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

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 · NCT06890273

This study is testing how well and safely a combination of Durvalumab and Olaparib works for women with advanced or recurrent endometrial cancer who are receiving specific first-line treatments.

Quick facts

Study typeObservational
Enrollment150 (estimated)
Ages18 Years to 130 Years
SexFemale
SponsorAstraZeneca (industry)
Drugs / interventionsdurvalumab, chemotherapy, radiation
Locations42 sites (Amberg and 41 other locations)
Trial IDNCT06890273 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are women aged 18 and older with advanced (FIGO III or IV) or recurrent endometrial cancer who are set to receive first-line treatment with the specified regimens.

Not a fit: Patients with early-stage endometrial cancer or those not eligible for the specified treatment regimens may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness and safety of Durvalumab and Olaparib, potentially improving treatment options for patients with endometrial cancer.

How similar studies have performed: While this study utilizes established treatments, it focuses on real-world data collection, which may provide new insights compared to previous studies that primarily relied on controlled clinical trial settings.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Amberg and 41 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Endometrial Cancer, Durvalumab, Olaparib, Primary advanced endometrial cancer, FIGO III or IV, Recurrent endometrial cancer, dMMR, pMMR

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.