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NCT04269200Active, not recruitingPhase 3

A study to assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent cancer in the lining of the uterus or womb.

A Randomised, Multicentre, Double-blind, Placebo-controlled, Phase III Study of First-line Carboplatin and Paclitaxel in Combination with Durvalumab, Followed by Maintenance Durvalumab with or without Olaparib in Patients with Newly Diagnosed Advanced or Recurrent Endometrial Cancer (DUO-E)

Source: EU CTIS (euclinicaltrials.eu) · Last updated 20 Jul 2026

Brief summary (registry, in English)

To demonstrate the efficacy of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab (Arm B) or durvalumab with olaparib (Arm C) when compared to platinum-based chemotherapy alone (Arm A) by assessment of progression free survival (PFS), in patients with newly diagnosed advanced or recurrent endometrial cancer

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
116 (estimated)
First submitted
25 Jul 2024
Start date
21 Aug 2020
Lead sponsor
AstraZeneca AB
NCT number
NCT04269200
EU CT number
2022-502746-27-00
EudraCT number
2019-004112-60

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 116
  • 23 sites in 8 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior treatment with PARP inhibitors.
  • Prior immune-mediated therapy including other anti-CTLA-4, anti-PD-1, anti-PD-L1 or anti-PD-L2 antibodies, excluding therapeutic anticancer vaccines"

Other illness

  • History of leptomeningeal carcinomatosis

Other

  • Brain metastases or spinal cord compression.

Who the study is looking for

  • Age ≥18 years at the time of screening and female.
  • Histologically confirmed diagnosis of epithelial endometrial carcinoma. All histologies, including carcinosarcomas, will be allowed. Sarcomas will not be allowed.
  • Patient must have endometrial cancer in one of the following categories: a) Newly diagnosed Stage III disease (measurable disease per RECIST 1.1 following surgery or diagnostic biopsy), b) Newly diagnosed Stage IV disease (with or without disease following surgery or diagnostic biopsy) c) Recurrence of disease (measurable or non-measurable disease per RECIST 1.1) where the potential for cure by surgery alone or in combination is poor.
  • Naïve to first line systemic anti-cancer treatment. For patients with recurrent disease only, prior systemic anti-cancer treatment is allowed only if it was administered in the adjuvant setting (as part of the upfront/adjuvant anti-cancer treatment, which may be concurrent or followed with chemoradiation) and there is at least 12 months from date of last dose of chemotherapy administered to date of subsequent relapse.
  • FPPE tumor sample must be available for MMR evaluation.
  • Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days of starting study treatment.

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (23)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
JESSA Ziekenhuis
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HasseltBelgiumActive, not recruiting
Algemeen Ziekenhuis Groeninge
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KortrijkBelgiumActive, not recruiting
UZ Leuven
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LeuvenBelgiumActive, not recruiting
Hopital De Libramont
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Libramont-ChevignyBelgiumActive, not recruiting
CHC MontLégia
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LiègeBelgiumActive, not recruiting
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumActive, not recruiting
Klinikum Chemnitz gGmbH
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ChemnitzGermanyActive, not recruiting
Tartu University Hospital
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Tartu LinnEstoniaActive, not recruiting
Institut Català d'Oncologia
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GironaSpainActive, not recruiting
Hospital Universitario de Jaén
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JaénSpainActive, not recruiting
University Clinical Hospital Virgen De La Arrixaca
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MurciaSpainActive, not recruiting
Parc Tauli Hospital Universitari
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SabadellSpainActive, not recruiting
Areteio Hospital
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AthensGreeceActive, not recruiting
Alexandra Hospital
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AthensGreeceActive, not recruiting
Orszagos Onkologiai Intezet
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Budapest XIIHungaryActive, not recruiting
Budapesti Uzsoki Utcai Korhaz
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Budapest XIVHungaryActive, not recruiting
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
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GyőrHungaryActive, not recruiting
Vilniaus universiteto ligonine Santaros klinikos VšĮ
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VilniusLithuaniaActive, not recruiting
Uniwersyteckie Centrum Kliniczne
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GdanskPolandActive, not recruiting
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
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LodzPolandActive, not recruiting
Umed Clinical Trials Sp. z o.o.
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LodzPolandActive, not recruiting
Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie
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LublinPolandActive, not recruiting
Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji z Warmińsko - Mazurskim Centrum Onkologii w Olsztynie
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OlsztynPolandActive, not recruiting

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.