TriangleNCT02460224 · OUTCOME
Phase 1: Disease Control Rate (DCR) Per RECIST 1.1
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 Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). DCR per RECIST 1.1 is defined as the percentage of participants with a best overall response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD). For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters; SD= Neither sufficient shrinkage to qualify for PR or CR 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 | 23.1 | Not reported | 6.6 | 49.5 | Not reported |
| Phase 1: LAG525 3 mg/kg Q2W | 41.7 | Not reported | 18.1 | 68.5 | 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 | 66.7 | Not reported | 27.1 | 93.7 | Not reported |
| Phase 1: LAG525 240 mg Q2W | 24.0 | Not reported | 11.0 | 42.0 | Not reported |
| Phase 1: LAG525 400 mg Q2W | 20.8 | Not reported | 8.6 | 38.9 | 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 | 33.3 | Not reported | 6.3 | 72.9 | Not reported |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | 33.3 | Not reported | 6.3 | 72.9 | 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 | 41.7 | Not reported | 18.1 | 68.5 | Not reported |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | 16.7 | Not reported | 0.9 | 58.2 | 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
- 6.6
- upper Limit
- 49.5
- value
- 23.1
- group Id
- OG001
- lower Limit
- 18.1
- upper Limit
- 68.5
- value
- 41.7
- 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
- 27.1
- upper Limit
- 93.7
- value
- 66.7
- group Id
- OG005
- lower Limit
- 11.0
- upper Limit
- 42.0
- value
- 24.0
- group Id
- OG006
- lower Limit
- 8.6
- upper Limit
- 38.9
- value
- 20.8
- 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 Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). DCR per RECIST 1.1 is defined as the percentage of participants with a best overall response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD). For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters; SD= Neither sufficient shrinkage to qualify for PR or CR 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 RECIST 1.1
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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