DESTINY-Ovarian01
Research type
Research Study
Full title
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/GEICO144O/GOG-3112)
IRAS ID
1011440
Contact name
Bettina Steffens
Contact email
Sponsor organisation
Daiichi Sankyo, Inc
Clinicaltrials.gov Identifier
Research summary
Ovarian cancer is the seventh most common cancer in woman worldwide, with approximately 324,000 new cases and 207,000 deaths annually worldwide. A majority of epithelial ovarian cancer, which accounts for approximately 90% of ovarian cancer, is diagnosed at advanced stage, in which over 70% will have recurrence within the first 5 years after surgery and recurrent disease is typically incurable.
This is a global, multicenter, open-label, phase 3 trial 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 advanced high-grade epithelial ovarian cancer.
The study consists of the safety run-in phase (non-randomised, to assess the safety of T-DXd in combination with bevacizumab) and the randomization phase with 2 treatment arms: T-DXd in combination with bevacizumab and Bevacizumab monotherapy, randomised in 1:1 ratio. It is expected that about 20 patients will participate in the safety run-in phase and approximately 562 randomization phase around the world. Since this is open label, participants will know whether they are receiving the study drug or comparator.
The purpose of Safety Run-in Phase is to evaluate safety and tolerability of T-DXd in combination with bevacizumab. The purpose of Randomization Phase is to compare the efficacy of T-DXd in combination with bevacizumab (Arm A) versus bevacizumab monotherapy (Arm B).
Each phase of this study is divided into 4 periods: a Tissue Pre-screening period, screening part (up to 28 days), a Treatment period (up to 24 months) and a Follow-up period. Participation in this study will last for approximately 72 months (6 years).REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
25/NE/0094
Date of REC Opinion
15 Jul 2025
REC opinion
Further Information Favourable Opinion