Study of Trastuzumab Deruxtecan With Bevacizumab Versus Bevacizumab Monotherapy for First-line Maintenance in HER2-Expressing Ovarian Cancer (DESTINY-Ovarian01) (DO-01)

Daiichi Sankyo

Status and phase: Enrolling; Phase 3

Conditions: Ovarian Cancer

Treatments: Drug: Trastuzumab Deruxtecan; Drug: Bevacizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06819007

APGOT-OV13 (Other Grant/Funding Number)

DS8201-772

GEICO144-O (Other Grant/Funding Number)

ENGOT-ov89 (Other Grant/Funding Number)

GOG-3112 (Other Grant/Funding Number)

2024-516982-35-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

This clinical trial is designed to evaluate the efficacy and safety of T-DXd in combination with bevacizumab versus bevacizumab monotherapy as first-line maintenance therapy, in participants with human epidermal growth factor 2 (HER2)-expressing (immunohistochemistry [IHC] 3+/2+/1+) advanced high-grade epithelial ovarian cancer.

Full description

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.

Enrollment: 582 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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582 participants in 2 patient groups

Treatment Arm A

Experimental group

Description:

Participants will receive T-DXd in combination with bevacizumab.

Treatment:

Drug: Bevacizumab

Drug: Trastuzumab Deruxtecan

Treatment Arm B

Active Comparator group

Description:

Participants will receive bevacizumab monotherapy.

Treatment:

Drug: Bevacizumab