Combining Trastuzumab Deruxtecan with Bevacizumab for Ovarian Cancer Treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

1. Sign and date the tissue prescreening informed consent form (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 International Federation of Gynecology and Obstetrics (FIGO) Stage III or IV.
5. Has HER2 expression.

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 participant eligible for poly (ADP-ribose) polymerase (PARP) inhibitor.
3. Participant to receive PARP inhibitor as maintenance per standard of care and investigator discretion.
4. Previous cerebral-vascular accident, transient ischemic attack or subarachnoid hemorrhage within 6 months prior to randomization.

   \*Note: For participants enrolled from the Republic of Korea, country-specific requirements are applicable.
5. Has evidence of bleeding diathesis or significant coagulopathy (in the absence of anticoagulation therapy).
6. Has a history of hemorrhagic disorders.

Where it's running

• Disney Family Cancer Center
  Burbank, California, United States Recruiting
• Scripps Clinic
  La Jolla, California, United States Recruiting
• Palo Alto Medical Foundation
  Palo Alto, California, United States Recruiting
• Broward Health Medical Center
  Fort Lauderdale, Florida, United States Recruiting
• Jupiter Medical Center
  Jupiter, Florida, United States Recruiting
• Mount Sinai Medical Center
  Miami Beach, Florida, United States Recruiting

+182 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Contact for Trial Information
• Email: CTRinfo_us@daiichisankyo.com
• Phone: 908-992-6400

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.