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NIS to Examine the Effectiveness and Safety of Durvalumab and Olaparib in Patients With Endometrial Cancer (DUOLife)

Recruitingn/aAges 18 Years - 130 YearsFemaleAstraZeneca
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In plain words

What the trial is, and whether it could suit you

This is a German multi-center, prospective, non-interventional study (NIS) to collect real-world clinical data in patients with primary advanced (FIGO stage III or IV) or recurrent endometrial cancer (EC) receiving first-line (1L) regimens with Carboplatin/Paclitaxel/Durvalumab (CPD) followed by maintenance therapy with durvalumab or durvalumab and olaparib in line with the applicable european summary of product characteristics (SmPC). Additionally, patient-reported outcomes after 1L treatment with CPD will be assessed.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Women aged ≥ 18 years at the time of screening. * 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% for each cohort 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: * Patient has already received \>2 cycles of 1L CPD * 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
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What it tests

  • Not listed
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Where

49 sites
Research Site
Amberg, Germany
Research Site
Bad Nauheim, Germany
Research Site
Bautzen, Germany
Research Site
Berlin, Germany
Research Site
Bielefeld, Germany
Research Site
Bonn, Germany
Research Site
Borna, Germany
Research Site
Bottrop, Germany

…and 41 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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