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

Korábbi kezelés

• Has a known or suspected deleterious BRCA alteration as per local test that makes the participant eligible for poly (ADP-ribose) polymerase (PARP) inhibitor.
• Participant to receive PARP inhibitor as maintenance per standard of care and investigator discretion.
• 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.

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• Has ovarian, fallopian tube, or peritoneal cancer of non-epithelial origin.
• Has evidence of bleeding diathesis or significant coagulopathy (in the absence of anticoagulation therapy).
• Has a history of hemorrhagic disorders.

• 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.
• 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.
• 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).
• Is newly diagnosed International Federation of Gynecology and Obstetrics (FIGO) Stage III or IV.
• Has HER2 expression.