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RECRUITING

NCT06989112

PHASE3

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

Sponsor: AstraZeneca

View on ClinicalTrials.gov

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

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

600

Start Date

2025-03-27

Completion Date

2031-02-19

Last Updated

2026-10-13

Healthy Volunteers

Conditions

Endometrial Cancer

Interventions

DRUG

Trastuzumab deruxtecan

Experimental therapy by intravenous infusion

DRUG

Rilvegostomig

Experimental therapy by intravenous infusion

DRUG

Pembrolizumab

Immunotherapy by intravenous infusion

DRUG

Carboplatin

Standard of Care (SoC) chemotherapy by intravenous infusion

DRUG

Paclitaxel

Standard of Care (SoC) chemotherapy by intravenous infusion

DRUG

Docetaxel

Standard of Care (SoC) chemotherapy by intravenous infusion

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.

Locations (257)

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Tucson, Arizona, United States

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Little Rock, Arkansas, United States

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Duarte, California, United States

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Irvine, California, United States

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La Jolla, California, United States

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Palo Alto, California, United States

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San Francisco, California, United States

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Sylmar, California, United States

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Fort Myers, Florida, United States

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Miami, Florida, United States

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Miami Beach, Florida, United States

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Orlando, Florida, United States

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St. Petersburg, Florida, United States

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Tampa, Florida, United States

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West Palm Beach, Florida, United States

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Augusta, Georgia, United States

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Honolulu, Hawaii, United States

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Arlington Heights, Illinois, United States

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Evanston, Illinois, United States

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Shreveport, Louisiana, United States

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Baltimore, Maryland, United States

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Silver Spring, Maryland, United States

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Boston, Massachusetts, United States

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Worcester, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Detroit, Michigan, United States

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Marshall, Minnesota, United States

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Minneapolis, Minnesota, United States

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Rochester, Minnesota, United States

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Jackson, Mississippi, United States

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Springfield, Missouri, United States

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St Louis, Missouri, United States

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Las Vegas, Nevada, United States

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Lebanon, New Hampshire, United States

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Hackensack, New Jersey, United States

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Albuquerque, New Mexico, United States

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New York, New York, United States

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New York, New York, United States

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New York, New York, United States

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Charlotte, North Carolina, United States

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Charlotte, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Eugene, Oregon, United States

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Abington, Pennsylvania, United States

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Hershey, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Providence, Rhode Island, United States

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Charleston, South Carolina, United States

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Sioux Falls, South Dakota, United States

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Austin, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Charlottesville, Virginia, United States

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Fairfax, Virginia, United States

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Seattle, Washington, United States

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Madison, Wisconsin, United States

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Blacktown, Australia

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East Melbourne, Australia

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Nedlands, Australia

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South Brisbane, Australia

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Innsbruck, Austria

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Linz, Austria

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Vienna, Austria

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Wein, Austria

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Anderlecht, Belgium

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Brussels, Belgium

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Charleroi, Belgium

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Ghent, Belgium

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Leuven, Belgium

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Liège, Belgium

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Barretos, Brazil

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Belo Horizonte, Brazil

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Goiânia, Brazil

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Londrina, Brazil

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Porto Alegre, Brazil

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Porto Alegre, Brazil

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Rio de Janeiro, Brazil

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Salvador, Brazil

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São Paulo, Brazil

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São Paulo, Brazil

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São Paulo, Brazil

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Teresina, Brazil

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Winnipeg, Manitoba, Canada

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Halifax, Nova Scotia, Canada

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London, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

And 157 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (257)