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NCT Number: NCT06890273

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

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.

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Key information

Conditions

Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–130 year

Sex eligibility

Female

Study type

Observational

Primary location

Research Site, Amberg, Germany

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About this study

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 and safety 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, as well as patient-reported outcomes after chemotherapy-phase (CPD) 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Real-world Time To Next Treatment (rwTTNT)

    Time frame: At 12 months

    rwTTNT is defined as time from start of 1L CPD until first dose of next systemic therapy or start of any other next anticancer therapy or death from any cause.

    1L maintenance therapy with durvalumab or durvalumab+olaparib is not considered as next systemic therapy.

    The measure of interest is the landmark at 12 months of time to first next therapy or death (rwTTNT).

Secondary outcomes

  1. Real-world Progression-free Survival (rwPFS)

    Time frame: At 12 months

    rwPFS is defined as time from start of 1L CPD until progression or death from any cause.

    The measure of interest is the landmark at 12 months of progression-free survival (rwPFS).

  2. Time to deterioration in health-related quality of life (HRQoL) based on EORTC QLQ-C30 questionnaire compared to baseline over time

    Time frame: Baseline to first clinically meaningful deterioration, up to 46 months

    The European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30), is a validated 30-item self-administered core questionnaire designed to assess HRQoL, functioning, and symptoms in all cancer patients or survivors.

    Time to deterioration is defined as time from baseline (≤ 14 days before first application of maintenance therapy) to date of first clinically meaningful deterioration i.e. a decrease by ≥10 points for the functional scales and an increase by ≥ 10 points for the symptom scales or death in:

    • Physical functioning score
    • Role functioning score

  3. Time to deterioration in HRQoL based on EORTC QLQ-EN24 questionnaire compared to baseline over time

    Time frame: Baseline to first clinically meaningful deterioration, up to 46 months

    The Endometrial Cancer Module EORTC QLQ-EN24, is a validated disease-specific extension to the EORTC QLQ-C30 designed to assess disease and treatment specific aspects of the QoLof patients with all stages of EC. The module consists of 24 questions grouped into 13 scales.

    Time to deterioration is defined as time from baseline (≤ 14 days before first application of maintenance therapy) to date of first clinically meaningful deterioration i.e. a decrease by ≥10 points for the functional scales and an increase by ≥ 10 points for the symptom scales or death in:

    • Back/pelvic pain
    • Gastrointestinal (GI) symptoms
    • Urological symptoms

  4. Duration of maintenance therapy

    Time frame: From first dose of maintenance therapy up to 46 months

    Time from first dose of maintenance therapy with durvalumab or durvalumab+olaparib to the last dose/cyle of durvalumab or olaparib, whatever is last, including number and duration of treatment interruptions.

  5. Duration of 1L CPD

    Time frame: Assessed up to 46 months

    Duration of therapy with durvalumab with carboplatin and/or paclitaxel

  6. Time between end of CPD until start of maintenance therapy

    Time frame: Assessed up to 46 months

    Time to start maintenance therapy defined as date of last cycle of chemotherapy until date of first dose of maintenance therapy

  7. Usage of treatment therapy

    Time frame: Assessed up to 46 months

    Dose, dose change, treatment interruption, number of cycles, cumulative dose of durvalumab.

Other outcomes

  1. Safety: Collection of Adverse Events (AE)

    Time frame: During routine visits up to 46 months

    Safety evaluated based on type of Adverse Event (AE), intensity, causal relationship to treatment, duration, handling, outcome, and seriousness.

  2. Change in timed up and go test (TUG)

    Time frame: Baseline up to 46 months

    The Timed up and go test (TUG) is a reliable and validated measure of functional mobility that can be used to assess frailty and functional impairment and to predict the risk of postoperative complications. The TUG records the time it takes a patient to get up from an armchair, walk 3 meters, turn around, walk back, and sit down again. Aids such as walking aids are permitted but help from other people is not.

    TUG should be assesd at every routine visit.

  3. Change in EORTC QLQ-C30

    Time frame: Baseline up to 46 months

    Changes of patient-reported outcomes (PROs) based on the European Organisation for Research and Treatment of Cancer Quality of Life - Core Questionnaire 30 (EORTC QLQ-C30) questionnaire from baseline (defined as ≤ 14 days before first application of maintenance therapy) over time in:

    • Physical functioning score of EORTC QLQC30
    • Role functioning score of the EORTC QLQ-C30
    • Global health status/quality of life (QoL) score of the EORTC QLQ-C30
    • All other functioning and symptom subscale scores of the EORTC QLQ-C30.

Study contacts

Contact information is provided by the study sponsor or research team.

AstraZeneca Clinical Study Information Center

CONTACT

[email protected]

1-877-240-9479

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • North-Eastern German Society of Gynecological Oncology (NOGGO e.V.)

Registry information

Official study 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

Acronym: DUOLife

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Mar 24, 2025
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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