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

Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Real-world Time To Next Treatment (rwTTNT) [Срок оценки: At 12 months]

Вторичные конечные точки (7)

• Real-world Progression-free Survival (rwPFS) [Срок оценки: At 12 months]
• Time to deterioration in health-related quality of life (HRQoL) based on EORTC QLQ-C30 questionnaire compared to baseline over time [Срок оценки: Baseline to first clinically meaningful deterioration, up to 46 months]
• Time to deterioration in HRQoL based on EORTC QLQ-EN24 questionnaire compared to baseline over time [Срок оценки: Baseline to first clinically meaningful deterioration, up to 46 months]
• Duration of maintenance therapy [Срок оценки: From first dose of maintenance therapy up to 46 months]
• Duration of 1L CPD [Срок оценки: Assessed up to 46 months]
• Time between end of CPD until start of maintenance therapy [Срок оценки: Assessed up to 46 months]
• Usage of treatment therapy [Срок оценки: Assessed up to 46 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Германия · 49 центров

• Research Site — Amberg
• Research Site — Bad Nauheim
• Research Site — Bautzen
• Research Site — Berlin
• Research Site — Bielefeld
• Research Site — Bonn
• Research Site — Borna
• Research Site — Bottrop
• … и ещё 41 центр

Идентификаторы

NCT: NCT06890273 · D9311R00001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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