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
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
| Group | Affected | At risk |
|---|---|---|
| Global Cohort - SoC | 73 | 236 |
| Global Cohort - SoC + Durvalumab | 73 | 235 |
| Global Cohort - SoC + Durvalumab + Olaparib | 85 | 238 |
| China Cohort - SoC | 14 | 44 |
| China Cohort - SoC + Durvalumab | 8 | 41 |
| China Cohort - SoC + Durvalumab + Olaparib | 19 | 41 |
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 PubMedPlain 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
PubMed 41943281 (opens in a new tab)DOI 10.1080/14796694.2026.2638677 (opens in a new tab)
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
PubMed 40590327 (opens in a new tab)DOI 10.3802/jgo.2025.36.e118 (opens in a new tab)
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
PubMed 38431043 (opens in a new tab)DOI 10.1016/j.annonc.2024.02.006 (opens in a new tab)
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
PubMed 37864337 (opens in a new tab)DOI 10.1200/JCO.23.02132 (opens in a new tab)
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-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT04269200 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
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.