TriangleNCT04003636 · OUTCOME
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
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
- Up to approximately 26 months
What was measured
ORR was defined as the percentage of participants who have a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: a ≥30% decrease in the sum of diameters \[SOD\] of target lesions) as assessed by BICR per RECIST 1.1, which was adjusted for this study to allow a maximum of 10 target lesions in total and 5 per organ.
Analysis population: All randomized participants
Groups in this outcome
Arm A: Pembrolizumab + Chemotherapy
Participants received pembrolizumab, 200 mg intravenous (IV) infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, IV infusion Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab 200mg IV Q3W, Day 1 of each 3-week cycle for up to 17 cycles. Treatment with Gemcitabine could have been stopped at any time in first or second course due to toxicity or disease progression.
Arm B: Placebo + Chemotherapy
Participants received Placebo to Pembrolizumab, 200 mg IV infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles.
| Group | Source count |
|---|---|
| Arm A: Pembrolizumab + Chemotherapy | 533 |
| Arm B: Placebo + Chemotherapy | 536 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Pembrolizumab + Chemotherapy | 28.7 | Not reported | 24.9 | 32.8 | Not reported |
| Arm B: Placebo + Chemotherapy | 28.5 | Not reported | 24.8 | 32.6 | Not reported |
Source statistical analyses
- ci Lower Limit
- -5.2
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 5.6
- estimate Comment
- Difference in percentage was calculated using Miettinen \& Nurminen method. Difference in percentage=Arm A minus Arm B
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.4735
- p Value Comment
- One-sided p-value was based on Miettinen \& Nurminen method.
- param Type
- Difference in Percentages
- param Value
- 0.2
- statistical Method
- Miettinen & Nurminen
Complete source fields
- analyses
- ci Lower Limit
- -5.2
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 5.6
- estimate Comment
- Difference in percentage was calculated using Miettinen \& Nurminen method. Difference in percentage=Arm A minus Arm B
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.4735
- p Value Comment
- One-sided p-value was based on Miettinen \& Nurminen method.
- param Type
- Difference in Percentages
- param Value
- 0.2
- statistical Method
- Miettinen & Nurminen
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 24.9
- upper Limit
- 32.8
- value
- 28.7
- group Id
- OG001
- lower Limit
- 24.8
- upper Limit
- 32.6
- value
- 28.5
- denoms
- counts
- group Id
- OG000
- value
- 533
- group Id
- OG001
- value
- 536
- units
- Participants
- description
- ORR was defined as the percentage of participants who have a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: a ≥30% decrease in the sum of diameters \[SOD\] of target lesions) as assessed by BICR per RECIST 1.1, which was adjusted for this study to allow a maximum of 10 target lesions in total and 5 per organ.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received pembrolizumab, 200 mg intravenous (IV) infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, IV infusion Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab 200mg IV Q3W, Day 1 of each 3-week cycle for up to 17 cycles. Treatment with Gemcitabine could have been stopped at any time in first or second course due to toxicity or disease progression.
- id
- OG000
- title
- Arm A: Pembrolizumab + Chemotherapy
- description
- Participants received Placebo to Pembrolizumab, 200 mg IV infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles.
- id
- OG001
- title
- Arm B: Placebo + Chemotherapy
- param Type
- NUMBER
- population Description
- All randomized participants
- reporting Status
- POSTED
- time Frame
- Up to approximately 26 months
- title
- Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
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Preserved source evidence · Not medical advice