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

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 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% 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

Conditions2

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