NCT06989112 · AstraZeneca
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
(DE-01)
What this study is about
DESTINY-Endometrial01 will investigate the effectiveness of first-line T-DXd + rilvegostomig (treatment group$1 A) and/or T-DXd+ pembrolizumab (treatment group$1 B) when compared to chemotherapy (carboplatin + paclitaxel) + pembrolizumab (treatment group$1 C), by assessment of time without the disease getting worse (PFS), as assessed by BICR, in participants with HER2-expressing (IHC 3+/2+), pMMR, primary advanced (Stage III/IV) or recurrent EC.
View original scientific description
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.
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
Primary outcome measures
Progression-free survival (PFS), as assessed by BICR
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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:
- Primary Stage III (per FIGO 2023) disease with measurable disease at baseline per RECIST 1.1 based on the investigator's assessment.
- Primary Stage IV disease (per FIGO 2023) regardless of presence of measurable disease at baseline.
- First recurrent disease regardless of presence of measurable disease at baseline.
- Endometrial cancer with HER2 IHC expression of 3+ or 2+ as assessed by prospective central testing.
- Endometrial cancer that is determined pMMR by prospectiv
Where
- Tucson, Arizona
- Little Rock, Arkansas
- Duarte, California
- Irvine, California
- La Jolla, California
- Palo Alto, California
- San Francisco, California
- Sylmar, California
- Fort Myers, Florida
- Miami Beach, Florida
- Orlando, Florida
- St. Petersburg, Florida
And 44 more locations — see the full list below.
Collaborators
Daiichi Sankyo Co., Ltd., GOG Foundation, European Network of Gynaecological Oncological Trial Groups (ENGOT)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 23, 2026 · Source of record for eligibility and locations