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 (DE-01)

September 2, 2026 updated by: AstraZeneca

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

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 HER2-expressing (IHC 3+/2+), pMMR, primary advanced (Stage III/IV) or recurrent EC.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
      • Blacktown, Australia, 2148
        • Recruiting
        • Research Site
      • East Melbourne, Australia, 3002
        • Recruiting
        • Research Site
      • Nedlands, Australia, 6009
        • Recruiting
        • Research Site
      • South Brisbane, Australia, 4101
        • Recruiting
        • Research Site
  • Austria
      • Innsbruck, Austria, 6020
        • Not yet recruiting
        • Research Site
      • Linz, Austria, 4021
        • Not yet recruiting
        • Research Site
      • Vienna, Austria, 1090
        • Not yet recruiting
        • Research Site
      • Wein, Austria, 1130
        • Recruiting
        • Research Site
  • Belgium
      • Anderlecht, Belgium, 1070
        • Recruiting
        • Research Site
      • Brussels, Belgium, 1200
        • Recruiting
        • Research Site
      • Charleroi, Belgium, 6060
        • Withdrawn
        • Research Site
      • Ghent, Belgium, 9000
        • Recruiting
        • Research Site
      • Leuven, Belgium, 3000
        • Recruiting
        • Research Site
      • Liège, Belgium, 4000
        • Recruiting
        • Research Site
  • Brazil
      • Barretos, Brazil, 14784-057
        • Recruiting
        • Research Site
      • Belo Horizonte, Brazil, 30130 100
        • Recruiting
        • Research Site
      • Goiânia, Brazil, 74000-000
        • Recruiting
        • Research Site
      • Londrina, Brazil, 86015-520
        • Recruiting
        • Research Site
      • Porto Alegre, Brazil, 90020-090
        • Recruiting
        • Research Site
      • Porto Alegre, Brazil, 90610000
        • Recruiting
        • Research Site
      • Rio de Janeiro, Brazil, 20220-410
        • Recruiting
        • Research Site
      • Salvador, Brazil, 41.950-610
        • Recruiting
        • Research Site
      • São Paulo, Brazil, 01246-000
        • Recruiting
        • Research Site
      • São Paulo, Brazil, 01317-001
        • Recruiting
        • Research Site
      • São Paulo, Brazil, 1409
        • Recruiting
        • Research Site
      • Teresina, Brazil, 64049-200
        • Recruiting
        • Research Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Recruiting
        • Research Site
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Recruiting
        • Research Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • Withdrawn
        • Research Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Withdrawn
        • Research Site
    • Ontario
      • London, Ontario, Canada, N6A 4L6
        • Recruiting
        • Research Site
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Research Site
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Recruiting
        • Research Site
      • Montreal, Quebec, Canada, H2X 0A9
        • Recruiting
        • Research Site
      • Montreal, Quebec, Canada, H3G 1A4
        • Recruiting
        • Research Site
      • Québec, Quebec, Canada, G1J 1Z4
        • Recruiting
        • Research Site
  • China
      • Beijing, China, 100142
        • Recruiting
        • Research Site
      • Changchun, China, 130021
        • Recruiting
        • Research Site
      • Changsha, China, 410013
        • Recruiting
        • Research Site
      • Chengdu, China, 610041
        • Recruiting
        • Research Site
      • Chengdu, China, 610072
        • Recruiting
        • Research Site
      • Chongqing, China, 400030
        • Recruiting
        • Research Site
      • Fuzhou, China, 350001
        • Recruiting
        • Research Site
      • Fuzhou, China, 350014
        • Recruiting
        • Research Site
      • Guangzhou, China, 510120
        • Recruiting
        • Research Site
      • Guangzhou, China, 510080
        • Recruiting
        • Research Site
      • Guangzhou, China, 510060
        • Recruiting
        • Research Site
      • Haikou, China, 570311
        • Recruiting
        • Research Site
      • Hangzhou, China, 310022
        • Recruiting
        • Research Site
      • Harbin, China, 150049
        • Recruiting
        • Research Site
      • Hefei, China, 230001
        • Recruiting
        • Research Site
      • Jinan, China, 250117
        • Recruiting
        • Research Site
      • Jinan, China, 250021
        • Recruiting
        • Research Site
      • Jining, China, 272029
        • Recruiting
        • Research Site
      • Kunming, China, 650118
        • Recruiting
        • Research Site
      • Lanzhou, China, 730030
        • Recruiting
        • Research Site
      • Nanchang, China, 330006
        • Withdrawn
        • Research Site
      • Nanning, China, 530021
        • Recruiting
        • Research Site
      • Shanghai, China, 200011
        • Recruiting
        • Research Site
      • Shanghai, China, 201318
        • Recruiting
        • Research Site
      • Shantou, China
        • Recruiting
        • Research Site
      • Shenyang, China, 110042
        • Recruiting
        • Research Site
      • Shenyang, China, 110004
        • Recruiting
        • Research Site
      • Taiyuan, China, 030001
        • Recruiting
        • Research Site
      • Tianjin, China, 300060
        • Recruiting
        • Research Site
      • Wuhan, China, 430022
        • Recruiting
        • Research Site
      • Wuhan, China, 430000
        • Recruiting
        • Research Site
      • Xi'an, China, 710061
        • Recruiting
        • Research Site
      • Xuzhou, China, 221009
        • Recruiting
        • Research Site
      • Yibin, China, 610500
        • Withdrawn
        • Research Site
      • Ürümqi, China, 830000
        • Withdrawn
        • Research Site
  • Denmark
      • Aalborg, Denmark, 9100
        • Recruiting
        • Research Site
      • Herlev, Denmark, 2730
        • Withdrawn
        • Research Site
      • København Ø, Denmark, 2100
        • Recruiting
        • Research Site
      • Odense, Denmark, 5000
        • Recruiting
        • Research Site
  • Finland
      • Helsinki, Finland, 00290
        • Recruiting
        • Research Site
      • Oulu, Finland, 90029
        • Recruiting
        • Research Site
      • Tampere, Finland, 33520
        • Recruiting
        • Research Site
      • Turku, Finland, 20521
        • Recruiting
        • Research Site
  • France
      • Besançon, France, 25030
        • Withdrawn
        • Research Site
      • Bordeaux, France, 33076
        • Recruiting
        • Research Site
      • Caen, France, 14076
        • Recruiting
        • Research Site
      • Clermont-Ferrand, France, 63000
        • Recruiting
        • Research Site
      • Lyon, France, 69373
        • Recruiting
        • Research Site
      • Montpellier, France, 34298
        • Recruiting
        • Research Site
      • Nice, France, 06100
        • Recruiting
        • Research Site
      • Paris, France, 75015
        • Recruiting
        • Research Site
      • Plérin, France, 22190
        • Recruiting
        • Research Site
      • Poitiers, France, 86021
        • Recruiting
        • Research Site
      • Saint-Herblain, France, 44805
        • Suspended
        • Research Site
      • Toulouse, France, 31059
        • Recruiting
        • Research Site
  • Germany
      • Berlin, Germany, 13353
        • Recruiting
        • Research Site
      • Chemnitz, Germany, 09116
        • Not yet recruiting
        • Research Site
      • Dessau, Germany, 06847
        • Recruiting
        • Research Site
      • Dresden, Germany, 01307
        • Recruiting
        • Research Site
      • Düsseldorf, Germany, 40225
        • Not yet recruiting
        • Research Site
      • Essen, Germany, 45147
        • Not yet recruiting
        • Research Site
      • Hamburg, Germany, 20246
        • Not yet recruiting
        • Research Site
      • Kassel, Germany, 34125
        • Not yet recruiting
        • Research Site
      • Kiel, Germany, 24105
        • Not yet recruiting
        • Research Site
      • Leipzig, Germany, 04103
        • Recruiting
        • Research Site
      • Mannheim, Germany, 68167
        • Not yet recruiting
        • Research Site
      • Marburg, Germany, 35043
        • Withdrawn
        • Research Site
      • München, Germany, 80637
        • Not yet recruiting
        • Research Site
      • Münster, Germany, 48149
        • Not yet recruiting
        • Research Site
      • Saarbrücken, Germany, 66113
        • Recruiting
        • Research Site
  • Hungary
      • Budapest, Hungary, 1122
        • Recruiting
        • Research Site
      • Budapest, Hungary, 1088
        • Recruiting
        • Research Site
      • Debrecen, Hungary, 4032
        • Recruiting
        • Research Site
  • Italy
      • Catania, Italy, 95100
        • Recruiting
        • Research Site
      • Florence, Italy, 50134
        • Recruiting
        • Research Site
      • Milan, Italy, 20141
        • Recruiting
        • Research Site
      • Milan, Italy, 20159
        • Recruiting
        • Research Site
      • Milan, Italy, 20162
        • Recruiting
        • Research Site
      • Monza, Italy, 20900
        • Recruiting
        • Research Site
      • Naples, Italy, 80131
        • Recruiting
        • Research Site
      • Reggio Emilia, Italy, 422122
        • Recruiting
        • Research Site
      • Roma, Italy, 00144
        • Recruiting
        • Research Site
      • Rome, Italy, 00168
        • Recruiting
        • Research Site
      • Torino, Italy, 10128
        • Recruiting
        • Research Site
      • Turin, Italy, 10128
        • Recruiting
        • Research Site
  • Japan
      • Akashi-shi, Japan, 673-8558
        • Withdrawn
        • Research Site
      • Ginowan-shi, Japan, 901-2725
        • Recruiting
        • Research Site
      • Hidaka-shi, Japan, 350-1298
        • Recruiting
        • Research Site
      • Isehara-shi, Japan, 259-1193
        • Recruiting
        • Research Site
      • Kashiwa, Japan, 227-8577
        • Recruiting
        • Research Site
      • Kashiwa-shi, Japan, 277-8567
        • Recruiting
        • Research Site
      • Kobe, Japan, 650-0047
        • Recruiting
        • Research Site
      • Kurume-shi, Japan, 830-0011
        • Recruiting
        • Research Site
      • Kōtoku, Japan, 135-8550
        • Recruiting
        • Research Site
      • Matsuyama, Japan, 791-0280
        • Recruiting
        • Research Site
      • Morioka, Japan, 028-3695
        • Recruiting
        • Research Site
      • Nagoya, Japan, 464-8681
        • Recruiting
        • Research Site
      • Niigata, Japan, 951-8520
        • Recruiting
        • Research Site
      • Osaka, Japan, 541-8567
        • Recruiting
        • Research Site
      • Ota-shi, Japan, 373-8550
        • Recruiting
        • Research Site
      • Sapporo, Japan, 060-8638
        • Recruiting
        • Research Site
      • Sendai, Japan, 980-8574
        • Recruiting
        • Research Site
      • Shinjuku-ku, Japan, 160-8582
        • Recruiting
        • Research Site
      • Sunto-gun, Japan, 411-8777
        • Recruiting
        • Research Site
      • Tokyo, Japan, 104-0045
        • Recruiting
        • Research Site
      • Yokohama, Japan, 241-8515
        • Not yet recruiting
        • Research Site
  • Netherlands
      • Amsterdam, Netherlands, 1066CX
        • Withdrawn
        • Research Site
      • Leiden, Netherlands, 2333 ZA
        • Withdrawn
        • Research Site
      • Nijmegen, Netherlands, 6525 GA
        • Withdrawn
        • Research Site
      • Rotterdam, Netherlands, 3015 GD
        • Withdrawn
        • Research Site
  • Norway
      • Oslo, Norway, 0379
        • Recruiting
        • Research Site
      • Stavanger, Norway, 4011
        • Recruiting
        • Research Site
  • Poland
      • Bialystok, Poland, 15-027
        • Recruiting
        • Research Site
      • Gdansk, Poland, 80-214
        • Recruiting
        • Research Site
      • Lodz, Poland, 93-338
        • Recruiting
        • Research Site
      • Poznan, Poland, 60-569
        • Recruiting
        • Research Site
      • Siedlce, Poland, 08-110
        • Recruiting
        • Research Site
      • Szczecin, Poland, 70-111
        • Recruiting
        • Research Site
  • South Korea
      • Goyang-si, South Korea, 10408
        • Recruiting
        • Research Site
      • Seoul, South Korea, 03080
        • Recruiting
        • Research Site
      • Seoul, South Korea, 06351
        • Recruiting
        • Research Site
      • Seoul, South Korea, 05505
        • Recruiting
        • Research Site
      • Seoul, South Korea, 03722
        • Recruiting
        • Research Site
      • Suwon, South Korea, 16499
        • Recruiting
        • Research Site
  • Spain
      • A Coruña, Spain, 15009
        • Recruiting
        • Research Site
      • Córdoba, Spain, 14004
        • Recruiting
        • Research Site
      • Donostia / San Sebastian, Spain, 20014
        • Recruiting
        • Research Site
      • El Palmar, Spain, 30120
        • Recruiting
        • Research Site
      • L'Hospitalet de Llobregat, Spain, 08908
        • Recruiting
        • Research Site
      • Madrid, Spain, 28034
        • Recruiting
        • Research Site
      • Madrid, Spain, 28041
        • Recruiting
        • Research Site
      • Palma de Mallorca, Spain, 07010
        • Not yet recruiting
        • Research Site
      • Valencia, Spain, 46009
        • Recruiting
        • Research Site
      • Valencia, Spain, 46006
        • Recruiting
        • Research Site
      • Zaragoza, Spain, 50009
        • Recruiting
        • Research Site
  • Sweden
      • Linköping, Sweden, 581 85
        • Recruiting
        • Research Site
      • Lund, Sweden, 22185
        • Recruiting
        • Research Site
      • Stockholm, Sweden, 17164
        • Recruiting
        • Research Site
      • Uppsala, Sweden, 751 85
        • Recruiting
        • Research Site
  • Switzerland
      • Frauenfeld, Switzerland, 8501
        • Withdrawn
        • Research Site
      • Liestal, Switzerland, CH- 4410
        • Recruiting
        • Research Site
      • Sankt Gallen, Switzerland, 9007
        • Recruiting
        • Research Site
      • Zurich, Switzerland, 8091
        • Recruiting
        • Research Site
  • Taiwan
      • Changhua, Taiwan, 500
        • Recruiting
        • Research Site
      • Kaohsiung City, Taiwan, 81362
        • Recruiting
        • Research Site
      • New Taipei City, Taiwan, 220
        • Recruiting
        • Research Site
      • Taichung, Taiwan, 40705
        • Recruiting
        • Research Site
      • Tainan, Taiwan, 704
        • Recruiting
        • Research Site
      • Taipei, Taiwan, 10449
        • Recruiting
        • Research Site
  • United Kingdom
      • Bath, United Kingdom, BA1 3NG
        • Recruiting
        • Research Site
      • Cambridge, United Kingdom, CB2 0QQ
        • Recruiting
        • Research Site
      • Leeds, United Kingdom, LS9 7TF
        • Recruiting
        • Research Site
      • London, United Kingdom, EC1A 7BE
        • Recruiting
        • Research Site
      • Manchester, United Kingdom, M20 4BX
        • Recruiting
        • Research Site
      • Northwood, United Kingdom, HA6 2RN
        • Recruiting
        • Research Site
      • Taunton, United Kingdom, TA1 5DA
        • Recruiting
        • Research Site
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85704
        • Withdrawn
        • Research Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • Research Site
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • Research Site
      • Irvine, California, United States, 92618
        • Recruiting
        • Research Site
      • La Jolla, California, United States, 92037
        • Recruiting
        • Research Site
      • Palo Alto, California, United States, 94304
        • Withdrawn
        • Research Site
      • San Francisco, California, United States, 94143
        • Withdrawn
        • Research Site
      • Sylmar, California, United States, 91342
        • Withdrawn
        • Research Site
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Recruiting
        • Research Site
      • Miami, Florida, United States, 33133
        • Not yet recruiting
        • Research Site
      • Miami Beach, Florida, United States, 33140
        • Recruiting
        • Research Site
      • Orlando, Florida, United States, 32804
        • Not yet recruiting
        • Research Site
      • St. Petersburg, Florida, United States, 33705
        • Recruiting
        • Research Site
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Research Site
      • West Palm Beach, Florida, United States, 33401
        • Recruiting
        • Research Site
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Withdrawn
        • Research Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Withdrawn
        • Research Site
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Recruiting
        • Research Site
      • Evanston, Illinois, United States, 60201
        • Recruiting
        • Research Site
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • Recruiting
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • Research Site
      • Silver Spring, Maryland, United States, 20910
        • Not yet recruiting
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Recruiting
        • Research Site
      • Worcester, Massachusetts, United States, 01655
        • Withdrawn
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • Research Site
      • Detroit, Michigan, United States, 48201
        • Withdrawn
        • Research Site
    • Minnesota
      • Marshall, Minnesota, United States, 56258
        • Not yet recruiting
        • Research Site
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • Research Site
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Research Site
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Recruiting
        • Research Site
    • Missouri
      • Springfield, Missouri, United States, 65804
        • Recruiting
        • Research Site
      • St Louis, Missouri, United States, 63141
        • Recruiting
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Withdrawn
        • Research Site
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Recruiting
        • Research Site
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Suspended
        • Research Site
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Research Site
      • New York, New York, United States, 10075
        • Withdrawn
        • Research Site
      • New York, New York, United States, 10016
        • Withdrawn
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Research Site
      • Charlotte, North Carolina, United States, 28204
        • Not yet recruiting
        • Research Site
      • Winston-Salem, North Carolina, United States, 27103
        • Recruiting
        • Research Site
      • Winston-Salem, North Carolina, United States, 27157
        • Not yet recruiting
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • Recruiting
        • Research Site
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Not yet recruiting
        • Research Site
      • Tulsa, Oklahoma, United States, 74134
        • Withdrawn
        • Research Site
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Recruiting
        • Research Site
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Withdrawn
        • Research Site
      • Philadelphia, Pennsylvania, United States, 19111
        • Recruiting
        • Research Site
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • Research Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Recruiting
        • Research Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Research Site
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Recruiting
        • Research Site
    • Texas
      • Austin, Texas, United States, 78758
        • Recruiting
        • Research Site
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • Research Site
      • Houston, Texas, United States, 77030
        • Recruiting
        • Research Site
      • San Antonio, Texas, United States, 78240
        • Recruiting
        • Research Site
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • Research Site
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Research Site
    • Washington
      • Seattle, Washington, United States, 98133
        • Withdrawn
        • Research Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm A: T-DXd + Rilvegostomig
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.
Drug: Trastuzumab deruxtecan
Experimental therapy by intravenous infusion
Other Names:
  • DS-8201a, T-DXd
Drug: Rilvegostomig
Experimental therapy by intravenous infusion
Experimental: Arm B: T-DXd + Pembrolizumab
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.
Drug: Trastuzumab deruxtecan
Experimental therapy by intravenous infusion
Other Names:
  • DS-8201a, T-DXd
Drug: Pembrolizumab
Immunotherapy by intravenous infusion
Other Names:
  • Keytruda
Active Comparator: Arm C: Carboplatin + Paclitaxel + Pembrolizumab
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.
Drug: Pembrolizumab
Immunotherapy by intravenous infusion
Other Names:
  • Keytruda
Drug: Carboplatin
Standard of Care (SoC) chemotherapy by intravenous infusion
Other Names:
  • Carbomedac, Carbosin, Paraplatin
Drug: Paclitaxel
Standard of Care (SoC) chemotherapy by intravenous infusion
Other Names:
  • Anzatax, Ebetaxel, Oncotaxel, Paclitax, Paclitaxin, Paxene, Taxol
Drug: Docetaxel
Standard of Care (SoC) chemotherapy by intravenous infusion
Other Names:
  • Docirena, Taxceus, Taxotere

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Until progression or death due to any cause (assessed up to approximately 45 months).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Until the date of death due to any cause (assessed up to approximately 70 months).
Defined as the time from randomization until the date of death due to any cause.
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).
PFS by investigator has the same attributes as estimand of PFS by BICR except tumor assessment is by the investigator.
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).
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.
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).
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.
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).

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.
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).
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.
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).
Serum concentration of T-DXd, total anti-HER2 antibody, DXd and rilvegostomig.
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).
Presence of ADAs for T-DXd or rilvegostomig.
Up to safety follow-up period (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.
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.
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.
OS defined as the time from randomization until the date of death due to any cause.
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.
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.
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.
OS is defined as the time from randomization until the date of death due to any cause.
Through completion of study, assessed up to approximately 70 months.
Patient-reported tolerability
Time Frame: Until progression as assessed by BICR (assessed up to approximately 45 months).

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
Until progression as assessed by BICR (assessed up to approximately 45 months).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
GOG Foundation
Daiichi Sankyo Co., Ltd.
European Network of Gynaecological Oncological Trial Groups (ENGOT)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 27, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 19, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 19, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D781DC00001
  • 2023 (U.S. NIH Grant/Contract: GRAMMY Museum Foundation)
  • 2023-508056-19-00 (Registry Identifier: CTIS (EU))
  • GOG-3098 (Other Identifier: Gynecologic Oncology Group Foundation)
  • ENGOT-EN24 (Other Identifier: European Network for Gynaecological Oncological Trial groups)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal 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.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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