At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Trastuzumab Deruxtecan (drug), Bevacizumab (drug)
- How long the study runs
- Study runs about 82 months (dates as stated)
- About the drug or intervention
- Trastuzumab Deruxtecan — drug: T-DXd will be administered at a dose of 5.4 mg/kg intravenously (IV) every 3 weeks (Q3W). · Bevacizumab — drug: Bevacizumab will be administered at a dose of 15 mg/kg IV Q3W.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- Female
- Number of participants
- 582
- Started
- 2025-03-19
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for ovarian cancer
- • Phase3 - 582 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with ovarian cancer
- • Female only
Where?
- • Cambridge - Addenbrooke's Hospital
- • London - Guys Hospital Cancer Centre
- • London - Barts Health NHS Trust
- • Manchester - The Christie Hospital
- • +2 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: Female only
Biomarkers mentioned
What the study is looking for
- ✓\*For participants in the safety run-in phase, a safety run-in ICF needs to be signed and dated prior to the start...
- ✓Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of...
- ✓Is newly diagnosed International Federation of Gynecology and Obstetrics (FIGO) Stage III or IV.
- ✓Has HER2 expression.
Who cannot take part
- ✗Has ovarian, fallopian tube, or peritoneal cancer of non-epithelial origin.
- ✗Has a known or suspected deleterious BRCA alteration as per local test that makes the participant eligible for poly...
- ✗Participant to receive PARP inhibitor as maintenance per the usual treatment and investigator discretion.
- ✗Previous cerebral-vascular accident, transient ischemic attack or subarachnoid hemorrhage within 6 months prior to...
- ✗\*Note: For participants enrolled from the Republic of Korea, country-specific requirements are applicable.
See the full criteria
Where Is This Study? (6 UK sites)
Addenbrooke's Hospital
Cambridge, United Kingdom
Guys Hospital Cancer Centre
London SE1 9RT, United Kingdom
Barts Health NHS Trust
London, United Kingdom
The Christie Hospital
Manchester, United Kingdom
Genesis Care, Beaumont House
Oxford OX4 6LB, United Kingdom
Weston Park Hospital
Sheffield S10 2SB, United Kingdom
How to Get in Touch
Contact for Trial Information
Sponsor contactCONTACT
