Durvalumab With or Without Olaparib as Maintenance Therapy After First-Line Treatment of Advanced and Recurrent Endometrial Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Progression-free Survival (PFS) According to RECIST 1.1, Based on Investigator Assessments — At baseline, every 9 weeks (wks) up to 18 wks, then every 12 wks until objective radiological disease progression. Assessed until 12 Apr 2023 DCO (08 Jul 2024 DCO for China cohort), up to 50 months
To demonstrate the efficacy of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab or durvalumab with olaparib when compared to platinum-based chemotherapy by assessment of PFS (using investigator assessment according to Response Evaluation Criteria in Solid Tumours version 1.1 \[RECIST 1.1\]) in patients with newly diagnosed advanced or recurrent endometrial cancer
Trial sites (201)
| Facility | City | Region | Status |
|---|---|---|---|
| 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.
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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 Spain