Study of Trastuzumab Deruxtecan With Bevacizumab Versus Bevacizumab Monotherapy for First-line Maintenance in HER2-Expressing Ovarian Cancer (DESTINY-Ovarian01)
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.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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).
