Endometrial NeoplasmsPhase 3DUO-ENCT04269200

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

A Phase 3 study testing olaparib, durvalumab and Carboplatin in people with Endometrial Neoplasms, run by AstraZeneca at 201 sites in 22 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 150 years, women only
Conditions the study is for: Endometrial Neoplasms
What is being tested?: olaparib, durvalumab and Carboplatin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 805 participants
Where: 201 sitesin 22 countries
Study dates: 5 May 2020to 1 Apr 2027
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 150 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Show all 9Show fewer

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.

Who cannot join

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.

Trial locations and contacts

201 sites in 22 countries.

Country

City, postcode or hospital

201 sites in 22 countries

United States50 sites

Research Site
Arlington Heights, Illinois, 60005
Research Site
Aurora, Colorado, 80012
Research Site
Baton Rouge, Louisiana, 70817
Research Site
Bedford, Texas, 76022
Research Site
Boston, Massachusetts, 02111
Research Site
Camden, New Jersey, 08103
Research Site
Chattanooga, Tennessee, 37403
Research Site
Chicago, Illinois, 60637
Research Site
Cleveland, Ohio, 44109
Research Site
Cleveland, Ohio, 44124
Research Site
Concord, California, 94520-2278
Research Site
Dallas, Texas, 75231
Research Site
Dayton, Ohio, 45459
Research Site
Eugene, Oregon, 97401
Research Site
Fairfax, Virginia, 22031
Research Site
Fort Lauderdale, Florida, 33316
Research Site
Germantown, Tennessee, 38138
Research Site
Honolulu, Hawaii, 96826
Research Site
Houston, Texas, 77030
Research Site
Indianapolis, Indiana, 46237
Research Site
Jackson, Mississippi, 39216
Research Site
Knoxville, Tennessee, 37920
Research Site
La Jolla, California, 92093
Research Site
Lebanon, New Hampshire, 03756
Research Site
Louisville, Kentucky, 40207
Research Site
Madison, Wisconsin, 53792
Research Site
Milwaukee, Wisconsin, 53226
Research Site
Morgantown, West Virginia, 26505
Research Site
New York, New York, 10011
Research Site
New York, New York, 10029
Research Site
Norfolk, Virginia, 23502
Research Site
Oklahoma City, Oklahoma, 73104
Research Site
Paramus, New Jersey, 07652
Research Site
Pinehurst, North Carolina, 28374
Research Site
Pittsburgh, Pennsylvania, 15224
Research Site
Providence, Rhode Island, 02905
Research Site
Saint Paul, Minnesota, 55125
Research Site
San Antonio, Texas, 78240
Research Site
San Francisco, California, 94158
Research Site
Santa Barbara, California, 93105
Research Site
Savannah, Georgia, 31404
Research Site
Seattle, Washington, 98195
Research Site
Sioux Falls, South Dakota, 57105
Research Site
Sugar Land, Texas, 77479
Research Site
Tampa, Florida, 33612
Research Site
Tigard, Oregon, 97223
Research Site
Tucson, Arizona, 85719
Research Site
Tulsa, Oklahoma, 74134
Research Site
Tyler, Texas, 75702
Research Site
Webster, Texas, 77598

Other trials in United States

China26 sites

Research Site
Beijing, 100034
Research Site
Beijing, 100142
Research Site
Changchun, 130012
Research Site
Changchun, 130021
Research Site
Changsha, 410003
Research Site
Changsha, 410008
Research Site
Chengdu, 610041
Research Site
Chongqing, 400038
Research Site
Chongqing, 408099
Research Site
Dalian, 116001
Research Site
Dalian, 116027
Research Site
Guangdong
Research Site
Guangzhou, 510060
Research Site
Haikou, 570311
Research Site
Harbin, 150081
Research Site
Hefei, 230031
Research Site
Nanning, 530021
Research Site
Shanghai, 200032
Research Site
Shenyang, 110042
Research Site
Taiyuan, 030001
Research Site
Tianjin, 300060
Research Site
Wuhan, 430022
Research Site
Wuhan, 430030
Research Site
Zhanjiang, 524001
Research Site
Zhengzhou, 450008
Research Site
Zhengzhou

Other trials in China

Japan18 sites

Research Site
Chūōku, 104-0045
Research Site
Kashiwa-shi, 277-8567
Research Site
Kōtoku, 135-8550
Research Site
Kurume-shi, 830-0011
Research Site
Kyoto, 606-8507
Research Site
Matsuyama, 791-0280
Research Site
Minatoku, 105-8471
Research Site
Nagoya, 464-8681
Research Site
Nakagami-gun, 903-0215
Research Site
Niigata, 951-8520
Research Site
Osaka, 541-8567
Research Site
Osaka, 637086
Research Site
Sapporo, 003-0804
Research Site
Shinjuku-ku, 160-8582
Research Site
Sunto-gun, 411-8777
Research Site
Toon-Shi, 791-0295
Research Site
Tsu, 514-8507
Research Site
Yokohama, 236-0004

Other trials in Japan

Brazil12 sites

Research Site
Belo Horizonte, 30130-090
Research Site
Belo Horizonte, 30150-274
Research Site
Curitiba, 80520-174
Research Site
Passo Fundo, 99010-080
Research Site
Pelotas, 96020-080
Research Site
Porto Alegre, 90020-090
Research Site
Porto Alegre, 90035-003
Research Site
Porto Alegre, 90110-270
Research Site
Rio de Janeiro, 20231-050
Research Site
São José do Rio Preto, 15090-000
Research Site
São Paulo, 01246-000
Research Site
São Paulo, 01317-001

Other trials in Brazil

Belgium9 sites

Research Site
Bruges, 8000
Research Site
Brussels, 1200
Research Site
Charleroi, 6000
Research Site
Ghent, 9000
Research Site
Hasselt, 3500
Research Site
Kortrijk, 8500
Research Site
Leuven, 3000
Research Site
Libramont-Chevigny, 6800
Research Site
Liège, 4000

Other trials in Belgium

Colombia9 sites

Research Site
Barranquilla, 80020
Research Site
Bogotá, 110321
Research Site
Bogotá, 111321
Research Site
Bogotá, 111511
Research Site
Cali, 760043
Research Site
Medellín, 50025
Research Site
Medellín, 50030
Research Site
Montería, 23001
Research Site
Pereira, 660001

Other trials in Colombia

South Korea9 sites

Research Site
Goyang-si, 10408
Research Site
Seoul, 01812
Research Site
Seoul, 03080
Research Site
Seoul, 03722
Research Site
Seoul, 06351
Research Site
Seoul, 06591
Research Site
Seoul, 138-736
Research Site
Suwon, 443380
Research Site
Yangsan, 50612

Other trials in South Korea

Russia8 sites

Research Site
Anzorey, 361350
Research Site
Kazan, Tatarstan, 420029
Research Site
Krasnodar, 350040
Research Site
Moscow, 115478
Research Site
Moscow, 117997
Research Site
Saint Petersburg, 198255
Research Site
Saransk, 430032
Research Site
Sochi, 354000

Other trials in Russia

Canada7 sites

Research Site
Calgary, Alberta, T2N 4N2
Research Site
Montreal, Quebec, H1T 2M4
Research Site
Montreal, Quebec, H2L 4M1
Research Site
Montreal, Quebec, H3A 1A1
Research Site
Montreal, Quebec, H3T 1E2
Research Site
Toronto, Ontario, M4N 3M5
Research Site
Toronto, Ontario, M5G 2M9

Other trials in Canada

Mexico7 sites

Research Site
Aguascalientes, 20116
Research Site
México, 06700
Research Site
Monterrey, 64000
Research Site
Oaxaca City, 68000
Research Site
Querétaro, 76090
Research Site
San Luis Potosí City, 78200
Research Site
Veracruz, 91910

Other trials in Mexico

Spain7 sites

Research Site
Barcelona, 08208
Research Site
Barcelona, 08907
Research Site
El Palmar, 30120
Research Site
Girona, 17007
Research Site
Jaén, 23007
Research Site
Madrid, 28046
Research Site
Mallorca, 07120

Other trials in Spain

Hungary6 sites

Research Site
Budapest, 1062
Research Site
Budapest, 1122
Research Site
Budapest, 1145
Research Site
Debrecen, 4032
Research Site
Győr, 9024
Research Site
Szolnok, 5004

Other trials in Hungary

Australia5 sites

Research Site
Clayton, 3168
Research Site
Malvern, 3144
Research Site
Melbourne, 3000
Research Site
Nedlands, 6009
Research Site
Sydney, NSW 2145

Other trials in Australia

Israel5 sites

Research Site
Be’er Ya‘aqov, 70300
Research Site
Hadera, 3810101
Research Site
Jerusalem, 91031
Research Site
Nahariya, 22100
Research Site
Tel Aviv, 6423906

Other trials in Israel

Poland5 sites

Research Site
Gdansk, 80-214
Research Site
Lodz, 93-513
Research Site
Lublin, 20-081
Research Site
Olsztyn, 10-228
Research Site
Olsztyn, 10-560

Other trials in Poland

Germany4 sites

Research Site
Bonn, 53127
Research Site
Chemnitz, 09116
Research Site
Dresden, 01307
Research Site
Leipzig, 4103

Other trials in Germany

Greece3 sites

Research Site
Athens, 11528
Research Site
Chaïdári, 124 62
Research Site
Thessaloniki, 54645

Other trials in Greece

Lithuania3 sites

Research Site
Kaunas, 50161
Research Site
Vilnius, 08661
Research Site
Vilnius, 8660

Other trials in Lithuania

Singapore3 sites

Research Site
Singapore, 119228
Research Site
Singapore, 169610
Research Site
Singapore, 258499

Other trials in Singapore

Estonia2 sites

Research Site
Tallinn, 1131
Research Site
Tartu, 50406

Other trials in Estonia

India2 sites

Research Site
Hisar, 125005
Research Site
Mumbai, 400012

Other trials in India

Hong Kong1 site

Research Site
Hong Kong

Other trials in Hong Kong

About this study

Official title: 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)

Read the 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: Endometrial Neoplasms
Being tested: olaparib, durvalumab, durvalumab placebo, olaparib placebo, Carboplatin
Keywords: Cancer of Endometrium, Cancer of the Endometrium, Carcinoma of Endometrium, Endometrial Cancer, Endometrial Carcinoma, Endometrium Cancer, Neoplasms, Endometrial
Medical subject headings: Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

olaparibDrug
Olaparib tablets
durvalumabBiological
Durvalumab by intravenous infusion
durvalumab placeboDrug
Matching placebo for intravenous infusion
olaparib placeboDrug
Placebo tablets to match olaparib
CarboplatinDrug
Standard of care chemotherapy
PaclitaxelDrug
Standard of care chemotherapy

Study groups in NCT04269200
Study group	Role	What they receive
Arm A (control)	Active comparator	Platinum-based chemotherapy and durvalumab placebo followed by maintenance durvalumab placebo and olaparib placebo (tablets). Receives: Drug: durvalumab placebo; Drug: olaparib placebo; Drug: Carboplatin; Drug: Paclitaxel
Arm B (durvalumab+placebo)	Experimental	Platinum-based chemotherapy and durvalumab followed by maintenance durvalumab and olaparib placebo Receives: Biological: durvalumab; Drug: olaparib placebo; Drug: Carboplatin; Drug: Paclitaxel
Arm C (durvalumab+olaparib)	Experimental	Platinum-based chemotherapy and durvalumab followed by maintenance durvalumab and olaparib. Receives: Drug: olaparib; Biological: durvalumab; Drug: Carboplatin; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
To determine 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 in newly diagnosed advanced or recurrent endometrial cancer patients by assessment of OS
Measured: 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
To determine 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 in newly diagnosed advanced or recurrent endometrial cancer patients by assessment of PFS2
Measured: 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
To determine 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 in newly diagnosed advanced or recurrent endometrial cancer patients by assessment of ORR
Measured: 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
To determine 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 in newly diagnosed advanced or recurrent endometrial cancer patients by assessment of DoR
Measured: 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)
To determine 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 in newly diagnosed advanced or recurrent endometrial cancer patients by assessment of TFST
Measured: Time elapsed from randomisation to first subsequent therapy or death. Assessed every 12 wks following treatment discontinuation, through study completion (up to 83 months)
Time From Randomisation to Second Subsequent Therapy or Death (TSST)
To determine 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 in newly diagnosed advanced or recurrent endometrial cancer patients by assessment of TSST
Measured: Time elapsed from randomisation to second subsequent therapy or death. Assessed every 12 wks following treatment discontinuation, through study completion (up to 83 months)
Time From Randomisation to Discontinuation of Treatment or Death (TDT)
To determine 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 in newly diagnosed advanced or recurrent endometrial cancer patients by assessment of TDT
Measured: Time elapsed from randomisation to study treatment discontinuation or death. Assessed through study completion, up to 83 months
Serum Concentration of Durvalumab
To characterise the pharmacokinetics (PK) of durvalumab and durvalumab in combination with olaparib
Measured: PK sampling performed on Day 85 pre-dose, Day 183 pre-dose, and 3 months after study treatment discontinuation (up to 36 months)
Anti-drug Antibodies (ADA) to Durvalumab
To characterise the immunogenicity of durvalumab and durvalumab in combination with olaparib
Measured: Immunogenicity sampling performed on Day 1 pre-dose, Day 85 pre-dose, Day 183 pre-dose, and 3 and 6 months after study treatment discontinuation (up to 39 months)
Change From Baseline in Physical Functioning Score of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer Patients 30 (EORTC QLQ-C30)
To determine effects on symptoms, functioning, and overall health related quality of life (HRQoL) 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 alone in newly diagnosed advanced or recurrent endometrial cancer patients. The physical functioning score is a score from 0 to 100. Higher scores on the physical functioning score indicate better health status/function.
Measured: At baseline, every 3 wks until Wk 18, and every 4 wks until the second progression. Assessed until 12 Apr 2023 DCO, up to 35 months. The average treatment effect over the first 12 months after randomisation is presented.
Change From Baseline in Global Health Status/QoL Score of the EORTC QLQ-C30
To determine effects on symptoms, functioning, and overall HRQoL 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 alone in newly diagnosed advanced or recurrent endometrial cancer patients. The global health status/quality of life (QoL) is a score from 0 to 100. Higher scores on the global health status/QoL indicate better health status/function.
Measured: At baseline, every 3 wks until Wk 18, and every 4 wks until the second progression. Assessed until 12 Apr 2023 DCO, up to 35 months. The average treatment effect over the first 12 months after randomisation is presented.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 May 20201 Apr 2027

First posted13 Feb 2020
Study start5 May 2020
Primary completion8 Jul 2024
Study completion1 Apr 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Endometrial NeoplasmsStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: double-blind, placebo-controlled
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 805 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04269200
Sponsor's protocol ID: D9311C00001
Other IDs: GOG-3041, ENGOT-EN10, D9311C00001, 2022-502746-27-00, 2019-004112-60, 2019
Acronym: DUO-E
Status last verified: Aug 2026
First submitted: 10 Feb 2020
Last updated: 7 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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

Publications

Westin 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, Liu X, Nieuwenhuysen EV; DUO-E Investigators. Plain language summary of results from the DUO-E study: durvalumab given with or without olaparib in patients with advanced endometrial cancer. Future Oncol. 2026 Apr;22(9):1031-1046. doi: 10.1080/14796694.2026.2638677. Epub 2026 Apr 6.
PubMed 41943281
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.
PubMed 40590327
Bogani 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.
PubMed 38431043
Westin 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.
PubMed 37864337

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT04269200
Acronym / sponsor ID: DUO-E / D9311C00001
Conditions: Endometrial Neoplasms
Keywords: Cancer of Endometrium, Cancer of the Endometrium, Carcinoma of Endometrium, Endometrial Cancer, Endometrial Carcinoma, Endometrium Cancer, Neoplasms, Endometrial
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 805 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: GOG Foundation, European Network of Gynaecological Oncological Trial Groups (ENGOT)
Study start: 5 May 2020 (actual)
Primary completion: 8 Jul 2024 (actual)
Study completion: 1 Apr 2027 (estimated)
First posted: 13 Feb 2020 (actual)
Results: Posted 23 Dec 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3
Model description: double-blind, placebo-controlled

Arm	Type	Receives
Arm A (control)	Active comparator	Drug: durvalumab placebo, Drug: olaparib placebo, Drug: Carboplatin, Drug: PaclitaxelPlatinum-based chemotherapy and durvalumab placebo followed by maintenance durvalumab placebo and olaparib placebo (tablets).
Arm B (durvalumab+placebo)	Experimental	Biological: durvalumab, Drug: olaparib placebo, Drug: Carboplatin, Drug: PaclitaxelPlatinum-based chemotherapy and durvalumab followed by maintenance durvalumab and olaparib placebo
Arm C (durvalumab+olaparib)	Experimental	Drug: olaparib, Biological: durvalumab, Drug: Carboplatin, Drug: PaclitaxelPlatinum-based chemotherapy and durvalumab followed by maintenance durvalumab and olaparib.

Who may qualify

Ages: 18 to 150 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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:
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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
olaparibOlaparib tablets	Drug	Arm C (durvalumab+olaparib)
durvalumabDurvalumab by intravenous infusion	Biological	Arm B (durvalumab+placebo), Arm C (durvalumab+olaparib)
durvalumab placeboMatching placebo for intravenous infusion	Drug	Arm A (control)
olaparib placeboPlacebo tablets to match olaparib	Drug	Arm A (control), Arm B (durvalumab+placebo)
CarboplatinStandard of care chemotherapy	Drug	Arm A (control), Arm B (durvalumab+placebo), Arm C (durvalumab+olaparib)
PaclitaxelStandard of care chemotherapy	Drug	Arm A (control), Arm B (durvalumab+placebo), Arm C (durvalumab+olaparib)

Primary outcome

Progression-free Survival (PFS) According to RECIST 1.1, Based on Investigator Assessments
Time frame: 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

11 secondary outcomes

Overall Survival (OS) Analysis
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 frame: Time elapsed from randomisation to first subsequent therapy or death. Assessed every 12 wks following treatment discontinuation, through study completion (up to 83 months)
Time From Randomisation to Second Subsequent Therapy or Death (TSST)
Time frame: Time elapsed from randomisation to second subsequent therapy or death. Assessed every 12 wks following treatment discontinuation, through study completion (up to 83 months)
Time From Randomisation to Discontinuation of Treatment or Death (TDT)
Time frame: Time elapsed from randomisation to study treatment discontinuation or death. Assessed through study completion, up to 83 months
Serum Concentration of Durvalumab
Time frame: PK sampling performed on Day 85 pre-dose, Day 183 pre-dose, and 3 months after study treatment discontinuation (up to 36 months)
Anti-drug Antibodies (ADA) to Durvalumab
Time frame: Immunogenicity sampling performed on Day 1 pre-dose, Day 85 pre-dose, Day 183 pre-dose, and 3 and 6 months after study treatment discontinuation (up to 39 months)
Change From Baseline in Physical Functioning Score of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer Patients 30 (EORTC QLQ-C30)
Time frame: At baseline, every 3 wks until Wk 18, and every 4 wks until the second progression. Assessed until 12 Apr 2023 DCO, up to 35 months. The average treatment effect over the first 12 months after randomisation is presented.
Change From Baseline in Global Health Status/QoL Score of the EORTC QLQ-C30
Time frame: At baseline, every 3 wks until Wk 18, and every 4 wks until the second progression. Assessed until 12 Apr 2023 DCO, up to 35 months. The average treatment effect over the first 12 months after randomisation is presented.

Results and safety

Results posted to the registry on 23 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard of Care (SoC)	241	147
SoC + Durvalumab	238	159
SoC + Durvalumab + Olaparib	239	170

Primary outcome: Progression-free Survival (PFS) According to RECIST 1.1, Based on Investigator Assessments

Time frame: 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. Median (95% Confidence Interval). Unit: Months

Measure	Global Cohort - SoC n = 241	Global Cohort - SoC + Durvalumab n = 238	Global Cohort - SoC + Durvalumab + Olaparib n = 239	China Cohort - SoC n = 44	China Cohort - SoC + Durvalumab n = 43	China Cohort - SoC + Durvalumab + Olaparib n = 42
Value	9.6 (9.0 to 9.9)	10.2 (9.7 to 14.7)	15.1 (12.6 to 20.7)	9.7 (7.6 to 12.3)	9.9 (8.2 to 20.6)	9.9 (7.1 to 12.6)

Global Cohort - SoC vs Global Cohort - SoC + Durvalumab: Hazard Ratio (HR): 0.71 (95% CI 0.57 to 0.89), p = 0.003, Regression, Cox
Global Cohort - SoC vs Global Cohort - SoC + Durvalumab + Olaparib: Hazard Ratio (HR): 0.55 (95% CI 0.43 to 0.69), p <0.0001, Regression, Cox
China Cohort - SoC vs China Cohort - SoC + Durvalumab: Hazard Ratio (HR): 0.73 (95% CI 0.42 to 1.25), Regression, Cox

Population analysed: Full Analysis Set (FAS) consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 20 Apr 2022). China FAS includes all patients who were randomised at sites in China and Hong Kong.

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Global Cohort - SoC	73 of 236 (30.9%)	233 of 236 (98.7%)	82 of 241
Global Cohort - SoC + Durvalumab	73 of 235 (31.1%)	228 of 235 (97%)	65 of 238
Global Cohort - SoC + Durvalumab + Olaparib	85 of 238 (35.7%)	236 of 238 (99.2%)	52 of 239
China Cohort - SoC	14 of 44 (31.8%)	44 of 44 (100%)	12 of 44
China Cohort - SoC + Durvalumab	8 of 41 (19.5%)	41 of 41 (100%)	11 of 43
China Cohort - SoC + Durvalumab + Olaparib	19 of 41 (46.3%)	39 of 41 (95.1%)	14 of 42

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41943281Westin 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, Liu X, Nieuwenhuysen EV; DUO-E Investigators. Plain language summary of results from the DUO-E study: durvalumab given with or without olaparib in patients with advanced endometrial cancer. Future Oncol. 2026 Apr;22(9):1031-1046. doi: 10.1080/14796694.2026.2638677. Epub 2026 Apr 6.
Derived from this study: PubMed 40590327Nishio 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.
Derived from this study: PubMed 38431043Bogani 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.
Derived from this study: PubMed 37864337Westin 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.
Redacted Statistical Analysis PlanLink provided by the sponsor.
Redacted ProtocolLink provided by the sponsor.
Redacted CSR synopsisLink provided by the sponsor.
Redacted CSR synopsisLink provided by the sponsor.
Individual participant dataSharing planned: Yes. 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

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shannon N. Westin, MD, MPH, FACOG principal investigator

M.D. Anderson Cancer Center

201 sites in 22 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing olaparib, durvalumab and Carboplatin in people with Endometrial Neoplasms, run by AstraZeneca at 201 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 201 sites in United States, China, Japan, Brazil, Belgium and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) According to RECIST 1.1, Based on Investigator Assessments (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04269200, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.