Status and phase
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Study type
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Identifiers
About
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.
Enrollment
Sex
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Volunteers
Inclusion and exclusion criteria
Key Inclusion Criteria:
Participants must be ≥ 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).
Following surgery or diagnostic biopsy, participant must have primary advanced disease (Stage III/IV) or first recurrent endometrial cancer and meet at least one of the following criteria:
Endometrial cancer with HER2 IHC expression of 3+ or 2+ as assessed by prospective central testing.
Endometrial cancer that is determined pMMR by prospective central IHC testing.
Provision of adequate FFPE tumor tissue sample of a tumor lesion that was not previously irradiated for central HER2, MMR, and PD-L1 IHC testing and valid central test results for randomization/ stratification.
Prior therapy:
Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1.
Left ventricular ejection fraction (LVEF) ≥ 50% within 28 days before randomization.
Adequate organ and bone marrow function within 14 days before randomization.
Key Exclusion Criteria:
History of organ transplant
Uncontrolled intercurrent illness, including, but not limited to ongoing or active known infection, serious chronic gastrointestinal conditions associated with diarrhea and active non-infectious skin disease requiring systemic treatment.
Spinal cord compression or clinically active central nervous system metastases
Participants with a medical history of myocardial infarction (MI) within 6 months before randomization, or symptomatic congestive heart failure (CHF) (NYHA Class II to IV), clinically significant arrhythmia, or cardiomyopathy of any etiology. Participants with troponin levels above ULN at screening (as defined by the manufacturer), should have a cardiologic consultation before enrollment to rule out MI
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:
Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.
Active primary immunodeficiency/ active infectious disease(s) including:
Any concurrent anticancer treatment without an adequate washout period prior to the first dose of study intervention. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., HRT) is allowed.
Primary purpose
Allocation
Interventional model
Masking
600 participants in 3 patient groups
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Central trial contact
AstraZeneca Clinical Study Information Center
Data sourced from clinicaltrials.gov
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