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
Trastuzumab deruxtecan: Experimental therapy by intravenous infusion
Rilvegostomig: Experimental therapy by intravenous infusion
Pembrolizumab: Immunotherapy by intravenous infusion
Carboplatin: Standard of Care (SoC) chemotherapy by intravenous infusion
Paclitaxel: Standard of Care (SoC) chemotherapy by intravenous infusion
Docetaxel: Standard of Care (SoC) chemotherapy by intravenous infusion
Study 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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Progression-free survival (PFS), as assessed by BICR — 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.
Trial sites (255)
Facility
City
Region
Status
Research Site
Tucson
Arizona
Withdrawn
Research Site
Little Rock
Arkansas
Recruiting
Research Site
Duarte
California
Recruiting
Research Site
Irvine
California
Recruiting
Research Site
La Jolla
California
Recruiting
Research Site
Palo Alto
California
Withdrawn
Research Site
San Francisco
California
Withdrawn
Research Site
Sylmar
California
Withdrawn
Research Site
Fort Myers
Florida
Recruiting
Research Site
Miami
Florida
Not Yet Recruiting
Research Site
Miami Beach
Florida
Recruiting
Research Site
Orlando
Florida
Not Yet Recruiting
Research Site
St. Petersburg
Florida
Recruiting
Research Site
Tampa
Florida
Recruiting
Research Site
West Palm Beach
Florida
Recruiting
Research Site
Augusta
Georgia
Withdrawn
Research Site
Honolulu
Hawaii
Withdrawn
Research Site
Arlington Heights
Illinois
Recruiting
Research Site
Evanston
Illinois
Recruiting
Research Site
Shreveport
Louisiana
Recruiting
Research Site
Baltimore
Maryland
Recruiting
Research Site
Silver Spring
Maryland
Not Yet Recruiting
Research Site
Boston
Massachusetts
Recruiting
Research Site
Worcester
Massachusetts
Withdrawn
Research Site
Ann Arbor
Michigan
Recruiting
Research Site
Detroit
Michigan
Withdrawn
Research Site
Marshall
Minnesota
Not Yet Recruiting
Research Site
Minneapolis
Minnesota
Recruiting
Research Site
Rochester
Minnesota
Recruiting
Research Site
Jackson
Mississippi
Recruiting
Research Site
Springfield
Missouri
Recruiting
Research Site
St Louis
Missouri
Recruiting
Research Site
Las Vegas
Nevada
Withdrawn
Research Site
Lebanon
New Hampshire
Recruiting
Research Site
Hackensack
New Jersey
Recruiting
Research Site
Albuquerque
New Mexico
Suspended
Research Site
New York
New York
Withdrawn
Research Site
New York
New York
Recruiting
Research Site
New York
New York
Withdrawn
Research Site
Charlotte
North Carolina
Recruiting
+ 215 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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