecutive assessment no less than 4 weeks from the date first documented) or a PR (decrease in tumor burden ≥50% relative to baseline confirmed by a consecutive assessment at least 4 weeks after first documentation). ORR per mRECIST was assessed by BICR in participants with strongly PD-L1 positive tumors (CPS ≥10%) up through the final analysis database cut-off date of 26-Oct-2017.
Analysis population: The analysis population consisted of all randomized strongly 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 | 90 |
| Pembrolizumab | 74 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Control | 7.8 | Not reported | 3.2 | 15.4 | Not reported |
| Pembrolizumab | 24.3 | Not reported | 15.1 | 35.7 | Not reported |
Source statistical analyses
- ci Lower Limit
- 10.1
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 34.2
- group Description
- ORR per mRECIST - Strongly PD-L1 Positive Participants
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.00009
- p Value Comment
- One-sided p-value for testing H0: difference in %=0; H1: difference in %\>0
- param Type
- Difference in Percentages
- param Value
- 21.5
- 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
- Miettinen & Nurminen method
Complete source fields
- analyses
- ci Lower Limit
- 10.1
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 34.2
- group Description
- ORR per mRECIST - Strongly PD-L1 Positive Participants
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.00009
- p Value Comment
- One-sided p-value for testing H0: difference in %=0; H1: difference in %\>0
- param Type
- Difference in Percentages
- param Value
- 21.5
- 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
- Miettinen & Nurminen method
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.2
- upper Limit
- 15.4
- value
- 7.8
- group Id
- OG001
- lower Limit
- 15.1
- upper Limit
- 35.7
- value
- 24.3
- denoms
- counts
- group Id
- OG000
- value
- 90
- group Id
- OG001
- value
- 74
- units
- Participants
- description
- ORR per mRECIST was defined as the percentage of participants in the analysis population who had a CR (complete disappearance of all lesions (and no new lesions), with confirmation by a repeat, consecutive assessment no less than 4 weeks from the date first documented) or a PR (decrease in tumor burden ≥50% relative to baseline confirmed by a consecutive assessment at least 4 weeks after first documentation). ORR per mRECIST was assessed by BICR in participants with strongly PD-L1 positive tumors (CPS ≥10%) 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
- NUMBER
- population Description
- The analysis population consisted of all randomized strongly 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
- ORR Per mRECIST - Participants With Strongly PD-L1 Positive Tumors
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
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Preserved source evidence · Not medical advice