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NCT02554812 · OUTCOME

Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab in Combination F

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 Day 1 and 15 of Cycle 1 (non-dosing); Pre-dose on Day 1 of Cycle 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 F Phase 1b SCCHN: CMP-001 10 mg + Avelumab

During Phase 1b participants with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 sub-cutaneous \[SC\] administered at weekly intervals, followed by 5 intra tumoral \[IT\] administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W. Phase 2 was not planned.

Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg

During Phase 1b participants with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 SC administered at weekly intervals, followed by 5 IT administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W all cohorts plus utomilumab 100 mg administered IV Q4W. Phase 2 was not planned.

Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg

During Phase 1b participants with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 SC administered at weekly intervals, followed by 5 IT administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W all cohorts plus PF-04518600 at 0.3 mg/kg administered IV Q2W. Phase 2 was not planned.

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 F Phase 1b SCCHN: CMP-001 10 mg + Avelumab6
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg7
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg6

Reported measurements

Cycle 1/Day1-0 Hour

Analysis denominator · Participants

GroupSource count
Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab6
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg7
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg6
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Combination F Phase 1b SCCHN: CMP-001 10 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 F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mgNANANot 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 F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg14.30NANot reportedNot reportedOnly 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
Cycle 1/Day15-0 Hour

Analysis denominator · Participants

GroupSource count
Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab5
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg5
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg6
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab16.3271Not reportedNot reportedNot reported
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg21.2618Not reportedNot reportedNot reported
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg18.5368Not reportedNot reportedNot reported
Cycle 2/Day1-0 Hour

Analysis denominator · Participants

GroupSource count
Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab5
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg5
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg5
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab10.97137Not reportedNot reportedNot reported
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg16.76122Not reportedNot reportedNot reported
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg18.17130Not reportedNot reportedNot reported
Cycle 4/Day1-0 Hour

Analysis denominator · Participants

GroupSource count
Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab2
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg3
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg1
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab40.9020Not reportedNot reportedNot reported
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg24.3669Not reportedNot reportedNot reported
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg24.00NANot reportedNot reportedOnly 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
Cycle 6/Day1-0 Hour

Analysis denominator · Participants

GroupSource count
Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab1
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg1
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg0
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab37.00NANot reportedNot reportedOnly 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg31.90NANot reportedNot reportedOnly 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
Cycle 10/Day1-0 Hour

Analysis denominator · Participants

GroupSource count
Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab1
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg1
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg0
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab30.40NANot reportedNot reportedOnly 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg30.50NANot 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
        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
        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
        14.30
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        6
      units
      Participants
    title
    Cycle 1/Day1-0 Hour
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        71
        value
        16.32
      2. group Id
        OG001
        spread
        18
        value
        21.26
      3. group Id
        OG002
        spread
        68
        value
        18.53
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        6
      units
      Participants
    title
    Cycle 1/Day15-0 Hour
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        137
        value
        10.97
      2. group Id
        OG001
        spread
        122
        value
        16.76
      3. group Id
        OG002
        spread
        130
        value
        18.17
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        5
      units
      Participants
    title
    Cycle 2/Day1-0 Hour
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        20
        value
        40.90
      2. group Id
        OG001
        spread
        69
        value
        24.36
      3. 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
        24.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        1
      units
      Participants
    title
    Cycle 4/Day1-0 Hour
  5. 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
        37.00
      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
        31.90
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    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
        OG000
        spread
        NA
        value
        30.40
      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
        30.50
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Cycle 10/Day1-0 Hour
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      7
    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 with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 sub-cutaneous \[SC\] administered at weekly intervals, followed by 5 intra tumoral \[IT\] administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W. Phase 2 was not planned.
    id
    OG000
    title
    Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab
  2. description
    During Phase 1b participants with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 SC administered at weekly intervals, followed by 5 IT administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W all cohorts plus utomilumab 100 mg administered IV Q4W. Phase 2 was not planned.
    id
    OG001
    title
    Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg
  3. description
    During Phase 1b participants with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 SC administered at weekly intervals, followed by 5 IT administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W all cohorts plus PF-04518600 at 0.3 mg/kg administered IV Q2W. Phase 2 was not planned.
    id
    OG002
    title
    Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg
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 Day 1 and 15 of Cycle 1 (non-dosing); Pre-dose on Day 1 of Cycle 2, 4, 6 and Cycle 10
title
Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab in Combination F
type
SECONDARY
unit Of Measure
Nanogram per milliliter

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

Preserved source evidence · Not medical advice