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NCT02554812 · OUTCOME

Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab and PD 0360324 in Combination C

A Study Of Avelumab In Combination With Other Cancer Immunotherapies In Advanced Malignancies (JAVELIN Medley) · Source last updated 2024-07-30

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
GEOMETRIC_MEAN
Unit
Nanogram per milliliter
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Pre-dose on Days 1 and 15 of Cycle 1 (non-dosing); Day 1 of Cycles 2, 4, 6 and Cycle 10

What was measured

Ctrough is steady-state pre-dose concentration.

Analysis population: PK analysis set included all participants who had received at least one dose of study drug and who had at least one of the PK concentrations of interest for Avelumab, Utomilumab, PD 0360324, PF-04518600. Here, "Number of participants analyzed'' signifies number of participants evaluable for this outcome measure, where "Number Analyzed" signifies number of participants evaluable for specified time points.

Groups in this outcome

Combination C Phase 1b: PD 0360324 50 mg + Avelumab

During Phase 1b participants received PD 0360324 50 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.

Combination C Phase 1b: PD 0360324 100 mg + Avelumab

During Phase 1b participants received PD 0360324 100 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.

Combination C Phase 1b: PD 0360324 150 mg + Avelumab

During Phase 1b participants received PD 0360324 150 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Combination C Phase 1b: PD 0360324 50 mg + Avelumab10
Combination C Phase 1b: PD 0360324 100 mg + Avelumab8
Combination C Phase 1b: PD 0360324 150 mg + Avelumab6

Reported measurements

Avelumab Cycle 1/Day1-0 Hour

Analysis denominator · Participants

GroupSource count
Combination C Phase 1b: PD 0360324 50 mg + Avelumab10
Combination C Phase 1b: PD 0360324 100 mg + Avelumab8
Combination C Phase 1b: PD 0360324 150 mg + Avelumab6
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Combination C Phase 1b: PD 0360324 50 mg + Avelumab0.2090NANot reportedNot reportedOnly 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
Combination C Phase 1b: PD 0360324 100 mg + AvelumabNANANot reportedNot reportedThere were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
Combination C Phase 1b: PD 0360324 150 mg + AvelumabNANANot reportedNot reportedThere were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
Avelumab Cycle 1/Day15-0 Hour

Analysis denominator · Participants

GroupSource count
Combination C Phase 1b: PD 0360324 50 mg + Avelumab9
Combination C Phase 1b: PD 0360324 100 mg + Avelumab8
Combination C Phase 1b: PD 0360324 150 mg + Avelumab6
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Combination C Phase 1b: PD 0360324 50 mg + Avelumab20.4539Not reportedNot reportedNot reported
Combination C Phase 1b: PD 0360324 100 mg + Avelumab32.3440Not reportedNot reportedNot reported
Combination C Phase 1b: PD 0360324 150 mg + Avelumab22.5363Not reportedNot reportedNot reported
Avelumab Cycle 2/Day1-0 Hour

Analysis denominator · Participants

GroupSource count
Combination C Phase 1b: PD 0360324 50 mg + Avelumab8
Combination C Phase 1b: PD 0360324 100 mg + Avelumab6
Combination C Phase 1b: PD 0360324 150 mg + Avelumab5
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Combination C Phase 1b: PD 0360324 50 mg + Avelumab16.35136Not reportedNot reportedNot reported
Combination C Phase 1b: PD 0360324 100 mg + Avelumab31.4498Not reportedNot reportedNot reported
Combination C Phase 1b: PD 0360324 150 mg + Avelumab15.94237Not reportedNot reportedNot reported
Avelumab Cycle 4/Day1-0 Hour

Analysis denominator · Participants

GroupSource count
Combination C Phase 1b: PD 0360324 50 mg + Avelumab2
Combination C Phase 1b: PD 0360324 100 mg + Avelumab2
Combination C Phase 1b: PD 0360324 150 mg + Avelumab5
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Combination C Phase 1b: PD 0360324 50 mg + Avelumab15.5023Not reportedNot reportedNot reported
Combination C Phase 1b: PD 0360324 100 mg + Avelumab57.1380Not reportedNot reportedNot reported
Combination C Phase 1b: PD 0360324 150 mg + Avelumab36.0437Not reportedNot reportedNot reported
Avelumab Cycle 6/Day1-0 Hour

Analysis denominator · Participants

GroupSource count
Combination C Phase 1b: PD 0360324 50 mg + Avelumab2
Combination C Phase 1b: PD 0360324 100 mg + Avelumab1
Combination C Phase 1b: PD 0360324 150 mg + Avelumab2
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Combination C Phase 1b: PD 0360324 50 mg + Avelumab26.3824Not reportedNot reportedNot reported
Combination C Phase 1b: PD 0360324 100 mg + Avelumab77.20NANot reportedNot reportedOnly 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
Combination C Phase 1b: PD 0360324 150 mg + Avelumab33.2315Not reportedNot reportedNot reported
Avelumab Cycle 10/Day1-0 Hour

Analysis denominator · Participants

GroupSource count
Combination C Phase 1b: PD 0360324 50 mg + Avelumab0
Combination C Phase 1b: PD 0360324 100 mg + Avelumab1
Combination C Phase 1b: PD 0360324 150 mg + Avelumab2
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Combination C Phase 1b: PD 0360324 100 mg + Avelumab46.90NANot reportedNot reportedOnly 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
Combination C Phase 1b: PD 0360324 150 mg + Avelumab27.094Not reportedNot reportedNot reported
PD 0360324 Cycle 1/Day1-0 Hour

Analysis denominator · Participants

GroupSource count
Combination C Phase 1b: PD 0360324 50 mg + Avelumab10
Combination C Phase 1b: PD 0360324 100 mg + Avelumab7
Combination C Phase 1b: PD 0360324 150 mg + Avelumab6
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Combination C Phase 1b: PD 0360324 50 mg + AvelumabNANANot reportedNot reportedThere were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
Combination C Phase 1b: PD 0360324 100 mg + AvelumabNANANot reportedNot reportedThere were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
Combination C Phase 1b: PD 0360324 150 mg + AvelumabNANANot reportedNot reportedThere were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
PD 0360324 Cycle 1/Day15-0 Hour

Analysis denominator · Participants

GroupSource count
Combination C Phase 1b: PD 0360324 50 mg + Avelumab9
Combination C Phase 1b: PD 0360324 100 mg + Avelumab6
Combination C Phase 1b: PD 0360324 150 mg + Avelumab6
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Combination C Phase 1b: PD 0360324 50 mg + Avelumab126.220Not reportedNot reportedNot reported
Combination C Phase 1b: PD 0360324 100 mg + Avelumab390.994Not reportedNot reportedNot reported
Combination C Phase 1b: PD 0360324 150 mg + Avelumab583.1101Not reportedNot reportedNot reported
PD 0360324 Cycle 2/Day1-0 Hour

Analysis denominator · Participants

GroupSource count
Combination C Phase 1b: PD 0360324 50 mg + Avelumab8
Combination C Phase 1b: PD 0360324 100 mg + Avelumab6
Combination C Phase 1b: PD 0360324 150 mg + Avelumab5
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Combination C Phase 1b: PD 0360324 50 mg + Avelumab137.746Not reportedNot reportedNot reported
Combination C Phase 1b: PD 0360324 100 mg + Avelumab360.4110Not reportedNot reportedNot reported
Combination C Phase 1b: PD 0360324 150 mg + Avelumab2987105Not reportedNot reportedNot reported
PD 0360324 Cycle 4/Day1-0 Hour

Analysis denominator · Participants

GroupSource count
Combination C Phase 1b: PD 0360324 50 mg + Avelumab2
Combination C Phase 1b: PD 0360324 100 mg + Avelumab2
Combination C Phase 1b: PD 0360324 150 mg + Avelumab5
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Combination C Phase 1b: PD 0360324 50 mg + AvelumabNANANot reportedNot reportedThere were \<=2 participants, and no observation was equal or above LLoQ . Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
Combination C Phase 1b: PD 0360324 100 mg + Avelumab447.262Not reportedNot reportedNot reported
Combination C Phase 1b: PD 0360324 150 mg + Avelumab1397190Not reportedNot reportedNot reported
PD 0360324 Cycle 6/Day1-0 Hour

Analysis denominator · Participants

GroupSource count
Combination C Phase 1b: PD 0360324 50 mg + Avelumab2
Combination C Phase 1b: PD 0360324 100 mg + Avelumab2
Combination C Phase 1b: PD 0360324 150 mg + Avelumab3
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Combination C Phase 1b: PD 0360324 50 mg + Avelumab134.0NANot reportedNot reportedOnly 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
Combination C Phase 1b: PD 0360324 100 mg + Avelumab654.0NANot reportedNot reportedOnly 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
Combination C Phase 1b: PD 0360324 150 mg + Avelumab312.1128Not reportedNot reportedNot reported
PD 0360324 Cycle 10/Day1-0 Hour

Analysis denominator · Participants

GroupSource count
Combination C Phase 1b: PD 0360324 50 mg + Avelumab0
Combination C Phase 1b: PD 0360324 100 mg + Avelumab1
Combination C Phase 1b: PD 0360324 150 mg + Avelumab1
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Combination C Phase 1b: PD 0360324 100 mg + Avelumab115.0NANot reportedNot reportedOnly 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
Combination C Phase 1b: PD 0360324 150 mg + Avelumab169.0NANot reportedNot reportedOnly 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Only 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
        group Id
        OG000
        spread
        NA
        value
        0.2090
      2. comment
        There were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
        group Id
        OG001
        spread
        NA
        value
        NA
      3. comment
        There were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
        group Id
        OG002
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        8
      3. group Id
        OG002
        value
        6
      units
      Participants
    title
    Avelumab Cycle 1/Day1-0 Hour
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        39
        value
        20.45
      2. group Id
        OG001
        spread
        40
        value
        32.34
      3. group Id
        OG002
        spread
        63
        value
        22.53
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        8
      3. group Id
        OG002
        value
        6
      units
      Participants
    title
    Avelumab Cycle 1/Day15-0 Hour
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        136
        value
        16.35
      2. group Id
        OG001
        spread
        98
        value
        31.44
      3. group Id
        OG002
        spread
        237
        value
        15.94
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        5
      units
      Participants
    title
    Avelumab Cycle 2/Day1-0 Hour
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        23
        value
        15.50
      2. group Id
        OG001
        spread
        80
        value
        57.13
      3. group Id
        OG002
        spread
        37
        value
        36.04
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        5
      units
      Participants
    title
    Avelumab Cycle 4/Day1-0 Hour
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        24
        value
        26.38
      2. comment
        Only 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
        group Id
        OG001
        spread
        NA
        value
        77.20
      3. group Id
        OG002
        spread
        15
        value
        33.23
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        2
      units
      Participants
    title
    Avelumab Cycle 6/Day1-0 Hour
  6. categories
    1. measurements
      1. comment
        Only 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
        group Id
        OG001
        spread
        NA
        value
        46.90
      2. group Id
        OG002
        spread
        4
        value
        27.09
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        2
      units
      Participants
    title
    Avelumab Cycle 10/Day1-0 Hour
  7. categories
    1. measurements
      1. comment
        There were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
        group Id
        OG000
        spread
        NA
        value
        NA
      2. comment
        There were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
        group Id
        OG001
        spread
        NA
        value
        NA
      3. comment
        There were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
        group Id
        OG002
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        6
      units
      Participants
    title
    PD 0360324 Cycle 1/Day1-0 Hour
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        20
        value
        126.2
      2. group Id
        OG001
        spread
        94
        value
        390.9
      3. group Id
        OG002
        spread
        101
        value
        583.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        6
      units
      Participants
    title
    PD 0360324 Cycle 1/Day15-0 Hour
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        46
        value
        137.7
      2. group Id
        OG001
        spread
        110
        value
        360.4
      3. group Id
        OG002
        spread
        105
        value
        2987
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        5
      units
      Participants
    title
    PD 0360324 Cycle 2/Day1-0 Hour
  10. categories
    1. measurements
      1. comment
        There were \<=2 participants, and no observation was equal or above LLoQ . Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
        group Id
        OG000
        spread
        NA
        value
        NA
      2. group Id
        OG001
        spread
        62
        value
        447.2
      3. group Id
        OG002
        spread
        190
        value
        1397
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        5
      units
      Participants
    title
    PD 0360324 Cycle 4/Day1-0 Hour
  11. categories
    1. measurements
      1. comment
        Only 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
        group Id
        OG000
        spread
        NA
        value
        134.0
      2. comment
        Only 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
        group Id
        OG001
        spread
        NA
        value
        654.0
      3. group Id
        OG002
        spread
        128
        value
        312.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        3
      units
      Participants
    title
    PD 0360324 Cycle 6/Day1-0 Hour
  12. categories
    1. measurements
      1. comment
        Only 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
        group Id
        OG001
        spread
        NA
        value
        115.0
      2. comment
        Only 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
        group Id
        OG002
        spread
        NA
        value
        169.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
      units
      Participants
    title
    PD 0360324 Cycle 10/Day1-0 Hour
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      8
    3. group Id
      OG002
      value
      6
    units
    Participants
description
Ctrough is steady-state pre-dose concentration.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    During Phase 1b participants received PD 0360324 50 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
    id
    OG000
    title
    Combination C Phase 1b: PD 0360324 50 mg + Avelumab
  2. description
    During Phase 1b participants received PD 0360324 100 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
    id
    OG001
    title
    Combination C Phase 1b: PD 0360324 100 mg + Avelumab
  3. description
    During Phase 1b participants received PD 0360324 150 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
    id
    OG002
    title
    Combination C Phase 1b: PD 0360324 150 mg + Avelumab
param Type
GEOMETRIC_MEAN
population Description
PK analysis set included all participants who had received at least one dose of study drug and who had at least one of the PK concentrations of interest for Avelumab, Utomilumab, PD 0360324, PF-04518600. Here, "Number of participants analyzed'' signifies number of participants evaluable for this outcome measure, where "Number Analyzed" signifies number of participants evaluable for specified time points.
reporting Status
POSTED
time Frame
Pre-dose on Days 1 and 15 of Cycle 1 (non-dosing); Day 1 of Cycles 2, 4, 6 and Cycle 10
title
Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab and PD 0360324 in Combination C
type
SECONDARY
unit Of Measure
Nanogram per milliliter

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

Preserved source evidence · Not medical advice