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

AstraZeneca150 enrolled

Overview

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).

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.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Endometrial Cancer

Eligibility

Medical Language ↔ Plain English

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

Locations (15)

Research Site

Berlin, Germany

RECRUITING

Research Site

Bielefeld, Germany

RECRUITING

Research Site

Borna, Germany

RECRUITING

Research Site

Bottrop, Germany

RECRUITING

Research Site

Brandenburg, Germany

RECRUITING

Research Site

Dessau, Germany

RECRUITING

Research Site

Ebersberg, Germany

RECRUITING

Research Site

Gütersloh, Germany

RECRUITING

Research Site

Landshut, Germany

RECRUITING

Research Site

Leipzig, Germany

RECRUITING

...and 5 more locations

Outcomes

Primary Outcomes

Real-world Time To Next Treatment (rwTTNT)

rwTTNT is defined as time from start of 1L CPD until the first dose of next systemic therapy or the start of any other next anticancer therapy or death from any cause. The measure of interest is the landmark at 12 months of time to first next therapy or death (rwTTNT).

Time frame: At 12 months

Secondary Outcomes

Real-world Progression-free Survival (rwPFS)

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).

Time frame: At 12 months

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

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 (defined as day 1 of cycle 1 before first application of maintenance therapy) to the date of the 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

Time frame: Baseline to first clinically meaningful deterioration, up to 42 months

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

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 (defined as day 1 of cycle 1 before first application of maintenance therapy) to the date of the 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

Time frame: Baseline to first clinically meaningful deterioration, up to 42 months

Treatment duration of maintenance therapy

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

Time frame: From first dose of maintenance therapy up to 42 months

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

Overview

Conditions

Eligibility

Locations (15)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts