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

Study acronym: DO-01
StatusRecruiting
PhasePhase 3
Started2025-03-19
View on ClinicalTrials.gov ↗

Amendment history

2026-07-01
Study Status, Contacts/Locations v16
Trial sites expanded: 205 → 208 locations
2026-06-17
Study Status, Contacts/Locations v15
Trial sites expanded: 193 → 205 locations
2026-05-21
Study Status, Contacts/Locations v14
Trial sites expanded: 180 → 193 locations
2026-03-03
Study Status, Contacts/Locations v13
Study sites165→180
2026-02-19
Study Status, Contacts/Locations v12
Study sites138→165
Show 11 earlier versions
2026-02-18
Study Identification, Study Status, Eligibility v11
Eligibility criteria-48 characters
Key Inclusion Criteria: Sign and date the tissue prescreening informed consent form (ICF), prior to HER2 central testing. Sign and date the mainMain ICF, prior to the start of any trial- specific qualificatio [...] dures. Consent to optional PGx prior to any PGx procedures. *For participants in the safety run-in phase, a safety run-in [...] ade ovarian, fallopian tube or primary peritoneal carcinoma per local assessment (including but not limiting to serous, endometrioid, clear c [...] ring (3+/2+/1+) guidelines1 by prospective central testing. *For participants in the safety run-in phase, HER2 expression [...] or HER2 t [...]
2026-01-07
Study Identification, Study Status, Contacts/Locations v10
Study sites110→138
2025-12-04
Study Identification, Study Status, Contacts/Locations v9
Study sites84→110
2025-11-11
Study Status, Contacts/Locations v8
Study sites59→84
2025-10-01
Study Status, Contacts/Locations v7
Study sites35→59
2025-08-04
Study Status, Contacts/Locations v6
Study sites19→35
2025-07-17
Study Status, Contacts/Locations v5
Study sites12→19
2025-05-30
Study Status, Contacts/Locations v4
Study sites3→12
2025-05-02
Study Identification, Study Status, Contacts/Locations v3
Study sites2→3
Study title+20 characters
[...] for First-line Maintenance in HER2-Expressing Ovarian Cancer (DESTINY-Ovarian01)
2025-04-17
Study Status, Contacts/Locations v2
Start date2025-03-18→2025-03-19
Study sites1→2
2025-03-19
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-03-01→confirmed 2025-03-18
Study sites0→1
2025-02-05
Original filing
Daiichi Sankyo
69 trials monitored
See 8 trials at risk
Ovarian Cancer
1,239 trials monitored
See 74 trials at risk
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.
Trial Details
NCT Number NCT06819007
Lead Sponsor Daiichi Sankyo
Conditions Ovarian Cancer
Enrollment 582 participants
Start Date 2025-03-19
Primary Completion 2028-11-01 (estimated)
Study Completion 2032-01-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-02