NIS to Examine the Effectiveness and Safety of Durvalumab and Olaparib in Patients With Endometrial Cancer (DUOLife)
Prospective NIS to Generate Real-World-Data on Effectiveness and Safety of First-line Therapy With Chemotherapy Combined With Durvalumab Followed by Maintenance Therapy With Durvalumab or Durvalumab + Olaparib in Endometrial Cancer
AstraZeneca
150 participants
May 20, 2025
OBSERVATIONAL
Conditions
Summary
This is a German multi-center, prospective, non-interventional study (NIS) to collect real-world clinical and patient-reported outcome (PRO) 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).
Eligibility
Inclusion Criteria10
- 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% 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 Criteria7
- 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
Locations(33)
View Full Details on ClinicalTrials.gov
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NCT06890273