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Durvalumab With or Without Olaparib as Maintenance Therapy After First-Line Treatment of Advanced and Recurrent Endometrial Cancer | Clinical Trials | Clareo Health

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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)

NCT04269200•AstraZeneca

View on ClinicalTrials.gov

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

Eligibility

Age

18 - 150 years

Sex

FEMALE

Healthy Volunteers

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.

Locations (202)

Research Site

Tucson, Arizona, United States

Research Site

Concord, California, United States

Research Site

La Jolla, California, United States

Research Site

San Francisco, California, United States

Research Site

Santa Barbara, California, United States

Research Site

Aurora, Colorado, United States

Research Site

Fort Lauderdale, Florida, United States

Research Site

Tampa, Florida, United States

Research Site

Savannah, Georgia, United States

Research Site

Honolulu, Hawaii, United States

Key Dates

Start Date

May 5, 2020

Primary Completion Date

July 8, 2024

Completion Date

April 1, 2027

Last Updated

December 23, 2025

Enrollment

805

ACTUAL participants

Conditions

Endometrial Neoplasms

Interventions

olaparib

DRUG

durvalumab

BIOLOGICAL

durvalumab placebo

DRUG

olaparib placebo

DRUG

Carboplatin

DRUG

Paclitaxel

DRUG

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NCT07046923

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RECRUITING

Registry Platform Ovarian and Endometrial Cancer

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Ovarian CancerEndometrial Cancer+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of LY4175408 in Participants With Advanced Cancer

Registry Platform Ovarian and Endometrial Cancer

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