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.)
No locations available
Arms | Assigned Interventions |
---|---|
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. | - |