TriangleNCT02252042 · OUTCOME
Objective Response Rate (ORR) Per RECIST 1.1 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 2 years
What was measured
ORR was defined as the percentage of the participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 based on blinded central imaging vendor review with or without confirmation. The ORR per RECIST 1.1 for all participants is presented. These efficacy results were reported after complete acquisition of all outstanding survival data using a 15-May-2017 data cut-off date with a database update date of 13-Oct-2017.
Analysis population: The efficacy population consisted of all randomized participants. Participants are included in the treatment group to which they were randomized.
Groups in this outcome
Pembrolizumab
Participants received pembrolizumab 200 mg intravenous (IV) on Day 1 of each 3-week cycle. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
Standard Treatment
Participants received standard treatment of either methotrexate 40 mg/m\^2 IV (could be escalated to 60 mg/m\^2 maximum dose) on Days 1, 8, and 15 of each 3-week cycle; or docetaxel 75 mg/m\^2 IV on Day 1 of each 3- week cycle; or cetuximab 400 mg/m\^2 IV loading dose on Day 1 and 250 mg/m\^2 IV on Days 8 and 15 of Cycle 1, followed by cetuximab 250 mg/m\^2 on Days 1, 8, and 15 of each subsequent 3-week cycle.
| Group | Source count |
|---|---|
| Pembrolizumab | 247 |
| Standard Treatment | 248 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab | 14.6 | Not reported | 10.4 | 19.6 | Not reported |
| Standard Treatment | 10.1 | Not reported | 6.6 | 14.5 | Not reported |
Source statistical analyses
- ci Lower Limit
- -1.2
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 10.6
- estimate Comment
- Stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0610
- param Type
- Difference in percentages
- param Value
- 4.6
- statistical Comment
- H0: difference in %=0; H1: difference in %\>0
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- -1.2
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 10.6
- estimate Comment
- Stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0610
- param Type
- Difference in percentages
- param Value
- 4.6
- statistical Comment
- H0: difference in %=0; H1: difference in %\>0
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 10.4
- upper Limit
- 19.6
- value
- 14.6
- group Id
- OG001
- lower Limit
- 6.6
- upper Limit
- 14.5
- value
- 10.1
- denoms
- counts
- group Id
- OG000
- value
- 247
- group Id
- OG001
- value
- 248
- units
- Participants
- description
- ORR was defined as the percentage of the participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 based on blinded central imaging vendor review with or without confirmation. The ORR per RECIST 1.1 for all participants is presented. These efficacy results were reported after complete acquisition of all outstanding survival data using a 15-May-2017 data cut-off date with a database update date of 13-Oct-2017.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received pembrolizumab 200 mg intravenous (IV) on Day 1 of each 3-week cycle. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
- id
- OG000
- title
- Pembrolizumab
- description
- Participants received standard treatment of either methotrexate 40 mg/m\^2 IV (could be escalated to 60 mg/m\^2 maximum dose) on Days 1, 8, and 15 of each 3-week cycle; or docetaxel 75 mg/m\^2 IV on Day 1 of each 3- week cycle; or cetuximab 400 mg/m\^2 IV loading dose on Day 1 and 250 mg/m\^2 IV on Days 8 and 15 of Cycle 1, followed by cetuximab 250 mg/m\^2 on Days 1, 8, and 15 of each subsequent 3-week cycle.
- id
- OG001
- title
- Standard Treatment
- param Type
- NUMBER
- population Description
- The efficacy population consisted of all randomized participants. Participants are included in the treatment group to which they were randomized.
- reporting Status
- POSTED
- time Frame
- Up to approximately 2 years
- title
- Objective Response Rate (ORR) Per RECIST 1.1 in All Participants
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
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Preserved source evidence · Not medical advice