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Clinical Trials in China / NCT04269200
Active, not recruiting Phase 3

Durvalumab With or Without Olaparib as Maintenance Therapy After First-Line Treatment of Advanced and Recurrent Endometrial Cancer

NCT04269200 · tracked via the Priya Life Science China tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2020-05-05
Last updated
2026-08-07

Condition(s) studied

Endometrial Neoplasms

Investigational drug(s) / intervention(s)

olaparibdurvalumabdurvalumab placeboolaparib placeboCarboplatinPaclitaxel

olaparib: Olaparib tablets

durvalumab: Durvalumab by intravenous infusion

durvalumab placebo: Matching placebo for intravenous infusion

olaparib placebo: Placebo tablets to match olaparib

Carboplatin: Standard of care chemotherapy

Paclitaxel: Standard of care chemotherapy

Study summary

A study to 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 cancer.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
150 Years
Healthy volunteers
No
Inclusion Criteria: * 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: 1. Newly diagnosed Stage III disease (measurable disease per RECIST 1.1 following surgery or diagnostic biopsy), 2. Newly diagnosed Stage IV disease (with or without disease following surgery or diagnostic biopsy) 3. Recurrence of disease (measurable or non-measurable disease per RECIST 1.1) 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 systemic anti-cancer treatment is allowed only if it was administered in the adjuvant setting and there is at least 12 months from date of last dose of systemic anti-cancer treatment 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. Exclusion Criteria: * History of leptomeningeal carcinomatosis. * Brain metastases or spinal cord compression. * Prior treatment with PARP inhibitors. * Any prior exposure to immune-mediated therapy, including (but not limited to) other anti CTLA-4, anti-PD-1, anti-PD-L1, or anti-programmed-cell-death ligand 2 (anti-PD-L2) antibodies, excluding therapeutic anticancer vaccines.

Primary outcome measure(s)

Trial sites (201)

FacilityCityRegionStatus
Research Site Tucson Arizona
Research Site Concord California
Research Site La Jolla California
Research Site San Francisco California
Research Site Santa Barbara California
Research Site Aurora Colorado
Research Site Fort Lauderdale Florida
Research Site Tampa Florida
Research Site Savannah Georgia
Research Site Honolulu Hawaii
Research Site Arlington Heights Illinois
Research Site Chicago Illinois
Research Site Indianapolis Indiana
Research Site Louisville Kentucky
Research Site Baton Rouge Louisiana
Research Site Boston Massachusetts
Research Site Saint Paul Minnesota
Research Site Jackson Mississippi
Research Site Lebanon New Hampshire
Research Site Camden New Jersey
Research Site Paramus New Jersey
Research Site New York New York
Research Site New York New York
Research Site Pinehurst North Carolina
Research Site Cleveland Ohio
Research Site Cleveland Ohio
Research Site Dayton Ohio
Research Site Oklahoma City Oklahoma
Research Site Tulsa Oklahoma
Research Site Eugene Oregon
Research Site Tigard Oregon
Research Site Pittsburgh Pennsylvania
Research Site Providence Rhode Island
Research Site Sioux Falls South Dakota
Research Site Chattanooga Tennessee
Research Site Germantown Tennessee
Research Site Knoxville Tennessee
Research Site Bedford Texas
Research Site Dallas Texas
Research Site Houston Texas

+ 161 more sites — see the full list on the official registry below.

On this site

📄 Lynparza (olaparib) drug profile → 📄 Imfinzi (durvalumab) drug profile →

More AstraZeneca trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04269200 on ClinicalTrials.gov ↗ ← All trials in China