Study of Trastuzumab Deruxtecan With Bevacizumab Versus Bevacizumab Monotherapy for First-line Maintenance in HER2-Expressing Ovarian Cancer (DESTINY-Ovarian01)
NCT ID: NCT06819007
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
582 participants
INTERVENTIONAL
2025-03-19
2032-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment Arm A
Participants will receive T-DXd in combination with bevacizumab
Trastuzumab Deruxtecan
T-DXd will be administered at a dose of 5.4 mg/kg intravenously (IV) every 3 weeks (Q3W)
Bevacizumab
Bevacizumab will be administered at a dose of 15/mg/kg IV Q3W
Treatment Arm B
Participants will receive bevacizumab monotherapy
Bevacizumab
Bevacizumab will be administered at a dose of 15/mg/kg IV Q3W
Interventions
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Trastuzumab Deruxtecan
T-DXd will be administered at a dose of 5.4 mg/kg intravenously (IV) every 3 weeks (Q3W)
Bevacizumab
Bevacizumab will be administered at a dose of 15/mg/kg IV Q3W
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 (including but not limiting to serous, endometrioid, clear cell, carcinosarcoma, mucinous).
4. Is newly diagnosed FIGO Stage III or IV.
5. Has HER2 expression per 2016 ASCO-CAP gastric cancer IHC scoring (3+/2+/1+) guidelines1 by prospective central testing. For participants in the safety run-in phase, HER2 expression assessed by either local (require using ASCO-CAP gastric cancer IHC scoring \[IHC 3+/2+/1+\] guidelines) or central assessment (if available) is acceptable. Submission of the pathology report is required for participants enrolled based on local HER2 IHC results.
6. Has adequate tumor tissue sample available for assessment of HER2 by central laboratory. Tumor tissue block or sufficient tissue slides are required for HER2 testing and retrospective HRD status determination. Participants in the safety run-in phase who are enrolled based on local HER2 IHC results are recommended to provide tumor tissue sample from the same specimen for central assessment.
7. Has a local HRD or breast cancer gene (BRCA) test result available. Participants with BRCA wildtype will have a local HRD test results, as applicable.
8. Has received standard of care bevacizumab in combination with front line platinum based chemotherapy as per approved indication and clinical guidelines and is eligible to continue single agent bevacizumab maintenance per standard of care and investigator discretion.
Exclusion Criteria
2. Has a BRCA mutation as per local test.
3. Participant to receive PARP inhibitor as maintenance per standard of care and investigator discretion. Reasons for which the participant is not eligible for PARP inhibitor will be recorded in the eCRF as follows: HRD negative HRD positive with SD as best response after platinum HRD positive non-serous histology HRD tested, but inconclusive HRD positive but safety concern (safety concern to be specified).
4. Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug products and other monoclonal antibodies.
5. Previous Cerebral-Vascular Accident, Transient Ischemic Attack or Sub- Arachnoids Hemorrhage within 6 months prior to randomization.
6. Has evidence of bleeding diathesis or significant coagulopathy (in the absence of anticoagulation therapy).
7. Has a history of hemorrhagic disorders, abdominal fistula, gastrointestinal perforation, or active gastrointestinal bleeding within 6 months before randomization.
8. Evidence of active or ongoing bowel obstruction.
9. Has lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of the trial randomization, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, pneumonectomy, etc.)
10. Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
11. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie pulmonary emboli within three months of the trial enrollment, severe asthma, severe COPD, restrictive lung disease, pleural effusion etc.), and any autoimmune, connective tissue or inflammatory disorders with potential pulmonary involvement (ie Rheumatoid arthritis, Sjogren's, sarcoidosis etc.), or prior pneumonectomy.
18 Years
FEMALE
No
Sponsors
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Daiichi Sankyo
INDUSTRY
Responsible Party
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Locations
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Broward Health Medical Center
Fort Lauderdale, Florida, United States
Indiana University
Indianapolis, Indiana, United States
Trials365 LLC
Shreveport, Louisiana, United States
Greater Baltimore Medical Center
Towson, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Valley Health System
Paramus, New Jersey, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
UNC Hospital
Chapel Hill, North Carolina, United States
Miami Valley Hospital South
Centerville, Ohio, United States
Avera Medical Group Gynecologic
Sioux Falls, South Dakota, United States
UZ Leuven
Leuven, , Belgium
Groupe Sante CHC/Clinique du MontLegia
Liège, , Belgium
CHU UCL Namur
Namur, , Belgium
Fundação Doutor Amaral Carvalho
Jaú, , Brazil
Liga Norte-Rio-Grandense Contra o Cancer
Natal, , Brazil
Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa Hospital Mae de Deus
Porto Alegre, , Brazil
BP A Beneficencia Portuguesa de Sao Paulo
São Paulo, , Brazil
MHAT Park Hospital EOOD
Plovdiv, , Bulgaria
UMHAT Tsaritsa Yoanna ISUL EAD
Sofia, , Bulgaria
Beijing Cancer Hospital
Beijing, , China
The First Hospital of Jilin University
Changchun, , China
Sichuan University West China Second University Hospital
Chengdu, , China
Chongqing Cancer Hospital
Chongqing, , China
The Second Hospital of Dalian Medical University
Dalian, , China
Fujian Cancer Hospital
Fuzhou, , China
Sun Yat-Sen University Cancer Center
Guangzhou, , China
Harbin Medical University - Tumor Hospital
Haerbing, , China
Hainan General Hospital
Haikou, , China
Zhejiang Cancer Hospital
Hangzhou, , China
Women's Hospital School of Medicine Zhejiang University
Hangzhoushi, , China
Shandong Cancer Hospital
Jinan, , China
Jiangxi Maternal and Child Health Hospital
Nanchang, , China
Zhong Da Hospital, Southeast University
Nanjing, , China
Guangxi Medical University Cancer Hopstial
Nanning, , China
Fudan University Shanghai Cancer Center
Shanghai Shi, , China
Affiliated Hospital (Suzhou First People's Hospital)
Suzhou, , China
Shanxi Cancer Hospital
Taiyuan, , China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, , China
Hubei Cancer Hospital
Wuhan, , China
Tongji Hospital Tongji Medical College of HUST
Wuhan, , China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, , China
Yantai Yuhuangding Hospital
Yantai, , China
Henan Cancer Hospital
Zhengzhou, , China
Institut Bergonie
Bordeaux, , France
CHU Montpellier, Saint Eloi
Montpellier, , France
Hospital Europeen Georges Pompidou
Paris, , France
CRLCC Eugene Marquis
Rennes, , France
CHU Saint Etienne
Saint-Etienne, , France
The Lady Davis Carmel Medical Center
Haifa, , Israel
Shaare Zedek
Jerusalem, , Israel
Meir Medical Center
Kfar Saba, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Hyogo Cancer Center
Akashi, , Japan
National Cancer Center Hospital
Chūōku, , Japan
Fukushima Medical University Hospital
Fukushima, , Japan
Saitama Medical University International Medical Center
Hidaka-Shi, , Japan
Cancer Institute Hospital of JFCR
Kōtoku, , Japan
Kurume University Hospital
Kurume-shi, , Japan
Aichi Cancer Center Hospital
Nagoya, , Japan
Niigata Cancer Center Hospital
Niigata, , Japan
Okayama University Hosptial
Okayama, , Japan
Kindai University Hospital
Osakasayama-shi, , Japan
NHO Hokkaido Cancer Center
Sapporo, , Japan
Iwate Medical University Hospital
Shiwa-Gun, , Japan
Shizuoka Cancer Center
Sunto-gun, , Japan
Mie University Hospital
Tsu, , Japan
Yamagata University Hospital
Yamagata, , Japan
Hospital Sultan
Johor Bahru, , Malaysia
Sarawak General Hospital
Kuching, , Malaysia
Keimyung University Dongsan Hospital
Daegu, , South Korea
National Cancer Center
Goyang-si, , South Korea
CHA Bundang Medical Center, CHA University
Seongnam-si, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Asan Medical Center
Seoul, , South Korea
Gangnam Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
Chang Gung Memorial Hospital
Linkou Taoyuan, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan, , Taiwan
MacKay Memorial Hospital- Taipei Branch
Taipei, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Other Identifiers
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ENGOT-ov89
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
GEICO144-O
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
GOG-3112
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
DS8201-772
Identifier Type: -
Identifier Source: org_study_id