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New hope for endometrial cancer: immunotherapy and targeted drug combo tested

NCT ID NCT04269200

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 07, 2026 · Updated 2 times

Summary

This Phase 3 trial tests whether adding the immunotherapy drug durvalumab and the targeted therapy olaparib to standard chemotherapy can help women with newly diagnosed advanced or recurrent endometrial cancer live longer without their cancer growing. About 805 participants will receive either chemotherapy alone or chemotherapy plus durvalumab, followed by maintenance durvalumab with or without olaparib. The study aims to see if these combinations improve progression-free survival and overall survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
durvalumab (an immunotherapy drug) and olaparib (a targeted therapy drug), given alongside standard chemotherapy (carboplatin and paclitaxel)
What this could lead to
If successful, this combination could offer a new first-line treatment option that delays cancer progression and improves survival for women with advanced or recurrent endometrial cancer.
What could go wrong
This is a Phase 3 trial, but results are not yet final. The added drugs may cause more side effects, and not all patients may benefit. The study is also specific to certain cancer types and stages.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

805 people

The number who actually took part.

Started

May 2020

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 150 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Research Site

    Tucson, Arizona, 85719, United States

  • Research Site

    Concord, California, 94520-2278, United States

  • Research Site

    La Jolla, California, 92093, United States

  • Research Site

    San Francisco, California, 94158, United States

  • Research Site

    Santa Barbara, California, 93105, United States

  • Research Site

    Aurora, Colorado, 80012, United States

  • Research Site

    Fort Lauderdale, Florida, 33316, United States

  • Research Site

    Tampa, Florida, 33612, United States

  • Research Site

    Savannah, Georgia, 31404, United States

  • Research Site

    Honolulu, Hawaii, 96826, United States

  • Research Site

    Arlington Heights, Illinois, 60005, United States

  • Research Site

    Chicago, Illinois, 60637, United States

  • Research Site

    Indianapolis, Indiana, 46237, United States

  • Research Site

    Louisville, Kentucky, 40207, United States

  • Research Site

    Baton Rouge, Louisiana, 70817, United States

  • Research Site

    Boston, Massachusetts, 02111, United States

  • Research Site

    Saint Paul, Minnesota, 55125, United States

  • Research Site

    Jackson, Mississippi, 39216, United States

  • Research Site

    Lebanon, New Hampshire, 03756, United States

  • Research Site

    Camden, New Jersey, 08103, United States

  • Research Site

    Paramus, New Jersey, 07652, United States

  • Research Site

    New York, New York, 10011, United States

  • Research Site

    New York, New York, 10029, United States

  • Research Site

    Pinehurst, North Carolina, 28374, United States

  • Research Site

    Cleveland, Ohio, 44109, United States

  • Research Site

    Cleveland, Ohio, 44124, United States

  • Research Site

    Dayton, Ohio, 45459, United States

  • Research Site

    Oklahoma City, Oklahoma, 73104, United States

  • Research Site

    Tulsa, Oklahoma, 74134, United States

  • Research Site

    Eugene, Oregon, 97401, United States

  • Research Site

    Tigard, Oregon, 97223, United States

  • Research Site

    Pittsburgh, Pennsylvania, 15224, United States

  • Research Site

    Providence, Rhode Island, 02905, United States

  • Research Site

    Sioux Falls, South Dakota, 57105, United States

  • Research Site

    Chattanooga, Tennessee, 37403, United States

  • Research Site

    Germantown, Tennessee, 38138, United States

  • Research Site

    Knoxville, Tennessee, 37920, United States

  • Research Site

    Bedford, Texas, 76022, United States

  • Research Site

    Dallas, Texas, 75231, United States

  • Research Site

    Houston, Texas, 77030, United States

  • Research Site

    San Antonio, Texas, 78240, United States

  • Research Site

    Sugar Land, Texas, 77479, United States

  • Research Site

    Tyler, Texas, 75702, United States

  • Research Site

    Webster, Texas, 77598, United States

  • Research Site

    Fairfax, Virginia, 22031, United States

  • Research Site

    Norfolk, Virginia, 23502, United States

  • Research Site

    Seattle, Washington, 98195, United States

  • Research Site

    Morgantown, West Virginia, 26505, United States

  • Research Site

    Madison, Wisconsin, 53792, United States

  • Research Site

    Milwaukee, Wisconsin, 53226, United States

  • Research Site

    Clayton, 3168, Australia

  • Research Site

    Malvern, 3144, Australia

  • Research Site

    Melbourne, 3000, Australia

  • Research Site

    Nedlands, 6009, Australia

  • Research Site

    Sydney, NSW 2145, Australia

  • Research Site

    Bruges, 8000, Belgium

  • Research Site

    Brussels, 1200, Belgium

  • Research Site

    Charleroi, 6000, Belgium

  • Research Site

    Ghent, 9000, Belgium

  • Research Site

    Hasselt, 3500, Belgium

  • Research Site

    Kortrijk, 8500, Belgium

  • Research Site

    Leuven, 3000, Belgium

  • Research Site

    Libramont-Chevigny, 6800, Belgium

  • Research Site

    Liège, 4000, Belgium

  • Research Site

    Belo Horizonte, 30130-090, Brazil

  • Research Site

    Belo Horizonte, 30150-274, Brazil

  • Research Site

    Curitiba, 80520-174, Brazil

  • Research Site

    Passo Fundo, 99010-080, Brazil

  • Research Site

    Pelotas, 96020-080, Brazil

  • Research Site

    Porto Alegre, 90020-090, Brazil

  • Research Site

    Porto Alegre, 90035-003, Brazil

  • Research Site

    Porto Alegre, 90110-270, Brazil

  • Research Site

    Rio de Janeiro, 20231-050, Brazil

  • Research Site

    São José do Rio Preto, 15090-000, Brazil

  • Research Site

    São Paulo, 01246-000, Brazil

  • Research Site

    São Paulo, 01317-001, Brazil

  • Research Site

    Calgary, Alberta, T2N 4N2, Canada

  • Research Site

    Toronto, Ontario, M4N 3M5, Canada

  • Research Site

    Toronto, Ontario, M5G 2M9, Canada

  • Research Site

    Montreal, Quebec, H1T 2M4, Canada

  • Research Site

    Montreal, Quebec, H2L 4M1, Canada

  • Research Site

    Montreal, Quebec, H3A 1A1, Canada

  • Research Site

    Montreal, Quebec, H3T 1E2, Canada

  • Research Site

    Beijing, 100034, China

  • Research Site

    Beijing, 100142, China

  • Research Site

    Changchun, 130012, China

  • Research Site

    Changchun, 130021, China

  • Research Site

    Changsha, 410003, China

  • Research Site

    Changsha, 410008, China

  • Research Site

    Chengdu, 610041, China

  • Research Site

    Chongqing, 400038, China

  • Research Site

    Chongqing, 408099, China

  • Research Site

    Dalian, 116001, China

  • Research Site

    Dalian, 116027, China

  • Research Site

    Guangdong, China

  • Research Site

    Guangzhou, 510060, China

  • Research Site

    Haikou, 570311, China

  • Research Site

    Harbin, 150081, China

  • Research Site

    Hefei, 230031, China

  • Research Site

    Nanning, 530021, China

  • Research Site

    Shanghai, 200032, China

  • Research Site

    Shenyang, 110042, China

  • Research Site

    Taiyuan, 030001, China

  • Research Site

    Tianjin, 300060, China

  • Research Site

    Wuhan, 430022, China

  • Research Site

    Wuhan, 430030, China

  • Research Site

    Zhanjiang, 524001, China

  • Research Site

    Zhengzhou, 450008, China

  • Research Site

    Zhengzhou, China

  • Research Site

    Barranquilla, 80020, Colombia

  • Research Site

    Bogotá, 110321, Colombia

  • Research Site

    Bogotá, 111321, Colombia

  • Research Site

    Bogotá, 111511, Colombia

  • Research Site

    Cali, 760043, Colombia

  • Research Site

    Medellín, 50025, Colombia

  • Research Site

    Medellín, 50030, Colombia

  • Research Site

    Montería, 23001, Colombia

  • Research Site

    Pereira, 660001, Colombia

  • Research Site

    Tallinn, 1131, Estonia

  • Research Site

    Tartu, 50406, Estonia

  • Research Site

    Bonn, 53127, Germany

  • Research Site

    Chemnitz, 09116, Germany

  • Research Site

    Dresden, 01307, Germany

  • Research Site

    Leipzig, 4103, Germany

  • Research Site

    Athens, 11528, Greece

  • Research Site

    Chaïdári, 124 62, Greece

  • Research Site

    Thessaloniki, 54645, Greece

  • Research Site

    Hong Kong, Hong Kong

  • Research Site

    Budapest, 1062, Hungary

  • Research Site

    Budapest, 1122, Hungary

  • Research Site

    Budapest, 1145, Hungary

  • Research Site

    Debrecen, 4032, Hungary

  • Research Site

    Győr, 9024, Hungary

  • Research Site

    Szolnok, 5004, Hungary

  • Research Site

    Hisar, 125005, India

  • Research Site

    Mumbai, 400012, India

  • Research Site

    Be’er Ya‘aqov, 70300, Israel

  • Research Site

    Hadera, 3810101, Israel

  • Research Site

    Jerusalem, 91031, Israel

  • Research Site

    Nahariya, 22100, Israel

  • Research Site

    Tel Aviv, 6423906, Israel

  • Research Site

    Chūōku, 104-0045, Japan

  • Research Site

    Kashiwa-shi, 277-8567, Japan

  • Research Site

    Kōtoku, 135-8550, Japan

  • Research Site

    Kurume-shi, 830-0011, Japan

  • Research Site

    Kyoto, 606-8507, Japan

  • Research Site

    Matsuyama, 791-0280, Japan

  • Research Site

    Minatoku, 105-8471, Japan

  • Research Site

    Nagoya, 464-8681, Japan

  • Research Site

    Nakagami-gun, 903-0215, Japan

  • Research Site

    Niigata, 951-8520, Japan

  • Research Site

    Osaka, 541-8567, Japan

  • Research Site

    Osaka, 637086, Japan

  • Research Site

    Sapporo, 003-0804, Japan

  • Research Site

    Shinjuku-ku, 160-8582, Japan

  • Research Site

    Sunto-gun, 411-8777, Japan

  • Research Site

    Toon-Shi, 791-0295, Japan

  • Research Site

    Tsu, 514-8507, Japan

  • Research Site

    Yokohama, 236-0004, Japan

  • Research Site

    Kaunas, 50161, Lithuania

  • Research Site

    Vilnius, 08661, Lithuania

  • Research Site

    Vilnius, 8660, Lithuania

  • Research Site

    Aguascalientes, 20116, Mexico

  • Research Site

    México, 06700, Mexico

  • Research Site

    Monterrey, 64000, Mexico

  • Research Site

    Oaxaca City, 68000, Mexico

  • Research Site

    Querétaro, 76090, Mexico

  • Research Site

    San Luis Potosí City, 78200, Mexico

  • Research Site

    Veracruz, 91910, Mexico

  • Research Site

    Gdansk, 80-214, Poland

  • Research Site

    Lodz, 93-513, Poland

  • Research Site

    Lublin, 20-081, Poland

  • Research Site

    Olsztyn, 10-228, Poland

  • Research Site

    Olsztyn, 10-560, Poland

  • Research Site

    Anzorey, 361350, Russia

  • Research Site

    Kazan, Tatarstan, 420029, Russia

  • Research Site

    Krasnodar, 350040, Russia

  • Research Site

    Moscow, 115478, Russia

  • Research Site

    Moscow, 117997, Russia

  • Research Site

    Saint Petersburg, 198255, Russia

  • Research Site

    Saransk, 430032, Russia

  • Research Site

    Sochi, 354000, Russia

  • Research Site

    Singapore, 119228, Singapore

  • Research Site

    Singapore, 169610, Singapore

  • Research Site

    Singapore, 258499, Singapore

  • Research Site

    Goyang-si, 10408, South Korea

  • Research Site

    Seoul, 01812, South Korea

  • Research Site

    Seoul, 03080, South Korea

  • Research Site

    Seoul, 03722, South Korea

  • Research Site

    Seoul, 06351, South Korea

  • Research Site

    Seoul, 06591, South Korea

  • Research Site

    Seoul, 138-736, South Korea

  • Research Site

    Suwon, 443380, South Korea

  • Research Site

    Yangsan, 50612, South Korea

  • Research Site

    Barcelona, 08208, Spain

  • Research Site

    Barcelona, 08907, Spain

  • Research Site

    El Palmar, 30120, Spain

  • Research Site

    Girona, 17007, Spain

  • Research Site

    Jaén, 23007, Spain

  • Research Site

    Madrid, 28046, Spain

  • Research Site

    Mallorca, 07120, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.