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DESTINY-Endometrial01: Study for HER2-Expressing Endometrial Cancer

This study is for women with advanced or recurrent endometrial cancer that is HER2-positive (meaning the cancer cells have high levels of a protein called HER2) and mismatch repair proficient (pMMR). It's testing new first-line treatments. You would receive either Trastuzumab deruxtecan plus Rilvegostomig, or Trastuzumab deruxtecan plus Pembrolizumab. These are compared to the standard treatment of Carboplatin and Paclitaxel chemotherapy plus Pembrolizumab. The main goal is to see how long people live without their cancer growing or spreading (progression-free survival). The study aims to enroll 600 participants, but its current recruitment status is unclear.

Study design
This interventional study plans to enroll 600 participants. It compares two experimental drug combinations to a standard treatment combination.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed until their cancer progresses or they pass away, for up to approximately 45 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06989112

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
AstraZeneca
~600 participants
Updated 2026-08-11 on ClinicalTrials.gov
What's tested:Trastuzumab deruxtecanRilvegostomigPembrolizumabCarboplatinPaclitaxelDocetaxel

At a glance

Recruiting sites
203 of 252 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free survival (PFS), as assessed by BICR
Measured over Until progression or death due to any cause (assessed up to approximately 45 months).

Conditions

Endometrial Cancer

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Where it's being run

252 sites across 57 states
China35
Japan21
Brazil12
France12
Germany12
Italy12
Spain11
Florida7

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

≥ 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.
Provision of an adequate FFPE tumor tissue sample for central HER2, MMR, and PD-L1 IHC testing.
Prior therapy:
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.

Exclusion

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:
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:

What this trial measures

  • Progression-free survival (PFS), as assessed by BICRUntil 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.