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Combining Trastuzumab Deruxtecan with Bevacizumab for Ovarian Cancer Treatment

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/GEICO144- O/GOG-3112/APGOT-OV13)

Phase 3 Interventional Daiichi Sankyo · NCT06819007

This study is testing if combining two drugs, Trastuzumab Deruxtecan and Bevacizumab, can help people with advanced ovarian cancer feel better compared to using Bevacizumab alone.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment582 (estimated)
Ages18 Years and up
SexFemale
SponsorDaiichi Sankyo Industry-sponsored
Drugs / interventionsbevacizumab, chemotherapy
Locations180 sites (La Jolla, California and 179 other locations)
Trial IDNCT06819007 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of Trastuzumab Deruxtecan (T-DXd) in combination with Bevacizumab compared to Bevacizumab alone as a first-line maintenance therapy for patients with HER2-expressing advanced high-grade epithelial ovarian cancer. Initially, a non-randomized safety run-in phase will assess the safety of the combination treatment before proceeding to a randomized phase. Participants must have a confirmed diagnosis of high-grade ovarian cancer and meet specific HER2 expression criteria. The study aims to provide insights into a potentially more effective treatment regimen for this patient population.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with newly diagnosed FIGO Stage III or IV high-grade epithelial ovarian cancer that expresses HER2.

Not a fit: Patients with low HER2 expression or those with non-epithelial ovarian cancers may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a more effective treatment option for patients with HER2-expressing ovarian cancer, potentially improving their outcomes.

How similar studies have performed: Other studies have shown promising results with similar combination therapies in HER2-expressing cancers, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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 this trial is running

La Jolla, California and 179 other locations

+130 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ovarian CancerOvarian cancerepithelial ovarian cancerHER2Trastuzumab DeruxtecanBevacizumab
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.