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.
Women aged ≥ 18 years at the time of screening.
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 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.
AstraZeneca
Lead sponsor
North-Eastern German Society of Gynecological Oncology (NOGGO e.V.)
Collaborator