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Clinical Trials in the UK / NCT06819007
Recruiting Phase 3

Study of Trastuzumab Deruxtecan With Bevacizumab Versus Bevacizumab Monotherapy for First-line Maintenance in HER2-Expressing Ovarian Cancer (DESTINY-Ovarian01)

NCT06819007 · tracked via the Priya Life Science UK tracker
Sponsor
Daiichi Sankyo
Phase
Phase 3
Started
2025-03-19
Last updated
2026-07-02

Condition(s) studied

Ovarian Cancer

Investigational drug(s) / intervention(s)

Trastuzumab DeruxtecanBevacizumab

Trastuzumab Deruxtecan: T-DXd will be administered at a dose of 5.4 mg/kg intravenously (IV) every 3 weeks (Q3W)

Bevacizumab: Bevacizumab will be administered at a dose of 15/mg/kg IV Q3W

Study summary

This clinical trial is designed to evaluate the efficacy and safety of T-DXd in combination with bevacizumab versus bevacizumab monotherapy as first-line maintenance therapy, in participants with human epidermal growth factor 2 (HER2)-expressing (immunohistochemistry \[IHC\] 3+/2+/1+) advanced high-grade epithelial ovarian cancer.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
Healthy volunteers
No
Key Inclusion Criteria: 1. Sign and date the tissue prescreening ICF, prior to HER2 central testing. Sign and date the Main ICF, prior to the start of any trial- specific qualification procedures. Consent to optional PGx prior to any PGx procedures. \*For participants in the safety run-in phase, a safety run-in ICF needs to be signed and dated prior to the start of any trial-specific qualification procedures. 2. Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is \>18 years old. 3. Has histologically confirmed diagnosis of epithelial high-grade ovarian, fallopian tube or primary peritoneal carcinoma per local assessment (including but not limiting to serous, endometrioid, clear cell, carcinosarcoma, mucinous). 4. Is newly diagnosed FIGO Stage III or IV. 5. Has HER2 expression per 2016 ASCO-CAP gastric cancer IHC scoring (3+/2+/1+) guidelines1 by prospective central testing. \*For participants in the safety run-in phase, HER2 expression assessed by either local (require using ASCO-CAP gastric cancer IHC scoring \[IHC 3+/2+/1+\] guidelines) or central assessment (if available) is acceptable. Submission of the pathology report is required for participants enrolled based on local HER2 IHC results. 6. Has adequate tumor tissue sample available for assessment of HER2 by central laboratory. Tumor tissue block or sufficient tissue slides are required for HER2 testing and retrospective HRD status determination. \*Participants in the safety run-in phase who are enrolled based on local HER2 IHC results are recommended to provide tumor tissue sample from the same specimen for central assessment. 7. Has a local HRD or BRCA test result available. Participants with BRCA-wildtype will have a local HRD test results, as applicable. 8. Has received up to 6 cycles of standard of care bevacizumab in combination with frontline platinum- based chemotherapy as per approved indication and clinical guidelines and is eligible to continue single agent bevacizumab maintenance per standard of care and investigator discretion. Key Exclusion Criteria: 1. Has ovarian, fallopian tube, or peritoneal cancer of non-epithelial origin. 2. Has a known or suspected deleterious BRCA alteration as per local test that makes the patient eligible for PARP inhibitor. 3. Participant to receive PARP inhibitor as maintenance per standard of care and investigator discretion. Reasons for which the participant is not eligible for PARP inhibitor will be recorded in the eCRF as follows: * HRD negative * HRD positive with SD as best response after platinum * HRD positive non-serous histology Note: For participants enrolled from the Republic of Korea * HRD tested, but inconclusive * HRD positive but safety concern (safety concern to be specified). 4. Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug products and other monoclonal antibodies. 5. Previous Cerebral-Vascular Accident, Transient Ischemic Attack or Sub- Arachnoids Hemorrhage within 6 months prior to randomization. \*Note: For participants enrolled from the Republic of Korea, 6. Has evidence of bleeding diathesis or significant coagulopathy (in the absence of anticoagulation therapy). 7. Has a history of hemorrhagic disorders, abdominal fistula, gastrointestinal perforation, or active gastrointestinal bleeding within 6 months before randomization. 8. Evidence of active or ongoing bowel obstruction. 9. Has a medical history of myocardial infarction within 6 months before randomization, symptomatic congestive heart failure (New York Heart Association Class II to IV). Participants with troponin levels above the upper limit of normal at Screening (as defined by the manufacturer), and without any myocardial infarction related symptoms should have a cardiologic consultation during the Screening Period to rule out myocardial infarction. 10. Has a corrected QT interval prolongation to \>480 msec based on average of the Screening triplicate 12-lead ECG. 11. Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.

Primary outcome measure(s)

Trial sites (208)

FacilityCityRegionStatus
Disney Family Cancer Center Burbank California Recruiting
Scripps Clinic La Jolla California Recruiting
Palo Alto Medical Foundation Palo Alto California Recruiting
Broward Health Medical Center Fort Lauderdale Florida Recruiting
Jupiter Medical Center Jupiter Florida Recruiting
Mount Sinai Medical Center Miami Beach Florida Recruiting
AdventHealth Cancer Institute Orlando Florida Recruiting
Woman's Care FL St. Petersburg Florida Recruiting
Nancy N. & J.C Lewis Cancer & Research Pavillion- St. Josephs/ Candler Health System Savannah Georgia Recruiting
Endeavor Health Evanston Kellogg Cancer Care Center Evanston Illinois Recruiting
Indiana University Indianapolis Indiana Recruiting
Trials365 LLC Shreveport Louisiana Recruiting
Greater Baltimore Medical Center Towson Maryland Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
Dana-Farber Cancer Institute Boston Massachusetts Recruiting
Trinity Health St. Joseph Mercy Ann Arbor Ann Arbor Michigan Recruiting
Corewell Health Grand Rapids Michigan Recruiting
Minnesota Oncology Hematology PA Minneapolis Minnesota Recruiting
St. Vincent Gynecologic Oncology Billings Montana Recruiting
Valley Health System Paramus New Jersey Recruiting
Laura and Isaac Perlmutter Cancer Center at NYU Langone New York New York Recruiting
Icahn School of Medicine at Mount Sinai New York New York Recruiting
Columbia University New York New York Recruiting
UNC Hospital Chapel Hill North Carolina Recruiting
Miami Valley Hospital South Centerville Ohio Recruiting
Legacy Medical Group Gynecologic Oncology Portland Oregon Recruiting
Providence Cancer Center Oncology Portland Oregon Recruiting
St. Lukes University Health Network Bethlehem Pennsylvania Recruiting
Ann B Barshinger Cancer Institute Lancaster Pennsylvania Recruiting
Avera Medical Group Gynecologic Sioux Falls South Dakota Recruiting
Sarah Cannon Research Institute (Oncology Associates of Oregon PC) Nashville Tennessee Recruiting
Utah Cancer Specialists Network Salt Lake City Utah Recruiting
Genesiscare St Andrews Hospital Adelaide Australia Recruiting
Icon Cancer Centre Wesley Auchenflower Australia Recruiting
Icon Cancer Centre Hobart Hobart Australia Recruiting
Genesis Care North Shore (Oncology) St Leonards Australia Recruiting
Westmead Hospital Sydney Australia Recruiting
Townsville University Hospital Cancer Centre Townsville Australia Recruiting
Medizinische Universitat Innsbruck Innsbruck Austria Recruiting
AZ Sint-Lucas Ghent Belgium Recruiting

+ 168 more sites — see the full list on the official registry below.

On this site

📄 Enhertu (trastuzumab deruxtecan) drug profile → 📄 Avastin (bevacizumab) drug profile →

More Daiichi Sankyo trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06819007 on ClinicalTrials.gov ↗ ← All trials in the UK