NCT02460224 · OUTCOME
Phase 2: Maximum Observed Serum Concentration (Cmax) of 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
- ug/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).
What was measured
Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose.
Analysis population: All patients in phase 2 who received at least one full or partial dose of PDR001 and who had at least one serum sample providing evaluable PK data.
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 | 92 |
|---|
Reported measurements
Cycle 1, 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 | 20 |
|---|
Values in ug/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 102 | 33 | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 68.9 | 17.3 | Not reported | Not reported | Not reported |
|---|
Cycle 3, NSCLC patients
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 16 |
|---|
| Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W | 0 |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 13 |
|---|
Values in ug/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 118 | 36.5 | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 100 | 24.2 | Not reported | Not reported | Not reported |
|---|
Cycle 1, melanoma 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 | 20 |
|---|
Values in ug/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 75.7 | 25.2 | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 71.3 | 26.2 | Not reported | Not reported | Not reported |
|---|
Cycle 3, melanoma patients
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 13 |
|---|
| Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W | 0 |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 14 |
|---|
Values in ug/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 117 | 29.8 | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 105 | 43.3 | Not reported | Not reported | Not reported |
|---|
Cycle 1, RCC patients
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 18 |
|---|
| Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W | 0 |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 15 |
|---|
Values in ug/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 81 | 21.3 | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 67 | 25.8 | Not reported | Not reported | Not reported |
|---|
Cycle 3, RCC patients
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 13 |
|---|
| Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W | 0 |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 13 |
|---|
Values in ug/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 104 | 23.8 | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 103 | 36.1 | Not reported | Not reported | Not reported |
|---|
Cycle 1, mesothelioma patients
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 35 |
|---|
| 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 ug/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 70.5 | 21.4 | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 82.7 | 39 | Not reported | Not reported | Not reported |
|---|
Cycle 3, mesothelioma patients
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 33 |
|---|
| 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 ug/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 96.5 | 31.5 | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 113 | 36.8 | Not reported | Not reported | Not reported |
|---|
Cycle 1, TNBC 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 | 19 |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 13 |
|---|
Values in ug/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 91.5 | 25.1 | Not reported | Not reported | Not reported |
|---|
| Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W | 117 | 36.7 | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 89.8 | 14.8 | Not reported | Not reported | Not reported |
|---|
Cycle 3, TNBC patients
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 11 |
|---|
| Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W | 5 |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 9 |
|---|
Values in ug/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 124 | 36.5 | Not reported | Not reported | Not reported |
|---|
| Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W | 134 | 54 | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 123 | 18.5 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 33
- value
- 102
- group Id
- OG002
- spread
- 17.3
- value
- 68.9
- denoms
- counts
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 20
- units
- Participants
- title
- Cycle 1, NSCLC patients
- categories
- measurements
- group Id
- OG000
- spread
- 36.5
- value
- 118
- group Id
- OG002
- spread
- 24.2
- value
- 100
- denoms
- counts
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 13
- units
- Participants
- title
- Cycle 3, NSCLC patients
- categories
- measurements
- group Id
- OG000
- spread
- 25.2
- value
- 75.7
- group Id
- OG002
- spread
- 26.2
- value
- 71.3
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 20
- units
- Participants
- title
- Cycle 1, melanoma patients
- categories
- measurements
- group Id
- OG000
- spread
- 29.8
- value
- 117
- group Id
- OG002
- spread
- 43.3
- value
- 105
- denoms
- counts
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 14
- units
- Participants
- title
- Cycle 3, melanoma patients
- categories
- measurements
- group Id
- OG000
- spread
- 21.3
- value
- 81
- group Id
- OG002
- spread
- 25.8
- value
- 67
- denoms
- counts
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 15
- units
- Participants
- title
- Cycle 1, RCC patients
- categories
- measurements
- group Id
- OG000
- spread
- 23.8
- value
- 104
- group Id
- OG002
- spread
- 36.1
- value
- 103
- denoms
- counts
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 13
- units
- Participants
- title
- Cycle 3, RCC patients
- categories
- measurements
- group Id
- OG000
- spread
- 21.4
- value
- 70.5
- group Id
- OG002
- spread
- 39
- value
- 82.7
- denoms
- counts
- group Id
- OG000
- value
- 35
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 16
- units
- Participants
- title
- Cycle 1, mesothelioma patients
- categories
- measurements
- group Id
- OG000
- spread
- 31.5
- value
- 96.5
- group Id
- OG002
- spread
- 36.8
- value
- 113
- denoms
- counts
- group Id
- OG000
- value
- 33
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 16
- units
- Participants
- title
- Cycle 3, mesothelioma patients
- categories
- measurements
- group Id
- OG000
- spread
- 25.1
- value
- 91.5
- group Id
- OG001
- spread
- 36.7
- value
- 117
- group Id
- OG002
- spread
- 14.8
- value
- 89.8
- denoms
- counts
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 13
- units
- Participants
- title
- Cycle 1, TNBC patients
- categories
- measurements
- group Id
- OG000
- spread
- 36.5
- value
- 124
- group Id
- OG001
- spread
- 54
- value
- 134
- group Id
- OG002
- spread
- 18.5
- value
- 123
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 9
- units
- Participants
- title
- Cycle 3, TNBC patients
- denoms
- counts
- group Id
- OG000
- value
- 121
- group Id
- OG001
- value
- 21
- group Id
- OG002
- value
- 92
- units
- Participants
- description
- Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose.
- 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 PDR001 and who had at least one serum sample providing evaluable PK data.
- reporting Status
- POSTED
- time Frame
- pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).
- title
- Phase 2: Maximum Observed Serum Concentration (Cmax) of PDR001
- type
- SECONDARY
- unit Of Measure
- ug/mL
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