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NCT02554812 · OUTCOME

Maximum Observed Plasma Concentration (Cmax) 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
1 hour (i.e. at the end of infusion) post-dose on Day 1,15 of Cycle 1; Day 8 of Cycle 1 (non-dosing); Day 1 of Cycle 2, 4, 6 and Cycle 10

What was measured

Cmax is maximum observed plasma 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 + Avelumab7
Combination C Phase 1b: PD 0360324 150 mg + Avelumab6

Reported measurements

Avelumab Cycle 1/Day1-1 Hour/EOI

Analysis denominator · Participants

GroupSource count
Combination C Phase 1b: PD 0360324 50 mg + Avelumab9
Combination C Phase 1b: PD 0360324 100 mg + Avelumab7
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 + Avelumab217.013Not reportedNot reportedNot reported
Combination C Phase 1b: PD 0360324 100 mg + Avelumab209.934Not reportedNot reportedNot reported
Combination C Phase 1b: PD 0360324 150 mg + Avelumab247.918Not reportedNot reportedNot reported
Avelumab Cycle 1/Day8-168 Hour

Analysis denominator · Participants

GroupSource count
Combination C Phase 1b: PD 0360324 50 mg + Avelumab9
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 + Avelumab53.3931Not reportedNot reportedNot reported
Combination C Phase 1b: PD 0360324 100 mg + Avelumab63.1225Not reportedNot reportedNot reported
Combination C Phase 1b: PD 0360324 150 mg + Avelumab47.8928Not reportedNot reportedNot reported
Avelumab Cycle 1/Day15-1 Hour/EOI

Analysis denominator · Participants

GroupSource count
Combination C Phase 1b: PD 0360324 50 mg + Avelumab8
Combination C Phase 1b: PD 0360324 100 mg + Avelumab7
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 + Avelumab233.826Not reportedNot reportedNot reported
Combination C Phase 1b: PD 0360324 100 mg + Avelumab277.420Not reportedNot reportedNot reported
Combination C Phase 1b: PD 0360324 150 mg + Avelumab263.633Not reportedNot reportedNot reported
Avelumab Cycle 2/Day1-1 Hour/EOI

Analysis denominator · Participants

GroupSource count
Combination C Phase 1b: PD 0360324 50 mg + Avelumab6
Combination C Phase 1b: PD 0360324 100 mg + Avelumab5
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 + Avelumab253.715Not reportedNot reportedNot reported
Combination C Phase 1b: PD 0360324 100 mg + Avelumab295.230Not reportedNot reportedNot reported
Combination C Phase 1b: PD 0360324 150 mg + Avelumab254.020Not reportedNot reportedNot reported
Avelumab Cycle 4/Day1-1 Hour/EOI

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 + Avelumab2
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Combination C Phase 1b: PD 0360324 50 mg + Avelumab242.024Not reportedNot reportedNot reported
Combination C Phase 1b: PD 0360324 100 mg + Avelumab331.129Not reportedNot reportedNot reported
Combination C Phase 1b: PD 0360324 150 mg + Avelumab304.844Not reportedNot reportedNot reported
Avelumab Cycle 6/Day1-1 Hour/EOI

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 + Avelumab1
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Combination C Phase 1b: PD 0360324 50 mg + Avelumab248.217Not reportedNot reportedNot reported
Combination C Phase 1b: PD 0360324 100 mg + Avelumab292.417Not reportedNot reportedNot reported
Combination C Phase 1b: PD 0360324 150 mg + Avelumab270.0NANot reportedNot reportedGeometric Coefficient of Variation was not estimable as there was only 1 participant analyzed.
Avelumab Cycle 10/Day1-1 Hour/EOI

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 + Avelumab0
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Combination C Phase 1b: PD 0360324 100 mg + Avelumab318.0NANot reportedNot reportedGeometric Coefficient of Variation was not estimable as there was only 1 participant analyzed.
PD 0360324 Cycle 1/Day1-30 Minutes (Min)/EOI

Analysis denominator · Participants

GroupSource count
Combination C Phase 1b: PD 0360324 50 mg + Avelumab10
Combination C Phase 1b: PD 0360324 100 mg + Avelumab5
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 + Avelumab1757022Not reportedNot reportedNot reported
Combination C Phase 1b: PD 0360324 100 mg + Avelumab3442055Not reportedNot reportedNot reported
Combination C Phase 1b: PD 0360324 150 mg + Avelumab3820044Not reportedNot reportedNot reported
PD 0360324 Cycle 1/Day8-168 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 + Avelumab1324109Not reportedNot reportedNot reported
Combination C Phase 1b: PD 0360324 100 mg + Avelumab884643Not reportedNot reportedNot reported
Combination C Phase 1b: PD 0360324 150 mg + Avelumab659847Not reportedNot reportedNot reported
PD 0360324 Cycle 1/Day15-30 min/EOI

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 + Avelumab5
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Combination C Phase 1b: PD 0360324 50 mg + Avelumab1662027Not reportedNot reportedNot reported
Combination C Phase 1b: PD 0360324 100 mg + Avelumab3255029Not reportedNot reportedNot reported
Combination C Phase 1b: PD 0360324 150 mg + Avelumab4613051Not reportedNot reportedNot reported
PD 0360324 Cycle 2/Day1-30 min/EOI

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 + Avelumab1705020Not reportedNot reportedNot reported
Combination C Phase 1b: PD 0360324 100 mg + Avelumab116901072Not reportedNot reportedNot reported
Combination C Phase 1b: PD 0360324 150 mg + Avelumab5742016Not reportedNot reportedNot reported
PD 0360324 Cycle 4/Day1-30 min/EOI

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 + Avelumab177002Not reportedNot reportedNot reported
Combination C Phase 1b: PD 0360324 100 mg + Avelumab270608Not reportedNot reportedNot reported
Combination C Phase 1b: PD 0360324 150 mg + Avelumab4365051Not reportedNot reportedNot reported
PD 0360324 Cycle 6/Day1-30 min/EOI

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 + Avelumab1559012Not reportedNot reportedNot reported
Combination C Phase 1b: PD 0360324 100 mg + Avelumab351408Not reportedNot reportedNot reported
Combination C Phase 1b: PD 0360324 150 mg + Avelumab5862027Not reportedNot reportedNot reported
PD 0360324 Cycle 10/Day1-30 min/EOI

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 + Avelumab33100NANot reportedNot reportedGeometric Coefficient of Variation was not estimable as there was only 1 participant analyzed.
Combination C Phase 1b: PD 0360324 150 mg + Avelumab321611668Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        13
        value
        217.0
      2. group Id
        OG001
        spread
        34
        value
        209.9
      3. group Id
        OG002
        spread
        18
        value
        247.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        2
      units
      Participants
    title
    Avelumab Cycle 1/Day1-1 Hour/EOI
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        31
        value
        53.39
      2. group Id
        OG001
        spread
        25
        value
        63.12
      3. group Id
        OG002
        spread
        28
        value
        47.89
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        6
      units
      Participants
    title
    Avelumab Cycle 1/Day8-168 Hour
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        26
        value
        233.8
      2. group Id
        OG001
        spread
        20
        value
        277.4
      3. group Id
        OG002
        spread
        33
        value
        263.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        3
      units
      Participants
    title
    Avelumab Cycle 1/Day15-1 Hour/EOI
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        15
        value
        253.7
      2. group Id
        OG001
        spread
        30
        value
        295.2
      3. group Id
        OG002
        spread
        20
        value
        254.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        3
      units
      Participants
    title
    Avelumab Cycle 2/Day1-1 Hour/EOI
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        24
        value
        242.0
      2. group Id
        OG001
        spread
        29
        value
        331.1
      3. group Id
        OG002
        spread
        44
        value
        304.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        2
      units
      Participants
    title
    Avelumab Cycle 4/Day1-1 Hour/EOI
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        17
        value
        248.2
      2. group Id
        OG001
        spread
        17
        value
        292.4
      3. comment
        Geometric Coefficient of Variation was not estimable as there was only 1 participant analyzed.
        group Id
        OG002
        spread
        NA
        value
        270.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        1
      units
      Participants
    title
    Avelumab Cycle 6/Day1-1 Hour/EOI
  7. categories
    1. measurements
      1. comment
        Geometric Coefficient of Variation was not estimable as there was only 1 participant analyzed.
        group Id
        OG001
        spread
        NA
        value
        318.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Avelumab Cycle 10/Day1-1 Hour/EOI
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        22
        value
        17570
      2. group Id
        OG001
        spread
        55
        value
        34420
      3. group Id
        OG002
        spread
        44
        value
        38200
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        5
      units
      Participants
    title
    PD 0360324 Cycle 1/Day1-30 Minutes (Min)/EOI
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        109
        value
        1324
      2. group Id
        OG001
        spread
        43
        value
        8846
      3. group Id
        OG002
        spread
        47
        value
        6598
    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/Day8-168 Hour
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        27
        value
        16620
      2. group Id
        OG001
        spread
        29
        value
        32550
      3. group Id
        OG002
        spread
        51
        value
        46130
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        5
      units
      Participants
    title
    PD 0360324 Cycle 1/Day15-30 min/EOI
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        20
        value
        17050
      2. group Id
        OG001
        spread
        1072
        value
        11690
      3. group Id
        OG002
        spread
        16
        value
        57420
    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/Day1-30 min/EOI
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        2
        value
        17700
      2. group Id
        OG001
        spread
        8
        value
        27060
      3. group Id
        OG002
        spread
        51
        value
        43650
    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/Day1-30 min/EOI
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      7
    3. group Id
      OG002
      value
      6
    units
    Participants
description
Cmax is maximum observed plasma 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
1 hour (i.e. at the end of infusion) post-dose on Day 1,15 of Cycle 1; Day 8 of Cycle 1 (non-dosing); Day 1 of Cycle 2, 4, 6 and Cycle 10
title
Maximum Observed Plasma Concentration (Cmax) 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