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

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified February 2026 by Daiichi Sankyo
Sponsor
Daiichi Sankyo
Information Provided by (Responsible Party)
Daiichi Sankyo
Clinicaltrials.gov Identifier
NCT06819007
Other Study ID Numbers:
DS8201-772
First Submitted
February 4, 2025
First Posted
February 10, 2025
Last Update Posted
March 4, 2026
Last Verified
February 2026

ClinicalTrials.gov processed this data on March 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study 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.

Condition or DiseaseIntervention/Treatment
Ovarian Cancer
Drug: Trastuzumab DeruxtecanDrug: Bevacizumab

Study Design

Study TypeInterventional
Actual Enrollment582 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleA 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)
Study Start DateMarch 18, 2025
Actual Primary Completion Date2yrs 6mos from now
Actual Study Completion Date5yrs 9mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Treatment Arm A
Participants will receive T-DXd in combination with bevacizumab
Drug: Trastuzumab Deruxtecan
T-DXd will be administered at a dose of 5.4 mg/kg intravenously (IV) every 3 weeks (Q3W)
Treatment Arm B
Participants will receive bevacizumab monotherapy
Drug: Bevacizumab
Bevacizumab will be administered at a dose of 15/mg/kg IV Q3W

Outcome Measures

Primary Outcome Measures
  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.
Secondary Outcome Measures
  1. Overall Survival in the HER2 IHC 3+/2+ population
    Time interval from the date of randomization to the date of death due to any cause.
  2. Progression Free Survival by BICR in the HER2 IHC 3+/2+/1+ 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.
  3. Overall Survival in the HER2 IHC 3+/2+/1+ population
    Time interval from the date of randomization to the date of death due to any cause.
  4. Progression Free Survival by the investigator in HER2 IHC 3+/2+ population
    Time from randomization to time of objective radiographic disease progression as assessed by the investigator based on RECIST v1.1 or death due to any cause.
  5. Progression Free Survival by the investigator in HER2 IHC 3+/2+/1+ population
    Time from randomization to time of objective radiographic disease progression as assessed by the investigator based on RECIST v1.1 or death due to any cause.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyFemale
Accepts Healthy VolunteersNo
Inclusion Criteria
1. 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. 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 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 BRCA test result available. Participants with BRCA-wildtype will have a local HRD test results, as applicable. 8. 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. 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 patient eligible for PARP inhibitor. 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 Note: For participants enrolled from the Republic of Korea
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. \
Note: For participants enrolled from the Republic of Korea, 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 a medical history of myocardial infarction within 6 months before randomization, symptomatic congestive heart failure (New York Heart Association Class II to IV). Participants with troponin levels above the upper limit of normal at Screening (as defined by the manufacturer), and without any myocardial infarction related symptoms should have a cardiologic consultation during the Screening Period to rule out myocardial infarction. 10. Has a corrected QT interval prolongation to \>480 msec based on average of the Screening triplicate 12-lead ECG. 11. 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.

Contacts and Locations

Sponsors and CollaboratorsDaiichi Sankyo
Locations
Scripps Clinic | La Jolla California, United States, 92037Broward Health Medical Center | Fort Lauderdale Florida, United States, 33316Jupiter Medical Center | Jupiter Florida, United States, 33458Mount Sinai Medical Center | Miami Beach Florida, United States, 33140AdventHealth Cancer Institute | Orlando Florida, United States, 32804Woman's Care FL | St. Petersburg Florida, United States, 33713Nancy N. & J.C Lewis Cancer & Research Pavillion- St. Josephs/ Candler Health System | Savannah Georgia, United States, 31405Indiana University | Indianapolis Indiana, United States, 46202Trials365 LLC | Shreveport Louisiana, United States, 71103Greater Baltimore Medical Center | Towson Maryland, United States, 21204Dana-Farber Cancer Institute | Boston Massachusetts, United States, 02215Trinity Health St. Joseph Mercy Ann Arbor | Ann Arbor Michigan, United States, 48106Corewell Health | Grand Rapids Michigan, United States, 49503St. Vincent Gynecologic Oncology | Billings Montana, United States, 59102Valley Health System | Paramus New Jersey, United States, 07652Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York New York, United States, 10016Icahn School of Medicine at Mount Sinai | New York New York, United States, 10029UNC Hospital | Chapel Hill North Carolina, United States, 27599Miami Valley Hospital South | Centerville Ohio, United States, 45459Legacy Medical Group Gynecologic Oncology | Portland Oregon, United States, 97210Providence Cancer Center Oncology | Portland Oregon, United States, 97213St. Lukes University Health Network | Bethlehem Pennsylvania, United States, 18015Ann B Barshinger Cancer Institute | Lancaster Pennsylvania, United States, 17601Avera Medical Group Gynecologic | Sioux Falls South Dakota, United States, 57105Genesiscare 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, 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 , China, 200032Liaoning 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, 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, 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 , Japan, 673-8558National Cancer Center Hospital | Chūōku , Japan, 104-0045Fukushima Medical University Hospital | Fukushima , Japan, 960-1295Saitama Medical University International Medical Center | Hidaka-Shi , Japan, 350-1298Cancer Institute Hospital of JFCR | Kōtoku , Japan, 135-8550Kurume University Hospital | Kurume-shi , Japan, Aichi Cancer Center Hospital | Nagoya , Japan, Niigata Cancer Center Hospital | Niigata , Japan, Okayama University Hosptial | Okayama , Japan, 700-8558Osaka International Cancer Institute | Osaka , Japan, Kindai University Hospital | Osakasayama-shi , Japan, NHO Hokkaido Cancer Center | Sapporo , Japan, 003-0804Iwate Medical University Hospital | Shiwa-Gun , Japan, 028-3695Shizuoka Cancer Center | Sunto-gun , Japan, Mie University Hospital | Tsu , Japan, 514-8507Yamagata University Hospital | Yamagata , Japan, 990-9585Hospital Sultan | Johor Bahru , Malaysia, Sarawak General Hospital | Kuching , Malaysia, HOSPITAL KUALA LUMPUR(HKL) Kuala | Lumpur , Malaysia, National Cancer Institute / Institut Kanser Negara | Putrajaya , Malaysia, 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 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, 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, Barts Health NHS Trust | London , United Kingdom, The Christie Hospital | Manchester , United Kingdom,