Durvalumab With or Without Olaparib as Maintenance Therapy After First-Line Treatment of Advanced and Recurrent Endometrial Cancer

NCT04269200 · DUO-E Phase 3Active, not recruiting

Lead sponsor
AstraZeneca (Industry)
Enrollment
805 (actual)
Start date
5 May 2020
Primary completion
8 Jul 2024 (actual)
Study completion
1 Apr 2027
Last update posted
7 Aug 2026

Design

Study type
Interventional
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel
Masking
Quadruple
Arms
3

Interventions

  • olaparib Drug
  • durvalumab Biological
  • durvalumab placebo Drug
  • olaparib placebo Drug
  • Carboplatin Drug
  • Paclitaxel Drug

Conditions and primary outcome

  • Endometrial Neoplasms

Primary outcome

Progression-free Survival (PFS) According to RECIST 1.1, Based on Investigator Assessments (At baseline, every 9 weeks (wks) up to 18 wks, then every 12 wks until objective radiological disease progression. Assessed until 12 Apr 2023 DCO (08 Jul 2024 DCO for China cohort), up to 50 months)

Posted results on ClinicalTrials.gov

Source: ClinicalTrials.gov results for NCT04269200 (opens in a new tab)· Licence: public-domain

First posted · Last update posted · Imported from ClinicalTrials.gov download 2026-10-25

Primary outcomes with a statistical analysis

  1. Progression-free Survival (PFS) According to RECIST 1.1, Based on Investigator Assessments

    Time frame
    At baseline, every 9 weeks (wks) up to 18 wks, then every 12 wks until objective radiological disease progression. Assessed until 12 Apr 2023 DCO (08 Jul 2024 DCO for China cohort), up to 50 months
    Measure
    Median
    Unit
    Months
    • Global Cohort - SoC vs Global Cohort - SoC + DurvalumabSuperiority

      Estimate
      0.71Hazard Ratio (HR)
      95% CI, two-sided
      0.57 to 0.89
      p-value
      0.003
      Method
      Regression, Cox
    • Global Cohort - SoC vs Global Cohort - SoC + Durvalumab + OlaparibSuperiority

      Estimate
      0.55Hazard Ratio (HR)
      95% CI, two-sided
      0.43 to 0.69
      p-value
      <0.0001
      Method
      Regression, Cox
    • China Cohort - SoC vs China Cohort - SoC + DurvalumabSuperiority

      Estimate
      0.73Hazard Ratio (HR)
      95% CI, two-sided
      0.42 to 1.25
      p-value
      Not given
      Method
      Regression, Cox
    • China Cohort - SoC vs China Cohort - SoC + Durvalumab + OlaparibSuperiority

      Estimate
      0.96Hazard Ratio (HR)
      95% CI, two-sided
      0.57 to 1.61
      p-value
      Not given
      Method
      Regression, Cox

Serious adverse events

Time frame: Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months

Participants with serious adverse events per group for DUO-E, as posted
GroupAffectedAt risk
Global Cohort - SoC73236
Global Cohort - SoC + Durvalumab73235
Global Cohort - SoC + Durvalumab + Olaparib85238
China Cohort - SoC1444
China Cohort - SoC + Durvalumab841
China Cohort - SoC + Durvalumab + Olaparib1941

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Results from company and journal sources

No editor-confirmed results are on record for this study.

Publications

4 on PubMed
  1. Plain language summary of results from the DUO-E study: durvalumab given with or without olaparib in patients with advanced endometrial cancer.

    Future oncology (London, England) · 2026 Apr

  2. Durvalumab plus carboplatin/paclitaxel followed by durvalumab with or without olaparib as first-line treatment for newly diagnosed advanced or recurrent endometrial cancer: Japan subset from the phase III DUO-E trial.

    Journal of gynecologic oncology · 2025 Jul

  3. Adding immunotherapy to first-line treatment of advanced and metastatic endometrial cancer.

    Annals of oncology : official journal of the European Society for Medical Oncology · 2024 May

  4. Durvalumab Plus Carboplatin/Paclitaxel Followed by Maintenance Durvalumab With or Without Olaparib as First-Line Treatment for Advanced Endometrial Cancer: The Phase III DUO-E Trial.

    Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024 Jan 20

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

CT-VCA trial quality

About CT-VCA

Loading CT-VCA scores…

Data integrity

Compare what the registry, company releases, FDA documents and publications say about this study.

Drugs on HealthTrade

Source

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Nothing on this page is medical or investment advice.