Ireland
--:--IST
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
Phase
Phase 3
Started
2025-03-19
Last updated
2026-10-28

Condition(s) studied

Ovarian Cancer

Investigational drug(s) / intervention(s)

Trastuzumab Deruxtecan →Bevacizumab →

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 informed consent form (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 International Federation of Gynecology and Obstetrics (FIGO) Stage III or IV. 5. Has HER2 expression. 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 participant eligible for poly (ADP-ribose) polymerase (PARP) inhibitor. 3. Participant to receive PARP inhibitor as maintenance per standard of care and investigator discretion. 4. Previous cerebral-vascular accident, transient ischemic attack or subarachnoid hemorrhage within 6 months prior to randomization. \*Note: For participants enrolled from the Republic of Korea, country-specific requirements are applicable. 5. Has evidence of bleeding diathesis or significant coagulopathy (in the absence of anticoagulation therapy). 6. Has a history of hemorrhagic disorders.

Primary outcome measure(s)

  • Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) in the HER2 IHC 3+/2+ Population — From date of randomization to radiographic disease progression or death due to any cause, up to approximately 35 months
    Time from randomization to time of objective radiographic disease progression as assessed by BICR based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or death due to any cause.

Trial sites (232)

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
University of Wisconsin Madison Wisconsin Recruiting
Genesiscare St Andrews Hospital Adelaide Australia Recruiting
Icon Cancer Centre Wesley Auchenflower Australia Recruiting
Icon Cancer Centre Hobart Hobart Australia Recruiting
Sir Charles Gairdner Hospital Perth Australia Recruiting
Epworth Healthcare Richmond Australia Recruiting
Genesis Care North Shore (Oncology) St Leonards Australia Recruiting
Westmead Hospital Sydney Australia Recruiting

+ 192 more sites — see the full list on the official registry below.

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