RecruitingPhase 3

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests trastuzumab deruxtecan (T-DXd) with either rilvegostomig or pembrolizumab against chemotherapy with pembrolizumab. It measures how long people live without their cancer getting worse. It is for adults with advanced or returning cancer of the womb lining that has certain HER2 protein levels and a working DNA repair system (pMMR).

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older. Local age rules may also apply.
  • Have confirmed cancer of the womb lining. Sarcomas are not allowed, but carcinosarcomas are allowed.
  • Have stage III cancer that can be measured, stage IV cancer, or cancer that has returned. The study doctor must judge that treatment to cure it is not an option.
  • Study lab tests must show HER2 protein levels of 3+ or 2+ and a working DNA repair system (pMMR). Provide enough tumor tissue for study tests.
  • No past chemotherapy for this cancer, except one course given around surgery to try to cure it, finished at least 6 months before consent. Trastuzumab given around surgery is allowed.
  • No past antibody-drug conjugates (antibodies linked to cancer drugs) or immune checkpoint drugs. Past radiation or hormone treatment is allowed after a required waiting period.
  • Be fully active or able to do light work despite some limits on hard physical activity.
  • Have adequate organ and blood-cell-making bone marrow function within 14 days before group assignment. Heart pumping strength must be at least 50% within 28 days before assignment.

Who can't join

  • A severe or uncontrolled illness that makes joining unsafe or makes study rules hard to follow.
  • Serious ongoing gut disease with diarrhea, a disorder that weakens the immune system, or a noninfectious skin disease needing medicine that treats the whole body.
  • An autoimmune disease, where the immune system attacks the body, or an inflammatory disease needing long-term medicines that treat the whole body.
  • Current or suspected lung inflammation, or past noninfectious lung inflammation that needed steroids. Serious lung disease, a lung blood clot within 3 months, immune-related lung problems, or removal of an entire lung also excludes you.
  • A heart attack or unstable chest pain within 6 months; heart failure with symptoms; a serious abnormal heartbeat; uncontrolled high blood pressure; heart muscle disease; or past heart muscle inflammation.
  • A past organ transplant or a stem cell transplant from another person.
  • Pressure on the spinal cord or active cancer spread to the brain or spinal cord. Inactive brain cancer spread may be allowed.
  • Active tuberculosis, HIV that is not well controlled, or active hepatitis B or C.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (63)

AR

AZ

CA

FL

GA

HI

IL

LA

MA

MD

MI

MN

MO

MS

NC

NH

NJ

NM

NV

NY

OH

OK

OR

PA

RI

SC

SD

TX

VA

WA

WI