TriangleNCT01704287 · OUTCOME
Interim Overall Survival (OS) - Initial Treatment Period
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
- Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015)
What was measured
OS was defined as the time from randomization to death due to any cause. Analysis of OS was not planned or conducted for the switch-to-pembrolizumab treatment groups. Median OS based on the product-limit (Kaplan-Meier) method for censored data is presented. This was the interim analysis for OS.
Analysis population: The analysis population consisted of all randomized participants. Participants were included in the initial treatment group to which they were randomized for the efficacy analysis.
Groups in this outcome
Pembrolizumab 2 mg/kg
Participants were initially randomized to receive pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to \~66 months)
Pembrolizumab 10 mg/kg
Participants were initially randomized to receive pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to \~66 months)
Investigator-Choice Chemotherapy (ICC)
Participants were initially randomized to receive 1 of 4 possible chemotherapy regimens decided at the treating institution (carboplatin+paclitaxel, paclitaxel alone, dacarbazine, or temozolomide). Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to \~66 months)
| Group | Source count |
|---|---|
| Pembrolizumab 2 mg/kg | 180 |
| Pembrolizumab 10 mg/kg | 181 |
| Investigator-Choice Chemotherapy (ICC) | 179 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab 2 mg/kg | 13.4 | Not reported | 11.0 | 16.4 | Not reported |
| Pembrolizumab 10 mg/kg | 14.7 | Not reported | 11.3 | 19.5 | Not reported |
| Investigator-Choice Chemotherapy (ICC) | 11.0 | Not reported | 8.9 | 13.8 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.67
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.10
- estimate Comment
- Numerator=Pembrolizumab 2 mg/kg Denominator=ICC
- group Description
- Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.1173
- p Value Comment
- One-sided p-value based on stratified log rank test
- param Type
- Hazard Ratio (HR)
- param Value
- 0.86
- statistical Method
- Log Rank
- ci Lower Limit
- 0.57
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.96
- estimate Comment
- Numerator=Pembrolizumab 10 mg/kg Denominator=ICC
- group Description
- Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.0106
- p Value Comment
- One-sided p-value based on stratified log rank test
- param Type
- Hazard Ratio (HR)
- param Value
- 0.74
- statistical Method
- Log Rank
- ci Lower Limit
- 0.67
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.12
- estimate Comment
- Numerator=Pembrolizumab 10 mg/kg Denominator=Pembrolizumab 2 mg/kg
- group Description
- Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.2905
- p Value Comment
- Two-sided p-value based on stratified log rank test
- param Type
- Hazard Ratio (HR)
- param Value
- 0.87
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.67
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.10
- estimate Comment
- Numerator=Pembrolizumab 2 mg/kg Denominator=ICC
- group Description
- Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.1173
- p Value Comment
- One-sided p-value based on stratified log rank test
- param Type
- Hazard Ratio (HR)
- param Value
- 0.86
- statistical Method
- Log Rank
- ci Lower Limit
- 0.57
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.96
- estimate Comment
- Numerator=Pembrolizumab 10 mg/kg Denominator=ICC
- group Description
- Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.0106
- p Value Comment
- One-sided p-value based on stratified log rank test
- param Type
- Hazard Ratio (HR)
- param Value
- 0.74
- statistical Method
- Log Rank
- ci Lower Limit
- 0.67
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.12
- estimate Comment
- Numerator=Pembrolizumab 10 mg/kg Denominator=Pembrolizumab 2 mg/kg
- group Description
- Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.2905
- p Value Comment
- Two-sided p-value based on stratified log rank test
- param Type
- Hazard Ratio (HR)
- param Value
- 0.87
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 11.0
- upper Limit
- 16.4
- value
- 13.4
- group Id
- OG001
- lower Limit
- 11.3
- upper Limit
- 19.5
- value
- 14.7
- group Id
- OG002
- lower Limit
- 8.9
- upper Limit
- 13.8
- value
- 11.0
- denoms
- counts
- group Id
- OG000
- value
- 180
- group Id
- OG001
- value
- 181
- group Id
- OG002
- value
- 179
- units
- Participants
- description
- OS was defined as the time from randomization to death due to any cause. Analysis of OS was not planned or conducted for the switch-to-pembrolizumab treatment groups. Median OS based on the product-limit (Kaplan-Meier) method for censored data is presented. This was the interim analysis for OS.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants were initially randomized to receive pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to \~66 months)
- id
- OG000
- title
- Pembrolizumab 2 mg/kg
- description
- Participants were initially randomized to receive pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to \~66 months)
- id
- OG001
- title
- Pembrolizumab 10 mg/kg
- description
- Participants were initially randomized to receive 1 of 4 possible chemotherapy regimens decided at the treating institution (carboplatin+paclitaxel, paclitaxel alone, dacarbazine, or temozolomide). Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to \~66 months)
- id
- OG002
- title
- Investigator-Choice Chemotherapy (ICC)
- param Type
- MEDIAN
- population Description
- The analysis population consisted of all randomized participants. Participants were included in the initial treatment group to which they were randomized for the efficacy analysis.
- reporting Status
- POSTED
- time Frame
- Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015)
- title
- Interim Overall Survival (OS) - Initial Treatment Period
- type
- PRIMARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice