TriangleNCT03189719 · OUTCOME
Objective Response Rate (ORR) Per RECIST 1.1 As Assessed By Investigator in All Participants
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 34 months
What was measured
ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. as assessed by the investigator. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, the percentage of participants who experienced CR or PR is reported here as the ORR for all participants of the ITT population (all randomized).
Analysis population: All randomized participants (ITT population) were analyzed.
Groups in this outcome
Pembrolizumab + SOC
Participants received pembrolizumab 200 mg IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
Placebo + SOC
Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
| Group | Source count |
|---|---|
| Pembrolizumab + SOC | 373 |
| Placebo + SOC | 376 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab + SOC | 45.0 | Not reported | 39.9 | 50.2 | Not reported |
| Placebo + SOC | 29.3 | Not reported | 24.7 | 34.1 | Not reported |
Source statistical analyses
- ci Lower Limit
- 9.0
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 22.5
- group Description
- ORR in all participants of the pembrolizumab + SOC arm was compared to ORR in all participants of the placebo + SOC arm based on the Miettinen \& Nurminen method stratified by geographic region (Asia versus Rest of the World), tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma), and ECOG performance status (0 versus 1).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Difference in Percentage
- param Value
- 15.8
- statistical Method
- One-sided p-value
Complete source fields
- analyses
- ci Lower Limit
- 9.0
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 22.5
- group Description
- ORR in all participants of the pembrolizumab + SOC arm was compared to ORR in all participants of the placebo + SOC arm based on the Miettinen \& Nurminen method stratified by geographic region (Asia versus Rest of the World), tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma), and ECOG performance status (0 versus 1).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Difference in Percentage
- param Value
- 15.8
- statistical Method
- One-sided p-value
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 39.9
- upper Limit
- 50.2
- value
- 45.0
- group Id
- OG001
- lower Limit
- 24.7
- upper Limit
- 34.1
- value
- 29.3
- denoms
- counts
- group Id
- OG000
- value
- 373
- group Id
- OG001
- value
- 376
- units
- Participants
- description
- ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. as assessed by the investigator. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, the percentage of participants who experienced CR or PR is reported here as the ORR for all participants of the ITT population (all randomized).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received pembrolizumab 200 mg IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
- id
- OG000
- title
- Pembrolizumab + SOC
- description
- Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
- id
- OG001
- title
- Placebo + SOC
- param Type
- NUMBER
- population Description
- All randomized participants (ITT population) were analyzed.
- reporting Status
- POSTED
- time Frame
- Up to approximately 34 months
- title
- Objective Response Rate (ORR) Per RECIST 1.1 As Assessed By Investigator in All Participants
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
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Preserved source evidence · Not medical advice