TriangleNCT01866319 · OUTCOME
Progression-free Survival (PFS) According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Independent Radiology Plus Oncology Review (IRO)
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 12 months (through first pre-specified statistical analysis cut-off date of 03-Sep-2014)
What was measured
PFS was defined as the time from randomization to the first documented disease progression, based on blinded Independent Radiology plus Oncology review (IRO) using RECIST 1.1, or death due to any cause, whichever occurred first. Disease progression was defined as a 20% or greater increase in the sum of diameters of target lesions with an absolute increase of at least 5 mm or the appearance of new lesions. The primary analysis of PFS was performed at the time of the first protocol pre-specified statistical analysis, with data cut-off of 03-Sep-2014.
Analysis population: The ITT population, comprising all participants as randomized to a study arm.
Groups in this outcome
Ipilimumab
Participants received ipilimumab, 3 mg/kg intravenously (IV), once every 3 weeks (Q3W) for a total of 4 doses (up to approximately 3 months).
Pembrolizumab Q2W
Participants received pembrolizumab, 10 mg/kg IV, once every 2 weeks (Q2W) for up to approximately 24 months.
Pembrolizumab Q3W
Participants received pembrolizumab, 10 mg/kg IV, Q3W for up to approximately 24 months.
| Group | Source count |
|---|---|
| Ipilimumab | 278 |
| Pembrolizumab Q2W | 279 |
| Pembrolizumab Q3W | 277 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ipilimumab | 2.8 | Not reported | 2.8 | 2.9 | Not reported |
| Pembrolizumab Q2W | 5.5 | Not reported | 3.4 | 6.9 | Not reported |
| Pembrolizumab Q3W | 4.1 | Not reported | 2.9 | 6.9 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.46
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.72
- group Description
- Statistical testing was stratified by line of therapy (1st vs. 2nd), programmed cell death ligand 1 (PD-L1) status (positive vs. negative) and Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1)
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- <0.00001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.58
- statistical Method
- Log Rank
- ci Lower Limit
- 0.47
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.72
- group Description
- Statistical testing was stratified by line of therapy (1st vs. 2nd), programmed cell death ligand 1 (PD-L1) status (positive vs. negative) and Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1)
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- <0.00001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.58
- statistical Method
- Log Rank
- ci Lower Limit
- 0.77
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.21
- group Description
- Statistical testing was stratified by line of therapy (1st vs. 2nd), programmed cell death ligand 1 (PD-L1) status (positive vs. negative) and Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1)
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.75869
- param Type
- Hazard Ratio (HR)
- param Value
- 0.97
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.46
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.72
- group Description
- Statistical testing was stratified by line of therapy (1st vs. 2nd), programmed cell death ligand 1 (PD-L1) status (positive vs. negative) and Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1)
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- <0.00001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.58
- statistical Method
- Log Rank
- ci Lower Limit
- 0.47
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.72
- group Description
- Statistical testing was stratified by line of therapy (1st vs. 2nd), programmed cell death ligand 1 (PD-L1) status (positive vs. negative) and Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1)
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- <0.00001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.58
- statistical Method
- Log Rank
- ci Lower Limit
- 0.77
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.21
- group Description
- Statistical testing was stratified by line of therapy (1st vs. 2nd), programmed cell death ligand 1 (PD-L1) status (positive vs. negative) and Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1)
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.75869
- param Type
- Hazard Ratio (HR)
- param Value
- 0.97
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.8
- upper Limit
- 2.9
- value
- 2.8
- group Id
- OG001
- lower Limit
- 3.4
- upper Limit
- 6.9
- value
- 5.5
- group Id
- OG002
- lower Limit
- 2.9
- upper Limit
- 6.9
- value
- 4.1
- denoms
- counts
- group Id
- OG000
- value
- 278
- group Id
- OG001
- value
- 279
- group Id
- OG002
- value
- 277
- units
- Participants
- description
- PFS was defined as the time from randomization to the first documented disease progression, based on blinded Independent Radiology plus Oncology review (IRO) using RECIST 1.1, or death due to any cause, whichever occurred first. Disease progression was defined as a 20% or greater increase in the sum of diameters of target lesions with an absolute increase of at least 5 mm or the appearance of new lesions. The primary analysis of PFS was performed at the time of the first protocol pre-specified statistical analysis, with data cut-off of 03-Sep-2014.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received ipilimumab, 3 mg/kg intravenously (IV), once every 3 weeks (Q3W) for a total of 4 doses (up to approximately 3 months).
- id
- OG000
- title
- Ipilimumab
- description
- Participants received pembrolizumab, 10 mg/kg IV, once every 2 weeks (Q2W) for up to approximately 24 months.
- id
- OG001
- title
- Pembrolizumab Q2W
- description
- Participants received pembrolizumab, 10 mg/kg IV, Q3W for up to approximately 24 months.
- id
- OG002
- title
- Pembrolizumab Q3W
- param Type
- MEDIAN
- population Description
- The ITT population, comprising all participants as randomized to a study arm.
- reporting Status
- POSTED
- time Frame
- Up to approximately 12 months (through first pre-specified statistical analysis cut-off date of 03-Sep-2014)
- title
- Progression-free Survival (PFS) According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Independent Radiology Plus Oncology Review (IRO)
- type
- PRIMARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice