Study of Trastuzumab Deruxtecan With Bevacizumab Versus Bevacizumab Monotherapy for First-line Maintenance in HER2-Expressing Ovarian Cancer (DESTINY-Ovarian01)
DO-01
A Phase 3, Open-label, Multicenter, Randomized Trial of Trastuzumab Deruxtecan With Bevacizumab Versus Bevacizumab Monotherapy as First-line Maintenance Therapy in HER2-Expressing Ovarian Cancer (DESTINY-Ovarian01/ENGOT-ov89/GEICO144- O/GOG-3112/APGOT-OV13)
5 other identifiers
interventional
582
23 countries
192
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 ovarian-cancer
Started Mar 2025
Typical duration for phase_3 ovarian-cancer
192 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2025
CompletedFirst Posted
Study publicly available on registry
February 11, 2025
CompletedStudy Start
First participant enrolled
March 19, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2032
May 26, 2026
May 1, 2026
3.6 years
February 5, 2025
May 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival by Blinded Independent Central Review (BICR) in the HER2 IHC 3+/2+ population
Time from randomization to time of objective radiographic disease progression as assessed by BICR based on RECIST v1.1 or death due to any cause.
From date of randomization to radiographic disease progression or death due to any cause, up to approximately 35 months
Secondary Outcomes (5)
Overall Survival in the HER2 IHC 3+/2+ population
From date of randomization to death due to any cause, up to approximately 72 months
Progression Free Survival by BICR in the HER2 IHC 3+/2+/1+ population
From date of randomization to radiographic disease progression or death due to any cause, up to approximately 35 months
Overall Survival in the HER2 IHC 3+/2+/1+ population
From date of randomization to death due to any cause, up to approximately 72 months
Progression Free Survival by the investigator in HER2 IHC 3+/2+ population
From date of randomization to radiographic disease progression or death due to any cause, up to approximately 35 months
Progression Free Survival by the investigator in HER2 IHC 3+/2+/1+ population
From date of randomization to radiographic disease progression or death due to any cause, up to approximately 35 months
Study Arms (2)
Treatment Arm A
EXPERIMENTALParticipants will receive T-DXd in combination with bevacizumab
Treatment Arm B
ACTIVE COMPARATORParticipants will receive bevacizumab monotherapy
Interventions
Bevacizumab will be administered at a dose of 15/mg/kg IV Q3W
T-DXd will be administered at a dose of 5.4 mg/kg intravenously (IV) every 3 weeks (Q3W)
Eligibility Criteria
You may qualify if:
- Sign and date the tissue prescreening 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 FIGO Stage III or IV.
- 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.
- 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.
- Has a local HRD or BRCA test result available. Participants with BRCA-wildtype will have a local HRD test results, as applicable.
- Has received up to 6 cycles of standard of care bevacizumab in combination with frontline 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.
You may not qualify if:
- Has ovarian, fallopian tube, or peritoneal cancer of non-epithelial origin.
- Has a known or suspected deleterious BRCA alteration as per local test that makes the patient eligible for PARP inhibitor.
- 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 Note: For participants enrolled from the Republic of Korea
- HRD tested, but inconclusive
- HRD positive but safety concern (safety concern to be specified).
- Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug products and other monoclonal antibodies.
- Previous Cerebral-Vascular Accident, Transient Ischemic Attack or Sub- Arachnoids Hemorrhage within 6 months prior to randomization.
- \*Note: For participants enrolled from the Republic of Korea,
- Has evidence of bleeding diathesis or significant coagulopathy (in the absence of anticoagulation therapy).
- Has a history of hemorrhagic disorders, abdominal fistula, gastrointestinal perforation, or active gastrointestinal bleeding within 6 months before randomization.
- Evidence of active or ongoing bowel obstruction.
- Has a medical history of myocardial infarction within 6 months before randomization, symptomatic congestive heart failure (New York Heart Association Class II to IV).
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
Study Sites (193)
Scripps Clinic
La Jolla, California, 92037, United States
Broward Health Medical Center
Fort Lauderdale, Florida, 33316, United States
Jupiter Medical Center
Jupiter, Florida, 33458, United States
Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
AdventHealth Cancer Institute
Orlando, Florida, 32804, United States
Woman's Care FL
St. Petersburg, Florida, 33713, United States
Nancy N. & J.C Lewis Cancer & Research Pavillion- St. Josephs/ Candler Health System
Savannah, Georgia, 31405, United States
Endeavor Health Evanston Kellogg Cancer Care Center
Evanston, Illinois, 60201, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Trials365 LLC
Shreveport, Louisiana, 71103, United States
Greater Baltimore Medical Center
Towson, Maryland, 21204, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Trinity Health St. Joseph Mercy Ann Arbor
Ann Arbor, Michigan, 48106, United States
Corewell Health
Grand Rapids, Michigan, 49503, United States
St. Vincent Gynecologic Oncology
Billings, Montana, 59102, United States
Valley Health System
Paramus, New Jersey, 07652, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Columbia University
New York, New York, 10032, United States
UNC Hospital
Chapel Hill, North Carolina, 27599, United States
Miami Valley Hospital South
Centerville, Ohio, 45459, United States
Legacy Medical Group Gynecologic Oncology
Portland, Oregon, 97210, United States
Providence Cancer Center Oncology
Portland, Oregon, 97213, United States
St. Lukes University Health Network
Bethlehem, Pennsylvania, 18015, United States
Ann B Barshinger Cancer Institute
Lancaster, Pennsylvania, 17601, United States
Avera Medical Group Gynecologic
Sioux Falls, South Dakota, 57105, United States
Sarah Cannon Research Institute (Oncology Associates of Oregon PC)
Nashville, Tennessee, 37203, United States
Genesiscare St Andrews Hospital
Adelaide, Australia
Icon Cancer Centre Wesley
Auchenflower, Australia
Icon Cancer Centre Hobart
Hobart, Australia
Genesis Care North Shore (Oncology)
St Leonards, Australia
Westmead Hospital
Sydney, Australia
Medizinische Universitat Innsbruck
Innsbruck, Austria
AZ Sint-Lucas
Ghent, Belgium
UZ Leuven
Leuven, Belgium
Groupe Sante CHC/Clinique du MontLegia
Liège, Belgium
CHU UCL Namur
Namur, Belgium
Cliniques Universitaires Saint-LUC
Woluwe-Saint-Lambert, Belgium
Oncocentro Belo Horizonte
Belo Horizonte, Brazil
Centro De Pesquisas Clinica Reichow
Blumenau, Brazil
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
Irmandade Da Santa Casa De Misericordia De Porto Alegre
Porto Alegre, Brazil
Ceon Pesquisas
Santo André, Brazil
Fundacao Faculdade Regional De Medicina De Sao Jose Do Rio Preto
Sao Jose Rio, Brazil
BP A Beneficencia Portuguesa de Sao Paulo
São Paulo, Brazil
Complex Oncology Center- Plovdiv EOOD
Plovdiv, Bulgaria
MHAT Park Hospital EOOD
Plovdiv, Bulgaria
MHAT Serdika EOOD
Sofia, Bulgaria
UMHAT Sofiamed EOOD
Sofia, Bulgaria
UMHAT Tsaritsa Yoanna ISUL EAD
Sofia, Bulgaria
Ushato Prof Ivan Chernozemski Ead
Sofia, Bulgaria
Beijing Cancer Hospital
Beijing, China
The First Hospital of Jilin University
Changchun, China
Hunan Cancer Hospital
Changsha, 410006, 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
Yunnan Cancer Hospital
Kunming, 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, 200032, China
Liaoning Cancer Hospital & Institute
Shenyang, 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
Fakultni Nemocnice Ostrava
Ostrava-Poruba, Czechia
Fakultni Nemocnice Bulovka
Prague, Czechia
Fakultni Nemocnice Kralovske Vinohrady
Prague, Czechia
Fakultni Nemocnice V Motole
Prague, Czechia
Vseobecna Fakultni Nemocnice V Praze
Prague, Czechia
Aarhus University Hospital
Aarhus, Denmark
Rigshospitalet
Copenhagen, 2100, Denmark
Sjællands Universitet Hospital
Roskilde, Denmark
Institut Bergonie
Bordeaux, France
Centre Georges Francois Leclerc
Dijon, France
Hopital Claude Huriez- CHU Lille
Lille, France
Centre Leon Berard
Lyon, France
CHU Montpellier, Saint Eloi
Montpellier, France
Hopital Prive Du Confluent
Nantes, France
Hopital Saint Joseph- Paris
Paris, France
Hospital Europeen Georges Pompidou
Paris, France
CRLCC Eugene Marquis
Rennes, France
CHU Saint Etienne
Saint-Etienne, France
Debreceni Egyetem
Debrecen, 4032, Hungary
Gujarat Cancer & Research Institute
Ahmedabad, India
Saroj Gupta Cancer Center and Research Institute SGCC&RI
Kolkata, India
National Cancer Institute Nagpur
Nagpur, India
HCG Manavata Cancer Centre
Nashik, India
Ruby Hall Clinic
Pune, India
HCG Cancer Centre Vadodara
Vadodara, India
King George Hospital
Visakhapatnam, India
The Lady Davis Carmel Medical Center
Haifa, Israel
Shaare Zedek
Jerusalem, Israel
Meir Medical Center
Kfar Saba, Israel
Rabin Medical Center-Beilinson Campus
Petah Tikva, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Sheba Medical Center
Tel Litwinsky, Israel
Istituto Tumori Giovanni Paolo II Irccs Ospedale Oncologico Bari
Bari, Italy
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
Bologna, Italy
Azienda Ospedaliera Per Lemergenza Cannizzaro
Catania, Italy
Humanitas San Pio X
Milan, Italy
IEO Istituto Europeo Di Oncologia
Milan, Italy
Azienda Socio Sanitaria Territoriale Di Monza (Presidio San Gerardo)
Monza, Italy
Istituto Nazionale Tumori Fondazione G. Pascale
Naples, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
Nuovo Ospedale Degli Infermi
Ponderano, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
Istituto Nazionale Tumori Regina Elena Irccs
Roma, Italy
Hyogo Cancer Center
Akashi, 673-8558, Japan
National Cancer Center Hospital
Chūōku, 104-0045, Japan
Fukushima Medical University Hospital
Fukushima, 960-1295, Japan
Saitama Medical University International Medical Center
Hidaka-Shi, 350-1298, Japan
Cancer Institute Hospital of JFCR
Kōtoku, 135-8550, Japan
Kurume University Hospital
Kurume-shi, Japan
Aichi Cancer Center Hospital
Nagoya, Japan
Niigata Cancer Center Hospital
Niigata, Japan
Okayama University Hosptial
Okayama, 700-8558, Japan
Osaka International Cancer Institute
Osaka, Japan
Kindai University Hospital
Osakasayama-shi, Japan
NHO Hokkaido Cancer Center
Sapporo, 003-0804, Japan
Iwate Medical University Hospital
Shiwa-Gun, 028-3695, Japan
Shizuoka Cancer Center
Sunto-gun, Japan
Mie University Hospital
Tsu, 514-8507, Japan
Yamagata University Hospital
Yamagata, 990-9585, Japan
Hospital Sultan
Johor Bahru, Malaysia
Sarawak General Hospital
Kuching, Malaysia
HOSPITAL KUALA LUMPUR(HKL) Kuala
Lumpur, Malaysia
National Cancer Institute / Institut Kanser Negara
Putrajaya, Malaysia
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, 61848, Poland
Mazowiecki Szpital Wojewodzki W Siedlcach SP Zoo
Siedlce, Poland
Gral Medical S.R.L
Bucharest, Romania
Medeuropa SRL
Bucharest, Romania
Memorial Healthcare International SRL
Bucharest, Romania
Medeuropa SRL
Oradea, Romania
National Cancer Centre Singapore
Singapore, 168583, Singapore
National University Hospital
Singapore, Singapore
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
Samsung Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
The Catholic University of Korea, Seoul St. Mary'S Hospital
Seoul, South Korea
Complejo Hospitalario Universitario A Coruna
A Coruña, Spain
Hospital Clinic De Barcelona
Barcelona, Spain
Hospital Universitari Vall D'Hebron
Barcelona, Spain
Hospital Universitario Reina Sofia
Córdoba, Spain
Hospital Universitario Virgen De La Arrixaca
El Palmar, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario Ramon y Cajal
Madrid, Spain
Hospital Universitari Son Espases
Palma, Spain
Clinica Universidad de Navarra (MAD)
Pamplona, Spain
Hospital Universitario Donostia
Planta Baja, Spain
Clinica Universidad de Navarra (Calle Marquesado de Santa Marta)
San Blas-Canillejas, Spain
Hospital Universitario Virgen del Rocio
Seville, Spain
Hospital Clinico Universitario De Valencia
Valencia, Spain
Hospital Universitari I Politecnic La Fe
Valencia, Spain
Skanes Universitetssjukhus Lund
Lund, Sweden
Karolinska Universitet Ssjukhuset
Solna, Sweden
Akademiska Sjukhuset (Uppsala University Hospital)
Uppsala, 75185, Sweden
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
Addenbrooke's Hospital
Cambridge, United Kingdom
Guys Hospital Cancer Centre
London, SE1 9RT, United Kingdom
Barts Health NHS Trust
London, United Kingdom
The Christie Hospital
Manchester, United Kingdom
Genesis Care, Beaumont House
Oxford, OX4 6LB, United Kingdom
Weston Park Hospital
Sheffield, S10 2SB, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- This is an open-label study.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2025
First Posted
February 11, 2025
Study Start
March 19, 2025
Primary Completion (Estimated)
November 1, 2028
Study Completion (Estimated)
January 31, 2032
Last Updated
May 26, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Completed studies that has reached a global end or completion with all data set collected and analyzed, and for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
- Access Criteria
- Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/