TriangleNCT02460224 · OUTCOME
Phase 1: Progression-free Survival (PFS) Per RECIST 1.1
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 90% Confidence Interval
- Time frame
- From start of treatment to first documented progression or death due to any cause, assessed up to 4.4 years
What was measured
PFS is the time from the date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, PFS is censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment and the assessment criteria was RECIST 1.1. PFS is reported for ROW and Japanese patients.
Analysis population: All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001.
Groups in this outcome
Phase 1: LAG525 1 mg/kg Q2W
Single-agent LAG525 1 mg/kg Q2W
Phase 1: LAG525 3 mg/kg Q2W
Single-agent LAG525 3 mg/kg Q2W
Phase 1: LAG525 5 mg/kg Q2W
Single-agent LAG525 5 mg/kg Q2W
Phase 1: LAG525 10 mg/kg Q2W
Single-agent LAG525 10 mg/kg Q2W
Phase 1: LAG525 15 mg/kg Q2W
Single-agent LAG525 15 mg/kg Q2W
Phase 1: LAG525 240 mg Q2W
Single-agent LAG525 240 mg Q2W
Phase 1: LAG525 400 mg Q2W
Single-agent LAG525 400 mg Q2W
Phase 1: LAG525 3 mg/kg Q4W
Single-agent LAG525 3 mg/kg Q4W
Phase 1: LAG525 5 mg/kg Q4W
Single-agent LAG525 5 mg/kg Q4W
Phase 1: LAG525 10 mg/kg Q4W
Single-agent LAG525 10 mg/kg Q4W
Phase 1: LAG525 400 mg Q4W
Single-agent LAG525 400 mg Q4W
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
| Group | Source count |
|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | 17 |
| Phase 1: LAG525 3 mg/kg Q2W | 12 |
| Phase 1: LAG525 5 mg/kg Q2W | 6 |
| Phase 1: LAG525 10 mg/kg Q2W | 6 |
| Phase 1: LAG525 15 mg/kg Q2W | 6 |
| Phase 1: LAG525 240 mg Q2W | 30 |
| Phase 1: LAG525 400 mg Q2W | 30 |
| Phase 1: LAG525 3 mg/kg Q4W | 5 |
| Phase 1: LAG525 5 mg/kg Q4W | 6 |
| Phase 1: LAG525 10 mg/kg Q4W | 11 |
| Phase 1: LAG525 400 mg Q4W | 5 |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | 6 |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | 6 |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | 6 |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | 5 |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | 6 |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | 20 |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | 6 |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | 12 |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | 7 |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | 6 |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | 12 |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | 6 |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | 11 |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | 6 |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | 6 |
Reported measurements
ROW
| Group | Source count |
|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | 13 |
| Phase 1: LAG525 3 mg/kg Q2W | 12 |
| Phase 1: LAG525 5 mg/kg Q2W | 6 |
| Phase 1: LAG525 10 mg/kg Q2W | 6 |
| Phase 1: LAG525 15 mg/kg Q2W | 6 |
| Phase 1: LAG525 240 mg Q2W | 25 |
| Phase 1: LAG525 400 mg Q2W | 24 |
| Phase 1: LAG525 3 mg/kg Q4W | 5 |
| Phase 1: LAG525 5 mg/kg Q4W | 6 |
| Phase 1: LAG525 10 mg/kg Q4W | 11 |
| Phase 1: LAG525 400 mg Q4W | 5 |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | 6 |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | 6 |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | 6 |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | 5 |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | 6 |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | 20 |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | 6 |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | 12 |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | 7 |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | 6 |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | 12 |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | 6 |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | 11 |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | 6 |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | 6 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | 1.8 | Not reported | 1.6 | 2.0 | Not reported |
| Phase 1: LAG525 3 mg/kg Q2W | 2.3 | Not reported | 1.7 | 3.5 | Not reported |
| Phase 1: LAG525 5 mg/kg Q2W | 1.6 | Not reported | 0.8 | 1.9 | Not reported |
| Phase 1: LAG525 10 mg/kg Q2W | 1.9 | Not reported | 1.6 | NA | Not estimable due to insufficient number of participants with events. |
| Phase 1: LAG525 15 mg/kg Q2W | 7.9 | Not reported | 1.3 | NA | Not estimable due to insufficient number of participants with events. |
| Phase 1: LAG525 240 mg Q2W | 1.7 | Not reported | 1.6 | 1.9 | Not reported |
| Phase 1: LAG525 400 mg Q2W | 1.8 | Not reported | 1.5 | 1.9 | Not reported |
| Phase 1: LAG525 3 mg/kg Q4W | 2.8 | Not reported | 1.6 | NA | Not estimable due to insufficient number of participants with events. |
| Phase 1: LAG525 5 mg/kg Q4W | 2.1 | Not reported | 0.3 | NA | Not estimable due to insufficient number of participants with events. |
| Phase 1: LAG525 10 mg/kg Q4W | 1.8 | Not reported | 1.0 | 2.0 | Not reported |
| Phase 1: LAG525 400 mg Q4W | 1.5 | Not reported | 1.4 | NA | Not estimable due to insufficient number of participants with events. |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | 3.8 | Not reported | 1.3 | NA | Not estimable due to insufficient number of participants with events. |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | 1.9 | Not reported | 1.8 | 3.5 | Not reported |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | 1.8 | Not reported | 1.1 | 3.4 | Not reported |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | 8.4 | Not reported | 1.7 | NA | Not estimable due to insufficient number of participants with events. |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | 1.8 | Not reported | 1.6 | NA | Not estimable due to insufficient number of participants with events. |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | 2.8 | Not reported | 2.0 | 4.2 | Not reported |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | 6.5 | Not reported | 0.6 | NA | Not estimable due to insufficient number of participants with events. |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | 1.4 | Not reported | 0.6 | 1.8 | Not reported |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | 1.8 | Not reported | 1.2 | 2.5 | Not reported |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | 3.1 | Not reported | 1.0 | 5.0 | Not reported |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | 2.3 | Not reported | 1.6 | 5.7 | Not reported |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | 1.5 | Not reported | 0.9 | NA | Not estimable due to insufficient number of participants with events. |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | 1.9 | Not reported | 1.7 | 2.9 | Not reported |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | 3.8 | Not reported | 1.6 | 7.6 | Not reported |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | 3.2 | Not reported | 1.7 | 5.8 | Not reported |
Japanese
| Group | Source count |
|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | 4 |
| Phase 1: LAG525 3 mg/kg Q2W | 0 |
| Phase 1: LAG525 5 mg/kg Q2W | 0 |
| Phase 1: LAG525 10 mg/kg Q2W | 0 |
| Phase 1: LAG525 15 mg/kg Q2W | 0 |
| Phase 1: LAG525 240 mg Q2W | 5 |
| Phase 1: LAG525 400 mg Q2W | 6 |
| Phase 1: LAG525 3 mg/kg Q4W | 0 |
| Phase 1: LAG525 5 mg/kg Q4W | 0 |
| Phase 1: LAG525 10 mg/kg Q4W | 0 |
| Phase 1: LAG525 400 mg Q4W | 0 |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | 0 |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | 0 |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | 0 |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | 0 |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | 0 |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | 0 |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | 0 |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | 0 |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | 0 |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | 0 |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | 0 |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | 0 |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | 0 |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | 0 |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | 1.8 | Not reported | 1.2 | NA | Not estimable due to insufficient number of participants with events. |
| Phase 1: LAG525 240 mg Q2W | 1.8 | Not reported | 1.0 | NA | Not estimable due to insufficient number of participants with events. |
| Phase 1: LAG525 400 mg Q2W | 1.7 | Not reported | 1.2 | 1.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.6
- upper Limit
- 2.0
- value
- 1.8
- group Id
- OG001
- lower Limit
- 1.7
- upper Limit
- 3.5
- value
- 2.3
- group Id
- OG002
- lower Limit
- 0.8
- upper Limit
- 1.9
- value
- 1.6
- comment
- Not estimable due to insufficient number of participants with events.
- group Id
- OG003
- lower Limit
- 1.6
- upper Limit
- NA
- value
- 1.9
- comment
- Not estimable due to insufficient number of participants with events.
- group Id
- OG004
- lower Limit
- 1.3
- upper Limit
- NA
- value
- 7.9
- group Id
- OG005
- lower Limit
- 1.6
- upper Limit
- 1.9
- value
- 1.7
- group Id
- OG006
- lower Limit
- 1.5
- upper Limit
- 1.9
- value
- 1.8
- comment
- Not estimable due to insufficient number of participants with events.
- group Id
- OG007
- lower Limit
- 1.6
- upper Limit
- NA
- value
- 2.8
- comment
- Not estimable due to insufficient number of participants with events.
- group Id
- OG008
- lower Limit
- 0.3
- upper Limit
- NA
- value
- 2.1
- group Id
- OG009
- lower Limit
- 1.0
- upper Limit
- 2.0
- value
- 1.8
- comment
- Not estimable due to insufficient number of participants with events.
- group Id
- OG010
- lower Limit
- 1.4
- upper Limit
- NA
- value
- 1.5
- comment
- Not estimable due to insufficient number of participants with events.
- group Id
- OG011
- lower Limit
- 1.3
- upper Limit
- NA
- value
- 3.8
- denoms
- counts
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 25
- group Id
- OG006
- value
- 24
- group Id
- OG007
- value
- 5
- group Id
- OG008
- value
- 6
- group Id
- OG009
- value
- 11
- group Id
- OG010
- value
- 5
- group Id
- OG011
- value
- 6
- units
- Participants
- title
- ROW
- categories
- measurements
- comment
- Not estimable due to insufficient number of participants with events.
- group Id
- OG000
- lower Limit
- 1.2
- upper Limit
- NA
- value
- 1.8
- comment
- Not estimable due to insufficient number of participants with events.
- group Id
- OG005
- lower Limit
- 1.0
- upper Limit
- NA
- value
- 1.8
- group Id
- OG006
- lower Limit
- 1.2
- upper Limit
- 1.8
- value
- 1.7
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 6
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- units
- Participants
- title
- Japanese
- denoms
- counts
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 30
- group Id
- OG006
- value
- 30
- group Id
- OG007
- value
- 5
- group Id
- OG008
- value
- 6
- group Id
- OG009
- value
- 11
- group Id
- OG010
- value
- 5
- group Id
- OG011
- value
- 6
- units
- Participants
- description
- PFS is the time from the date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, PFS is censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment and the assessment criteria was RECIST 1.1. PFS is reported for ROW and Japanese patients.
- dispersion Type
- 90% Confidence Interval
- groups
- description
- Single-agent LAG525 1 mg/kg Q2W
- id
- OG000
- title
- Phase 1: LAG525 1 mg/kg Q2W
- description
- Single-agent LAG525 3 mg/kg Q2W
- id
- OG001
- title
- Phase 1: LAG525 3 mg/kg Q2W
- description
- Single-agent LAG525 5 mg/kg Q2W
- id
- OG002
- title
- Phase 1: LAG525 5 mg/kg Q2W
- description
- Single-agent LAG525 10 mg/kg Q2W
- id
- OG003
- title
- Phase 1: LAG525 10 mg/kg Q2W
- description
- Single-agent LAG525 15 mg/kg Q2W
- id
- OG004
- title
- Phase 1: LAG525 15 mg/kg Q2W
- description
- Single-agent LAG525 240 mg Q2W
- id
- OG005
- title
- Phase 1: LAG525 240 mg Q2W
- description
- Single-agent LAG525 400 mg Q2W
- id
- OG006
- title
- Phase 1: LAG525 400 mg Q2W
- description
- Single-agent LAG525 3 mg/kg Q4W
- id
- OG007
- title
- Phase 1: LAG525 3 mg/kg Q4W
- description
- Single-agent LAG525 5 mg/kg Q4W
- id
- OG008
- title
- Phase 1: LAG525 5 mg/kg Q4W
- description
- Single-agent LAG525 10 mg/kg Q4W
- id
- OG009
- title
- Phase 1: LAG525 10 mg/kg Q4W
- description
- Single-agent LAG525 400 mg Q4W
- id
- OG010
- title
- Phase 1: LAG525 400 mg Q4W
- description
- Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
- id
- OG011
- title
- Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
- param Type
- MEDIAN
- population Description
- All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001.
- reporting Status
- POSTED
- time Frame
- From start of treatment to first documented progression or death due to any cause, assessed up to 4.4 years
- title
- Phase 1: Progression-free Survival (PFS) Per RECIST 1.1
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice