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

NCT ID: NCT04269200

Last Updated: 2025-12-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 805 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-05
• Study Completion Date: 2027-04-01

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.

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

Keywords

Cancer of Endometrium; Cancer of the Endometrium; Carcinoma of Endometrium; Endometrial Cancer; Endometrial Carcinoma; Endometrium Cancer; Neoplasms, Endometrial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Arm C (durvalumab+olaparib)

Platinum-based chemotherapy and durvalumab followed by maintenance durvalumab and olaparib.

Group Type: EXPERIMENTAL

olaparib

Intervention Type: DRUG

Olaparib tablets

durvalumab

Intervention Type: BIOLOGICAL

Durvalumab by intravenous infusion

Carboplatin

Intervention Type: DRUG

Standard of care chemotherapy

Paclitaxel

Intervention Type: DRUG

Standard of care chemotherapy

Arm A (control)

Platinum-based chemotherapy and durvalumab placebo followed by maintenance durvalumab placebo and olaparib placebo (tablets).

Group Type: ACTIVE_COMPARATOR

durvalumab placebo

Intervention Type: DRUG

Matching placebo for intravenous infusion

olaparib placebo

Intervention Type: DRUG

Placebo tablets to match olaparib

Carboplatin

Intervention Type: DRUG

Standard of care chemotherapy

Paclitaxel

Intervention Type: DRUG

Standard of care chemotherapy

Arm B (durvalumab+placebo)

Platinum-based chemotherapy and durvalumab followed by maintenance durvalumab and olaparib placebo

Group Type: EXPERIMENTAL

durvalumab

Intervention Type: BIOLOGICAL

Durvalumab by intravenous infusion

olaparib placebo

Intervention Type: DRUG

Placebo tablets to match olaparib

Carboplatin

Intervention Type: DRUG

Standard of care chemotherapy

Paclitaxel

Intervention Type: DRUG

Standard of care chemotherapy

Interventions

olaparib

Olaparib tablets

Intervention Type: DRUG

durvalumab

Durvalumab by intravenous infusion

Intervention Type: BIOLOGICAL

durvalumab placebo

Matching placebo for intravenous infusion

Intervention Type: DRUG

olaparib placebo

Placebo tablets to match olaparib

Intervention Type: DRUG

Carboplatin

Standard of care chemotherapy

Intervention Type: DRUG

Paclitaxel

Standard of care chemotherapy

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 150 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Gynecologic Oncology Group (GOG) Foundation Inc

UNKNOWN

Sponsor Role: collaborator

The European Network for Gynaecological Oncological Trial groups (ENGOT)

UNKNOWN

Sponsor Role: collaborator

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shannon N. Westin, MD, MPH, FACOG

Role: PRINCIPAL_INVESTIGATOR

The University of Texas MD Anderson Cancer Center

Locations

Research Site

Tucson, Arizona, United States

Research Site

Concord, California, United States

Research Site

La Jolla, California, United States

Research Site

San Francisco, California, United States

Research Site

Santa Barbara, California, United States

Research Site

Aurora, Colorado, United States

Research Site

Fort Lauderdale, Florida, United States

Research Site

Tampa, Florida, United States

Research Site

Savannah, Georgia, United States

Research Site

Honolulu, Hawaii, United States

Research Site

Arlington Heights, Illinois, United States

Research Site

Chicago, Illinois, United States

Research Site

Indianapolis, Indiana, United States

Research Site

Louisville, Kentucky, United States

Research Site

Baton Rouge, Louisiana, United States

Research Site

Boston, Massachusetts, United States

Research Site

Saint Paul, Minnesota, United States

Research Site

Jackson, Mississippi, United States

Research Site

Lebanon, New Hampshire, United States

Research Site

Camden, New Jersey, United States

Research Site

Paramus, New Jersey, United States

Research Site

New York, New York, United States

Research Site

New York, New York, United States

Research Site

Pinehurst, North Carolina, United States

Research Site

Cleveland, Ohio, United States

Research Site

Cleveland, Ohio, United States

Research Site

Dayton, Ohio, United States

Research Site

Oklahoma City, Oklahoma, United States

Research Site

Tulsa, Oklahoma, United States

Research Site

Eugene, Oregon, United States

Research Site

Tigard, Oregon, United States

Research Site

Pittsburgh, Pennsylvania, United States

Research Site

Providence, Rhode Island, United States

Research Site

Sioux Falls, South Dakota, United States

Research Site

Chattanooga, Tennessee, United States

Research Site

Germantown, Tennessee, United States

Research Site

Knoxville, Tennessee, United States

Research Site

Bedford, Texas, United States

Research Site

Dallas, Texas, United States

Research Site

Houston, Texas, United States

Research Site

San Antonio, Texas, United States

Research Site

Sugar Land, Texas, United States

Research Site

Tyler, Texas, United States

Research Site

Webster, Texas, United States

Research Site

Fairfax, Virginia, United States

Research Site

Norfolk, Virginia, United States

Research Site

Seattle, Washington, United States

Research Site

Morgantown, West Virginia, United States

Research Site

Madison, Wisconsin, United States

Research Site

Milwaukee, Wisconsin, United States

Research Site

Clayton, , Australia

Research Site

Malvern, , Australia

Research Site

Melbourne, , Australia

Research Site

Nedlands, , Australia

Research Site

Sydney, , Australia

Research Site

Bruges, , Belgium

Research Site

Brussels, , Belgium

Research Site

Charleroi, , Belgium

Research Site

Ghent, , Belgium

Research Site

Hasselt, , Belgium

Research Site

Kortrijk, , Belgium

Research Site

Leuven, , Belgium

Research Site

Libramont-Chevigny, , Belgium

Research Site

Liège, , Belgium

Research Site

Belo Horizonte, , Brazil

Research Site

Belo Horizonte, , Brazil

Research Site

Curitiba, , Brazil

Research Site

Passo Fundo, , Brazil

Research Site

Pelotas, , Brazil

Research Site

Porto Alegre, , Brazil

Research Site

Porto Alegre, , Brazil

Research Site

Porto Alegre, , Brazil

Research Site

Rio de Janeiro, , Brazil

Research Site

São José do Rio Preto, , Brazil

Research Site

São Paulo, , Brazil

Research Site

São Paulo, , Brazil

Research Site

Calgary, Alberta, Canada

Research Site

Toronto, Ontario, Canada

Research Site

Toronto, Ontario, Canada

Research Site

Montreal, Quebec, Canada

Research Site

Montreal, Quebec, Canada

Research Site

Montreal, Quebec, Canada

Research Site

Montreal, Quebec, Canada

Research Site

Beijing, , China

Research Site

Beijing, , China

Research Site

Changchun, , China

Research Site

Changchun, , China

Research Site

Changsha, , China

Research Site

Changsha, , China

Research Site

Chengdu, , China

Research Site

Chongqing, , China

Research Site

Chongqing, , China

Research Site

Dalian, , China

Research Site

Dalian, , China

Research Site

Guangdong, , China

Research Site

Guangzhou, , China

Research Site

Haikou, , China

Research Site

Harbin, , China

Research Site

Hefei, , China

Research Site

Nanning, , China

Research Site

Shanghai, , China

Research Site

Shenyang, , China

Research Site

Taiyuan, , China

Research Site

Tianjin, , China

Research Site

Wuhan, , China

Research Site

Wuhan, , China

Research Site

Zhanjiang, , China

Research Site

Zhengzhou, , China

Research Site

Zhengzhou, , China

Research Site

Barranquilla, , Colombia

Research Site

Bogotá, , Colombia

Research Site

Bogotá, , Colombia

Research Site

Bogotá, , Colombia

Research Site

Cali, , Colombia

Research Site

Medellín, , Colombia

Research Site

Medellín, , Colombia

Research Site

Montería, , Colombia

Research Site

Pereira, , Colombia

Research Site

Tallinn, , Estonia

Research Site

Tartu, , Estonia

Research Site

Bonn, , Germany

Research Site

Chemnitz, , Germany

Research Site

Dresden, , Germany

Research Site

Erlangen, , Germany

Research Site

Leipzig, , Germany

Research Site

Athens, , Greece

Research Site

Chaïdári, , Greece

Research Site

Thessaloniki, , Greece

Research Site

Hong Kong, , Hong Kong

Research Site

Budapest, , Hungary

Research Site

Budapest, , Hungary

Research Site

Budapest, , Hungary

Research Site

Debrecen, , Hungary

Research Site

Győr, , Hungary

Research Site

Szolnok, , Hungary

Research Site

Hisar, , India

Research Site

Mumbai, , India

Research Site

Be’er Ya‘aqov, , Israel

Research Site

Hadera, , Israel

Research Site

Jerusalem, , Israel

Research Site

Nahariya, , Israel

Research Site

Tel Aviv, , Israel

Research Site

Chūōku, , Japan

Research Site

Kashiwa-shi, , Japan

Research Site

Kōtoku, , Japan

Research Site

Kurume-shi, , Japan

Research Site

Kyoto, , Japan

Research Site

Matsuyama, , Japan

Research Site

Minatoku, , Japan

Research Site

Nagoya, , Japan

Research Site

Nakagami-gun, , Japan

Research Site

Niigata, , Japan

Research Site

Osaka, , Japan

Research Site

Osaka, , Japan

Research Site

Sapporo, , Japan

Research Site

Shinjuku-ku, , Japan

Research Site

Sunto-gun, , Japan

Research Site

Toon-Shi, , Japan

Research Site

Tsu, , Japan

Research Site

Yokohama, , Japan

Research Site

Kaunas, , Lithuania

Research Site

Vilnius, , Lithuania

Research Site

Vilnius, , Lithuania

Research Site

Aguascalientes, , Mexico

Research Site

México, , Mexico

Research Site

Monterrey, , Mexico

Research Site

Oaxaca City, , Mexico

Research Site

Querétaro, , Mexico

Research Site

San Luis Potosí City, , Mexico

Research Site

Veracruz, , Mexico

Research Site

Gdansk, , Poland

Research Site

Lodz, , Poland

Research Site

Lublin, , Poland

Research Site

Olsztyn, , Poland

Research Site

Olsztyn, , Poland

Research Site

Anzorey, , Russia

Research Site

Kazan, Tatarstan, , Russia

Research Site

Krasnodar, , Russia

Research Site

Moscow, , Russia

Research Site

Moscow, , Russia

Research Site

Saint Petersburg, , Russia

Research Site

Saransk, , Russia

Research Site

Sochi, , Russia

Research Site

Singapore, , Singapore

Research Site

Singapore, , Singapore

Research Site

Singapore, , Singapore

Research Site

Goyang-si, , South Korea

Research Site

Seoul, , South Korea

Research Site

Seoul, , South Korea

Research Site

Seoul, , South Korea

Research Site

Seoul, , South Korea

Research Site

Seoul, , South Korea

Research Site

Seoul, , South Korea

Research Site

Suwon, , South Korea

Research Site

Yangsan, , South Korea

Research Site

Barcelona, , Spain

Research Site

Barcelona, , Spain

Research Site

El Palmar, , Spain

Research Site

Girona, , Spain

Research Site

Jaén, , Spain

Research Site

Madrid, , Spain

Research Site

Mallorca, , Spain

Countries

United States; Australia; Belgium; Brazil; Canada; China; Colombia; Estonia; Germany; Greece; Hong Kong; Hungary; India; Israel; Japan; Lithuania; Mexico; Poland; Russia; Singapore; South Korea; Spain

References

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.

Reference Type: DERIVED

PMID: 40590327 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38431043 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37864337 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D9311C00001&attachmentIdentifier=911f5098-85b6-4bc7-a5ed-a96253cccca6&fileName=D9311C00001_16.1.9_Statistical_Methods_and_Analysis-final-4.0_for_RRF.pdf&versionIdentifier=

Redacted Statistical Analysis Plan

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D9311C00001&attachmentIdentifier=aadf8b74-3143-4698-87a8-919885a5487a&fileName=d9311c00001-csp-v6_Redacted.pdf&versionIdentifier=

Redacted Protocol

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D9311C00001&attachmentIdentifier=40f19bd2-bcd3-443f-8eab-09293f2ec2fb&fileName=d9311c00001-study-synopsis-china_Redacted.pdf&versionIdentifier=

Redacted CSR synopsis

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D9311C00001&attachmentIdentifier=0b345ab2-2cb9-45b1-8127-5e84e448ac9a&fileName=d9311c00001-study-synopsis-global_Redacted.pdf&versionIdentifier=

Redacted CSR synopsis

Other Identifiers

GOG-3041

Identifier Type: OTHER

Identifier Source: secondary_id

ENGOT-EN10

Identifier Type: OTHER

Identifier Source: secondary_id

D9311C00001

Identifier Type: OTHER

Identifier Source: secondary_id

2022-502746-27-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

2019-004112-60

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

D9311C00001

Identifier Type: -

Identifier Source: org_study_id