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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06989112




Registration number
NCT06989112
Ethics application status
Date submitted
11/03/2025
Date registered
25/05/2025
Date last updated
25/05/2025

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 0 0
2023-508056-19-00
Secondary ID [2] 0 0
D781DC00001
Universal Trial Number (UTN)
Trial acronym
DE-01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometrial Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Trastuzumab deruxtecan
Treatment: Drugs - Rilvegostomig
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Carboplatin
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Docetaxel

Experimental: Arm A: T-DXd + Rilvegostomig - T-DXd IV Q3W plus rilvegostomig IV Q3W. Treatment will continue until objective disease progression according to RECIST v1.1 as assessed by the Investigator and confirmed by BICR or until other discontinuation criteria is met, whichever occurs first.

Experimental: Arm B: T-DXd + Pembrolizumab - T-DXd IV Q3W plus pembrolizumab IV Q3W. Treatment will continue until objective disease progression according to RECIST v1.1 as assessed by the Investigator and confirmed by BICR or until other discontinuation criteria is met, whichever occurs first.

Active comparator: Arm C: Carboplatin + Paclitaxel + Pembrolizumab - Carboplatin, paclitaxel and pembrolizumab administered Q3W during 6 cycles, followed by maintenance with pembrolizumab IV Q6W during 14 cycles. Treatment with pembrolizumab will continue for up to 20 total cycles (approximately 24 months, accounting for combination and maintenance phases) or until other discontinuation criteria is met, whichever occurs first. At the discretion of the investigator, participants may continue to receive carboplatin, paclitaxel and pembrolizumab Q3W for up to 10 cycles. Docetaxel can be used as an alternative to paclitaxel for participants who had a hypersensitivity reaction to paclitaxel with a failed rechallenge (or not amenable to rechallenge), according to the investigator's clinical judgment.


Treatment: Drugs: Trastuzumab deruxtecan
Experimental therapy by intravenous infusion

Treatment: Drugs: Rilvegostomig
Experimental therapy by intravenous infusion

Treatment: Drugs: Pembrolizumab
Immunotherapy by intravenous infusion

Treatment: Drugs: Carboplatin
Standard of Care (SoC) chemotherapy by intravenous infusion

Treatment: Drugs: Paclitaxel
Standard of Care (SoC) chemotherapy by intravenous infusion

Treatment: Drugs: Docetaxel
Standard of Care (SoC) chemotherapy by intravenous infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival (PFS), as assessed by BICR
Timepoint [1] 0 0
Until progression or death due to any cause (assessed up to approximately 45 months).
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Until the date of death due to any cause (assessed up to approximately 70 months).
Secondary outcome [2] 0 0
Progression Free Survival (PFS) as assessed by the investigator
Timepoint [2] 0 0
Until progression or death due to any cause (assessed up to approximately 70 months).
Secondary outcome [3] 0 0
Time from randomization to second progression or death (PFS2)
Timepoint [3] 0 0
Until the earliest of the progression event (following the initial investigator-assessed progression), after first subsequent therapy, or death (assessed up to approximately 70 months).
Secondary outcome [4] 0 0
Objective response rate (ORR), as assessed by BICR and investigator
Timepoint [4] 0 0
Until progression or the starting of subsequent anticancer therapy (assessed up to approximately 45 months).
Secondary outcome [5] 0 0
Duration of response (DoR), as assessed by BICR and investigator
Timepoint [5] 0 0
Until progression or death due to any cause (assessed up to approximately 45 months).
Secondary outcome [6] 0 0
Safety and tolerability
Timepoint [6] 0 0
Safety is assessed until the 90 days (+7) after the last dose (assessed up to approximately 70 months).
Secondary outcome [7] 0 0
Pharmacokinetics of T-DXd, total anti-HER2 antibody, DXd and rilvegostomig
Timepoint [7] 0 0
Up to safety follow-up period (assessed up to approximately 45 months).
Secondary outcome [8] 0 0
Immunogenicity of T- DXd and rilvegostomig
Timepoint [8] 0 0
Up to safety follow-up period (assessed up to approximately 45 months).
Secondary outcome [9] 0 0
Patient-reported tolerability
Timepoint [9] 0 0
Up to progression as assessed by BICR (assessed up to approximately 45 months).
Secondary outcome [10] 0 0
Progression-free survival (PFS) according to MMR status to determine the clinical utility of a MMR diagnostic test
Timepoint [10] 0 0
Through completion of study, assessed up to approximately 70 months.
Secondary outcome [11] 0 0
Overall survival (OS) according to MMR status to determine the clinical utility of a MMR diagnostic test
Timepoint [11] 0 0
Through completion of study, assessed up to approximately 70 months.
Secondary outcome [12] 0 0
Progression-free survival (PFS) according to HER2 expression to determine the clinical utility of a HER2 diagnostic test
Timepoint [12] 0 0
Through completion of study, assessed up to approximately 70 months.
Secondary outcome [13] 0 0
Overall survival (OS) according to HER2 expression to determine the clinical utility of a HER2 diagnostic test
Timepoint [13] 0 0
Through completion of study, assessed up to approximately 70 months.

Eligibility
Key inclusion criteria
* Key

* 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 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:

* Naïve to first-line systemic anticancer therapy. Participants may have received one prior line of adjuvant/neoadjuvant chemotherapy with curative intent (chemotherapy or chemoradiation) if disease recurrence or progression occurred = 6 months after last dose of chemotherapy. Prior trastuzumab in the adjuvant/neoadjuvant setting is allowed.
* No prior exposure to ADCs or immune checkpoint inhibitors including (but not limited to) anti-PD-1/PD-L1/PD-L2 and anti-CTLA-4 antibodies and therapeutic anticancer vaccines.
* Participants may have received prior radiation therapy for the treatment of endometrial cancer. Prior radiation therapy may have included pelvic radiation therapy, extended field pelvic/para-aortic radiation therapy, and/or intravaginal brachytherapy. Adequate treatment washout period is required.
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
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:

* 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, pleural effusion etc.).
* Any autoimmune, connective tissue or inflammatory disorders where there is documented, or a suspicion of pulmonary involvement at the time of screening.
* Prior pneumonectomy (complete).
* 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:

* Tuberculosis (TB)
* HIV infection that is not well controlled.
* Chronic or active hepatitis B, chronic or active hepatitis C; however, participants who have chronic hepatitis B and are receiving suppressive antiviral therapy are allowed to be enrolled if alanine aminotransferase (ALT) is normal and viral load is controlled.
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/03/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
20/02/2031
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Blacktown
Recruitment hospital [2] 0 0
Research Site - East Melbourne
Recruitment hospital [3] 0 0
Research Site - Nedlands
Recruitment hospital [4] 0 0
Research Site - South Brisbane
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
3002 - East Melbourne
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment outside Australia
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United States of America
State/province [1] 0 0
Arizona
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Valencia
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Linköping
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Lund
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Stockholm
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Changhua
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London
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Manchester
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United Kingdom
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Northwood

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Daiichi Sankyo Co., Ltd.
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Gynecologic Oncology Group (GOG) Foundation Inc.
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
European Network for Gynaecological Oncological Trial groups(ENGOT)
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06989112