DESTINY-Ovarian01: Trastuzumab Deruxtecan with Bevacizumab for Ovarian Cancer

This study, called DESTINY-Ovarian01, is looking at a new way to treat advanced ovarian cancer that has a specific marker called HER2. It compares two treatments: Trastuzumab Deruxtecan (T-DXd) combined with Bevacizumab, versus Bevacizumab alone. The goal is to see if the combination treatment can prevent the cancer from growing or spreading for longer. You might be able to join if you are an adult woman with HER2-expressing ovarian cancer. The main way we'll know if the treatment is successful is by measuring how long you live without the cancer getting worse. The study is currently unclear about its recruitment status and plans to enroll 582 participants.

Study design
This is an interventional study that will first have a safety run-in phase before a randomized phase. It plans to enroll 582 participants.
What's involved
You will need to sign consent forms before any testing. Trastuzumab Deruxtecan and Bevacizumab will be given intravenously (into a vein) every 3 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be followed from the date of randomization until radiographic disease progression or death, for up to approximately 35 months.

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NCT06819007

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Daiichi Sankyo
~582 participants
Updated 2026-07-02 on ClinicalTrials.gov
What's tested:Trastuzumab DeruxtecanBevacizumab

At a glance

Recruiting sites
208 of 208 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression Free Survival by Blinded Independent Central Review (BICR) in the HER2 IHC 3+/2+ population
Measured over From date of randomization to radiographic disease progression or death due to any cause, up to approximately 35 months
Ovarian Cancer
208 sites across 44 states
China27
Japan16
Spain15
Italy13
France10
South Korea10
Brazil9
India9

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

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.
  • Progression Free Survival by Blinded Independent Central Review (BICR) in the HER2 IHC 3+/2+ populationFrom date of randomization to radiographic disease progression or death due to any cause, up to approximately 35 months

    Time from randomization to time of objective radiographic disease progression as assessed by BICR based on RECIST v1.1 or death due to any cause.