Trials / Active Not Recruiting
Active Not RecruitingNCT04269200
Durvalumab With or Without Olaparib as Maintenance Therapy After First-Line Treatment of Advanced and Recurrent Endometrial Cancer
A Randomised, Multicentre, Double-blind, Placebo-controlled, Phase III Study of First-line Carboplatin and Paclitaxel in Combination With Durvalumab, Followed by Maintenance Durvalumab With or Without Olaparib in Patients With Newly Diagnosed Advanced or Recurrent Endometrial Cancer (DUO-E)
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 805 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- Female
- Age
- 18 Years – 150 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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 cancer. 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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | olaparib | Olaparib tablets |
| BIOLOGICAL | durvalumab | Durvalumab by intravenous infusion |
| DRUG | durvalumab placebo | Matching placebo for intravenous infusion |
| DRUG | olaparib placebo | Placebo tablets to match olaparib |
| DRUG | Carboplatin | Standard of care chemotherapy |
| DRUG | Paclitaxel | Standard of care chemotherapy |
Timeline
- Start date
- 2020-05-05
- Primary completion
- 2024-07-08
- Completion
- 2027-04-01
- First posted
- 2020-02-13
- Last updated
- 2025-12-23
- Results posted
- 2025-12-23
Locations
202 sites across 22 countries: United States, Australia, Belgium, Brazil, Canada, China, Colombia, Estonia, Germany, Greece, Hong Kong, Hungary, India, Israel, Japan, Lithuania, Mexico, Poland, Russia, Singapore, South Korea, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04269200. Inclusion in this directory is not an endorsement.