NCT02460224 · OUTCOME
Phase 2: Disease Control Rate (DCR) Per RECIST 1.1
Safety and Efficacy of LAG525 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies. · Source last updated 2022-02-10
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 2.6 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 by tumor type.
Analysis population: All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001.
Groups in this outcome
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1
Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 121 |
|---|
| Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W | 21 |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 93 |
|---|
Reported measurements
Non-small cell lung cancer (NSCLC)
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 20 |
|---|
| Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W | 0 |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 22 |
|---|
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 50.0 | Not reported | 30.2 | 69.8 | Not reported |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 50.0 | Not reported | 31.1 | 68.9 | Not reported |
|---|
Melanoma
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 20 |
|---|
| Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W | 0 |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 22 |
|---|
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 45.0 | Not reported | 25.9 | 65.3 | Not reported |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 40.9 | Not reported | 23.3 | 60.5 | Not reported |
|---|
Renal cell cancer (RCC)
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 19 |
|---|
| Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W | 0 |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 19 |
|---|
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 63.2 | Not reported | 41.8 | 81.2 | Not reported |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 42.1 | Not reported | 23.0 | 63.2 | Not reported |
|---|
Mesothelioma
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 41 |
|---|
| Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W | 0 |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 16 |
|---|
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 65.9 | Not reported | 51.9 | 78.0 | Not reported |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 56.3 | Not reported | 33.3 | 77.3 | Not reported |
|---|
Triple negative breast cancer (TNBC)
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 21 |
|---|
| Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W | 21 |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 14 |
|---|
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 33.3 | Not reported | 16.8 | 53.6 | Not reported |
|---|
| Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W | 23.8 | Not reported | 9.9 | 43.7 | Not reported |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 21.4 | Not reported | 6.1 | 46.6 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 30.2
- upper Limit
- 69.8
- value
- 50.0
- group Id
- OG002
- lower Limit
- 31.1
- upper Limit
- 68.9
- value
- 50.0
- denoms
- counts
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 22
- units
- Participants
- title
- Non-small cell lung cancer (NSCLC)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 25.9
- upper Limit
- 65.3
- value
- 45.0
- group Id
- OG002
- lower Limit
- 23.3
- upper Limit
- 60.5
- value
- 40.9
- denoms
- counts
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 22
- units
- Participants
- title
- Melanoma
- categories
- measurements
- group Id
- OG000
- lower Limit
- 41.8
- upper Limit
- 81.2
- value
- 63.2
- group Id
- OG002
- lower Limit
- 23.0
- upper Limit
- 63.2
- value
- 42.1
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 19
- units
- Participants
- title
- Renal cell cancer (RCC)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 51.9
- upper Limit
- 78.0
- value
- 65.9
- group Id
- OG002
- lower Limit
- 33.3
- upper Limit
- 77.3
- value
- 56.3
- denoms
- counts
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 16
- units
- Participants
- title
- Mesothelioma
- categories
- measurements
- group Id
- OG000
- lower Limit
- 16.8
- upper Limit
- 53.6
- value
- 33.3
- group Id
- OG001
- lower Limit
- 9.9
- upper Limit
- 43.7
- value
- 23.8
- group Id
- OG002
- lower Limit
- 6.1
- upper Limit
- 46.6
- value
- 21.4
- denoms
- counts
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 21
- group Id
- OG002
- value
- 14
- units
- Participants
- title
- Triple negative breast cancer (TNBC)
- denoms
- counts
- group Id
- OG000
- value
- 121
- group Id
- OG001
- value
- 21
- group Id
- OG002
- value
- 93
- 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 by tumor type.
- dispersion Type
- 90% Confidence Interval
- groups
- description
- Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1
- id
- OG000
- title
- Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W
- description
- Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1
- id
- OG001
- title
- Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W
- description
- Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1
- id
- OG002
- title
- Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W
- param Type
- NUMBER
- population Description
- All patients in phase 2 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 2.6 years
- title
- Phase 2: Disease Control Rate (DCR) Per RECIST 1.1
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
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