Study of Trastuzumab Deruxtecan With Bevacizumab Versus Bevacizumab Monotherapy for First-line Maintenance in HER2-Expressing Ovarian Cancer (DESTINY-Ovarian01)
NCT06819007 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 582
Last updated 2026-03-05
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.
Conditions
Interventions
- DRUG
-
T-DXd will be administered at a dose of 5.4 mg/kg intravenously (IV) every 3 weeks (Q3W)
- DRUG
-
Bevacizumab will be administered at a dose of 15/mg/kg IV Q3W
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-19
- Primary Completion
- 2028-11-01
- Completion
- 2032-01-31
- FDA Drug
- Yes
Countries
- United States
- Australia
- Austria
- Belgium
- Brazil
- Bulgaria
- China
- Czechia
- Denmark
- France
- India
- Israel
- Italy
- Japan
- Malaysia
- Poland
- Romania
- Singapore
- South Korea
- Spain
- Sweden
- Taiwan
- United Kingdom
Study Locations
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