New drug cocktail aims to outsmart aggressive uterine cancer

NCT ID NCT06989112

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 4 times

Summary

This phase 3 trial is testing whether a targeted drug (trastuzumab deruxtecan) combined with immunotherapy (rilvegostomig or pembrolizumab) works better than standard chemotherapy plus pembrolizumab for people with advanced or recurrent endometrial cancer that has a specific protein (HER2) and is mismatch repair proficient. About 600 participants will be randomly assigned to one of three treatment arms. The main goal is to see how long the cancer stays under control.

What this could mean

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

Active substance: trastuzumab deruxtecan (T-DXd) plus rilvegostomig or pembrolizumab
What this could lead to: If successful, this could offer a new first-line treatment option that delays cancer progression and improves survival for people with HER2-expressing endometrial cancer.
What could go wrong: This is an early-phase 3 trial, so results are not yet known. The experimental drugs may cause side effects like lung inflammation or infusion reactions, and the combination may not prove better than current chemotherapy plus immunotherapy.

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

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Feb 2031

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 years and older

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.

Key Inclusion Criteria: * ≥ 18 years of age at the time of screening. Other age restrictions may apply as per local regulations. * Histologically confirmed diagnosis of epithelial endometrial carcinoma. All histologies are allowed except for sarcomas (carcinosarcomas are allowed). * Participant must have primary advanced disease (Stage III/IV) or recurrent endometrial cancer and meet at least one of the following criteria: 1. Primary Stage III (per FIGO 2023) disease with measurable disease at baseline per RECIST 1.1 based on the investigator's assessment. 2. Primary Stage IV (per FIGO 2023) disease regardless of presence of measurable disease at baseline. 3. Recurrent disease regardless of presence of measurable disease at baseline. * Endometrial cancer with HER2 IHC expression of 3+ or 2+ by prospective central testing. * Endometrial cancer that is determined pMMR by prospective central testing. * Provision of an adequate FFPE tumor tissue sample for central HER2, MMR, and PD-L1 IHC testing. * Prior therapy: 1. No prior chemotherapy for the treatment of EC, except for one prior line of adjuvant/ neoadjuvant chemotherapy with curative intent (chemotherapy or chemoradiation) if completed ≥ 6 months prior to signature of the main ICF. Prior trastuzumab in the adjuvant/neoadjuvant setting is allowed. 2. No prior exposure to antibody-drug conjugates or immune checkpoint inhibitors 3. Participants may have received prior radiation therapy for the treatment of endometrial cancer. Adequate treatment washout period is required 4. Participants may have received prior hormonal therapy for the treatment of endometrial cancer. Adequate treatment washout period is required * ECOG 0-1. * Left ventricular ejection fraction ≥ 50% within 28 days before randomization. * Adequate organ and bone marrow function within 14 days before randomization. * The participant is not considered a candidate for curative therapy in the judgment of the investigator. Key Exclusion Criteria: * Any severe or uncontrolled systemic diseases which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or would jeopardize compliance with the protocol. * Active or ongoing serious chronic gastrointestinal conditions associated with diarrhea, primary immunodeficiency, or non-infectious skin disease requiring systemic treatment. * Active or prior documented autoimmune or inflammatory disorders requiring chronic systemic treatment with the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs. * History of (non-infectious) ILD/pneumonitis that required steroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening. * Lung criteria: 1. Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (e.g., pulmonary emboli within 3 months of the study enrollment, severe asthma, severe chronic obstructive pulmonary disease \[COPD\], restrictive lung disease, etc.). 2. Any autoimmune, connective tissue or inflammatory disorders where there is documented, or a suspicion of pulmonary involvement at the time of screening. 3. Prior pneumonectomy (complete). * History of myocardial infarction or unstable angina within 6 months before randomization, or symptomatic congestive heart failure (NYHA Class II to IV), clinically significant arrhythmia, uncontrolled hypertension, cardiomyopathy of any etiology or history of myocarditis. * History of organ transplant or allogeneic stem cell transplant. * Spinal cord compression or clinically active central nervous system metastases. Participants with clinically inactive brain metastases may be included in the study. * Evidence of any of the following infections: 1. Active tuberculosis 2. HIV infection that is not well controlled. 3. Active hepatitis B or C infection.

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Conditions

The condition(s) this trial relates to.

autosomal dominant Parkinson disease 4 endometrial cancer endometrial carcinoma endometrium neoplasm uterine cancer

As listed by the trial registrant

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

Endometrial cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

226 sites in 22 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Research Site
WITHDRAWN

Tucson, Arizona, 85704, United States
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Little Rock, Arkansas, 72205, United States
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Duarte, California, 91010, United States
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Irvine, California, 92618, United States
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La Jolla, California, 92037, United States
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Palo Alto, California, 94304, United States
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San Francisco, California, 94143, United States
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Sylmar, California, 91342, United States
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Fort Myers, Florida, 33901, United States
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Miami, Florida, 33133, United States
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Miami Beach, Florida, 33140, United States
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Orlando, Florida, 32804, United States
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St. Petersburg, Florida, 33705, United States
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Tampa, Florida, 33612, United States
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West Palm Beach, Florida, 33401, United States
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Augusta, Georgia, 30912, United States
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Honolulu, Hawaii, 96813, United States
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Arlington Heights, Illinois, 60005, United States
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Evanston, Illinois, 60201, United States
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Shreveport, Louisiana, 71103, United States
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Baltimore, Maryland, 21201, United States
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Silver Spring, Maryland, 20910, United States
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Boston, Massachusetts, 02111, United States
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Worcester, Massachusetts, 01655, United States
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Ann Arbor, Michigan, 48109, United States
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Detroit, Michigan, 48201, United States
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Marshall, Minnesota, 56258, United States
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Minneapolis, Minnesota, 55455, United States
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Rochester, Minnesota, 55905, United States
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Jackson, Mississippi, 39216, United States
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Springfield, Missouri, 65804, United States
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St Louis, Missouri, 63141, United States
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Las Vegas, Nevada, 89169, United States
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Lebanon, New Hampshire, 03756, United States
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Hackensack, New Jersey, 07601, United States
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Albuquerque, New Mexico, 87109, United States
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New York, New York, 10016, United States
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New York, New York, 10065, United States
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New York, New York, 10075, United States
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Charlotte, North Carolina, 28204, United States
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Charlotte, North Carolina, 28204, United States
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Winston-Salem, North Carolina, 27103, United States
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Winston-Salem, North Carolina, 27157, United States
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Cincinnati, Ohio, 45220, United States
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Columbus, Ohio, 43210, United States
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Oklahoma City, Oklahoma, 73104, United States
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Tulsa, Oklahoma, 74134, United States
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Eugene, Oregon, 97401, United States
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Abington, Pennsylvania, 19001, United States
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Philadelphia, Pennsylvania, 19111, United States
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Pittsburgh, Pennsylvania, 15224, United States
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Providence, Rhode Island, 02905, United States
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Charleston, South Carolina, 29425, United States
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Sioux Falls, South Dakota, 57105, United States
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Austin, Texas, 78758, United States
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Fort Worth, Texas, 76104, United States
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Houston, Texas, 77030, United States
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San Antonio, Texas, 78240, United States
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Charlottesville, Virginia, 22908, United States
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Fairfax, Virginia, 22031, United States
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Seattle, Washington, 98133, United States
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Madison, Wisconsin, 53792, United States
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Blacktown, 2148, Australia
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East Melbourne, 3002, Australia
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Nedlands, 6009, Australia
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South Brisbane, 4101, Australia
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Innsbruck, 6020, Austria
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Linz, 4021, Austria
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Vienna, 1090, Austria
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Wein, 1130, Austria
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Anderlecht, 1070, Belgium
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Brussels, 1200, Belgium
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Charleroi, 6060, Belgium
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Ghent, 9000, Belgium
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Barretos, 14784-057, Brazil
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Belo Horizonte, 30130 100, Brazil
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Goiânia, 74000-000, Brazil
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Londrina, 86015-520, Brazil
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Porto Alegre, 90020-090, Brazil
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Porto Alegre, 90610000, Brazil
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Rio de Janeiro, 20220-410, Brazil
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Salvador, 41.950-610, Brazil
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São Paulo, 01246-000, Brazil
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São Paulo, 01317-001, Brazil
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São Paulo, 1409, Brazil
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Teresina, 64049-200, Brazil
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Calgary, Alberta, T2N 5G2, Canada
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Edmonton, Alberta, T6G 1Z2, Canada
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Winnipeg, Manitoba, R3E 0V9, Canada
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Halifax, Nova Scotia, B3H 2Y9, Canada
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London, Ontario, N6A 4L6, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Montreal, Quebec, H1T 2M4, Canada
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Montreal, Quebec, H2X 0A9, Canada
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Montreal, Quebec, H3G 1A4, Canada
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Québec, Quebec, G1J 1Z4, Canada
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Beijing, 100142, China
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Changchun, 130021, China
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Changsha, 410013, China
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Chengdu, 610041, China
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Chengdu, 610072, China
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Chongqing, 400030, China
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Fuzhou, 350001, China
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Fuzhou, 350014, China
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Guangzhou, 510060, China
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Guangzhou, 510080, China
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Guangzhou, 510120, China
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Haikou, 570311, China
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Hangzhou, 310022, China
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Harbin, 150049, China
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Hefei, 230001, China
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Jinan, 250021, China
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Jinan, 250117, China
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Jining, 272029, China
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Kunming, 650118, China
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Lanzhou, 730030, China
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Nanchang, 330006, China
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Nanning, 530021, China
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Shanghai, 200011, China
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Shanghai, 201318, China
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Shantou, China
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Shenyang, 110004, China
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Shenyang, 110042, China
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Taiyuan, 030001, China
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Tianjin, 300060, China
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Ürümqi, 830000, China
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Wuhan, 430000, China
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Wuhan, 430022, China
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Xi'an, 710061, China
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Xuzhou, 221009, China
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Yibin, 610500, China
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Aalborg, 9100, Denmark
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Herlev, 2730, Denmark
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København Ø, 2100, Denmark
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Odense, 5000, Denmark
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Helsinki, 00290, Finland
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Oulu, 90029, Finland
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Tampere, 33520, Finland
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Turku, 20521, Finland
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Besançon, 25030, France
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Bordeaux, 33076, France
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Caen, 14076, France
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Clermont-Ferrand, 63000, France
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Lyon, 69373, France
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Montpellier, 34298, France
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Nice, 06100, France
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Paris, 75015, France
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Plérin, 22190, France
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Poitiers, 86021, France
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SUSPENDED

Saint-Herblain, 44805, France
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Toulouse, 31059, France
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Berlin, 13353, Germany
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NOT_YET_RECRUITING

Chemnitz, 09116, Germany
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Dessau, 06847, Germany
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Dresden, 01307, Germany
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NOT_YET_RECRUITING

Düsseldorf, 40225, Germany
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NOT_YET_RECRUITING

Essen, 45147, Germany
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NOT_YET_RECRUITING

Hamburg, 20246, Germany
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NOT_YET_RECRUITING

Kassel, 34125, Germany
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NOT_YET_RECRUITING

Kiel, 24105, Germany
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Leipzig, 04103, Germany
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NOT_YET_RECRUITING

Mannheim, 68167, Germany
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WITHDRAWN

Marburg, 35043, Germany
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NOT_YET_RECRUITING

München, 80637, Germany
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NOT_YET_RECRUITING

Münster, 48149, Germany
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Saarbrücken, 66113, Germany
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Budapest, 1088, Hungary
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Budapest, 1122, Hungary
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Debrecen, 4032, Hungary
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Catania, 95100, Italy
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Florence, 50134, Italy
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Milan, 20141, Italy
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Milan, 20159, Italy
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Milan, 20162, Italy
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Monza, 20900, Italy
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Naples, 80131, Italy
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Reggio Emilia, 422122, Italy
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Roma, 00144, Italy
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Rome, 00168, Italy
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Torino, 10128, Italy
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Turin, 10128, Italy
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WITHDRAWN

Akashi-shi, 673-8558, Japan
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Ginowan-shi, 901-2725, Japan
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Hidaka-shi, 350-1298, Japan
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Isehara-shi, 259-1193, Japan
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Kashiwa, 227-8577, Japan
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Kashiwa-shi, 277-8567, Japan
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Kobe, 650-0047, Japan
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Kōtoku, 135-8550, Japan
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Kurume-shi, 830-0011, Japan
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Matsuyama, 791-0280, Japan
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Morioka, 028-3695, Japan
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Nagoya, 464-8681, Japan
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Niigata, 951-8520, Japan
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Osaka, 541-8567, Japan
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Ota-shi, 373-8550, Japan
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Sapporo, 060-8638, Japan
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Sendai, 980-8574, Japan
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Shinjuku-ku, 160-8582, Japan
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Sunto-gun, 411-8777, Japan
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Tokyo, 104-0045, Japan
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NOT_YET_RECRUITING

Yokohama, 241-8515, Japan
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WITHDRAWN

Amsterdam, 1066CX, Netherlands
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Leiden, 2333 ZA, Netherlands
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Nijmegen, 6525 GA, Netherlands
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Rotterdam, 3015 GD, Netherlands
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Oslo, 0379, Norway
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Stavanger, 4011, Norway
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Bialystok, 15-027, Poland
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Gdansk, 80-214, Poland
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Lodz, 93-338, Poland
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Poznan, 60-569, Poland
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Siedlce, 08-110, Poland
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Szczecin, 70-111, Poland
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Goyang-si, 10408, South Korea
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Seoul, 03080, South Korea
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Seoul, 03722, South Korea
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Seoul, 05505, South Korea
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Seoul, 06351, South Korea
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Suwon, 16499, South Korea
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A Coruña, 15009, Spain
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Córdoba, 14004, Spain
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Donostia / San Sebastian, 20014, Spain
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El Palmar, 30120, Spain
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L'Hospitalet de Llobregat, 08908, Spain
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Madrid, 28034, Spain
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Madrid, 28041, Spain
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NOT_YET_RECRUITING

Palma de Mallorca, 07010, Spain
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Valencia, 46006, Spain
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Valencia, 46009, Spain
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Zaragoza, 50009, Spain
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Linköping, 581 85, Sweden
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Lund, 22185, Sweden
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Stockholm, 17164, Sweden
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Uppsala, 751 85, Sweden
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Frauenfeld, 8501, Switzerland
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Liestal, CH- 4410, Switzerland
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Sankt Gallen, 9007, Switzerland
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Zurich, 8091, Switzerland
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Changhua, 500, Taiwan
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Kaohsiung City, 81362, Taiwan
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New Taipei City, 220, Taiwan
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Taichung, 40705, Taiwan
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Tainan, 704, Taiwan
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Taipei, 10449, Taiwan
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Bath, BA1 3NG, United Kingdom
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Cambridge, CB2 0QQ, United Kingdom
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Leeds, LS9 7TF, United Kingdom
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London, EC1A 7BE, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Northwood, HA6 2RN, United Kingdom
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Taunton, TA1 5DA, United Kingdom

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