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

RecruitingN/A

Sponsor: AstraZeneca

Conditions: Endometrial Cancer

Countries: Germany

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.

Eligibility overview

Sex: FEMALE

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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

Locations (49)

Amberg, Germany
Bad Nauheim, Germany
Bautzen, Germany
Berlin, Germany
Bielefeld, Germany
Bonn, Germany
Borna, Germany
Bottrop, Germany
Brandenburg an der Havel, Germany
Braunschweig, Germany
Cologne, Germany
Dessau, Germany
Dresden, Germany
Ebersberg, Germany
Eggenfelden, Germany
Essen, Germany
Goslar, Germany
Greifswald, Germany
Gütersloh, Germany
Hamburg, Germany
Heilbronn, Germany
Homburg, Germany
Hösbach, Germany
Kiel, Germany
Krefeld, Germany
Kulmbach, Germany
Landshut, Germany
Leipzig, Germany
Limburg, Germany
Lüneburg, Germany
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