Study identifier:D9311R00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
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
endometrial cancer
N/A
No
-
Female
150
Observational
18 Years - 130 Years
Allocation: N/A
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verified 01 Mar 2025 by AstraZeneca
AstraZeneca
North-Eastern German Society of Gynecological Oncology (NOGGO e.V.)
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.
No locations available
Arms | Assigned Interventions |
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DNA mismatch repair deficient (dMMR) Patients with primary advanced or recurrent endometrial cancer receiving 1L regimens of CPD with prior tested dMMR status. Following the SmPC patients of this cohort will receive durvalumab in the maintenance phase if they achieved and maintained disease control, i.e., complete response (CR), partial response (PR), or stable disease (SD) with CPD during the chemotherapy phase. | - |
DNA mismatch repair proficient (pMMR) Patients with primary advanced or recurrent endometrial cancer receiving 1L regimens of CPD with prior tested pMMR status. Following the SmPC patients of this cohort will receive durvalumab and olaparib in the maintenance phase if they achieved and maintained disease control i.e., CR, PR, or SD with CPD during the chemotherapy phase. | - |
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