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
In plain English
This study, run by Daiichi Sankyo, looks at two treatment options for people with newly diagnosed stage 3 or 4 ovarian, fallopian tube, or primary peritoneal cancer whose tumours show HER2 protein. It compares taking trastuzumab deruxtecan together with bevacizumab against taking bevacizumab alone, as maintenance treatment after initial chemotherapy.
Who can take part
- Adults aged 18 or over
- Newly diagnosed stage 3 or 4 high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer
- The tumour shows HER2 protein, confirmed by testing
- Tissue sample from the tumour is available for testing
- A test result for HRD (homologous recombination deficiency) or BRCA is available
- Have had up to 6 cycles of standard treatment with bevacizumab plus platinum chemotherapy, and are able to continue bevacizumab alone as standard care
Who may not be able to
- Cancer that is not epithelial in origin
- A known or suspected harmful BRCA change that would make a PARP inhibitor suitable
- Being due to receive a PARP inhibitor as maintenance treatment
- Severe allergic reactions to the drugs or other monoclonal antibodies
- Stroke, mini-stroke, or bleeding around the brain in the last 6 months
- Bleeding disorders, tummy fistula, hole in the bowel, or bowel bleeding in the last 6 months
- Active bowel blockage
- Heart attack in the last 6 months, or symptomatic heart failure
- A certain heart rhythm change on an ECG (corrected QT interval over 480 milliseconds)
- Current or past lung inflammation (interstitial lung disease or pneumonitis) needing steroids, or suspected lung inflammation that cannot be ruled out on scans
What taking part involves
- • Being given either trastuzumab deruxtecan plus bevacizumab, or bevacizumab alone
- • Continuing maintenance treatment after initial chemotherapy
- • HER2 testing of tumour tissue at a central laboratory
Time commitment: Not stated — ask the trial team about how many hospital visits, how long the trial lasts, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- Female
- Number of participants
- 582
- Started
- 2025-03-19
- Last checked
- 2026-07
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
Treatment history
Treatments you must have had:
- ✓ for HER2 testing and retrospective HRD status determination
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 FIGO Stage III or IV.
- ✓Has HER2 expression per 2016 ASCO-CAP gastric cancer IHC scoring (3+/2+/1+) guidelines1 by prospective central testing.
- ✓\*Participants in the safety run-in phase who are enrolled based on local HER2 IHC results are recommended to...
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 patient eligible for PARP...
- ✗HRD negative
- ✗HRD positive with SD as best response after platinum
- ✗HRD positive non-serous histology Note: For participants enrolled from the Republic of Korea
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
