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Looking for participantsPhase3

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

Sponsor: Daiichi Sankyo

NCT ID: NCT06819007

View on ClinicalTrials.gov ↗

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.

Ovarian Cancer

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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

HER2HRDHRD negativeHRD positive

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
Key Inclusion Criteria: 1. Sign and date the tissue prescreening ICF, prior to HER2 central testing. Sign and date the Main ICF, prior to the start of any trial- specific qualification procedures. Consent to optional PGx prior to any PGx procedures. \*For participants in the safety run-in phase, a safety run-in ICF needs to be signed and dated prior to the start of any trial-specific qualification procedures. 2. Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is \>18 years old. 3. Has histologically confirmed diagnosis of epithelial high-grade ovarian, fallopian tube or primary peritoneal carcinoma per local assessment (including but not limiting to serous, endometrioid, clear cell, carcinosarcoma, mucinous). 4. Is newly diagnosed FIGO Stage III or IV. 5. Has HER2 expression per 2016 ASCO-CAP gastric cancer IHC scoring (3+/2+/1+) guidelines1 by prospective central testing. \*For participants in the safety run-in phase, HER2 expression assessed by either local (require using ASCO-CAP gastric cancer IHC scoring \[IHC 3+/2+/1+\] guidelines) or central assessment (if available) is acceptable. Submission of the pathology report is required for participants enrolled based on local HER2 IHC results. 6. Has adequate tumor tissue sample available for assessment of HER2 by central laboratory. Tumor tissue block or sufficient tissue slides are required for HER2 testing and retrospective HRD status determination. \*Participants in the safety run-in phase who are enrolled based on local HER2 IHC results are recommended to provide tumor tissue sample from the same specimen for central assessment. 7. Has a local HRD or BRCA test result available. Participants with BRCA-wildtype will have a local HRD test results, as applicable. 8. Has received up to 6 cycles of standard of care bevacizumab in combination with frontline platinum- based chemotherapy as per approved indication and clinical guidelines and is eligible to continue single agent bevacizumab maintenance per standard of care and investigator discretion. Key Exclusion Criteria: 1. Has ovarian, fallopian tube, or peritoneal cancer of non-epithelial origin. 2. Has a known or suspected deleterious BRCA alteration as per local test that makes the patient eligible for PARP inhibitor. 3. Participant to receive PARP inhibitor as maintenance per standard of care and investigator discretion. Reasons for which the participant is not eligible for PARP inhibitor will be recorded in the eCRF as follows: * 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 * HRD tested, but inconclusive * HRD positive but safety concern (safety concern to be specified). 4. Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug products and other monoclonal antibodies. 5. Previous Cerebral-Vascular Accident, Transient Ischemic Attack or Sub- Arachnoids Hemorrhage within 6 months prior to randomization. \*Note: For participants enrolled from the Republic of Korea, 6. Has evidence of bleeding diathesis or significant coagulopathy (in the absence of anticoagulation therapy). 7. Has a history of hemorrhagic disorders, abdominal fistula, gastrointestinal perforation, or active gastrointestinal bleeding within 6 months before randomization. 8. Evidence of active or ongoing bowel obstruction. 9. Has a medical history of myocardial infarction within 6 months before randomization, symptomatic congestive heart failure (New York Heart Association Class II to IV). Participants with troponin levels above the upper limit of normal at Screening (as defined by the manufacturer), and without any myocardial infarction related symptoms should have a cardiologic consultation during the Screening Period to rule out myocardial infarction. 10. Has a corrected QT interval prolongation to \>480 msec based on average of the Screening triplicate 12-lead ECG. 11. Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.

Where Is This Study? (6 UK sites)

Addenbrooke's Hospital

Cambridge, United Kingdom

Recruiting
Hospital R&D contact (matched)

Stephen Kelleher

cuh.research@nhs.net01223 348490

Guys Hospital Cancer Centre

London SE1 9RT, United Kingdom

Recruiting

Barts Health NHS Trust

London, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Mays Jawad

research.governance@qmul.ac.uk020 7882 6826

The Christie Hospital

Manchester, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Innovation Office

the-christie.ri@nhs.net---

Genesis Care, Beaumont House

Oxford OX4 6LB, United Kingdom

Recruiting

Weston Park Hospital

Sheffield S10 2SB, United Kingdom

Recruiting

How to Get in Touch

Contact for Trial Information

Sponsor contact

CONTACT

908-992-6400 CTRinfo_us@daiichisankyo.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-07