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

May 21, 2026 updated by: Daiichi Sankyo

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

582

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
      • Adelaide, Australia
        • Recruiting
        • Genesiscare St Andrews Hospital
      • Auchenflower, Australia
        • Recruiting
        • Icon Cancer Centre Wesley
      • Hobart, Australia
        • Recruiting
        • Icon Cancer Centre Hobart
      • St Leonards, Australia
        • Recruiting
        • Genesis Care North Shore (Oncology)
      • Sydney, Australia
        • Recruiting
        • Westmead Hospital
  • Austria
      • Innsbruck, Austria
        • Recruiting
        • Medizinische Universität Innsbruck
  • Belgium
      • Ghent, Belgium
        • Recruiting
        • AZ Sint-Lucas
      • Leuven, Belgium
        • Recruiting
        • UZ Leuven
      • Liège, Belgium
        • Recruiting
        • Groupe Sante CHC/Clinique du MontLegia
      • Namur, Belgium
        • Recruiting
        • Chu Ucl Namur
      • Woluwe-Saint-Lambert, Belgium
        • Recruiting
        • Cliniques Universitaires Saint-Luc
  • Brazil
      • Belo Horizonte, Brazil
        • Recruiting
        • Oncocentro Belo Horizonte
      • Blumenau, Brazil
        • Recruiting
        • Centro de Pesquisas Clinica Reichow
      • Jaú, Brazil
        • Recruiting
        • Fundacao Doutor Amaral Carvalho
      • Natal, Brazil
        • Recruiting
        • Liga Norte-Rio-Grandense Contra O Câncer
      • Porto Alegre, Brazil
        • Recruiting
        • Irmandade Da Santa Casa de Misericordia de Porto Alegre
      • Porto Alegre, Brazil
        • Recruiting
        • Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa Hospital Mae de Deus
      • Santo André, Brazil
        • Recruiting
        • Ceon Pesquisas
      • Sao Jose Rio, Brazil
        • Recruiting
        • Fundação Faculdade Regional de Medicina de São José do Rio Preto
      • São Paulo, Brazil
        • Recruiting
        • BP A Beneficencia Portuguesa de Sao Paulo
  • Bulgaria
      • Plovdiv, Bulgaria
        • Recruiting
        • MHAT Park Hospital EOOD
      • Plovdiv, Bulgaria
        • Recruiting
        • Complex Oncology Center- Plovdiv EOOD
      • Sofia, Bulgaria
        • Recruiting
        • UMHAT Tsaritsa Yoanna ISUL EAD
      • Sofia, Bulgaria
        • Recruiting
        • MHAT Serdika EOOD
      • Sofia, Bulgaria
        • Recruiting
        • UMHAT Sofiamed EOOD
      • Sofia, Bulgaria
        • Recruiting
        • Ushato Prof Ivan Chernozemski Ead
  • China
      • Beijing, China
        • Recruiting
        • Beijing Cancer Hospital
      • Changchun, China
        • Recruiting
        • The First Hospital of Jilin University
      • Changsha, China, 410006
        • Recruiting
        • Hunan Cancer Hospital
      • Chengdu, China
        • Recruiting
        • Sichuan University West China Second University Hospital
      • Chongqing, China
        • Recruiting
        • Chongqing Cancer Hospital
      • Dalian, China
        • Recruiting
        • The Second Hospital of Dalian Medical University
      • Fuzhou, China
        • Recruiting
        • Fujian Cancer Hospital
      • Guangzhou, China
        • Recruiting
        • Sun Yat-sen University Cancer Center
      • Haerbing, China
        • Recruiting
        • Harbin Medical University - Tumor Hospital
      • Haikou, China
        • Recruiting
        • Hainan General Hospital
      • Hangzhou, China
        • Recruiting
        • Zhejiang Cancer Hospital
      • Hangzhoushi, China
        • Recruiting
        • Women's Hospital School of Medicine Zhejiang University
      • Jinan, China
        • Recruiting
        • Shandong Cancer Hospital
      • Kunming, China
        • Recruiting
        • Yunnan Cancer Hospital
      • Nanchang, China
        • Recruiting
        • Jiangxi Maternal and Child Health Hospital
      • Nanjing, China
        • Recruiting
        • Zhong Da Hospital, Southeast University
      • Nanning, China
        • Recruiting
        • Guangxi Medical University Cancer Hopstial
      • Shanghai Shi, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
      • Shenyang, China
        • Recruiting
        • Liaoning Cancer Hospital & Institute
      • Suzhou, China
        • Recruiting
        • Affiliated Hospital (Suzhou First People's Hospital)
      • Taiyuan, China
        • Recruiting
        • Shanxi Cancer hospital
      • Tianjin, China
        • Recruiting
        • Tianjin Medical University Cancer Institute & Hospital
      • Wuhan, China
        • Recruiting
        • Hubei Cancer Hospital
      • Wuhan, China
        • Recruiting
        • Tongji Hospital Tongji Medical College Of Hust
      • Xi'an, China
        • Recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
      • Yantai, China
        • Recruiting
        • Yantai Yuhuangding Hospital
      • Zhengzhou, China
        • Recruiting
        • Henan Cancer Hospital
  • Czechia
      • Ostrava-Poruba, Czechia
        • Recruiting
        • Fakultni nemocnice Ostrava
      • Prague, Czechia
        • Recruiting
        • Fakultní Nemocnice Královské Vinohrady
      • Prague, Czechia
        • Recruiting
        • Vseobecna fakultni nemocnice v Praze
      • Prague, Czechia
        • Recruiting
        • Fakultni nemocnice v Motole
      • Prague, Czechia
        • Recruiting
        • Fakultní nemocnice Bulovka
  • Denmark
      • Aarhus, Denmark
        • Recruiting
        • Aarhus University Hospital
      • Copenhagen, Denmark, 2100
        • Recruiting
        • Rigshospitalet
      • Roskilde, Denmark
        • Recruiting
        • Sjællands Universitet Hospital
  • France
      • Bordeaux, France
        • Recruiting
        • Institut Bergonie
      • Dijon, France
        • Recruiting
        • Centre Georges François Leclerc
      • Lille, France
        • Recruiting
        • Hopital Claude Huriez- CHU Lille
      • Lyon, France
        • Recruiting
        • Centre Leon Berard
      • Montpellier, France
        • Recruiting
        • CHU Montpellier, Saint Eloi
      • Nantes, France
        • Recruiting
        • Hôpital Privé du Confluent
      • Paris, France
        • Recruiting
        • Hospital Europeen Georges Pompidou
      • Paris, France
        • Recruiting
        • Hopital Saint Joseph- Paris
      • Rennes, France
        • Recruiting
        • CRLCC Eugene Marquis
      • Saint-Etienne, France
        • Recruiting
        • CHU Saint Etienne
  • Hungary
      • Debrecen, Hungary, 4032
        • Recruiting
        • Debreceni Egyetem
  • India
      • Ahmedabad, India
        • Recruiting
        • Gujarat Cancer & Research Institute
      • Kolkata, India
        • Recruiting
        • Saroj Gupta Cancer Center and Research Institute SGCC&RI
      • Nagpur, India
        • Recruiting
        • National Cancer Institute Nagpur
      • Nashik, India
        • Recruiting
        • HCG Manavata Cancer Centre
      • Pune, India
        • Recruiting
        • Ruby Hall Clinic
      • Vadodara, India
        • Recruiting
        • HCG Cancer Centre Vadodara
      • Visakhapatnam, India
        • Recruiting
        • King George Hospital
  • Israel
      • Haifa, Israel
        • Recruiting
        • The Lady Davis Carmel Medical Center
      • Jerusalem, Israel
        • Recruiting
        • Shaare Zedek
      • Kfar Saba, Israel
        • Recruiting
        • Meir Medical Center
      • Petah Tikva, Israel
        • Recruiting
        • Rabin Medical Center-Beilinson Campus
      • Tel Aviv, Israel
        • Recruiting
        • Tel Aviv Sourasky Medical Center
      • Tel Litwinsky, Israel
        • Recruiting
        • Sheba Medical Center
  • Italy
      • Bari, Italy
        • Recruiting
        • Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari
      • Bologna, Italy
        • Recruiting
        • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
      • Catania, Italy
        • Recruiting
        • Azienda Ospedaliera Per Lemergenza Cannizzaro
      • Milan, Italy
        • Recruiting
        • IEO Istituto Europeo di Oncologia
      • Milan, Italy
        • Recruiting
        • Humanitas San Pio X
      • Monza, Italy
        • Recruiting
        • Azienda Socio Sanitaria Territoriale Di Monza (Presidio San Gerardo)
      • Naples, Italy
        • Recruiting
        • Istituto Nazionale Tumori Fondazione G. Pascale
      • Pisa, Italy
        • Recruiting
        • Azienda Ospedaliero Universitaria Pisana
      • Ponderano, Italy
        • Recruiting
        • Nuovo Ospedale Degli Infermi
      • Roma, Italy
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
      • Roma, Italy
        • Recruiting
        • Istituto Nazionale Tumori Regina Elena Irccs
  • Japan
      • Akashi, Japan, 673-8558
        • Recruiting
        • Hyogo Cancer Center
      • Chūōku, Japan, 104-0045
        • Recruiting
        • National Cancer Center Hospital
      • Fukushima, Japan, 960-1295
        • Recruiting
        • Fukushima Medical University Hospital
      • Hidaka-Shi, Japan, 350-1298
        • Recruiting
        • Saitama Medical University International Medical Center
      • Kurume-shi, Japan
        • Recruiting
        • Kurume University Hospital
      • Kōtoku, Japan, 135-8550
        • Recruiting
        • Cancer Institute Hospital of JFCR
      • Nagoya, Japan
        • Recruiting
        • Aichi Cancer Center Hospital
      • Niigata, Japan
        • Recruiting
        • Niigata Cancer Center Hospital
      • Okayama, Japan, 700-8558
        • Recruiting
        • Okayama University Hosptial
      • Osaka, Japan
        • Recruiting
        • Osaka International Cancer Institute
      • Osakasayama-shi, Japan
        • Recruiting
        • Kindai University Hospital
      • Sapporo, Japan, 003-0804
        • Recruiting
        • NHO Hokkaido Cancer Center
      • Shiwa-Gun, Japan, 028-3695
        • Recruiting
        • Iwate Medical University Hospital
      • Sunto-gun, Japan
        • Recruiting
        • Shizuoka Cancer Center
      • Tsu, Japan, 514-8507
        • Recruiting
        • Mie University Hospital
      • Yamagata, Japan, 990-9585
        • Recruiting
        • Yamagata University Hospital
  • Malaysia
      • Johor Bahru, Malaysia
        • Recruiting
        • Hospital Sultan
      • Kuching, Malaysia
        • Recruiting
        • Sarawak General Hospital
      • Lumpur, Malaysia
        • Recruiting
        • HOSPITAL KUALA LUMPUR(HKL) Kuala
      • Putrajaya, Malaysia
        • Recruiting
        • National Cancer Institute / Institut Kanser Negara
  • Poland
      • Poznan, Poland, 61848
        • Recruiting
        • Uniwersytecki Szpital Kliniczny w Poznaniu
      • Siedlce, Poland
        • Recruiting
        • Mazowiecki Szpital Wojewodzki W Siedlcach SP Zoo
  • Romania
      • Bucharest, Romania
        • Recruiting
        • Gral Medical S.R.L
      • Bucharest, Romania
        • Recruiting
        • Medeuropa SRL
      • Bucharest, Romania
        • Recruiting
        • Memorial Healthcare International SRL
      • Oradea, Romania
        • Recruiting
        • Medeuropa SRL
  • Singapore
      • Singapore, Singapore
        • Recruiting
        • National University Hospital
      • Singapore, Singapore, 168583
        • Recruiting
        • National Cancer Centre Singapore
  • South Korea
      • Daegu, South Korea
        • Recruiting
        • Keimyung University Dongsan Hospital
      • Goyang-si, South Korea
        • Recruiting
        • National Cancer Center
      • Seongnam-si, South Korea
        • Recruiting
        • Seoul National University Bundang Hospital
      • Seongnam-si, South Korea
        • Recruiting
        • CHA Bundang Medical Center, CHA University
      • Seoul, South Korea
        • Recruiting
        • Samsung Medical Center
      • Seoul, South Korea
        • Recruiting
        • Seoul National University Hospital
      • Seoul, South Korea
        • Recruiting
        • Asan Medical Center
      • Seoul, South Korea
        • Recruiting
        • Severance Hospital, Yonsei University Health System
      • Seoul, South Korea
        • Recruiting
        • The Catholic University of Korea, Seoul St. Mary's Hospital
      • Seoul, South Korea
        • Recruiting
        • Gangnam Severance Hospital, Yonsei University Health System
  • Spain
      • A Coruña, Spain
        • Recruiting
        • Complejo Hospitalario Universitario A Coruna
      • Barcelona, Spain
        • Recruiting
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Spain
        • Recruiting
        • Hospital Clinic de Barcelona
      • Córdoba, Spain
        • Recruiting
        • Hospital Universitario Reina Sofia
      • El Palmar, Spain
        • Recruiting
        • Hospital Universitario Virgen de La Arrixaca
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario La Paz
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario Ramón y Cajal
      • Palma, Spain
        • Recruiting
        • Hospital Universitari Son Espases
      • Pamplona, Spain
        • Recruiting
        • Clinica Universidad de Navarra (MAD)
      • Planta Baja, Spain
        • Recruiting
        • Hospital Universitario Donostia
      • San Blas-Canillejas, Spain
        • Recruiting
        • Clinica Universidad de Navarra (Calle Marquesado de Santa Marta)
      • Seville, Spain
        • Recruiting
        • Hospital Universitario Virgen del Rocio
      • Valencia, Spain
        • Recruiting
        • Hospital Clinico Universitario de Valencia
      • Valencia, Spain
        • Recruiting
        • Hospital Universitari i Politècnic La Fe
  • Sweden
      • Lund, Sweden
        • Recruiting
        • Skånes Universitetssjukhus Lund
      • Solna, Sweden
        • Recruiting
        • Karolinska Universitet Ssjukhuset
      • Uppsala, Sweden, 75185
        • Recruiting
        • Akademiska Sjukhuset (Uppsala University Hospital)
  • Taiwan
      • Kaohsiung City, Taiwan
        • Recruiting
        • Kaohsiung Chang Gung Memorial Hospital
      • Linkou Taoyuan, Taiwan
        • Recruiting
        • Chang Gung Memorial Hospital
      • Taichung, Taiwan
        • Recruiting
        • Taichung Veterans General Hospital
      • Tainan, Taiwan
        • Recruiting
        • National Cheng Kung University Hospital
      • Taipei, Taiwan
        • Recruiting
        • Taipei Veterans General Hospital
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Hospital
      • Taipei, Taiwan
        • Recruiting
        • MacKay Memorial Hospital- Taipei Branch
  • United Kingdom
      • Cambridge, United Kingdom
        • Recruiting
        • Addenbrooke's Hospital
      • London, United Kingdom
        • Recruiting
        • Barts Health NHS Trust
      • London, United Kingdom, SE1 9RT
        • Recruiting
        • Guys Hospital Cancer Centre
      • Manchester, United Kingdom
        • Recruiting
        • The Christie Hospital
      • Oxford, United Kingdom, OX4 6LB
        • Recruiting
        • Genesis Care, Beaumont House
      • Sheffield, United Kingdom, S10 2SB
        • Recruiting
        • Weston Park Hospital
  • United States
    • California
      • La Jolla, California, United States, 92037
        • Recruiting
        • Scripps Clinic
    • Florida
      • Fort Lauderdale, Florida, United States, 33316
        • Recruiting
        • Broward Health Medical Center
      • Jupiter, Florida, United States, 33458
        • Recruiting
        • Jupiter Medical Center
      • Miami Beach, Florida, United States, 33140
        • Recruiting
        • Mount Sinai Medical Center
      • Orlando, Florida, United States, 32804
        • Recruiting
        • AdventHealth Cancer Institute
      • St. Petersburg, Florida, United States, 33713
        • Recruiting
        • Woman's Care FL
    • Georgia
      • Savannah, Georgia, United States, 31405
        • Recruiting
        • Nancy N. & J.C Lewis Cancer & Research Pavillion- St. Josephs/ Candler Health System
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Recruiting
        • Endeavor Health Evanston Kellogg Cancer Care Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • Recruiting
        • Trials365 LLC
    • Maryland
      • Towson, Maryland, United States, 21204
        • Recruiting
        • Greater Baltimore Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana-Farber Cancer Institute
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • Recruiting
        • Trinity Health St. Joseph Mercy Ann Arbor
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Corewell Health
    • Montana
      • Billings, Montana, United States, 59102
        • Recruiting
        • St. Vincent Gynecologic Oncology
    • New Jersey
      • Paramus, New Jersey, United States, 07652
        • Recruiting
        • Valley Health System
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • UNC Hospital
    • Ohio
      • Centerville, Ohio, United States, 45459
        • Recruiting
        • Miami Valley Hospital South
    • Oregon
      • Portland, Oregon, United States, 97210
        • Recruiting
        • Legacy Medical Group Gynecologic Oncology
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Cancer Center Oncology
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • Recruiting
        • St. Lukes University Health Network
      • Lancaster, Pennsylvania, United States, 17601
        • Recruiting
        • Ann B Barshinger Cancer Institute
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Recruiting
        • Avera Medical Group Gynecologic
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Sarah Cannon Research Institute (Oncology Associates of Oregon PC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)
Other Names:
  • T-DXd
  • ENHERTU®
Drug: Bevacizumab
Bevacizumab will be administered at a dose of 15/mg/kg IV Q3W
Active Comparator: Treatment Arm B
Participants will receive bevacizumab monotherapy
Drug: Bevacizumab
Bevacizumab will be administered at a dose of 15/mg/kg IV Q3W

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival by Blinded Independent Central Review (BICR) in the HER2 IHC 3+/2+ population
Time Frame: From date of randomization to radiographic disease progression or death due to any cause, up to approximately 35 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival in the HER2 IHC 3+/2+ population
Time Frame: From date of randomization to death due to any cause, up to approximately 72 months
Time interval from the date of randomization to the date of death due to any cause.
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
Time Frame: From date of randomization to radiographic disease progression or death due to any cause, up to approximately 35 months
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
Overall Survival in the HER2 IHC 3+/2+/1+ population
Time Frame: From date of randomization to death due to any cause, up to approximately 72 months
Time interval from the date of randomization to the date of death due to any cause.
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
Time Frame: From date of randomization to radiographic disease progression or death due to any cause, up to approximately 35 months
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.
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
Time Frame: From date of randomization to radiographic disease progression or death due to any cause, up to approximately 35 months
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.
From date of randomization to radiographic disease progression or death due to any cause, up to approximately 35 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daiichi Sankyo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 19, 2025

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

January 31, 2032

Study Registration Dates

First Submitted

February 5, 2025

First Submitted That Met QC Criteria

February 5, 2025

First Posted (Actual)

February 11, 2025

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DS8201-772
  • ENGOT-ov89 (Other Grant/Funding Number: ENGOT)
  • GEICO144-O (Other Grant/Funding Number: ENGOT)
  • GOG-3112 (Other Grant/Funding Number: GOG)
  • APGOT-OV13 (Other Grant/Funding Number: APGOT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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/

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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