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NCT04269200 · OUTCOME

Serum Concentration of Durvalumab

Durvalumab With or Without Olaparib as Maintenance Therapy After First-Line Treatment of Advanced and Recurrent Endometrial Cancer · Source last updated 2026-08-07

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

Measure
GEOMETRIC_MEAN
Unit
μg/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
PK sampling performed on Day 85 pre-dose, Day 183 pre-dose, and 3 months after study treatment discontinuation (up to 36 months)

What was measured

To characterise the pharmacokinetics (PK) of durvalumab and durvalumab in combination with olaparib

Analysis population: The Overall Number of Participants Analyzed reflects the total number of patients included in the PK Analysis Set, which comprises those treated with durvalumab per protocol and with valid PK data. However, PK concentrations were excluded at the sample level if they do not meet protocol-defined criteria. While some patients may not have any valid samples due to these exclusions, they remain part of the analysis population set by definition.

Groups in this outcome

Global Cohort - SoC + Durvalumab

Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, participants without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.

Global Cohort - SoC + Durvalumab + Olaparib

Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.

China Cohort - SoC + Durvalumab

Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.

China Cohort - SoC + Durvalumab + Olaparib

Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.

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

Analysis denominator · Participants

GroupSource count
Global Cohort - SoC + Durvalumab204
Global Cohort - SoC + Durvalumab + Olaparib213
China Cohort - SoC + Durvalumab36
China Cohort - SoC + Durvalumab + Olaparib35

Reported measurements

Day 85, pre-dose (Trough concentration)

Analysis denominator · Participants

GroupSource count
Global Cohort - SoC + Durvalumab76
Global Cohort - SoC + Durvalumab + Olaparib90
China Cohort - SoC + Durvalumab7
China Cohort - SoC + Durvalumab + Olaparib2
Values in μg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Global Cohort - SoC + Durvalumab203.13353832.6Not reportedNot reportedNot reported
Global Cohort - SoC + Durvalumab + Olaparib196.21827631.7Not reportedNot reportedNot reported
China Cohort - SoC + Durvalumab183.41444232.7Not reportedNot reportedNot reported
China Cohort - SoC + Durvalumab + OlaparibNANANot reportedNot reportedAs pre-specified in the Statistical Analysis Plan, three observations above the lower limit of quantification (LLOQ) are required as a minimum for a serum concentration to be summarised. Two observations above the LLOQ are presented as minimum and maximum with the other summary statistics as not calculated.
Day 183, pre-dose (Trough concentration)

Analysis denominator · Participants

GroupSource count
Global Cohort - SoC + Durvalumab26
Global Cohort - SoC + Durvalumab + Olaparib35
China Cohort - SoC + Durvalumab0
China Cohort - SoC + Durvalumab + Olaparib1
Values in μg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Global Cohort - SoC + Durvalumab265.57584039.6Not reportedNot reportedNot reported
Global Cohort - SoC + Durvalumab + Olaparib236.31536538.0Not reportedNot reportedNot reported
China Cohort - SoC + Durvalumab + OlaparibNANANot reportedNot reportedAs pre-specified in the Statistical Analysis Plan, three observations above the lower limit of quantification (LLOQ) are required as a minimum for a serum concentration to be summarised. Two observations above the LLOQ are presented as minimum and maximum with the other summary statistics as not calculated.
Follow-up 3-months (Last valid dose + 3 months)

Analysis denominator · Participants

GroupSource count
Global Cohort - SoC + Durvalumab21
Global Cohort - SoC + Durvalumab + Olaparib20
China Cohort - SoC + Durvalumab5
China Cohort - SoC + Durvalumab + Olaparib8
Values in μg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Global Cohort - SoC + Durvalumab27.977227104.4Not reportedNot reportedNot reported
Global Cohort - SoC + Durvalumab + Olaparib14.031316206.8Not reportedNot reportedNot reported
China Cohort - SoC + Durvalumab33.31092143.0Not reportedNot reportedNot reported
China Cohort - SoC + Durvalumab + Olaparib11.2521551429.7Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        32.6
        value
        203.133538
      2. group Id
        OG001
        spread
        31.7
        value
        196.218276
      3. group Id
        OG002
        spread
        32.7
        value
        183.414442
      4. comment
        As pre-specified in the Statistical Analysis Plan, three observations above the lower limit of quantification (LLOQ) are required as a minimum for a serum concentration to be summarised. Two observations above the LLOQ are presented as minimum and maximum with the other summary statistics as not calculated.
        group Id
        OG003
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        76
      2. group Id
        OG001
        value
        90
      3. group Id
        OG002
        value
        7
      4. group Id
        OG003
        value
        2
      units
      Participants
    title
    Day 85, pre-dose (Trough concentration)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        39.6
        value
        265.575840
      2. group Id
        OG001
        spread
        38.0
        value
        236.315365
      3. comment
        As pre-specified in the Statistical Analysis Plan, three observations above the lower limit of quantification (LLOQ) are required as a minimum for a serum concentration to be summarised. Two observations above the LLOQ are presented as minimum and maximum with the other summary statistics as not calculated.
        group Id
        OG003
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      2. group Id
        OG001
        value
        35
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
      units
      Participants
    title
    Day 183, pre-dose (Trough concentration)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        104.4
        value
        27.977227
      2. group Id
        OG001
        spread
        206.8
        value
        14.031316
      3. group Id
        OG002
        spread
        43.0
        value
        33.310921
      4. group Id
        OG003
        spread
        1429.7
        value
        11.252155
    denoms
    1. counts
      1. group Id
        OG000
        value
        21
      2. group Id
        OG001
        value
        20
      3. group Id
        OG002
        value
        5
      4. group Id
        OG003
        value
        8
      units
      Participants
    title
    Follow-up 3-months (Last valid dose + 3 months)
denoms
  1. counts
    1. group Id
      OG000
      value
      204
    2. group Id
      OG001
      value
      213
    3. group Id
      OG002
      value
      36
    4. group Id
      OG003
      value
      35
    units
    Participants
description
To characterise the pharmacokinetics (PK) of durvalumab and durvalumab in combination with olaparib
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, participants without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.
    id
    OG000
    title
    Global Cohort - SoC + Durvalumab
  2. description
    Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.
    id
    OG001
    title
    Global Cohort - SoC + Durvalumab + Olaparib
  3. description
    Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.
    id
    OG002
    title
    China Cohort - SoC + Durvalumab
  4. description
    Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.
    id
    OG003
    title
    China Cohort - SoC + Durvalumab + Olaparib
param Type
GEOMETRIC_MEAN
population Description
The Overall Number of Participants Analyzed reflects the total number of patients included in the PK Analysis Set, which comprises those treated with durvalumab per protocol and with valid PK data. However, PK concentrations were excluded at the sample level if they do not meet protocol-defined criteria. While some patients may not have any valid samples due to these exclusions, they remain part of the analysis population set by definition.
reporting Status
POSTED
time Frame
PK sampling performed on Day 85 pre-dose, Day 183 pre-dose, and 3 months after study treatment discontinuation (up to 36 months)
title
Serum Concentration of Durvalumab
type
SECONDARY
unit Of Measure
μg/mL

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

Preserved source evidence · Not medical advice