Durvalumab With or Without Olaparib as Maintenance Therapy After First-Line Treatment of Advanced and Recurrent Endometrial Cancer
DUO-E
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)
5 other identifiers
interventional
805
21 countries
200
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2020
Longer than P75 for phase_3
200 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2020
CompletedFirst Posted
Study publicly available on registry
February 13, 2020
CompletedStudy Start
First participant enrolled
May 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 8, 2024
CompletedResults Posted
Study results publicly available
December 23, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
ExpectedDecember 23, 2025
December 1, 2025
4.2 years
February 10, 2020
July 2, 2025
December 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free Survival (PFS) According to RECIST 1.1, Based on Investigator Assessments
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
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
Secondary Outcomes (11)
Overall Survival (OS) Analysis
Survival assessed every 2 months after RECIST defined radiological progression; assessed through study completion, up to 83 months
Time From Randomisation to Second Progression or Death (PFS2) Based on Local Standard Clinical Practice
At baseline, every 9 to 18 wks, then every 12 wks until objective radiological disease progression. Assessments then per local practice every 12 wks until second progression. Assessed until 12Apr2023 DCO (08Jul2024 DCO for China cohort), up to 50 months
Objective Response Rate (ORR) Based on Investigator Assessment
At baseline, every 9 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
Duration of Response (DoR) Based on Investigator Assessment
At baseline, every 9 wks up to 18 wks, then every 12 wks until objective radiological disease progression. Assessed until 12 Apr 2023 DCO, up to 35 months
Time From Randomisation to First Subsequent Therapy or Death (TFST)
Time elapsed from randomisation to first subsequent therapy or death. Assessed every 12 wks following treatment discontinuation, through study completion (up to 83 months)
- +6 more secondary outcomes
Study Arms (3)
Arm A (control)
ACTIVE COMPARATORPlatinum-based chemotherapy and durvalumab placebo followed by maintenance durvalumab placebo and olaparib placebo (tablets).
Arm B (durvalumab+placebo)
EXPERIMENTALPlatinum-based chemotherapy and durvalumab followed by maintenance durvalumab and olaparib placebo
Arm C (durvalumab+olaparib)
EXPERIMENTALPlatinum-based chemotherapy and durvalumab followed by maintenance durvalumab and olaparib.
Interventions
Durvalumab by intravenous infusion
Standard of care chemotherapy
Standard of care chemotherapy
Eligibility Criteria
You may qualify if:
- 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 (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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (202)
Research Site
Tucson, Arizona, 85719, United States
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Concord, California, 94520-2278, United States
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La Jolla, California, 92093, United States
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San Francisco, California, 94158, United States
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Santa Barbara, California, 93105, United States
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Aurora, Colorado, 80012, United States
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Fort Lauderdale, Florida, 33316, United States
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Tampa, Florida, 33612, United States
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Savannah, Georgia, 31404, United States
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Honolulu, Hawaii, 96826, United States
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Arlington Heights, Illinois, 60005, United States
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Chicago, Illinois, 60637, United States
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Indianapolis, Indiana, 46237, United States
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Louisville, Kentucky, 40207, United States
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Baton Rouge, Louisiana, 70817, United States
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Boston, Massachusetts, 02111, United States
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Saint Paul, Minnesota, 55125, United States
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Jackson, Mississippi, 39216, United States
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Lebanon, New Hampshire, 03756, United States
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Camden, New Jersey, 08103, United States
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Paramus, New Jersey, 07652, United States
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New York, New York, 10011, United States
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New York, New York, 10029, United States
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Pinehurst, North Carolina, 28374, United States
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Cleveland, Ohio, 44109, United States
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Cleveland, Ohio, 44124, United States
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Dayton, Ohio, 45459, United States
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Oklahoma City, Oklahoma, 73104, United States
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Tulsa, Oklahoma, 74134, United States
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Eugene, Oregon, 97401, United States
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Tigard, Oregon, 97223, United States
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Pittsburgh, Pennsylvania, 15224, United States
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Providence, Rhode Island, 02905, United States
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Sioux Falls, South Dakota, 57105, United States
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Chattanooga, Tennessee, 37403, United States
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Germantown, Tennessee, 38138, United States
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Knoxville, Tennessee, 37920, United States
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Bedford, Texas, 76022, United States
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Dallas, Texas, 75231, United States
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Houston, Texas, 77030, United States
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San Antonio, Texas, 78240, United States
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Sugar Land, Texas, 77479, United States
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Tyler, Texas, 75702, United States
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Webster, Texas, 77598, United States
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Fairfax, Virginia, 22031, United States
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Norfolk, Virginia, 23502, United States
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Seattle, Washington, 98195, United States
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Morgantown, West Virginia, 26505, United States
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Madison, Wisconsin, 53792, United States
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Milwaukee, Wisconsin, 53226, United States
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Clayton, 3168, Australia
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Malvern, 3144, Australia
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Melbourne, 3000, Australia
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Nedlands, 6009, Australia
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Sydney, NSW 2145, Australia
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Bruges, 8000, Belgium
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Brussels, 1200, Belgium
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Charleroi, 6000, Belgium
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Ghent, 9000, Belgium
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Hasselt, 3500, Belgium
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Kortrijk, 8500, Belgium
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Leuven, 3000, Belgium
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Libramont-Chevigny, 6800, Belgium
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Liège, 4000, Belgium
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Belo Horizonte, 30130-090, Brazil
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Belo Horizonte, 30150-274, Brazil
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Curitiba, 80520-174, Brazil
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Passo Fundo, 99010-080, Brazil
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Pelotas, 96020-080, Brazil
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Porto Alegre, 90020-090, Brazil
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Porto Alegre, 90035-003, Brazil
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Porto Alegre, 90110-270, Brazil
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Rio de Janeiro, 20231-050, Brazil
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São José do Rio Preto, 15090-000, Brazil
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São Paulo, 01246-000, Brazil
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São Paulo, 01317-001, Brazil
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Calgary, Alberta, T2N 4N2, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Montreal, Quebec, H1T 2M4, Canada
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Montreal, Quebec, H2L 4M1, Canada
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Montreal, Quebec, H3A 1A1, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Beijing, 100034, China
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Beijing, 100142, China
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Changchun, 130012, China
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Changchun, 130021, China
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Changsha, 410003, China
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Changsha, 410008, China
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Chengdu, 610041, China
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Chongqing, 400038, China
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Chongqing, 408099, China
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Dalian, 116001, China
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Dalian, 116027, China
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Guangdong, China
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Guangzhou, 510060, China
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Haikou, 570311, China
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Harbin, 150081, China
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Hefei, 230031, China
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Nanning, 530021, China
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Shanghai, 200032, China
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Shenyang, 110042, China
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Taiyuan, 030001, China
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Tianjin, 300060, China
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Wuhan, 430022, China
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Wuhan, 430030, China
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Zhanjiang, 524001, China
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Zhengzhou, 450008, China
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Zhengzhou, China
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Barranquilla, 80020, Colombia
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Bogotá, 110321, Colombia
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Bogotá, 111321, Colombia
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Bogotá, 111511, Colombia
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Cali, 760043, Colombia
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Medellín, 50025, Colombia
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Medellín, 50030, Colombia
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Montería, 23001, Colombia
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Pereira, 660001, Colombia
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Tallinn, 1131, Estonia
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Tartu, 50406, Estonia
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Bonn, 53127, Germany
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Chemnitz, 09116, Germany
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Dresden, 01307, Germany
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Erlangen, 91054, Germany
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Leipzig, 4103, Germany
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Athens, 11528, Greece
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Chaïdári, 124 62, Greece
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Thessaloniki, 54645, Greece
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Hong Kong, Hong Kong
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Budapest, 1062, Hungary
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Budapest, 1122, Hungary
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Budapest, 1145, Hungary
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Debrecen, 4032, Hungary
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Győr, 9024, Hungary
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Szolnok, 5004, Hungary
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Hisar, 125005, India
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Mumbai, 400012, India
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Be’er Ya‘aqov, 70300, Israel
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Hadera, 3810101, Israel
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Jerusalem, 91031, Israel
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Nahariya, 22100, Israel
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Tel Aviv, 6423906, Israel
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Chūōku, 104-0045, Japan
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Kashiwa-shi, 277-8567, Japan
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Kōtoku, 135-8550, Japan
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Kurume-shi, 830-0011, Japan
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Kyoto, 606-8507, Japan
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Matsuyama, 791-0280, Japan
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Minatoku, 105-8471, Japan
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Nagoya, 464-8681, Japan
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Nakagami-gun, 903-0215, Japan
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Niigata, 951-8520, Japan
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Osaka, 541-8567, Japan
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Osaka, 637086, Japan
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Sapporo, 003-0804, Japan
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Shinjuku-ku, 160-8582, Japan
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Sunto-gun, 411-8777, Japan
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Toon-Shi, 791-0295, Japan
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Tsu, 514-8507, Japan
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Yokohama, 236-0004, Japan
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Kaunas, 50161, Lithuania
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Vilnius, 08661, Lithuania
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Vilnius, 8660, Lithuania
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Aguascalientes, 20116, Mexico
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México, 06700, Mexico
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Monterrey, 64000, Mexico
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Oaxaca City, 68000, Mexico
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Querétaro, 76090, Mexico
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San Luis Potosí City, 78200, Mexico
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Veracruz, 91910, Mexico
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Gdansk, 80-214, Poland
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Lodz, 93-513, Poland
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Lublin, 20-081, Poland
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Olsztyn, 10-228, Poland
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Olsztyn, 10-560, Poland
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Anzorey, 361350, Russia
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Kazan, Tatarstan, 420029, Russia
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Krasnodar, 350040, Russia
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Moscow, 115478, Russia
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Moscow, 117997, Russia
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Saint Petersburg, 198255, Russia
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Saransk, 430032, Russia
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Sochi, 354000, Russia
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Singapore, 119228, Singapore
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Singapore, 169610, Singapore
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Singapore, 258499, Singapore
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Goyang-si, 10408, South Korea
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Seoul, 01812, South Korea
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Seoul, 03080, South Korea
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Seoul, 03722, South Korea
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Seoul, 06351, South Korea
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Seoul, 06591, South Korea
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Seoul, 138-736, South Korea
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Suwon, 443380, South Korea
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Yangsan, 50612, South Korea
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Barcelona, 08208, Spain
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Barcelona, 08907, Spain
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El Palmar, 30120, Spain
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Girona, 17007, Spain
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Jaén, 23007, Spain
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Madrid, 28046, Spain
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Mallorca, 07120, Spain
Related Publications (3)
Nishio S, Nishikawa T, Mori M, Kamiura S, Sumi T, Yunokawa M, Imai Y, Kondo E, Takehara K, Takano H, Kudaka W, Kado N, Yamagami W, Kato H, Nishino K, Usami T, Hamanishi J, Nii M, Takaya I, Okamoto A. Durvalumab plus carboplatin/paclitaxel followed by durvalumab with or without olaparib as first-line treatment for newly diagnosed advanced or recurrent endometrial cancer: Japan subset from the phase III DUO-E trial. J Gynecol Oncol. 2025 Jul;36(4):e118. doi: 10.3802/jgo.2025.36.e118.
PMID: 40590327DERIVEDBogani G, Monk BJ, Powell MA, Westin SN, Slomovitz B, Moore KN, Eskander RN, Raspagliesi F, Barretina-Ginesta MP, Colombo N, Mirza MR. Adding immunotherapy to first-line treatment of advanced and metastatic endometrial cancer. Ann Oncol. 2024 May;35(5):414-428. doi: 10.1016/j.annonc.2024.02.006. Epub 2024 Feb 29.
PMID: 38431043DERIVEDWestin SN, Moore K, Chon HS, Lee JY, Thomes Pepin J, Sundborg M, Shai A, de la Garza J, Nishio S, Gold MA, Wang K, McIntyre K, Tillmanns TD, Blank SV, Liu JH, McCollum M, Contreras Mejia F, Nishikawa T, Pennington K, Novak Z, De Melo AC, Sehouli J, Klasa-Mazurkiewicz D, Papadimitriou C, Gil-Martin M, Brasiuniene B, Donnelly C, Del Rosario PM, Liu X, Van Nieuwenhuysen E; DUO-E Investigators. Durvalumab Plus Carboplatin/Paclitaxel Followed by Maintenance Durvalumab With or Without Olaparib as First-Line Treatment for Advanced Endometrial Cancer: The Phase III DUO-E Trial. J Clin Oncol. 2024 Jan 20;42(3):283-299. doi: 10.1200/JCO.23.02132. Epub 2023 Oct 21.
PMID: 37864337DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Shannon N. Westin, MD, MPH, FACOG
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2020
First Posted
February 13, 2020
Study Start
May 5, 2020
Primary Completion
July 8, 2024
Study Completion (Estimated)
April 1, 2027
Last Updated
December 23, 2025
Results First Posted
December 23, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure