Clinical trial NCT06890273: NIS to Examine the Effectiveness and Safety of Durvalumab and Olaparib in Patients With Endometrial Cancer (DUOLife)
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endometrial Cancer
Keywords: Durvalumab
Olaparib
Primary advanced endometrial cancer (1L)
FIGO III or IV
Recurrent endometrial cancer (1L)
dMMR
pMMR
Real-World Evidence
Patient-Reported Outcome
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: North-Eastern German Society of Gynecological Oncology (NOGGO e.V.)
First posted: 2025-03-24
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 150 patients with documented primary advanced (FIGO stage III or IV) or recurrent EC of epithelial histology (excluding sarcomas) who are eligible for first-line therapy with CPD followed by durvalumab or durvalumab and olaparib in line with the applicable SmPC within routine clinical practice will be recruited in Germany. The study allows recruitment of patients that already started and may have received up to 2 cycles of CPD. Inclusion of patients having started CPD will be capped to 25% of the study population. Testing results for MMR status of the patients' tumor must be available. Patients must be willing and able to report PROs. Eligible patients will be included into the study after and independently of the treating physician's treatment and diagnostic decisions.

Brief 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).

Detailed description: This is a multi-center, prospective, non-interventional study (NIS) to collect real-world clinical and PRO data in patients with primary advanced (FIGO stage III or IV) or recurrent EC receiving 1L CPD followed by maintenance therapy with durvalumab (DNA mismatch repair deficient; dMMR cohort) or durvalumab and olaparib (DNA mismatch repair proficient, pMMR cohort) in accordance with the applicable SmPC within routine clinical practice. Following surgery and/or radiation (if applicable) the decision to initiate 1L CPD followed by durvalumab or durvalumab and olaparib is made in a shared decision between the patient and the treating physician as part of routine care outside of and independent of this study.

The aim of the NIS is to describe the outcomes including effectiveness, safety and PRO of patients with primary advanced and recurrent EC treated with the two approved 1L regimens of CPD followed by durvalumab maintenance and CPD followed by durvalumab and olaparib maintenance in Germany. The study also aims to better understand characteristics of patients with primary advanced or recurrent EC that benefit from maintenance therapy with durvalumab or durvalumab and olaparib.

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% 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

Primary outcomes:
measure: Real-world Time To Next Treatment (rwTTNT)
timeFrame: At 12 months
Secondary outcomes:
measure: Real-world Progression-free Survival (rwPFS)
timeFrame: At 12 months
measure: Time to deterioration in health-related quality of life (HRQoL) based on EORTC QLQ-C30 questionnaire compared to baseline over time
timeFrame: Baseline to first clinically meaningful deterioration, up to 42 months
measure: Time to deterioration in HRQoL based on EORTC QLQ-EN24 questionnaire compared to baseline over time
timeFrame: Baseline to first clinically meaningful deterioration, up to 42 months
measure: Treatment duration of maintenance therapy
timeFrame: From first dose of maintenance therapy up to 42 months
Other outcomes:
measure: Safety: Collection of Adverse Events (AE)
timeFrame: During routine visits up to 42 months
measure: Change in timed up and go test (TUG)
timeFrame: Baseline up to 42 months
measure: Change in EORTC QLQ-C30
timeFrame: Baseline up to 42 months
Locations:
city: Berlin
country: Germany
facility: Research Site
Study officials:
References: