Examining the effectiveness and safety of Durvalumab and Olaparib in endometrial cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to collect real-world clinical and patient-reported outcome data from women with primary advanced or recurrent endometrial cancer receiving first-line treatment with Carboplatin/Paclitaxel/Durvalumab, followed by maintenance therapy with either Durvalumab or a combination of Durvalumab and Olaparib. The study will analyze the effectiveness and safety of these treatment regimens in a multi-center setting across Germany. Patients will be categorized based on their DNA mismatch repair status, allowing for a tailored approach to treatment evaluation.

Why it matters

Who can join: the full rules

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

Where it's running

• Research Site
  Amberg, Germany Recruiting
• Research Site
  Bad Nauheim, Germany Recruiting
• Research Site
  Bautzen, Germany Recruiting
• Research Site
  Berlin, Germany Recruiting
• Research Site
  Bielefeld, Germany Recruiting
• Research Site
  Bonn, Germany Recruiting

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.