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NCT04269200 · OUTCOME

Anti-drug Antibodies (ADA) to 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
NUMBER
Unit
Number of participants
Interval / dispersion
Not reported
Time frame
Immunogenicity sampling performed on Day 1 pre-dose, Day 85 pre-dose, Day 183 pre-dose, and 3 and 6 months after study treatment discontinuation (up to 39 months)

What was measured

To characterise the immunogenicity of durvalumab and durvalumab in combination with olaparib

Analysis population: ADA Analysis Set. This includes all patients who receive at least 1 dose of durvalumab and have non-missing baseline ADA and at least 1 post-baseline ADA result.

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 + Durvalumab198
Global Cohort - SoC + Durvalumab + Olaparib207
China Cohort - SoC + Durvalumab35
China Cohort - SoC + Durvalumab + Olaparib33

Reported measurements

ADA-positive at any visit (ADA prevalence)
Values in Number of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Global Cohort - SoC + Durvalumab8Not reportedNot reportedNot reportedNot reported
Global Cohort - SoC + Durvalumab + Olaparib9Not reportedNot reportedNot reportedNot reported
China Cohort - SoC + Durvalumab0Not reportedNot reportedNot reportedNot reported
China Cohort - SoC + Durvalumab + Olaparib1Not reportedNot reportedNot reportedNot reported
Treatment-emergent ADA-positive (ADA incidence)
Values in Number of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Global Cohort - SoC + Durvalumab2Not reportedNot reportedNot reportedNot reported
Global Cohort - SoC + Durvalumab + Olaparib0Not reportedNot reportedNot reportedNot reported
China Cohort - SoC + Durvalumab0Not reportedNot reportedNot reportedNot reported
China Cohort - SoC + Durvalumab + Olaparib0Not reportedNot reportedNot reportedNot reported
Treatment-boosted ADA
Values in Number of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Global Cohort - SoC + Durvalumab0Not reportedNot reportedNot reportedNot reported
Global Cohort - SoC + Durvalumab + Olaparib0Not reportedNot reportedNot reportedNot reported
China Cohort - SoC + Durvalumab0Not reportedNot reportedNot reportedNot reported
China Cohort - SoC + Durvalumab + Olaparib0Not reportedNot reportedNot reportedNot reported
Treatment-induced ADA (positive post-baseline only)
Values in Number of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Global Cohort - SoC + Durvalumab2Not reportedNot reportedNot reportedNot reported
Global Cohort - SoC + Durvalumab + Olaparib0Not reportedNot reportedNot reportedNot reported
China Cohort - SoC + Durvalumab0Not reportedNot reportedNot reportedNot reported
China Cohort - SoC + Durvalumab + Olaparib0Not reportedNot reportedNot reportedNot reported
ADA positive at baseline only
Values in Number of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Global Cohort - SoC + Durvalumab6Not reportedNot reportedNot reportedNot reported
Global Cohort - SoC + Durvalumab + Olaparib9Not reportedNot reportedNot reportedNot reported
China Cohort - SoC + Durvalumab0Not reportedNot reportedNot reportedNot reported
China Cohort - SoC + Durvalumab + Olaparib1Not reportedNot reportedNot reportedNot reported
ADA positive post-baseline and positive at baseline
Values in Number of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Global Cohort - SoC + Durvalumab0Not reportedNot reportedNot reportedNot reported
Global Cohort - SoC + Durvalumab + Olaparib0Not reportedNot reportedNot reportedNot reported
China Cohort - SoC + Durvalumab0Not reportedNot reportedNot reportedNot reported
China Cohort - SoC + Durvalumab + Olaparib0Not reportedNot reportedNot reportedNot reported
Persistently positive
Values in Number of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Global Cohort - SoC + Durvalumab2Not reportedNot reportedNot reportedNot reported
Global Cohort - SoC + Durvalumab + Olaparib0Not reportedNot reportedNot reportedNot reported
China Cohort - SoC + Durvalumab0Not reportedNot reportedNot reportedNot reported
China Cohort - SoC + Durvalumab + Olaparib0Not reportedNot reportedNot reportedNot reported
Transiently positive
Values in Number of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Global Cohort - SoC + Durvalumab0Not reportedNot reportedNot reportedNot reported
Global Cohort - SoC + Durvalumab + Olaparib0Not reportedNot reportedNot reportedNot reported
China Cohort - SoC + Durvalumab0Not reportedNot reportedNot reportedNot reported
China Cohort - SoC + Durvalumab + Olaparib0Not reportedNot reportedNot reportedNot reported
Neutralising antibody positive at any visit
Values in Number of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Global Cohort - SoC + Durvalumab1Not reportedNot reportedNot reportedNot reported
Global Cohort - SoC + Durvalumab + Olaparib0Not reportedNot reportedNot reportedNot reported
China Cohort - SoC + Durvalumab0Not reportedNot reportedNot reportedNot reported
China Cohort - SoC + Durvalumab + Olaparib0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        9
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
    title
    ADA-positive at any visit (ADA prevalence)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    title
    Treatment-emergent ADA-positive (ADA incidence)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    title
    Treatment-boosted ADA
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    title
    Treatment-induced ADA (positive post-baseline only)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        9
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
    title
    ADA positive at baseline only
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    title
    ADA positive post-baseline and positive at baseline
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    title
    Persistently positive
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    title
    Transiently positive
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    title
    Neutralising antibody positive at any visit
denoms
  1. counts
    1. group Id
      OG000
      value
      198
    2. group Id
      OG001
      value
      207
    3. group Id
      OG002
      value
      35
    4. group Id
      OG003
      value
      33
    units
    Participants
description
To characterise the immunogenicity of durvalumab and durvalumab in combination with olaparib
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
NUMBER
population Description
ADA Analysis Set. This includes all patients who receive at least 1 dose of durvalumab and have non-missing baseline ADA and at least 1 post-baseline ADA result.
reporting Status
POSTED
time Frame
Immunogenicity sampling performed on Day 1 pre-dose, Day 85 pre-dose, Day 183 pre-dose, and 3 and 6 months after study treatment discontinuation (up to 39 months)
title
Anti-drug Antibodies (ADA) to Durvalumab
type
SECONDARY
unit Of Measure
Number of participants

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Preserved source evidence · Not medical advice