NCT06746116 · ClinicalTrials.gov record · last posted 2026-07-17
A Study to Evaluate the Use of Durvalumab in Combination With Platinum-based Chemotherapy Followed by Durvalumab With Olaparib as First-line Treatment in Advanced or Recurrent Endometrial Cancer in Spain
Study acronym: DUoENDE
StatusActive, Not Recruiting
PhasePhase 3
Started2024-12-30
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from the ClinicalTrials.gov record
This is a phase IIIb, interventional, single arm, multicentre study assessing the safety profile of durvalumab in combination with carboplatin-paclitaxel chemotherapy followed by durvalumab with olaparib as first-line treatment for patients with pMMR aEC as the primary endpoint.
The study will include approximately 85 patients distributed in approximately 20 sites in Spain.
The planned duration of patient recruitment is approximately 12 months. Each patient will be followed up from screening for 36 months, until end of study period, death, withdrawal from study or loss to follow-up; whichever occurs first.
Enrolment will be opened to all eligible patients treated with durvalumab in combination with carboplatin-paclitaxel chemotherapy followed by durvalumab with olaparib as first-line treatment for patients with pMMR aEC. In addition, adequate tumour tissue before study entry, stool and blood sample collected will be required for central analysis to monitor the status of relevant biomarkers.
Amendment record
10 amendments on the ClinicalTrials.gov record
This ClinicalTrials.gov record has been amended 10 times since 2024-12-17; most recent amendment 2026-07-16. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history.
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2025-07-18
Status change Recruiting→Active, Not Recruitingv6
2025-01-20
Status change Not Yet Recruiting→Recruitingv1
| NCT Number |
NCT06746116 |
| Lead Sponsor |
AstraZeneca
Collaborators: Apices Soluciones S.L. |
| Conditions |
Advanced or Recurrent Endometrial Cancer |
| Enrollment |
45 participants |
| Start Date |
2024-12-30 |
| Primary Completion |
2028-11-30 (estimated) |
| Study Completion |
2028-11-30 (estimated) |
| Updated on ClinicalTrials.gov |
2026-07-17 |