TriangleNCT02460224 · OUTCOME
Phase 1: Disease Control Rate (DCR) Per irRC
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
- 90% Confidence Interval
- Time frame
- From start of treatment until end of treatment, assessed up to 4.4 years
What was measured
Tumor response was based on local investigator assessment and the assessment criteria was immune-related Response Criteria (irRC). DCR per irRC is defined as the percentage of participants with a best overall response of immune related Complete Response (irCR), immune related Partial Response (irPR) or immune related Stable Disease (irSD). For irRC, irCR=Disappearance of all non-nodal target lesions and non-target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; irPR= At least a 30% decrease in the sum of diameters of all target lesions including new target lesions, taking as reference the baseline sum of diameters; SD= Neither sufficient shrinkage to qualify for irPR or irCR nor an increase in lesions which would qualify for progression. DCR 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 | 30.8 | Not reported | 11.3 | 57.3 | Not reported |
| Phase 1: LAG525 3 mg/kg Q2W | 33.3 | Not reported | 12.3 | 60.9 | Not reported |
| Phase 1: LAG525 5 mg/kg Q2W | 16.7 | Not reported | 0.9 | 58.2 | Not reported |
| Phase 1: LAG525 10 mg/kg Q2W | 0 | Not reported | 0.0 | 39.3 | Not reported |
| Phase 1: LAG525 15 mg/kg Q2W | 50.0 | Not reported | 15.3 | 84.7 | Not reported |
| Phase 1: LAG525 240 mg Q2W | 28.0 | Not reported | 13.9 | 46.2 | Not reported |
| Phase 1: LAG525 400 mg Q2W | 33.3 | Not reported | 17.8 | 52.1 | Not reported |
| Phase 1: LAG525 3 mg/kg Q4W | 20.0 | Not reported | 1.0 | 65.7 | Not reported |
| Phase 1: LAG525 5 mg/kg Q4W | 33.3 | Not reported | 6.3 | 72.9 | Not reported |
| Phase 1: LAG525 10 mg/kg Q4W | 18.2 | Not reported | 3.3 | 47.0 | Not reported |
| Phase 1: LAG525 400 mg Q4W | 20.0 | Not reported | 1.0 | 65.7 | Not reported |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | 50.0 | Not reported | 15.3 | 84.7 | Not reported |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | 66.7 | Not reported | 27.1 | 93.7 | Not reported |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | 50.0 | Not reported | 15.3 | 84.7 | Not reported |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | 60.0 | Not reported | 18.9 | 92.4 | Not reported |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | 33.3 | Not reported | 6.3 | 72.9 | Not reported |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | 55.0 | Not reported | 34.7 | 74.1 | Not reported |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | 50.0 | Not reported | 15.3 | 84.7 | Not reported |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | 8.3 | Not reported | 0.4 | 33.9 | Not reported |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | 28.6 | Not reported | 5.3 | 65.9 | Not reported |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | 66.7 | Not reported | 27.1 | 93.7 | Not reported |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | 50.0 | Not reported | 24.5 | 75.5 | Not reported |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | 33.3 | Not reported | 6.3 | 72.9 | Not reported |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | 36.4 | Not reported | 13.5 | 65.0 | Not reported |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | 50.0 | Not reported | 15.3 | 84.7 | Not reported |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | 50.0 | Not reported | 15.3 | 84.7 | 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 | 25.0 | Not reported | 1.3 | 75.1 | Not reported |
| Phase 1: LAG525 240 mg Q2W | 40.0 | Not reported | 7.6 | 81.1 | Not reported |
| Phase 1: LAG525 400 mg Q2W | 16.7 | Not reported | 0.9 | 58.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 11.3
- upper Limit
- 57.3
- value
- 30.8
- group Id
- OG001
- lower Limit
- 12.3
- upper Limit
- 60.9
- value
- 33.3
- group Id
- OG002
- lower Limit
- 0.9
- upper Limit
- 58.2
- value
- 16.7
- group Id
- OG003
- lower Limit
- 0.0
- upper Limit
- 39.3
- value
- 0
- group Id
- OG004
- lower Limit
- 15.3
- upper Limit
- 84.7
- value
- 50.0
- group Id
- OG005
- lower Limit
- 13.9
- upper Limit
- 46.2
- value
- 28.0
- group Id
- OG006
- lower Limit
- 17.8
- upper Limit
- 52.1
- value
- 33.3
- group Id
- OG007
- lower Limit
- 1.0
- upper Limit
- 65.7
- value
- 20.0
- group Id
- OG008
- lower Limit
- 6.3
- upper Limit
- 72.9
- value
- 33.3
- group Id
- OG009
- lower Limit
- 3.3
- upper Limit
- 47.0
- value
- 18.2
- group Id
- OG010
- lower Limit
- 1.0
- upper Limit
- 65.7
- value
- 20.0
- group Id
- OG011
- lower Limit
- 15.3
- upper Limit
- 84.7
- value
- 50.0
- 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
- group Id
- OG000
- lower Limit
- 1.3
- upper Limit
- 75.1
- value
- 25.0
- group Id
- OG005
- lower Limit
- 7.6
- upper Limit
- 81.1
- value
- 40.0
- group Id
- OG006
- lower Limit
- 0.9
- upper Limit
- 58.2
- value
- 16.7
- 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
- Tumor response was based on local investigator assessment and the assessment criteria was immune-related Response Criteria (irRC). DCR per irRC is defined as the percentage of participants with a best overall response of immune related Complete Response (irCR), immune related Partial Response (irPR) or immune related Stable Disease (irSD). For irRC, irCR=Disappearance of all non-nodal target lesions and non-target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; irPR= At least a 30% decrease in the sum of diameters of all target lesions including new target lesions, taking as reference the baseline sum of diameters; SD= Neither sufficient shrinkage to qualify for irPR or irCR nor an increase in lesions which would qualify for progression. DCR 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
- NUMBER
- 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 until end of treatment, assessed up to 4.4 years
- title
- Phase 1: Disease Control Rate (DCR) Per irRC
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice