Durvalumab With or Without Olaparib as Maintenance Therapy After First-Line Treatment of Advanced and Recurrent Endometrial Cancer
- Age ≥18 years at the time of screening and female.
- Histologically confirmed diagnosis of epithelial endometrial carcinoma. All histologies, including carcinosarcomas, will be allowed. Sarcomas will not be allowed.
- Patient must have endometrial cancer in one of the following categories:
- Newly diagnosed Stage III disease (measurable disease per RECIST 1.1 following surgery or diagnostic biopsy),
- Newly diagnosed Stage IV disease (with or without disease following surgery or diagnostic biopsy)
- Recurrence of disease where the potential for cure by surgery alone or in combination is poor.
- Naïve to first line systemic anti-cancer treatment. For patients with recurrent disease only, prior chemotherapy is allowed only if it was administered in the adjuvant setting and there is at least 12 months from date of last dose of chemotherapy administered to date of subsequent relapse
- FPPE tumor sample must be available for MMR evaluation.
- Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days of starting study treatment.
- History of leptomeningeal carcinomatosis.
- Brain metastases or spinal cord compression.
- Prior treatment with PARP inhibitors.
- Prior immune checkpoint inhibitors or prior treatment with an agent directed to a
This Phase III study will assess the efficacy and safety of durvalumab in combination with
platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab
with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial
Target patient population: Adult female patients with histologically confirmed diagnosis of
epithelial endometrial carcinoma (excluding sarcomas): newly diagnosed Stage III, newly
diagnosed Stage IV, or recurrent endometrial cancer
Trial Phase Phase III
Trial Type Treatment
AstraZeneca Pharmaceuticals LP
- Primary ID D9311C00001
- Secondary IDs NCI-2020-04434, ENGOT-EN10, GOG-3041, 2019-004112-60
- Clinicaltrials.gov ID NCT04269200