NCT06819007

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

A Phase 3, Open-label, Multicenter, Randomized Trial of Trastuzumab Deruxtecan With Bevacizumab Versus Bevacizumab Monotherapy as First-line Maintenance Therapy in HER2-Expressing Ovarian Cancer (DESTINY-Ovarian01/ENGOT-ov89/GEICO144- O/GOG-3112/APGOT-OV13)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 582 (estimated)
• Sponsor: Daiichi Sankyo · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A non-randomized safety run-in phase will be conducted prior to randomization phase to assess the safety of T-DXd in combination with bevacizumab.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Trastuzumab Deruxtecan	T-DXd will be administered at a dose of 5.4 mg/kg intravenously (IV) every 3 weeks (Q3W)
DRUG	Bevacizumab	Bevacizumab will be administered at a dose of 15/mg/kg IV Q3W

Timeline

• Start date: 2025-03-19
• Primary completion: 2028-11-01
• Completion: 2032-01-31
• First posted: 2025-02-11
• Last updated: 2026-03-05

Locations

180 sites across 23 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

Regulatory

• FDA-regulated drug study