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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Endometrial Neoplasms
• Intervention / Treatment: Drug: durvalumab placebo; Drug: olaparib placebo; Drug: Carboplatin; Drug: Paclitaxel; Biological: durvalumab; Drug: olaparib

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

• Study Type: Interventional
• Enrollment (Actual): 805
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Clayton, Australia, 3168
    • Research Site
  • Malvern, Australia, 3144
    • Research Site
  • Melbourne, Australia, 3000
    • Research Site
  • Nedlands, Australia, 6009
    • Research Site
  • Sydney, Australia, NSW 2145
    • Research Site
• Belgium
  • Bruges, Belgium, 8000
    • Research Site
  • Brussels, Belgium, 1200
    • Research Site
  • Charleroi, Belgium, 6000
    • Research Site
  • Ghent, Belgium, 9000
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  • Hasselt, Belgium, 3500
    • Research Site
  • Kortrijk, Belgium, 8500
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  • Leuven, Belgium, 3000
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  • Libramont-Chevigny, Belgium, 6800
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  • Liège, Belgium, 4000
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• Brazil
  • Belo Horizonte, Brazil, 30130-090
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  • Belo Horizonte, Brazil, 30150-274
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  • Curitiba, Brazil, 80520-174
    • Research Site
  • Passo Fundo, Brazil, 99010-080
    • Research Site
  • Pelotas, Brazil, 96020-080
    • Research Site
  • Porto Alegre, Brazil, 90035-003
    • Research Site
  • Porto Alegre, Brazil, 90020-090
    • Research Site
  • Porto Alegre, Brazil, 90110-270
    • Research Site
  • Rio de Janeiro, Brazil, 20231-050
    • Research Site
  • São José do Rio Preto, Brazil, 15090-000
    • Research Site
  • São Paulo, Brazil, 01246-000
    • Research Site
  • São Paulo, Brazil, 01317-001
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• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Research Site
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Research Site
    • Toronto, Ontario, Canada, M4N 3M5
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  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Research Site
    • Montreal, Quebec, Canada, H1T 2M4
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    • Montreal, Quebec, Canada, H2L 4M1
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    • Montreal, Quebec, Canada, H3A 1A1
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• China
  • Beijing, China, 100142
    • Research Site
  • Beijing, China, 100034
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  • Changchun, China, 130012
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  • Changchun, China, 130021
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  • Changsha, China, 410008
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  • Changsha, China, 410003
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  • Chengdu, China, 610041
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  • Chongqing, China, 400038
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  • Chongqing, China, 408099
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  • Dalian, China, 116027
    • Research Site
  • Dalian, China, 116001
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  • Guangdong, China
    • Research Site
  • Guangzhou, China, 510060
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  • Haikou, China, 570311
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  • Harbin, China, 150081
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  • Hefei, China, 230031
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  • Nanning, China, 530021
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  • Shanghai, China, 200032
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  • Shenyang, China, 110042
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  • Taiyuan, China, 030001
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  • Tianjin, China, 300060
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  • Wuhan, China, 430022
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  • Wuhan, China, 430030
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  • Zhanjiang, China, 524001
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  • Zhengzhou, China, 450008
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  • Zhengzhou, China
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• Colombia
  • Barranquilla, Colombia, 80020
    • Research Site
  • Bogotá, Colombia, 110321
    • Research Site
  • Bogotá, Colombia, 111321
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  • Bogotá, Colombia, 111511
    • Research Site
  • Cali, Colombia, 760043
    • Research Site
  • Medellín, Colombia, 50025
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  • Medellín, Colombia, 50030
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  • Montería, Colombia, 23001
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  • Pereira, Colombia, 660001
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• Estonia
  • Tallinn, Estonia, 1131
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  • Tartu, Estonia, 50406
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• Germany
  • Bonn, Germany, 53127
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  • Chemnitz, Germany, 09116
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  • Dresden, Germany, 01307
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  • Leipzig, Germany, 4103
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• Greece
  • Athens, Greece, 11528
    • Research Site
  • Chaïdári, Greece, 124 62
    • Research Site
  • Thessaloniki, Greece, 54645
    • Research Site
• Hong Kong
  • Hong Kong, Hong Kong
    • Research Site
• Hungary
  • Budapest, Hungary, 1145
    • Research Site
  • Budapest, Hungary, 1122
    • Research Site
  • Budapest, Hungary, 1062
    • Research Site
  • Debrecen, Hungary, 4032
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  • Győr, Hungary, 9024
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  • Szolnok, Hungary, 5004
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• India
  • Hisar, India, 125005
    • Research Site
  • Mumbai, India, 400012
    • Research Site
• Israel
  • Be’er Ya‘aqov, Israel, 70300
    • Research Site
  • Hadera, Israel, 3810101
    • Research Site
  • Jerusalem, Israel, 91031
    • Research Site
  • Nahariya, Israel, 22100
    • Research Site
  • Tel Aviv, Israel, 6423906
    • Research Site
• Japan
  • Chūōku, Japan, 104-0045
    • Research Site
  • Kashiwa-shi, Japan, 277-8567
    • Research Site
  • Kurume-shi, Japan, 830-0011
    • Research Site
  • Kyoto, Japan, 606-8507
    • Research Site
  • Kōtoku, Japan, 135-8550
    • Research Site
  • Matsuyama, Japan, 791-0280
    • Research Site
  • Minatoku, Japan, 105-8471
    • Research Site
  • Nagoya, Japan, 464-8681
    • Research Site
  • Nakagami-gun, Japan, 903-0215
    • Research Site
  • Niigata, Japan, 951-8520
    • Research Site
  • Osaka, Japan, 637086
    • Research Site
  • Osaka, Japan, 541-8567
    • Research Site
  • Sapporo, Japan, 003-0804
    • Research Site
  • Shinjuku-ku, Japan, 160-8582
    • Research Site
  • Sunto-gun, Japan, 411-8777
    • Research Site
  • Toon-Shi, Japan, 791-0295
    • Research Site
  • Tsu, Japan, 514-8507
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  • Yokohama, Japan, 236-0004
    • Research Site
• Lithuania
  • Kaunas, Lithuania, 50161
    • Research Site
  • Vilnius, Lithuania, 08661
    • Research Site
  • Vilnius, Lithuania, 8660
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• Mexico
  • Aguascalientes, Mexico, 20116
    • Research Site
  • Monterrey, Mexico, 64000
    • Research Site
  • México, Mexico, 06700
    • Research Site
  • Oaxaca City, Mexico, 68000
    • Research Site
  • Querétaro, Mexico, 76090
    • Research Site
  • San Luis Potosí City, Mexico, 78200
    • Research Site
  • Veracruz, Mexico, 91910
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• Poland
  • Gdansk, Poland, 80-214
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  • Lodz, Poland, 93-513
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  • Lublin, Poland, 20-081
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  • Olsztyn, Poland, 10-228
    • Research Site
  • Olsztyn, Poland, 10-560
    • Research Site
• Russia
  • Anzorey, Russia, 361350
    • Research Site
  • Kazan, Tatarstan, Russia, 420029
    • Research Site
  • Krasnodar, Russia, 350040
    • Research Site
  • Moscow, Russia, 115478
    • Research Site
  • Moscow, Russia, 117997
    • Research Site
  • Saint Petersburg, Russia, 198255
    • Research Site
  • Saransk, Russia, 430032
    • Research Site
  • Sochi, Russia, 354000
    • Research Site
• Singapore
  • Singapore, Singapore, 169610
    • Research Site
  • Singapore, Singapore, 119228
    • Research Site
  • Singapore, Singapore, 258499
    • Research Site
• South Korea
  • Goyang-si, South Korea, 10408
    • Research Site
  • Seoul, South Korea, 03080
    • Research Site
  • Seoul, South Korea, 03722
    • Research Site
  • Seoul, South Korea, 06351
    • Research Site
  • Seoul, South Korea, 06591
    • Research Site
  • Seoul, South Korea, 138-736
    • Research Site
  • Seoul, South Korea, 01812
    • Research Site
  • Suwon, South Korea, 443380
    • Research Site
  • Yangsan, South Korea, 50612
    • Research Site
• Spain
  • Barcelona, Spain, 08907
    • Research Site
  • Barcelona, Spain, 08208
    • Research Site
  • El Palmar, Spain, 30120
    • Research Site
  • Girona, Spain, 17007
    • Research Site
  • Jaén, Spain, 23007
    • Research Site
  • Madrid, Spain, 28046
    • Research Site
  • Mallorca, Spain, 07120
    • Research Site
• United States
  • Arizona
    • Tucson, Arizona, United States, 85719
      • Research Site
  • California
    • Concord, California, United States, 94520-2278
      • Research Site
    • La Jolla, California, United States, 92093
      • Research Site
    • San Francisco, California, United States, 94158
      • Research Site
    • Santa Barbara, California, United States, 93105
      • Research Site
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Research Site
  • Florida
    • Fort Lauderdale, Florida, United States, 33316
      • Research Site
    • Tampa, Florida, United States, 33612
      • Research Site
  • Georgia
    • Savannah, Georgia, United States, 31404
      • Research Site
  • Hawaii
    • Honolulu, Hawaii, United States, 96826
      • Research Site
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
      • Research Site
    • Chicago, Illinois, United States, 60637
      • Research Site
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • Research Site
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Research Site
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70817
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  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Research Site
  • Minnesota
    • Saint Paul, Minnesota, United States, 55125
      • Research Site
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • Research Site
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
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  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Research Site
    • Paramus, New Jersey, United States, 07652
      • Research Site
  • New York
    • New York, New York, United States, 10029
      • Research Site
    • New York, New York, United States, 10011
      • Research Site
  • North Carolina
    • Pinehurst, North Carolina, United States, 28374
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  • Ohio
    • Cleveland, Ohio, United States, 44109
      • Research Site
    • Cleveland, Ohio, United States, 44124
      • Research Site
    • Dayton, Ohio, United States, 45459
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  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Research Site
    • Tulsa, Oklahoma, United States, 74134
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  • Oregon
    • Eugene, Oregon, United States, 97401
      • Research Site
    • Tigard, Oregon, United States, 97223
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  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
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  • Rhode Island
    • Providence, Rhode Island, United States, 02905
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  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
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  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
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    • Germantown, Tennessee, United States, 38138
      • Research Site
    • Knoxville, Tennessee, United States, 37920
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  • Texas
    • Bedford, Texas, United States, 76022
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    • Dallas, Texas, United States, 75231
      • Research Site
    • Houston, Texas, United States, 77030
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    • San Antonio, Texas, United States, 78240
      • Research Site
    • Sugar Land, Texas, United States, 77479
      • Research Site
    • Tyler, Texas, United States, 75702
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    • Webster, Texas, United States, 77598
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  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Research Site
    • Norfolk, Virginia, United States, 23502
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  • Washington
    • Seattle, Washington, United States, 98195
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  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • Research Site
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Research Site
    • Milwaukee, Wisconsin, United States, 53226
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 146 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm A (control); Platinum-based chemotherapy and durvalumab placebo followed by maintenance durvalumab placebo and olaparib placebo (tablets).	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
Experimental: Arm B (durvalumab+placebo); Platinum-based chemotherapy and durvalumab followed by maintenance durvalumab and olaparib placebo	Drug: olaparib placebo; Placebo tablets to match olaparib; Drug: Carboplatin; Standard of care chemotherapy; Drug: Paclitaxel; Standard of care chemotherapy; Biological: durvalumab; Durvalumab by intravenous infusion
Experimental: Arm C (durvalumab+olaparib); Platinum-based chemotherapy and durvalumab followed by maintenance durvalumab and olaparib.	Drug: Carboplatin; Standard of care chemotherapy; Drug: Paclitaxel; Standard of care chemotherapy; Biological: durvalumab; Durvalumab by intravenous infusion; Drug: olaparib; Olaparib tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	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	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	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	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.	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.	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.

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: GOG Foundation; European Network of Gynaecological Oncological Trial Groups (ENGOT)
• Investigators: Principal Investigator: Shannon N. Westin, MD, MPH, FACOG, M.D. Anderson Cancer Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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 Melou 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.

Helpful Links

• Redacted Statistical Analysis Plan
• Redacted Protocol
• Redacted CSR synopsis
• Redacted CSR synopsis

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2020
• Primary Completion (Actual): July 8, 2024
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: February 12, 2020
• First Posted (Actual): February 13, 2020

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Endometrial Carcinoma; Endometrium Cancer; Endometrial Cancer; Cancer of Endometrium; Cancer of the Endometrium; Carcinoma of Endometrium; Neoplasms, Endometrial
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Neoplasms; Endometrial Neoplasms; Organic Chemicals; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Coordination Complexes; Taxoids; Cyclodecanes; Diterpenes; Carboplatin; Paclitaxel; durvalumab; olaparib
• Other Study ID Numbers: D9311C00001 (Other Identifier: AZ DCode); 2019-004112-60 (EudraCT Number); GOG-3041 (Other Identifier: Gynecologic Oncology Group(GOG) Foundation Inc); ENGOT-EN10 (Other Identifier: The European Network for Gynaecological Oncological Trial groups); 2022-502746-27-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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

• IPD Sharing 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
• IPD Sharing 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No