NCT02460224 · OUTCOME
Phase 2: Relative Dose Intensity (RDI) of LAG525 and PDR001
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
- MEAN
- Unit
- percentage
- Interval / dispersion
- Standard Deviation
- Time frame
- From start of treatment until end of treatment, assessed up to 2.6 years.
What was measured
Relative dose intensity of each study drug is calculated with the following formula: 100 x actual dose intensity (mg/day)/planned dose intensity (mg/day).
The RDI of both study drugs is reported for each 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
LAG525, NSCLC patients
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 · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 100 | 0 | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 100 | 0 | Not reported | Not reported | Not reported |
|---|
PDR001, NSCLC patients
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 · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 100 | 0 | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 99.8 | 0.71 | Not reported | Not reported | Not reported |
|---|
LAG525, melanoma patients
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 · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 99.4 | 2.80 | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 99.7 | 1.47 | Not reported | Not reported | Not reported |
|---|
PDR001, melanoma patients
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 · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 99.4 | 2.80 | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 99.7 | 1.47 | Not reported | Not reported | Not reported |
|---|
LAG525, RCC patients
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 · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 100 | 0 | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 100 | 0 | Not reported | Not reported | Not reported |
|---|
PDR001, RCC patients
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 · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 100 | 0 | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 100 | 0 | Not reported | Not reported | Not reported |
|---|
LAG525, mesothelioma patients
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 · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 99.3 | 4.26 | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 99.4 | 1.99 | Not reported | Not reported | Not reported |
|---|
PDR001, mesothelioma patients
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 · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 99.3 | 4.26 | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 99.4 | 1.99 | Not reported | Not reported | Not reported |
|---|
LAG525, TNBC patients
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 · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 96.5 | 11.08 | Not reported | Not reported | Not reported |
|---|
| Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W | 100 | 0 | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 100 | 0 | Not reported | Not reported | Not reported |
|---|
PDR001, TNBC patients
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 · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 98.4 | 7.21 | Not reported | Not reported | Not reported |
|---|
| Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W | 100 | 0 | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 100 | 0 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0
- value
- 100
- group Id
- OG002
- spread
- 0
- value
- 100
- denoms
- counts
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 22
- units
- Participants
- title
- LAG525, NSCLC patients
- categories
- measurements
- group Id
- OG000
- spread
- 0
- value
- 100
- group Id
- OG002
- spread
- 0.71
- value
- 99.8
- denoms
- counts
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 22
- units
- Participants
- title
- PDR001, NSCLC patients
- categories
- measurements
- group Id
- OG000
- spread
- 2.80
- value
- 99.4
- group Id
- OG002
- spread
- 1.47
- value
- 99.7
- denoms
- counts
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 22
- units
- Participants
- title
- LAG525, melanoma patients
- categories
- measurements
- group Id
- OG000
- spread
- 2.80
- value
- 99.4
- group Id
- OG002
- spread
- 1.47
- value
- 99.7
- denoms
- counts
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 22
- units
- Participants
- title
- PDR001, melanoma patients
- categories
- measurements
- group Id
- OG000
- spread
- 0
- value
- 100
- group Id
- OG002
- spread
- 0
- value
- 100
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 19
- units
- Participants
- title
- LAG525, RCC patients
- categories
- measurements
- group Id
- OG000
- spread
- 0
- value
- 100
- group Id
- OG002
- spread
- 0
- value
- 100
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 19
- units
- Participants
- title
- PDR001, RCC patients
- categories
- measurements
- group Id
- OG000
- spread
- 4.26
- value
- 99.3
- group Id
- OG002
- spread
- 1.99
- value
- 99.4
- denoms
- counts
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 16
- units
- Participants
- title
- LAG525, mesothelioma patients
- categories
- measurements
- group Id
- OG000
- spread
- 4.26
- value
- 99.3
- group Id
- OG002
- spread
- 1.99
- value
- 99.4
- denoms
- counts
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 16
- units
- Participants
- title
- PDR001, mesothelioma patients
- categories
- measurements
- group Id
- OG000
- spread
- 11.08
- value
- 96.5
- group Id
- OG001
- spread
- 0
- value
- 100
- group Id
- OG002
- spread
- 0
- value
- 100
- denoms
- counts
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 21
- group Id
- OG002
- value
- 14
- units
- Participants
- title
- LAG525, TNBC patients
- categories
- measurements
- group Id
- OG000
- spread
- 7.21
- value
- 98.4
- group Id
- OG001
- spread
- 0
- value
- 100
- group Id
- OG002
- spread
- 0
- value
- 100
- denoms
- counts
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 21
- group Id
- OG002
- value
- 14
- units
- Participants
- title
- PDR001, TNBC patients
- denoms
- counts
- group Id
- OG000
- value
- 121
- group Id
- OG001
- value
- 21
- group Id
- OG002
- value
- 93
- units
- Participants
- description
- Relative dose intensity of each study drug is calculated with the following formula: 100 x actual dose intensity (mg/day)/planned dose intensity (mg/day).
The RDI of both study drugs is reported for each tumor type.
- dispersion Type
- Standard Deviation
- 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
- MEAN
- 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: Relative Dose Intensity (RDI) of LAG525 and PDR001
- type
- SECONDARY
- unit Of Measure
- percentage
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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