Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02460224 · OUTCOME

Phase 2: Time to Reach Maximum Serum Concentration (Tmax) 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
MEDIAN
Unit
days
Interval / dispersion
Full Range
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. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations.

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

GroupSource count
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W121
Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W21
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W92

Reported measurements

Cycle 1, NSCLC patients

Analysis denominator · Participants

GroupSource count
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W20
Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W0
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W20
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W1.57Not reported1.523Not reported
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W1.57Not reported12.12Not reported
Cycle 3, NSCLC patients

Analysis denominator · Participants

GroupSource count
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W16
Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W0
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W13
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W1.57Not reported1.322.08Not reported
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W1.58Not reported1.472.08Not reported
Cycle 1, melanoma patients

Analysis denominator · Participants

GroupSource count
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W19
Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W0
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W20
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W1.55Not reported0.353.08Not reported
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W1.53Not reported0.5672.5Not reported
Cycle 3, melanoma patients

Analysis denominator · Participants

GroupSource count
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W13
Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W0
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W14
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W1.57Not reported1.082.08Not reported
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W1.53Not reported0.5831.63Not reported
Cycle 1, RCC patients

Analysis denominator · Participants

GroupSource count
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W18
Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W0
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W15
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W1.58Not reported13.08Not reported
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W1.57Not reported0.552Not reported
Cycle 3, RCC patients

Analysis denominator · Participants

GroupSource count
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W13
Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W0
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W13
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W1.53Not reported1.52.08Not reported
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W1.58Not reported1.472Not reported
Cycle 1, mesothelioma patients

Analysis denominator · Participants

GroupSource count
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W35
Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W0
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W16
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W1.55Not reported0.4833Not reported
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W1.54Not reported0.52Not reported
Cycle 3, mesothelioma patients

Analysis denominator · Participants

GroupSource count
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W33
Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W0
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W16
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W1.52Not reported0.12.05Not reported
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W1.5Not reported0.2832.08Not reported
Cycle 1, TNBC patients

Analysis denominator · Participants

GroupSource count
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W20
Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W19
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W13
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W1.58Not reported0.53Not reported
Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W1.57Not reported1.452.92Not reported
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W1.53Not reported0.9672.08Not reported
Cycle 3, TNBC patients

Analysis denominator · Participants

GroupSource count
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W11
Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W5
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W9
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W1.6Not reported1.482.5Not reported
Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W1.75Not reported1.62.43Not reported
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W1.65Not reported1.52.42Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.52
        upper Limit
        3
        value
        1.57
      2. group Id
        OG002
        lower Limit
        1
        upper Limit
        2.12
        value
        1.57
    denoms
    1. counts
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        20
      units
      Participants
    title
    Cycle 1, NSCLC patients
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.32
        upper Limit
        2.08
        value
        1.57
      2. group Id
        OG002
        lower Limit
        1.47
        upper Limit
        2.08
        value
        1.58
    denoms
    1. counts
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        13
      units
      Participants
    title
    Cycle 3, NSCLC patients
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.35
        upper Limit
        3.08
        value
        1.55
      2. group Id
        OG002
        lower Limit
        0.567
        upper Limit
        2.5
        value
        1.53
    denoms
    1. counts
      1. group Id
        OG000
        value
        19
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        20
      units
      Participants
    title
    Cycle 1, melanoma patients
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.08
        upper Limit
        2.08
        value
        1.57
      2. group Id
        OG002
        lower Limit
        0.583
        upper Limit
        1.63
        value
        1.53
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        14
      units
      Participants
    title
    Cycle 3, melanoma patients
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1
        upper Limit
        3.08
        value
        1.58
      2. group Id
        OG002
        lower Limit
        0.55
        upper Limit
        2
        value
        1.57
    denoms
    1. counts
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        15
      units
      Participants
    title
    Cycle 1, RCC patients
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.5
        upper Limit
        2.08
        value
        1.53
      2. group Id
        OG002
        lower Limit
        1.47
        upper Limit
        2
        value
        1.58
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        13
      units
      Participants
    title
    Cycle 3, RCC patients
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.483
        upper Limit
        3
        value
        1.55
      2. group Id
        OG002
        lower Limit
        0.5
        upper Limit
        2
        value
        1.54
    denoms
    1. counts
      1. group Id
        OG000
        value
        35
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        16
      units
      Participants
    title
    Cycle 1, mesothelioma patients
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.1
        upper Limit
        2.05
        value
        1.52
      2. group Id
        OG002
        lower Limit
        0.283
        upper Limit
        2.08
        value
        1.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        16
      units
      Participants
    title
    Cycle 3, mesothelioma patients
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.5
        upper Limit
        3
        value
        1.58
      2. group Id
        OG001
        lower Limit
        1.45
        upper Limit
        2.92
        value
        1.57
      3. group Id
        OG002
        lower Limit
        0.967
        upper Limit
        2.08
        value
        1.53
    denoms
    1. counts
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        19
      3. group Id
        OG002
        value
        13
      units
      Participants
    title
    Cycle 1, TNBC patients
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.48
        upper Limit
        2.5
        value
        1.6
      2. group Id
        OG001
        lower Limit
        1.6
        upper Limit
        2.43
        value
        1.75
      3. group Id
        OG002
        lower Limit
        1.5
        upper Limit
        2.42
        value
        1.65
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        9
      units
      Participants
    title
    Cycle 3, TNBC patients
denoms
  1. counts
    1. group Id
      OG000
      value
      121
    2. group Id
      OG001
      value
      21
    3. group Id
      OG002
      value
      92
    units
    Participants
description
Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations.
dispersion Type
Full Range
groups
  1. 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
  2. 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
  3. 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
MEDIAN
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: Time to Reach Maximum Serum Concentration (Tmax) of PDR001
type
SECONDARY
unit Of Measure
days

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice