Endometrial CancerPhase 3DE-01NCT06989112

DESTINY-Endometrial01: A Phase III Study of Trastuzumab Deruxtecan Plus Rilvegostomig or Pembrolizumab as First-Line Treatment of HER2-Expressing (IHC 3+/2+), Mismatch Repair Proficient (pMMR) Endometrial Cancer

A Phase 3 study testing Trastuzumab deruxtecan, Rilvegostomig and Pembrolizumab in people with Endometrial Cancer, run by AstraZeneca at 257 sites in 23 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

DESTINY-Endometrial01 will investigate the efficacy of first-line T-DXd + rilvegostomig (Arm A) and/or T-DXd+ pembrolizumab (Arm B) when compared to chemotherapy (carboplatin + paclitaxel) + pembrolizumab (Arm C), by assessment of progression free survival (PFS), as assessed by BICR, in participants with… Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Endometrial Cancer
What is being tested?: Trastuzumab deruxtecan, Rilvegostomig and Pembrolizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 600 participants
Where: 257 sitesin 23 countries
Study dates: 27 Mar 2025to 19 Feb 2031
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

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

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

≥ 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:
Primary Stage III (per FIGO 2023) disease with measurable disease at baseline per RECIST 1.1 based on the investigator's assessment.
Primary Stage IV (per FIGO 2023) disease regardless of presence of measurable disease at baseline.
Recurrent disease regardless of presence of measurable disease at baseline.

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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:
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.
No prior exposure to antibody-drug conjugates or immune checkpoint inhibitors
Participants may have received prior radiation therapy for the treatment of endometrial cancer. Adequate treatment washout period is required
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.

Who cannot join

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:
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.).

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Any autoimmune, connective tissue or inflammatory disorders where there is documented, or a suspicion of pulmonary involvement at the time of screening.
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:
Active tuberculosis
HIV infection that is not well controlled.
Active hepatitis B or C infection.

Trial locations and contacts

257 sites in 23 countries. Contact the study team or a site near you to ask about taking part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

Country

City, postcode or hospital

Sites recruiting now only

257 sites in 23 countries

United States63 sites, 49 recruiting

Research Site
Abington, Pennsylvania, 19001
Withdrawn
Research Site
Albuquerque, New Mexico, 87109
Withdrawn
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Ann Arbor, Michigan, 48109
Recruiting
Research Site
Arlington Heights, Illinois, 60005
Recruiting
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Augusta, Georgia, 30912
Withdrawn
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Austin, Texas, 78758
Recruiting
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Baltimore, Maryland, 21201
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Boston, Massachusetts, 02111
Recruiting
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Charleston, South Carolina, 29425
Recruiting
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Charlotte, North Carolina, 28204
Recruiting
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Charlotte, North Carolina, 28204
Not yet recruiting
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Charlottesville, Virginia, 22908
Recruiting
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Cincinnati, Ohio, 45220
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Research Site
Columbus, Ohio, 43210
Recruiting
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Detroit, Michigan, 48201
Withdrawn
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Duarte, California, 91010
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Eugene, Oregon, 97401
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Evanston, Illinois, 60201
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Fairfax, Virginia, 22031
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Fort Myers, Florida, 33901
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Fort Worth, Texas, 76104
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Hackensack, New Jersey, 07601
Recruiting
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Hershey, Pennsylvania, 17033
Not yet recruiting
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Honolulu, Hawaii, 96813
Withdrawn
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Houston, Texas, 77030
Recruiting
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Irvine, California, 92618
Recruiting
Research Site
Jackson, Mississippi, 39216
Recruiting
Research Site
La Jolla, California, 92037
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Las Vegas, Nevada, 89169
Withdrawn
Research Site
Lebanon, New Hampshire, 03756
Recruiting
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Little Rock, Arkansas, 72205
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Madison, Wisconsin, 53792
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Marshall, Minnesota, 56258
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Miami, Florida, 33133
Not yet recruiting
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Miami Beach, Florida, 33140
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Minneapolis, Minnesota, 55455
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Research Site
New York, New York, 10016
Withdrawn
Research Site
New York, New York, 10065
Recruiting
Research Site
New York, New York, 10075
Withdrawn
Research Site
Oklahoma City, Oklahoma, 73104
Not yet recruiting
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Orlando, Florida, 32804
Not yet recruiting
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Palo Alto, California, 94304
Withdrawn
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Philadelphia, Pennsylvania, 19111
Recruiting
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Pittsburgh, Pennsylvania, 15224
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Research Site
Providence, Rhode Island, 02905
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Rochester, Minnesota, 55905
Recruiting
Research Site
San Antonio, Texas, 78240
Recruiting
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San Francisco, California, 94143
Not yet recruiting
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Seattle, Washington, 98133
Withdrawn
Research Site
Shreveport, Louisiana, 71103
Recruiting
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Silver Spring, Maryland, 20910
Not yet recruiting
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Sioux Falls, South Dakota, 57105
Recruiting
Research Site
Springfield, Missouri, 65804
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St Louis, Missouri, 63141
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Research Site
St. Petersburg, Florida, 33705
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Sylmar, California, 91342
Withdrawn
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Tampa, Florida, 33612
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Tucson, Arizona, 85704
Withdrawn
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Tulsa, Oklahoma, 74134
Withdrawn
Research Site
West Palm Beach, Florida, 33401
Recruiting
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Winston-Salem, North Carolina, 27103
Recruiting
Research Site
Winston-Salem, North Carolina, 27157
Not yet recruiting
Research Site
Worcester, Massachusetts, 01655
Withdrawn

Other trials in United States

China35 sites, 31 recruiting

Research Site
Beijing, 100142
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Changchun, 130021
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Changsha, 410013
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Chengdu, 610041
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Chengdu, 610072
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Chongqing, 400030
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Fuzhou, 350001
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Fuzhou, 350014
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Guangzhou, 510060
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Guangzhou, 510080
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Guangzhou, 510120
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Haikou, 570311
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Hangzhou, 310022
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Harbin, 150049
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Hefei, 230001
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Jinan, 250021
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Jinan, 250117
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Jining, 272029
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Kunming, 650118
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Lanzhou, 730030
Withdrawn
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Nanchang, 330006
Withdrawn
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Nanning, 530021
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Shanghai, 200011
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Shanghai, 201318
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Shantou
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Shenyang, 110004
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Shenyang, 110042
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Taiyuan, 030001
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Tianjin, 300060
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Ürümqi, 830000
Withdrawn
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Wuhan, 430000
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Wuhan, 430022
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Research Site
Xi'an, 710061
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Research Site
Xuzhou, 221009
Recruiting
Research Site
Yibin, 610500
Withdrawn

Other trials in China

Japan21 sites, 20 recruiting

Research Site
Akashi-shi, 673-8558
Withdrawn
Research Site
Ginowan-shi, 901-2725
Recruiting
Research Site
Hidaka-shi, 350-1298
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Research Site
Isehara-shi, 259-1193
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Kashiwa, 227-8577
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Kashiwa-shi, 277-8567
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Kobe, 650-0047
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Research Site
Kōtoku, 135-8550
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Kurume-shi, 830-0011
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Matsuyama, 791-0280
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Morioka, 028-3695
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Nagoya, 464-8681
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Niigata, 951-8520
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Osaka, 541-8567
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Ota-shi, 373-8550
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Sapporo, 060-8638
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Sendai, 980-8574
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Shinjuku-ku, 160-8582
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Sunto-gun, 411-8777
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Tokyo, 104-0045
Recruiting
Research Site
Yokohama, 241-8515
Not yet recruiting

Other trials in Japan

Germany15 sites, 14 recruiting

Research Site
Berlin, 13353
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Chemnitz, 09116
Not yet recruiting
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Dessau, 06847
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Dresden, 01307
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Düsseldorf, 40225
Not yet recruiting
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Essen, 45147
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Hamburg, 20246
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Kassel, 34125
Not yet recruiting
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Kiel, 24105
Not yet recruiting
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Leipzig, 04103
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Mannheim, 68167
Not yet recruiting
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Marburg, 35043
Withdrawn
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München, 80637
Not yet recruiting
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Münster, 48149
Not yet recruiting
Research Site
Saarbrücken, 66113
Recruiting

Other trials in Germany

Brazil12 sites, 12 recruiting

Research Site
Barretos, 14784-057
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Belo Horizonte, 30130 100
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Goiânia, 74000-000
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Londrina, 86015-520
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Porto Alegre, 90020-090
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Porto Alegre, 90610000
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Rio de Janeiro, 20220-410
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Research Site
Salvador, 41.950-610
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São Paulo, 01246-000
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Research Site
São Paulo, 01317-001
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Research Site
São Paulo, 1409
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Research Site
Teresina, 64049-200
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Other trials in Brazil

Canada12 sites, 10 recruiting

Research Site
Calgary, Alberta, T2N 5G2
Recruiting
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Edmonton, Alberta, T6G 1Z2
Recruiting
Research Site
Halifax, Nova Scotia, B3H 2Y9
Withdrawn
Research Site
London, Ontario, N6A 4L6
Recruiting
Research Site
Montreal, Quebec, H1T 2M4
Recruiting
Research Site
Montreal, Quebec, H2X 0A9
Recruiting
Research Site
Montreal, Quebec, H3G 1A4
Recruiting
Research Site
Montreal, Quebec, H3T 1E2
Not yet recruiting
Research Site
Québec, Quebec, G1J 1Z4
Recruiting
Research Site
Toronto, Ontario, M4N 3M5
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Research Site
Toronto, Ontario, M5G 2M9
Recruiting
Research Site
Winnipeg, Manitoba, R3E 0V9
Withdrawn

Other trials in Canada

France12 sites, 10 recruiting

Research Site
Besançon, 25030
Withdrawn
Research Site
Bordeaux, 33076
Recruiting
Research Site
Caen, 14076
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Research Site
Clermont-Ferrand, 63000
Recruiting
Research Site
Lyon, 69373
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Research Site
Montpellier, 34298
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Research Site
Nice, 06100
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Paris, 75015
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Research Site
Plérin, 22190
Recruiting
Research Site
Poitiers, 86021
Recruiting
Research Site
Saint-Herblain, 44805
Suspended
Research Site
Toulouse, 31059
Recruiting

Other trials in France

Italy12 sites, 12 recruiting

Research Site
Catania, 95100
Recruiting
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Florence, 50134
Recruiting
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Milan, 20141
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Milan, 20159
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Milan, 20162
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Monza, 20900
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Naples, 80131
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Reggio Emilia, 422122
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Roma, 00144
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Research Site
Rome, 00168
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Research Site
Torino, 10128
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Research Site
Turin, 10128
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Other trials in Italy

Spain11 sites, 11 recruiting

Research Site
A Coruña, 15009
Recruiting
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Córdoba, 14004
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Donostia / San Sebastian, 20014
Recruiting
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El Palmar, 30120
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Research Site
L'Hospitalet de Llobregat, 08908
Recruiting
Research Site
Madrid, 28034
Recruiting
Research Site
Madrid, 28041
Recruiting
Research Site
Palma de Mallorca, 07010
Not yet recruiting
Research Site
Valencia, 46006
Recruiting
Research Site
Valencia, 46009
Recruiting
Research Site
Zaragoza, 50009
Recruiting

Other trials in Spain

United Kingdom7 sites, 7 recruiting

Research Site
Bath, BA1 3NG
Recruiting
Research Site
Cambridge, CB2 0QQ
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Research Site
Leeds, LS9 7TF
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Research Site
London, EC1A 7BE
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Manchester, M20 4BX
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Research Site
Northwood, HA6 2RN
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Research Site
Taunton, TA1 5DA
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Other trials in United Kingdom

Belgium6 sites, 5 recruiting

Research Site
Anderlecht, 1070
Recruiting
Research Site
Brussels, 1200
Recruiting
Research Site
Charleroi, 6060
Withdrawn
Research Site
Ghent, 9000
Recruiting
Research Site
Leuven, 3000
Recruiting
Research Site
Liège, 4000
Recruiting

Other trials in Belgium

Poland6 sites, 6 recruiting

Research Site
Bialystok, 15-027
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Gdansk, 80-214
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Research Site
Lodz, 93-338
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Research Site
Poznan, 60-569
Recruiting
Research Site
Siedlce, 08-110
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Research Site
Szczecin, 70-111
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Other trials in Poland

South Korea6 sites, 6 recruiting

Research Site
Goyang-si, 10408
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Research Site
Seoul, 03080
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Research Site
Seoul, 03722
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Research Site
Seoul, 05505
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Research Site
Seoul, 06351
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Research Site
Suwon, 16499
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Other trials in South Korea

Taiwan6 sites, 6 recruiting

Research Site
Changhua, 500
Recruiting
Research Site
Kaohsiung City, 81362
Recruiting
Research Site
New Taipei City, 220
Recruiting
Research Site
Taichung, 40705
Recruiting
Research Site
Tainan, 704
Recruiting
Research Site
Taipei, 10449
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Other trials in Taiwan

Australia4 sites, 4 recruiting

Research Site
Blacktown, 2148
Recruiting
Research Site
East Melbourne, 3002
Recruiting
Research Site
Nedlands, 6009
Recruiting
Research Site
South Brisbane, 4101
Recruiting

Other trials in Australia

Austria4 sites, 4 recruiting

Research Site
Innsbruck, 6020
Not yet recruiting
Research Site
Linz, 4021
Not yet recruiting
Research Site
Vienna, 1090
Not yet recruiting
Research Site
Wein, 1130
Recruiting

Other trials in Austria

Denmark4 sites, 3 recruiting

Research Site
Aalborg, 9100
Recruiting
Research Site
Herlev, 2730
Withdrawn
Research Site
København Ø, 2100
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Research Site
Odense, 5000
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Other trials in Denmark

Finland4 sites, 4 recruiting

Research Site
Helsinki, 00290
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Research Site
Oulu, 90029
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Tampere, 33520
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Research Site
Turku, 20521
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Other trials in Finland

Netherlands4 sites

Research Site
Amsterdam, 1066CX
Withdrawn
Research Site
Leiden, 2333 ZA
Withdrawn
Research Site
Nijmegen, 6525 GA
Withdrawn
Research Site
Rotterdam, 3015 GD
Withdrawn

Other trials in Netherlands

Sweden4 sites, 4 recruiting

Research Site
Linköping, 581 85
Recruiting
Research Site
Lund, 22185
Recruiting
Research Site
Stockholm, 17164
Recruiting
Research Site
Uppsala, 751 85
Recruiting

Other trials in Sweden

Switzerland4 sites, 3 recruiting

Research Site
Frauenfeld, 8501
Withdrawn
Research Site
Liestal, CH- 4410
Recruiting
Research Site
Sankt Gallen, 9007
Recruiting
Research Site
Zurich, 8091
Recruiting

Other trials in Switzerland

Hungary3 sites, 3 recruiting

Research Site
Budapest, 1088
Recruiting
Research Site
Budapest, 1122
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Research Site
Debrecen, 4032
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Other trials in Hungary

Norway2 sites, 2 recruiting

Research Site
Oslo, 0379
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Research Site
Stavanger, 4011
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Other trials in Norway

About this study

Official title: DESTINY-Endometrial01: An Open-Label, Sponsor-Blinded, Randomized, Controlled, Multicenter, Phase III Study of Trastuzumab Deruxtecan (T-DXd) Plus Rilvegostomig or Pembrolizumab vs Chemotherapy Plus Pembrolizumab as First-Line Therapy of HER2-Expressing (IHC 3+/2+), Mismatch Repair Proficient (pMMR), Primary Advanced or Recurrent Endometrial Cancer

Conditions: Endometrial Cancer
Being tested: Trastuzumab deruxtecan, Rilvegostomig, Pembrolizumab, Carboplatin, Paclitaxel
Keywords: Endometrial Cancer, Uterine Cancer, Endometrial Carcinoma, Human epidermal growth factor receptor 2 (HER2), pMMR, Trastuzumab deruxtecan, T-DXd, DS-8201a, Anti-HER2-Antibody Drug Conjugate(ADC), DESTINY-Endometrial01, Programmed Cell Death-1 (PD1, PD-1), Immune checkpoint inhibitor, TIGIT, Pembrolizumab, Carboplatin, Paclitaxel, Rilvegostomig
Medical subject headings: Endometrial Neoplasms, Uterine Neoplasms, Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

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

Trastuzumab deruxtecanDrug
Also called DS-8201a, T-DXd
Experimental therapy by intravenous infusion
RilvegostomigDrug
Experimental therapy by intravenous infusion
PembrolizumabDrug
Also called Keytruda
Immunotherapy by intravenous infusion
CarboplatinDrug
Also called Carbomedac, Carbosin, Paraplatin
Standard of Care (SoC) chemotherapy by intravenous infusion
PaclitaxelDrug
Also called Anzatax, Ebetaxel, Oncotaxel, Paclitax, Paclitaxin, Paxene, Taxol
Standard of Care (SoC) chemotherapy by intravenous infusion
DocetaxelDrug
Also called Docirena, Taxceus, Taxotere
Standard of Care (SoC) chemotherapy by intravenous infusion

Study groups in NCT06989112
Study group	Role	What they receive
Arm A: T-DXd + Rilvegostomig	Experimental	T-DXd IV Q3W plus rilvegostomig IV Q3W. Treatment will continue until objective disease progression according to RECIST v1.1 as assessed by the Investigator and confirmed by BICR or until other discontinuation criteria is met, whichever occurs first. Receives: Drug: Trastuzumab deruxtecan; Drug: Rilvegostomig
Arm B: T-DXd + Pembrolizumab	Experimental	T-DXd IV Q3W plus pembrolizumab IV Q3W. Treatment will continue until objective disease progression according to RECIST v1.1 as assessed by the Investigator and confirmed by BICR or until other discontinuation criteria is met, whichever occurs first. Receives: Drug: Trastuzumab deruxtecan; Drug: Pembrolizumab
Arm C: Carboplatin + Paclitaxel + Pembrolizumab	Active comparator	Carboplatin, paclitaxel and pembrolizumab administered Q3W for 6 cycles, followed by maintenance with pembrolizumab IV Q6W for 14 cycles. Treatment with pembrolizumab will continue for up to 20 total cycles (approximately 24 months, accounting for combination and maintenance phases) or until other discontinuation criteria is met, whichever occurs first. At the discretion of the investigator, participants may continue to receive carboplatin, paclitaxel and pembrolizumab Q3W for up to 10 cycles. Docetaxel can be used as an alternative to paclitaxel for participants who had a hypersensitivity reaction to paclitaxel with a failed rechallenge (or not amenable to rechallenge), according to the investigator's clinical judgment. Receives: Drug: Pembrolizumab; Drug: Carboplatin; Drug: Paclitaxel; Drug: Docetaxel

What is being measured

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

Progression-free survival (PFS), as assessed by BICR
Defined as time from randomization until progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR), or death due to any cause.
Measured: Until progression or death due to any cause (assessed up to approximately 45 months).

Secondary outcomes (13)

Overall Survival (OS)
Defined as the time from randomization until the date of death due to any cause.
Measured: Until the date of death due to any cause (assessed up to approximately 70 months).
Progression Free Survival (PFS) as assessed by the investigator
PFS by investigator has the same attributes as estimand of PFS by BICR except tumor assessment is by the investigator.
Measured: Until progression or death due to any cause (assessed up to approximately 70 months).
Time from randomization to second progression or death (PFS2)
PFS2 will be defined as the time from randomization to the earliest of the progression event (following the initial investigator-assessed progression), after first subsequent therapy, or death.
Measured: Until the earliest of the progression event (following the initial investigator-assessed progression), after first subsequent therapy, or death (assessed up to approximately 70 months).
Objective response rate (ORR), as assessed by BICR and investigator
ORR as assessed and confirmed by BICR is defined as the proportion of participants who have a complete response (CR) or partial response (PR), as determined and confirmed by BICR. ORR as assessed and confirmed by the investigator has the same attributes as estimand of ORR by BICR except tumor assessment per the investigator.
Measured: Until progression or the starting of subsequent anticancer therapy (assessed up to approximately 45 months).
Duration of response (DoR), as assessed by BICR and investigator
DoR as assessed by BICR will be defined as the time from the date of first documented response of confirmed responders until date of documented progression per RECIST 1.1, or death due to any cause.
DoR as assessed by the investigator has the same attributes as estimand of DoR by BICR except tumor assessment per the investigator.
Measured: Until progression or death due to any cause (assessed up to approximately 45 months).
Safety and tolerability
Safety and tolerability will be evaluated in terms of AEs/serious AEs (SAEs), AESI, vital signs, clinical safety laboratory assessments, ECG and ECHO/MUGA scan results.
Measured: Safety is assessed until the 90 days (+7) after the last dose (assessed up to approximately 70 months).
Pharmacokinetics of T-DXd, total anti-HER2 antibody, DXd and rilvegostomig
Serum concentration of T-DXd, total anti-HER2 antibody, DXd and rilvegostomig.
Measured: Up to safety follow-up period (assessed up to approximately 45 months).
Immunogenicity of T- DXd and rilvegostomig
Presence of ADAs for T-DXd or rilvegostomig.
Measured: Up to safety follow-up period (assessed up to approximately 45 months).
Patient-reported tolerability
Patient-reported tolerability will be described among participants, as treated, using the following outcomes:
- Symptomatic AEs: Descriptive summary of the proportion of participants reporting symptomatic AEs while on treatment, as assessed by items from the EORTC Item Library and the FACT/GOG-NTX-4
- Overall side-effect bother: Descriptive summary of the proportion of participants reporting overall side-effect bother on the PGI-TT while on treatment
Measured: Until progression as assessed by BICR (assessed up to approximately 45 months).
Progression-free survival (PFS) according to MMR status to determine the clinical utility of a MMR diagnostic test
PFS is defined as time from randomization until progression per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) as assessed by BICR, or death due to any cause.
Measured: Through completion of study, assessed up to approximately 70 months.
Overall survival (OS) according to MMR status to determine the clinical utility of a MMR diagnostic test
OS defined as the time from randomization until the date of death due to any cause.
Measured: Through completion of study, assessed up to approximately 70 months.
Progression-free survival (PFS) according to HER2 expression to determine the clinical utility of a HER2 diagnostic test
PFS is defined as time from randomization until progression per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) as assessed by BICR, or death due to any cause.
Measured: Through completion of study, assessed up to approximately 70 months.
Overall survival (OS) according to HER2 expression to determine the clinical utility of a HER2 diagnostic test
OS is defined as the time from randomization until the date of death due to any cause.
Measured: Through completion of study, assessed up to approximately 70 months.

Timeline

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

27 Mar 202519 Feb 2031

First posted25 May 2025
Study start27 Mar 2025
Primary completion19 Jan 2029 (estimated)
Study completion19 Feb 2031 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Endometrial CancerStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Participants with HER2-expressing (IHC 3+/2+), pMMR, primary advanced (Stage III/IV) or recurrent EC will be randomly assigned to treatment with trastuzumab deruxtecan (T-DXd) plus rilvegostomig (Arm A), T-DXd plus pembrolizumab (Arm B), or chemotherapy (carboplatin plus paclitaxel) plus pembrolizumab (Arm C).
Masking: None (open label)
Enrolment: 600 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06989112
Sponsor's protocol ID: D781DC00001
Other IDs: 2023-508056-19-00, GOG-3098, ENGOT-EN24, 2023
Acronym: DE-01
Status last verified: Oct 2026
First submitted: 11 Mar 2025
Last updated: 13 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

Interested in taking part?

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

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

Questions to ask the study team

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

See sites and contacts

Recruiting
Feasibility of the "One-Finger Technique" for Identifying the Upper Left Ureter During Para-Aortic Lymphadenectomy
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A Study of LY4257496 in Participants With Cancer (OMNIRAY)
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RecruitingPhase 1
A Phase 1 Study to Evaluate OPB-201 in Recurrent Endometrial and Platinum-resistant Ovarian Cancer.
Endometrial Cancer Recurrent, Endometrial Cancer
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)
Recurrent or Metastatic Solid Tumors
RecruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8

All Endometrial Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: DESTINY-Endometrial01: An Open-Label, Sponsor-Blinded, Randomized, Controlled, Multicenter, Phase III Study of Trastuzumab Deruxtecan (T-DXd) Plus Rilvegostomig or Pembrolizumab vs Chemotherapy Plus Pembrolizumab as First-Line Therapy of HER2-Expressing (IHC 3+/2+), Mismatch Repair Proficient (pMMR), Primary Advanced or Recurrent Endometrial Cancer
ClinicalTrials.gov ID: NCT06989112
Acronym / sponsor ID: DE-01 / D781DC00001
Conditions: Endometrial Cancer
Keywords: Endometrial Cancer, Uterine Cancer, Endometrial Carcinoma, Human epidermal growth factor receptor 2 (HER2), pMMR, Trastuzumab deruxtecan, T-DXd, DS-8201a
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 600 participants (estimated)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Daiichi Sankyo Co., Ltd., GOG Foundation, European Network of Gynaecological Oncological Trial Groups (ENGOT)
Study start: 27 Mar 2025 (actual)
Primary completion: 19 Jan 2029 (estimated)
Study completion: 19 Feb 2031 (estimated)
First posted: 25 May 2025 (actual)
Results: Not posted in the source record

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: Participants with HER2-expressing (IHC 3+/2+), pMMR, primary advanced (Stage III/IV) or recurrent EC will be randomly assigned to treatment with trastuzumab deruxtecan (T-DXd) plus rilvegostomig (Arm A), T-DXd plus pembrolizumab (Arm B), or chemotherapy (carboplatin plus paclitaxel) plus pembrolizumab (Arm C).

Arm	Type	Receives
Arm A: T-DXd + Rilvegostomig	Experimental	Drug: Trastuzumab deruxtecan, Drug: RilvegostomigT-DXd IV Q3W plus rilvegostomig IV Q3W. Treatment will continue until objective disease progression according to RECIST v1.1 as assessed by the Investigator and confirmed by BICR or until other discontinuation criteria is met, whichever occurs first.
Arm B: T-DXd + Pembrolizumab	Experimental	Drug: Trastuzumab deruxtecan, Drug: PembrolizumabT-DXd IV Q3W plus pembrolizumab IV Q3W. Treatment will continue until objective disease progression according to RECIST v1.1 as assessed by the Investigator and confirmed by BICR or until other discontinuation criteria is met, whichever occurs first.
Arm C: Carboplatin + Paclitaxel + Pembrolizumab	Active comparator	Drug: Pembrolizumab, Drug: Carboplatin, Drug: Paclitaxel, Drug: DocetaxelCarboplatin, paclitaxel and pembrolizumab administered Q3W for 6 cycles, followed by maintenance with pembrolizumab IV Q6W for 14 cycles. Treatment with pembrolizumab will continue for up to 20 total cycles (approximately 24 months, accounting for combination and maintenance phases) or until other discontinuation criteria is met, whichever occurs first. At the discretion of the investigator, participants may continue to receive carboplatin, paclitaxel and pembrolizumab Q3W for up to 10 cycles. Docetaxel can be used as an alternative to paclitaxel for participants who had a hypersensitivity reaction to paclitaxel with a failed rechallenge (or not amenable to rechallenge), according to the investigator's clinical judgment.

Who may qualify

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

Key inclusion criteria (18 listed)

≥ 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:
Endometrial cancer with HER2 IHC expression of 3+ or 2+ by prospective central testing.
Endometrial cancer that is determined pMMR by prospective central testing.

Key exclusion criteria (15 listed)

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:

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

Interventions

Intervention	Type	Arms
Trastuzumab deruxtecanAlso: DS-8201a, T-DXdExperimental therapy by intravenous infusion	Drug	Arm A: T-DXd + Rilvegostomig, Arm B: T-DXd + Pembrolizumab
RilvegostomigExperimental therapy by intravenous infusion	Drug	Arm A: T-DXd + Rilvegostomig
PembrolizumabAlso: KeytrudaImmunotherapy by intravenous infusion	Drug	Arm B: T-DXd + Pembrolizumab, Arm C: Carboplatin + Paclitaxel + Pembrolizumab
CarboplatinAlso: Carbomedac, Carbosin, ParaplatinStandard of Care (SoC) chemotherapy by intravenous infusion	Drug	Arm C: Carboplatin + Paclitaxel + Pembrolizumab
PaclitaxelAlso: Anzatax, Ebetaxel, Oncotaxel, Paclitax, Paclitaxin, Paxene, TaxolStandard of Care (SoC) chemotherapy by intravenous infusion	Drug	Arm C: Carboplatin + Paclitaxel + Pembrolizumab
DocetaxelAlso: Docirena, Taxceus, TaxotereStandard of Care (SoC) chemotherapy by intravenous infusion	Drug	Arm C: Carboplatin + Paclitaxel + Pembrolizumab

Primary outcome

Progression-free survival (PFS), as assessed by BICR
Time frame: Until progression or death due to any cause (assessed up to approximately 45 months).
Defined as time from randomization until progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR), or death due to any cause.

13 secondary outcomes

Overall Survival (OS)
Time frame: Until the date of death due to any cause (assessed up to approximately 70 months).
Progression Free Survival (PFS) as assessed by the investigator
Time frame: Until progression or death due to any cause (assessed up to approximately 70 months).
Time from randomization to second progression or death (PFS2)
Time frame: Until the earliest of the progression event (following the initial investigator-assessed progression), after first subsequent therapy, or death (assessed up to approximately 70 months).
Objective response rate (ORR), as assessed by BICR and investigator
Time frame: Until progression or the starting of subsequent anticancer therapy (assessed up to approximately 45 months).
Duration of response (DoR), as assessed by BICR and investigator
Time frame: Until progression or death due to any cause (assessed up to approximately 45 months).
Safety and tolerability
Time frame: Safety is assessed until the 90 days (+7) after the last dose (assessed up to approximately 70 months).
Pharmacokinetics of T-DXd, total anti-HER2 antibody, DXd and rilvegostomig
Time frame: Up to safety follow-up period (assessed up to approximately 45 months).
Immunogenicity of T- DXd and rilvegostomig
Time frame: Up to safety follow-up period (assessed up to approximately 45 months).
Patient-reported tolerability
Time frame: Until progression as assessed by BICR (assessed up to approximately 45 months).
Progression-free survival (PFS) according to MMR status to determine the clinical utility of a MMR diagnostic test
Time frame: Through completion of study, assessed up to approximately 70 months.
Overall survival (OS) according to MMR status to determine the clinical utility of a MMR diagnostic test
Time frame: Through completion of study, assessed up to approximately 70 months.
Progression-free survival (PFS) according to HER2 expression to determine the clinical utility of a HER2 diagnostic test
Time frame: Through completion of study, assessed up to approximately 70 months.
Overall survival (OS) according to HER2 expression to determine the clinical utility of a HER2 diagnostic test
Time frame: Through completion of study, assessed up to approximately 70 months.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

Related trials for Endometrial Cancer

Recruiting
Feasibility of the "One-Finger Technique" for Identifying the Upper Left Ureter During Para-Aortic Lymphadenectomy
Ovary Cancer, Cervical Cancer
RecruitingPhase 1
A Study of LY4257496 in Participants With Cancer (OMNIRAY)
Breast Neoplasms, Colorectal Neoplasms
RecruitingPhase 1
A Phase 1 Study to Evaluate OPB-201 in Recurrent Endometrial and Platinum-resistant Ovarian Cancer.
Endometrial Cancer Recurrent, Endometrial Cancer
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)
Recurrent or Metastatic Solid Tumors
RecruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8

Referral and contact

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

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

257 sites in 23 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Trastuzumab deruxtecan, Rilvegostomig and Pembrolizumab in people with Endometrial Cancer, run by AstraZeneca at 257 sites in 23 countries.

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

Who may be eligible to take part?

The sponsor lists 18 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 257 sites in United States, China, Japan, Germany, Brazil and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

What does this phase mean?

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

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS), as assessed by BICR (time frame: Until progression or death due to any cause (assessed up to approximately 45 months).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06989112.

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

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

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.