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NCT02516241 · OUTCOME

Serum Concentrations of Durvalumab, Pharmacokinetic Analysis Set

Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer · Source last updated 2026-07-14

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

Measure
MEAN
Unit
μg/mL
Interval / dispersion
Standard Deviation
Time frame
Pre-dose and within 1 hour after end of infusion at Week 0, 12 and 24, pre-dose at week 4, and at follow-up Month 3.

What was measured

Blood samples were collected to determine the serum concentration of durvalumab.

Analysis population: Pharmacokinetic analysis set included all patients who received at least 1 dose of durvalumab or tremelimumab per the protocol and had at least one post dose evaluable PK data of durvalumab or tremelimumab

Groups in this outcome

Combination Therapy

MEDI4736 (Durvalumab) + Tremelimumab

Monotherapy

MEDI4736 (Durvalumab)

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 Therapy339
Monotherapy343

Reported measurements

Week 0 - Predose

Analysis denominator · Participants

GroupSource count
Combination Therapy329
Monotherapy339
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Combination TherapyNANANot reportedNot reportedweek 0 pre-dose serum concentrations are below the level of detection
MonotherapyNANANot reportedNot reportedweek 0 pre-dose serum concentrations are below the level of detection
Week 0 - Postdose

Analysis denominator · Participants

GroupSource count
Combination Therapy328
Monotherapy334
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Combination Therapy511338Not reportedNot reportedNot reported
Monotherapy484162Not reportedNot reportedNot reported
Week 4 - Predose

Analysis denominator · Participants

GroupSource count
Combination Therapy285
Monotherapy300
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Combination Therapy75.384.4Not reportedNot reportedNot reported
Monotherapy78.956.5Not reportedNot reportedNot reported
Week 12 - Predose

Analysis denominator · Participants

GroupSource count
Combination Therapy198
Monotherapy195
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Combination Therapy12597.7Not reportedNot reportedNot reported
Monotherapy14482.5Not reportedNot reportedNot reported
Week 12 - Postdose

Analysis denominator · Participants

GroupSource count
Combination Therapy184
Monotherapy186
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Combination Therapy594298Not reportedNot reportedNot reported
Monotherapy576233Not reportedNot reportedNot reported
Week 24 - Predose

Analysis denominator · Participants

GroupSource count
Combination Therapy127
Monotherapy119
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Combination Therapy15094.4Not reportedNot reportedNot reported
Monotherapy16382.5Not reportedNot reportedNot reported
Week 24 - Postdose

Analysis denominator · Participants

GroupSource count
Combination Therapy126
Monotherapy116
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Combination Therapy604249Not reportedNot reportedNot reported
Monotherapy600244Not reportedNot reportedNot reported
Follow-up Month 3

Analysis denominator · Participants

GroupSource count
Combination Therapy77
Monotherapy66
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Combination Therapy23.350Not reportedNot reportedNot reported
Monotherapy19.918.4Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        week 0 pre-dose serum concentrations are below the level of detection
        group Id
        OG000
        spread
        NA
        value
        NA
      2. comment
        week 0 pre-dose serum concentrations are below the level of detection
        group Id
        OG001
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        329
      2. group Id
        OG001
        value
        339
      units
      Participants
    title
    Week 0 - Predose
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        338
        value
        511
      2. group Id
        OG001
        spread
        162
        value
        484
    denoms
    1. counts
      1. group Id
        OG000
        value
        328
      2. group Id
        OG001
        value
        334
      units
      Participants
    title
    Week 0 - Postdose
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        84.4
        value
        75.3
      2. group Id
        OG001
        spread
        56.5
        value
        78.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        285
      2. group Id
        OG001
        value
        300
      units
      Participants
    title
    Week 4 - Predose
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        97.7
        value
        125
      2. group Id
        OG001
        spread
        82.5
        value
        144
    denoms
    1. counts
      1. group Id
        OG000
        value
        198
      2. group Id
        OG001
        value
        195
      units
      Participants
    title
    Week 12 - Predose
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        298
        value
        594
      2. group Id
        OG001
        spread
        233
        value
        576
    denoms
    1. counts
      1. group Id
        OG000
        value
        184
      2. group Id
        OG001
        value
        186
      units
      Participants
    title
    Week 12 - Postdose
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        94.4
        value
        150
      2. group Id
        OG001
        spread
        82.5
        value
        163
    denoms
    1. counts
      1. group Id
        OG000
        value
        127
      2. group Id
        OG001
        value
        119
      units
      Participants
    title
    Week 24 - Predose
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        249
        value
        604
      2. group Id
        OG001
        spread
        244
        value
        600
    denoms
    1. counts
      1. group Id
        OG000
        value
        126
      2. group Id
        OG001
        value
        116
      units
      Participants
    title
    Week 24 - Postdose
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        50
        value
        23.3
      2. group Id
        OG001
        spread
        18.4
        value
        19.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        77
      2. group Id
        OG001
        value
        66
      units
      Participants
    title
    Follow-up Month 3
denoms
  1. counts
    1. group Id
      OG000
      value
      339
    2. group Id
      OG001
      value
      343
    units
    Participants
description
Blood samples were collected to determine the serum concentration of durvalumab.
dispersion Type
Standard Deviation
groups
  1. description
    MEDI4736 (Durvalumab) + Tremelimumab
    id
    OG000
    title
    Combination Therapy
  2. description
    MEDI4736 (Durvalumab)
    id
    OG001
    title
    Monotherapy
param Type
MEAN
population Description
Pharmacokinetic analysis set included all patients who received at least 1 dose of durvalumab or tremelimumab per the protocol and had at least one post dose evaluable PK data of durvalumab or tremelimumab
reporting Status
POSTED
time Frame
Pre-dose and within 1 hour after end of infusion at Week 0, 12 and 24, pre-dose at week 4, and at follow-up Month 3.
title
Serum Concentrations of Durvalumab, Pharmacokinetic Analysis Set
type
SECONDARY
unit Of Measure
μg/mL

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Preserved source evidence · Not medical advice