NIS to Examine the Effectiveness and Safety of Durvalumab and Olaparib in Patients With Endometrial Cancer (DUOLife)
NCT ID: NCT06890273
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
150 participants
OBSERVATIONAL
2025-05-20
2028-09-30
Brief Summary
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Detailed Description
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The aim of the NIS is to describe the outcomes including effectiveness, safety and PRO of patients with primary advanced and recurrent EC treated with the two approved 1L regimens of CPD followed by durvalumab maintenance and CPD followed by durvalumab and olaparib maintenance in Germany. The study also aims to better understand characteristics of patients with primary advanced or recurrent EC that benefit from maintenance therapy with durvalumab or durvalumab and olaparib.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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DNA mismatch repair deficient (dMMR)
Patients with primary advanced or recurrent endometrial cancer receiving 1L regimens of CPD with prior tested dMMR status. Following the SmPC patients of this cohort will receive durvalumab in the maintenance phase if they achieved and maintained disease control, i.e., complete response (CR), partial response (PR), or stable disease (SD) with CPD during the chemotherapy phase.
No interventions assigned to this group
DNA mismatch repair proficient (pMMR)
Patients with primary advanced or recurrent endometrial cancer receiving 1L regimens of CPD with prior tested pMMR status. Following the SmPC patients of this cohort will receive durvalumab and olaparib in the maintenance phase if they achieved and maintained disease control i.e., CR, PR, or SD with CPD during the chemotherapy phase.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Patient has pathologically documented:
* Primary advanced (FIGO III and IV) epithelial EC OR
* Recurrent disease that is unlikely to be cured and where the multidisciplinary tumor board decision is systemic therapy. Carcinosarcomas are allowed,
* Patient is intended or initiated to receive 1L CPD followed by maintenance therapy with durvalumab (dMMR cohort) or with durvalumab and olaparib (pMMR cohort) according to the SmPC of IMFINZI® and Lynparza®\* prior to enrollment. Recruitment of patients that already started and may have received up to 2 cycles of CPD is allowed but will be capped to 25% of the study population.
* Patient is eligible for treatment with durvalumab and/or olaparib as specified in the IMFINZI® and Lynparza® SmPC. The prescription of the medicinal product is clearly separated from the decision to include the patient in the study.
* MMR-testing results of the patient's tumor are known.
* Patient is willing and able to complete PRO questionnaires.
* Patient can read and understand German, English, Arab, Russian or Turkish.
* Signed written informed consent.
Exclusion Criteria
* Known hypersensitivity to carboplatin, paclitaxel, durvalumab and/or olaparib or any of the excipients of the drug.
* Pregnancy or breast-feeding.
* Unable to swallow orally administered medication.
* Current or planned participation in an interventional clinical trial.
* Current or planned systemic treatment of any tumor other than primary advanced or recurrent EC.
* Patient has pathologically documented sarcoma
18 Years
130 Years
FEMALE
No
Sponsors
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North-Eastern German Society of Gynecological Oncology (NOGGO e.V.)
UNKNOWN
AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Berlin, , Germany
Research Site
Bielefeld, , Germany
Research Site
Borna, , Germany
Research Site
Bottrop, , Germany
Research Site
Brandenburg, , Germany
Research Site
Dessau, , Germany
Research Site
Ebersberg, , Germany
Research Site
Gütersloh, , Germany
Research Site
Landshut, , Germany
Research Site
Leipzig, , Germany
Research Site
Lüneburg, , Germany
Research Site
Mainz, , Germany
Research Site
Plauen, , Germany
Research Site
Unna, , Germany
Research Site
Worms, , Germany
Countries
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Central Contacts
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Other Identifiers
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D9311R00001
Identifier Type: -
Identifier Source: org_study_id