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NCT02684006 · OUTCOME

Trough Plasma Concentration (Ctrough) of Avelumab

A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101) · Source last updated 2025-07-30

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

Measure
GEOMETRIC_MEAN
Unit
Micrograms per milliliter
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Pre dose (0 hour) on Day 1, 15 and 29 of Cycle 1, Day 1 and 29 of Cycles 2, 3, 4 and Day 1 of Cycle 6

What was measured

Predose concentration during multiple dosing.

Analysis population: Avelumab PK concentration analysis set: all participants who had at least one post-dose concentration above lower limit of quantitation (LLQ) for avelumab. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. "Number Analyzed" signifies number of participants evaluable for the specified rows. This outcome measure was not planned to be analyzed in ''Sunitinib'' reporting group.

Groups in this outcome

Avelumab + Axitinib

Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.

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

Analysis denominator · Participants

GroupSource count
Avelumab + Axitinib389

Reported measurements

Cycle 1 (day 1)

Analysis denominator · Participants

GroupSource count
Avelumab + Axitinib389
Values in Micrograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib4.2181232Not reportedNot reportedNot reported
Cycle 1 (day 15)

Analysis denominator · Participants

GroupSource count
Avelumab + Axitinib267
Values in Micrograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib18.69102Not reportedNot reportedNot reported
Cycle 1 (day 29)

Analysis denominator · Participants

GroupSource count
Avelumab + Axitinib270
Values in Micrograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib21.9996Not reportedNot reportedNot reported
Cycle 2 (day 1)

Analysis denominator · Participants

GroupSource count
Avelumab + Axitinib314
Values in Micrograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib24.8792Not reportedNot reportedNot reported
Cycle 2 (day 29)

Analysis denominator · Participants

GroupSource count
Avelumab + Axitinib215
Values in Micrograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib22.62113Not reportedNot reportedNot reported
Cycle 3 (day 1)

Analysis denominator · Participants

GroupSource count
Avelumab + Axitinib202
Values in Micrograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib26.0498Not reportedNot reportedNot reported
Cycle 3 (day 29)

Analysis denominator · Participants

GroupSource count
Avelumab + Axitinib181
Values in Micrograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib30.1382Not reportedNot reportedNot reported
Cycle 4 (day 1)

Analysis denominator · Participants

GroupSource count
Avelumab + Axitinib186
Values in Micrograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib29.1598Not reportedNot reportedNot reported
Cycle 4 (day 29)

Analysis denominator · Participants

GroupSource count
Avelumab + Axitinib160
Values in Micrograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib31.3886Not reportedNot reportedNot reported
Cycle 6 (day 1)

Analysis denominator · Participants

GroupSource count
Avelumab + Axitinib130
Values in Micrograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib39.1158Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1232
        value
        4.218
    denoms
    1. counts
      1. group Id
        OG000
        value
        389
      units
      Participants
    title
    Cycle 1 (day 1)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        102
        value
        18.69
    denoms
    1. counts
      1. group Id
        OG000
        value
        267
      units
      Participants
    title
    Cycle 1 (day 15)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        96
        value
        21.99
    denoms
    1. counts
      1. group Id
        OG000
        value
        270
      units
      Participants
    title
    Cycle 1 (day 29)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        92
        value
        24.87
    denoms
    1. counts
      1. group Id
        OG000
        value
        314
      units
      Participants
    title
    Cycle 2 (day 1)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        113
        value
        22.62
    denoms
    1. counts
      1. group Id
        OG000
        value
        215
      units
      Participants
    title
    Cycle 2 (day 29)
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        98
        value
        26.04
    denoms
    1. counts
      1. group Id
        OG000
        value
        202
      units
      Participants
    title
    Cycle 3 (day 1)
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        82
        value
        30.13
    denoms
    1. counts
      1. group Id
        OG000
        value
        181
      units
      Participants
    title
    Cycle 3 (day 29)
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        98
        value
        29.15
    denoms
    1. counts
      1. group Id
        OG000
        value
        186
      units
      Participants
    title
    Cycle 4 (day 1)
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        86
        value
        31.38
    denoms
    1. counts
      1. group Id
        OG000
        value
        160
      units
      Participants
    title
    Cycle 4 (day 29)
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        58
        value
        39.11
    denoms
    1. counts
      1. group Id
        OG000
        value
        130
      units
      Participants
    title
    Cycle 6 (day 1)
denoms
  1. counts
    1. group Id
      OG000
      value
      389
    units
    Participants
description
Predose concentration during multiple dosing.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.
    id
    OG000
    title
    Avelumab + Axitinib
param Type
GEOMETRIC_MEAN
population Description
Avelumab PK concentration analysis set: all participants who had at least one post-dose concentration above lower limit of quantitation (LLQ) for avelumab. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. "Number Analyzed" signifies number of participants evaluable for the specified rows. This outcome measure was not planned to be analyzed in ''Sunitinib'' reporting group.
reporting Status
POSTED
time Frame
Pre dose (0 hour) on Day 1, 15 and 29 of Cycle 1, Day 1 and 29 of Cycles 2, 3, 4 and Day 1 of Cycle 6
title
Trough Plasma Concentration (Ctrough) of Avelumab
type
SECONDARY
unit Of Measure
Micrograms per milliliter

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice