AzTrials
AzTrials

Ovarian CancerPhase 3DO-01NCT06819007

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

A Phase 3 study testing Trastuzumab Deruxtecan and Bevacizumab in people with Ovarian Cancer, run by Daiichi Sankyo at 232 sites in 26 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Trastuzumab Deruxtecan and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
582 participants
Where
232 sitesin 26 countries
Study dates
19 Mar 2025to 31 Jan 2032
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Sign and date the tissue prescreening informed consent form (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 International Federation of Gynecology and Obstetrics (FIGO) Stage III or IV.
  • Has HER2 expression.

Who cannot join

  • 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 participant eligible for poly (ADP-ribose) polymerase (PARP) inhibitor.
  • Participant to receive PARP inhibitor as maintenance per standard of care and investigator discretion.
  • Previous cerebral-vascular accident, transient ischemic attack or subarachnoid hemorrhage within 6 months prior to randomization.
  • Note: For participants enrolled from the Republic of Korea, country-specific requirements are applicable.
  • Has evidence of bleeding diathesis or significant coagulopathy (in the absence of anticoagulation therapy).
  • Has a history of hemorrhagic disorders.

Trial locations and contacts

232 sites in 26 countries. Contact the study team or a site near you to ask about taking part.

Contact for Trial Information contact

908-992-6400

CTRinfo_us@daiichisankyo.com

232 sites in 26 countries

United States33 sites, 33 recruiting

  • Trinity Health St. Joseph Mercy Ann Arbor

    Ann Arbor, Michigan, 48106

    Recruiting

  • St. Lukes University Health Network

    Bethlehem, Pennsylvania, 18015

    Recruiting

  • St. Vincent Gynecologic Oncology

    Billings, Montana, 59102

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Recruiting

  • Disney Family Cancer Center

    Burbank, California, 91505

    Recruiting

  • Miami Valley Hospital South

    Centerville, Ohio, 45459

    Recruiting

  • UNC Hospital

    Chapel Hill, North Carolina, 27599

    Recruiting

  • Endeavor Health Evanston Kellogg Cancer Care Center

    Evanston, Illinois, 60201

    Recruiting

  • Broward Health Medical Center

    Fort Lauderdale, Florida, 33316

    Recruiting

  • Corewell Health

    Grand Rapids, Michigan, 49503

    Recruiting

  • Indiana University

    Indianapolis, Indiana, 46202

    Recruiting

  • Jupiter Medical Center

    Jupiter, Florida, 33458

    Recruiting

  • Scripps Clinic

    La Jolla, California, 92037

    Recruiting

  • Ann B Barshinger Cancer Institute

    Lancaster, Pennsylvania, 17601

    Recruiting

  • University of Wisconsin

    Madison, Wisconsin, 53792

    Recruiting

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

    Recruiting

  • Minnesota Oncology Hematology PA

    Minneapolis, Minnesota, 55404

    Recruiting

  • Sarah Cannon Research Institute (Oncology Associates of Oregon PC)

    Nashville, Tennessee, 37203

    Recruiting

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016

    Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

    Recruiting

  • Columbia University

    New York, New York, 10032

    Recruiting

  • AdventHealth Cancer Institute

    Orlando, Florida, 32804

    Recruiting

  • Palo Alto Medical Foundation

    Palo Alto, California, 94301

    Recruiting

  • Valley Health System

    Paramus, New Jersey, 07652

    Recruiting

  • Legacy Medical Group Gynecologic Oncology

    Portland, Oregon, 97210

    Recruiting

  • Providence Cancer Center Oncology

    Portland, Oregon, 97213

    Recruiting

  • Utah Cancer Specialists Network

    Salt Lake City, Utah, 84106

    Recruiting

  • Nancy N. & J.C Lewis Cancer & Research Pavillion- St. Josephs/ Candler Health System

    Savannah, Georgia, 31405

    Recruiting

  • Trials365 LLC

    Shreveport, Louisiana, 71103

    Recruiting

  • Avera Medical Group Gynecologic

    Sioux Falls, South Dakota, 57105

    Recruiting

  • Woman's Care FL

    St. Petersburg, Florida, 33713

    Recruiting

  • Greater Baltimore Medical Center

    Towson, Maryland, 21204

    Recruiting

Other trials in United States

China27 sites, 27 recruiting

  • Beijing Cancer Hospital

    Beijing

    Recruiting

  • The First Hospital of Jilin University

    Changchun

    Recruiting

  • Hunan Cancer Hospital

    Changsha, 410006

    Recruiting

  • Sichuan University West China Second University Hospital

    Chengdu

    Recruiting

  • Chongqing Cancer Hospital

    Chongqing

    Recruiting

  • The Second Hospital of Dalian Medical University

    Dalian

    Recruiting

  • Fujian Cancer Hospital

    Fuzhou

    Recruiting

  • Sun Yat-Sen University Cancer Center

    Guangzhou

    Recruiting

  • Hainan General Hospital

    Haikou

    Recruiting

  • Women's Hospital School of Medicine Zhejiang University

    Hangzhou

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou

    Recruiting

  • Harbin Medical University - Tumor Hospital

    Harbin

    Recruiting

  • Shandong Cancer Hospital

    Jinan

    Recruiting

  • Yunnan Cancer Hospital

    Kunming

    Recruiting

  • Jiangxi Maternal and Child Health Hospital

    Nanchang

    Recruiting

  • Zhong Da Hospital, Southeast University

    Nanjing

    Recruiting

  • Guangxi Medical University Cancer Hopstial

    Nanning

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

    Recruiting

  • Liaoning Cancer Hospital & Institute

    Shenyang

    Recruiting

  • Affiliated Hospital (Suzhou First People's Hospital)

    Suzhou

    Recruiting

  • Shanxi Cancer Hospital

    Taiyuan

    Recruiting

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin

    Recruiting

  • Hubei Cancer Hospital

    Wuhan

    Recruiting

  • Tongji Hospital Tongji Medical College of HUST

    Wuhan

    Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

    Recruiting

  • Yantai Yuhuangding Hospital

    Yantai

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou

    Recruiting

Other trials in China

Spain19 sites, 19 recruiting

  • Complejo Hospitalario Universitario A Coruna

    A Coruña

    Recruiting

  • ICO L'Hospitalet - Hospital Duran I Reynals

    Barcelona, 08908

    Recruiting

  • Hospital Clinic De Barcelona

    Barcelona

    Recruiting

  • Hospital Universitari Vall D'Hebron

    Barcelona

    Recruiting

  • Hospital Universitario Reina Sofia

    Córdoba

    Recruiting

  • Hospital Universitario Donostia

    Donostia / San Sebastian

    Recruiting

  • Hospital Universitario Virgen De La Arrixaca

    El Palmar

    Recruiting

  • Institut Catala d'Oncologia de Girona

    Girona, 17007

    Recruiting

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid

    Recruiting

  • Hospital Universitario La Paz

    Madrid

    Recruiting

  • Hospital Universitario Ramon y Cajal

    Madrid

    Recruiting

  • Hospital Universitari Son Espases

    Palma

    Recruiting

  • Clinica Universidad de Navarra (MAD)

    Pamplona

    Recruiting

  • Clinica Universidad de Navarra (Calle Marquesado de Santa Marta)

    San Blas-Canillejas

    Recruiting

  • Hospital Universitario Virgen del Rocio

    Seville

    Recruiting

  • Instituto Valenciano de Oncologia IVO

    Valencia, 46009

    Recruiting

  • Hospital Clinico Universitario De Valencia

    Valencia

    Recruiting

  • Hospital Universitari I Politecnic La Fe

    Valencia

    Recruiting

Other trials in Spain

Japan16 sites, 16 recruiting

  • Hyogo Cancer Center

    Akashi, 673-8558

    Recruiting

  • Fukushima Medical University Hospital

    Fukushima, 960-1295

    Recruiting

  • Saitama Medical University International Medical Center

    Hidaka, 350-1298

    Recruiting

  • Cancer Institute Hospital of JFCR

    Kōtoku, 135-8550

    Recruiting

  • Kurume University Hospital

    Kurume

    Recruiting

  • Aichi Cancer Center Hospital

    Nagoya

    Recruiting

  • Shizuoka Cancer Center

    Nakatogari

    Recruiting

  • Niigata Cancer Center Hospital

    Niigata

    Recruiting

  • Okayama University Hosptial

    Okayama, 700-8558

    Recruiting

  • Kindai University Hospital

    Osaka

    Recruiting

  • Osaka International Cancer Institute

    Osaka

    Recruiting

  • NHO Hokkaido Cancer Center

    Sapporo, 003-0804

    Recruiting

  • National Cancer Center Hospital

    Tokyo, 104-0045

    Recruiting

  • Mie University Hospital

    Tsu, 514-8507

    Recruiting

  • Iwate Medical University Hospital

    Yahaba-cho, Shiwa-gun, 028-3695

    Recruiting

  • Yamagata University Hospital

    Yamagata, 990-9585

    Recruiting

Other trials in Japan

Italy15 sites, 15 recruiting

  • Istituto Tumori Giovanni Paolo II Irccs Ospedale Oncologico Bari

    Bari

    Recruiting

  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS

    Bologna

    Recruiting

  • Azienda Ospedaliera Per Lemergenza Cannizzaro

    Catania

    Recruiting

  • Azienda Socio Sanitaria Territoriale Niguarda

    Milan, 20162

    Recruiting

  • Humanitas San Pio X

    Milan

    Recruiting

  • IEO Istituto Europeo Di Oncologia

    Milan

    Recruiting

  • Azienda Socio Sanitaria Territoriale Di Monza (Presidio San Gerardo)

    Monza

    Recruiting

  • Istituto Nazionale Tumori Fondazione G. Pascale

    Naples

    Recruiting

  • Azienda Ospedaliero Universitaria Pisana

    Pisa

    Recruiting

  • Nuovo Ospedale Degli Infermi

    Ponderano

    Recruiting

  • Arcispedale S. Maria Nuova Azienda Ospedaliera Di Reggio Emilia

    Reggio Emilia, 42123

    Recruiting

  • Azienda Ospedaliera Universitaria Policlinico Umberto

    Roma, 00161

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma

    Recruiting

  • Istituto Nazionale Tumori Regina Elena Irccs

    Roma

    Recruiting

  • Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza Di Torino

    Torino, 10126

    Recruiting

Other trials in Italy

Germany11 sites, 11 recruiting

  • Charite-Universitatsmedizin

    Berlin, 13353

    Recruiting

  • Universitaetsklinikum Bonn

    Bonn, 53127

    Recruiting

  • Klinikum Lippe GmbH

    Detmold, 32756

    Recruiting

  • Universitatsklinikum Hamburg-Eppendorf

    Hamburg, 20246

    Recruiting

  • SLK-Kliniken Heilbronn GmbH

    Heilbronn, 74078

    Recruiting

  • Universitatsklinikum Jena

    Jena, 07747

    Recruiting

  • University Medical Center Mannheim

    Mannheim, 68167

    Recruiting

  • Philipps-Universitat Marburg

    Marburg, 35043

    Recruiting

  • Univeristy Regensburg, Caritas-Krankenhaus St. Josef

    Regensburg, 93053

    Recruiting

  • Universitaetsklinikum Ulm

    Ulm, 89081

    Recruiting

  • Helios Dr. Horst Schmidt Kliniken Wiesbaden

    Wiesbaden, 65199

    Recruiting

Other trials in Germany

France10 sites, 10 recruiting

  • Institut Bergonie

    Bordeaux

    Recruiting

  • Centre Georges Francois Leclerc

    Dijon

    Recruiting

  • Hopital Claude Huriez- CHU Lille

    Lille

    Recruiting

  • Centre Leon Berard

    Lyon

    Recruiting

  • CHU Montpellier, Saint Eloi

    Montpellier

    Recruiting

  • Hopital Prive Du Confluent

    Nantes

    Recruiting

  • Hopital Saint Joseph- Paris

    Paris

    Recruiting

  • Hospital Europeen Georges Pompidou

    Paris

    Recruiting

  • CRLCC Eugene Marquis

    Rennes

    Recruiting

  • CHU Saint Etienne

    Saint-Etienne

    Recruiting

Other trials in France

India10 sites, 10 recruiting

  • Gujarat Cancer & Research Institute

    Ahmedabad

    Recruiting

  • Vardhman Mahavir Medical College & Safdarjung Hospital

    Delhi, 110029

    Recruiting

  • Saroj Gupta Cancer Center and Research Institute SGCC&RI

    Kolkata

    Recruiting

  • Tata Memorial Hospital

    Mumbai, 400012

    Recruiting

  • National Cancer Institute Nagpur

    Nagpur

    Recruiting

  • HCG Manavata Cancer Centre

    Nashik

    Recruiting

  • Ruby Hall Clinic

    Pune

    Recruiting

  • HCG Cancer Centre Vadodara

    Vadodara

    Recruiting

  • Mahamana Pandit Madan Mohan Malaviya Cancer Centre

    Varanasi, 221005

    Recruiting

  • King George Hospital

    Visakhapatnam

    Recruiting

Other trials in India

South Korea10 sites, 10 recruiting

  • Keimyung University Dongsan Hospital

    Daegu

    Recruiting

  • National Cancer Center

    Goyang-si

    Recruiting

  • CHA Bundang Medical Center, CHA University

    Seongnam-si

    Recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si

    Recruiting

  • Asan Medical Center

    Seoul

    Recruiting

  • Gangnam Severance Hospital, Yonsei University Health System

    Seoul

    Recruiting

  • Samsung Medical Center

    Seoul

    Recruiting

  • Seoul National University Hospital

    Seoul

    Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul

    Recruiting

  • The Catholic University of Korea, Seoul St. Mary'S Hospital

    Seoul

    Recruiting

Other trials in South Korea

Brazil9 sites, 9 recruiting

  • Oncocentro Belo Horizonte

    Belo Horizonte

    Recruiting

  • Centro De Pesquisas Clinica Reichow

    Blumenau

    Recruiting

  • Fundação Doutor Amaral Carvalho

    Jaú

    Recruiting

  • Liga Norte-Rio-Grandense Contra o Cancer

    Natal

    Recruiting

  • Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa Hospital Mae de Deus

    Porto Alegre

    Recruiting

  • Irmandade Da Santa Casa De Misericordia De Porto Alegre

    Porto Alegre

    Recruiting

  • Ceon Pesquisas

    Santo André

    Recruiting

  • Fundacao Faculdade Regional De Medicina De Sao Jose Do Rio Preto

    São José do Rio Preto

    Recruiting

  • BP A Beneficencia Portuguesa de Sao Paulo

    São Paulo

    Recruiting

Other trials in Brazil

Australia8 sites, 8 recruiting

  • Genesiscare St Andrews Hospital

    Adelaide

    Recruiting

  • Icon Cancer Centre Wesley

    Auchenflower

    Recruiting

  • Icon Cancer Centre Hobart

    Hobart

    Recruiting

  • Sir Charles Gairdner Hospital

    Perth, 6009

    Recruiting

  • Epworth Healthcare

    Richmond, 3121

    Recruiting

  • Genesis Care North Shore (Oncology)

    St Leonards

    Recruiting

  • Westmead Hospital

    Sydney

    Recruiting

  • Townsville University Hospital Cancer Centre

    Townsville, 4814

    Recruiting

Other trials in Australia

Taiwan7 sites, 7 recruiting

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City

    Recruiting

  • Taichung Veterans General Hospital

    Taichung

    Recruiting

  • National Cheng Kung University Hospital

    Tainan

    Recruiting

  • MacKay Memorial Hospital- Taipei Branch

    Taipei

    Recruiting

  • National Taiwan University Hospital

    Taipei

    Recruiting

  • Taipei Veterans General Hospital

    Taipei

    Recruiting

  • Chang Gung Memorial Hospital

    Taoyuan City

    Recruiting

Other trials in Taiwan

Bulgaria6 sites, 6 recruiting

  • Complex Oncology Center- Plovdiv EOOD

    Plovdiv

    Recruiting

  • MHAT Park Hospital EOOD

    Plovdiv

    Recruiting

  • MHAT Serdika EOOD

    Sofia

    Recruiting

  • UMHAT Sofiamed EOOD

    Sofia

    Recruiting

  • UMHAT Tsaritsa Yoanna ISUL EAD

    Sofia

    Recruiting

  • Ushato Prof Ivan Chernozemski Ead

    Sofia

    Recruiting

Other trials in Bulgaria

Israel6 sites, 6 recruiting

  • The Lady Davis Carmel Medical Center

    Haifa

    Recruiting

  • Shaare Zedek

    Jerusalem

    Recruiting

  • Meir Medical Center

    Kfar Saba

    Recruiting

  • Rabin Medical Center-Beilinson Campus

    Petah Tikva

    Recruiting

  • Tel Aviv Sourasky Medical Center

    Tel Aviv

    Recruiting

  • Sheba Medical Center

    Tel HaShomer

    Recruiting

Other trials in Israel

United Kingdom6 sites, 6 recruiting

  • Addenbrooke's Hospital

    Cambridge

    Recruiting

  • Guys Hospital Cancer Centre

    London, SE1 9RT

    Recruiting

  • Barts Health NHS Trust

    London

    Recruiting

  • The Christie Hospital

    Manchester

    Recruiting

  • Genesis Care, Beaumont House

    Oxford, OX4 6LB

    Recruiting

  • Weston Park Hospital

    Sheffield, S10 2SB

    Recruiting

Other trials in United Kingdom

Belgium5 sites, 5 recruiting

  • AZ Sint-Lucas

    Ghent

    Recruiting

  • UZ Leuven

    Leuven

    Recruiting

  • Groupe Sante CHC/Clinique du MontLegia

    Liège

    Recruiting

  • CHU UCL Namur

    Namur

    Recruiting

  • Cliniques Universitaires Saint-LUC

    Woluwe-Saint-Lambert

    Recruiting

Other trials in Belgium

Czechia5 sites, 5 recruiting

  • Fakultni Nemocnice Ostrava

    Ostrava-Poruba

    Recruiting

  • Fakultni Nemocnice Bulovka

    Prague

    Recruiting

  • Fakultni Nemocnice Kralovske Vinohrady

    Prague

    Recruiting

  • Fakultni Nemocnice V Motole

    Prague

    Recruiting

  • Vseobecna Fakultni Nemocnice V Praze

    Prague

    Recruiting

Other trials in Czechia

Greece5 sites, 5 recruiting

  • Aretaieio Hospital

    Athens, 11528

    Recruiting

  • General Hospital of Athens Alexandra

    Athens, 11528

    Recruiting

  • National And Hapodistrian University of Athens (University General Hospital Attikon)

    Athens, 12462

    Recruiting

  • Metropolitan Hospital

    Neo Faliro, 18547

    Recruiting

  • St Luke's Hospital

    Thessaloniki, 55236

    Recruiting

Other trials in Greece

Malaysia5 sites, 5 recruiting

  • Hospital Sultan

    Johor Bahru

    Recruiting

  • University Malaya Medical Centre

    Kuala Lumpur, 59100

    Recruiting

  • Hospital Kuala Lumpur(Hkl)

    Kuala Lumpur

    Recruiting

  • Sarawak General Hospital

    Kuching

    Recruiting

  • National Cancer Institute / Institut Kanser Negara

    Putrajaya

    Recruiting

Other trials in Malaysia

Hungary4 sites, 4 recruiting

  • Semmelweis Egyetem

    Budapest, 1088

    Recruiting

  • Orszagos Onkologiai Intezet Nogyogyaszati Osztaly

    Budapest, 1122

    Recruiting

  • Debreceni Egyetem

    Debrecen, 4032

    Recruiting

  • Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz

    Győr, 9024

    Recruiting

Other trials in Hungary

Romania4 sites, 4 recruiting

  • Gral Medical S.R.L

    Bucharest

    Recruiting

  • Medeuropa SRL

    Bucharest

    Recruiting

  • Memorial Healthcare International SRL

    Bucharest

    Recruiting

  • Medeuropa SRL

    Oradea

    Recruiting

Other trials in Romania

Denmark3 sites, 3 recruiting

  • Aarhus University Hospital

    Aarhus

    Recruiting

  • Rigshospitalet

    Copenhagen, 2100

    Recruiting

  • Sjællands Universitet Hospital

    Roskilde

    Recruiting

Other trials in Denmark

Sweden3 sites, 3 recruiting

  • Skanes Universitetssjukhus Lund

    Lund

    Recruiting

  • Karolinska Universitet Ssjukhuset

    Solna

    Recruiting

  • Akademiska Sjukhuset (Uppsala University Hospital)

    Uppsala, 75185

    Recruiting

Other trials in Sweden

Poland2 sites, 2 recruiting

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Poznan, 61848

    Recruiting

  • Mazowiecki Szpital Wojewodzki W Siedlcach SP Zoo

    Siedlce

    Recruiting

Other trials in Poland

Singapore2 sites, 2 recruiting

  • National Cancer Centre Singapore

    Singapore, 168583

    Recruiting

  • National University Hospital

    Singapore

    Recruiting

Other trials in Singapore

Austria1 site, 1 recruiting

  • Medizinische Universitat Innsbruck

    Innsbruck

    Recruiting

Other trials in Austria

About this study

Official title: 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.

Read the 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.

Conditions
Ovarian Cancer
Being tested
Trastuzumab Deruxtecan, Bevacizumab
Keywords
Ovarian cancer, epithelial ovarian cancer, HER2, Trastuzumab Deruxtecan, Bevacizumab
Medical subject headings
Ovarian Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trastuzumab DeruxtecanDrug

    Also called T-DXd, ENHERTU®

    T-DXd will be administered at a dose of 5.4 mg/kg intravenously (IV) every 3 weeks (Q3W).

  • BevacizumabDrug

    Bevacizumab will be administered at a dose of 15 mg/kg IV Q3W.

Study groups in NCT06819007
Study groupRoleWhat they receive
Treatment Arm AExperimentalParticipants will receive T-DXd in combination with bevacizumab.
Receives: Drug: Trastuzumab Deruxtecan; Drug: Bevacizumab
Treatment Arm BActive comparatorParticipants will receive bevacizumab monotherapy.
Receives: Drug: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS) 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 Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or death due to any cause.

    Measured: From date of randomization to radiographic disease progression or death due to any cause, up to approximately 35 months

Secondary outcomes (28)

  1. Overall Survival (OS) in the HER2 IHC 3+/2+ Population

    Time interval from the date of randomization to the date of death due to any cause.

    Measured: From date of randomization to death due to any cause, up to approximately 72 months

  2. PFS 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.

    Measured: From date of randomization to radiographic disease progression or death due to any cause, up to approximately 35 months

  3. OS in the HER2 IHC 3+/2+/1+ Population

    Time interval from the date of randomization to the date of death due to any cause.

    Measured: From date of randomization to death due to any cause, up to approximately 72 months

  4. PFS 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.

    Measured: From date of randomization to radiographic disease progression or death due to any cause, up to approximately 35 months

  5. PFS 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.

    Measured: From date of randomization to radiographic disease progression or death due to any cause, up to approximately 35 months

  6. Progression Free Survival 2 (PFS2) by the Investigator in HER2 IHC 3+/2+ Population

    Time from date of randomization to the first documented progression on subsequent systemic therapy by investigator assessment, or death due to any cause, whichever occurs first.

    Measured: From date of randomization to first documented progression or death due to any cause, up to approximately 72 months

  7. PFS2 by the Investigator in HER2 IHC 3+/2+/1+ Population

    Time from date of randomization to the first documented progression on subsequent systemic therapy by investigator assessment, or death due to any cause, whichever occurs first.

    Measured: From date of randomization to first documented progression or death due to any cause, up to approximately 72 months

  8. Confirmed Objective Response (OR) by BICR in HER2 IHC 3+/2+ Population

    OR is defined as participants with best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) assessed by BICR according to RECIST v1.1. CR: Disappearance of all target lesions and non-target lesions and normalization of tumor marker level. PR: At least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: Up to approximately 35 months

  9. Confirmed OR by the Investigator in HER2 IHC 3+/2+ Population

    OR is defined as participants with BOR of confirmed CR or confirmed PR assessed by the investigator, according to RECIST v1.1. CR: Disappearance of all target lesions and non-target lesions and normalization of tumor marker level. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: Up to approximately 35 months

  10. Confirmed OR by BICR in HER2 3+/2+/1+ Population

    OR is defined as participants with BOR of confirmed CR or confirmed PR as assessed by BICR according to RECIST v1.1. CR: Disappearance of all target lesions and non-target lesions and normalization of tumor marker level. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: Up to approximately 35 months

  11. Confirmed OR by the Investigator in HER2 IHC 3+/2+/1+ Population

    OR is defined as participants with BOR of confirmed CR or confirmed PR assessed by the investigator, according to RECIST v1.1. CR: Disappearance of all target lesions and non-target lesions and normalization of tumor marker level. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: Up to approximately 35 months

  12. Duration of Response (DoR) by BICR in HER2 IHC 3+/2+ Population

    Time from the date of first documentation of objective tumor response (CR or PR), that is subsequently confirmed by BICR, to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. CR: Disappearance of all target lesions and non-target lesions and normalization of tumor marker level. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: Up to approximately 35 months

  13. DoR by the Investigator in HER2 IHC 3+/2+ Population

    Time from the date of first documentation of objective tumor response (CR or PR), that is subsequently confirmed by investigator, to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. CR: Disappearance of all target lesions and non-target lesions and normalization of tumor marker level. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: Up to approximately 35 months

  14. DoR by BICR in HER2 IHC 3+/2+/1+ Population

    Time from the date of first documentation of objective tumor response (CR or PR), that is subsequently confirmed by BICR, to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. CR: Disappearance of all target lesions and non-target lesions and normalization of tumor marker level. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: Up to approximately 35 months

  15. DoR by the Investigator in HER2 IHC 3+/2+/1+ Population

    Time from the date of first documentation of objective tumor response (CR or PR), that is subsequently confirmed by investigator, to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. CR: Disappearance of all target lesions and non-target lesions and normalization of tumor marker level. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: Up to approximately 35 months

  16. Time to First Subsequent Treatment (TFST) in HER2 IHC 3+/2+ Population

    Time from randomization until the start date of the first subsequent anticancer therapy after discontinuation of randomized treatment, or death due to any cause.

    Measured: Up to approximately 72 months

  17. TFST in HER2 IHC 3+/2+/1+ Population

    Time from randomization until the start date of the first subsequent anticancer therapy after discontinuation of randomized treatment, or death due to any cause.

    Measured: Up to approximately 72 months

  18. Time to Second Subsequent Treatment (TSST) in HER2 IHC 3+/2+ Population

    Time from randomization until the start date of the second subsequent anticancer therapy after discontinuation of first subsequent treatment, or death due to any cause.

    Measured: Up to approximately 72 months

  19. TSST in HER2 3+/2+/1+ Population

    Time from randomization until the start date of the second subsequent anticancer therapy after discontinuation of first subsequent treatment, or death due to any cause.

    Measured: Up to approximately 72 months

  20. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs are defined as those AEs with start or worsening date during the on-treatment period (from the first dose date of trial intervention to 47 days after the last dose date of trial intervention).

    Measured: Up to approximately 82 months

  21. Change from Baseline in Physical Function from European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 (QLQ-C30)

    The EORTC QLQ-C30 assesses 5 functional scales, 3 symptom scales, a global health/QoL scale, and 6 single items. The physical functional scale is scored on a 4-point scale ranging from 1 ("not at all") to 4 ("very much"). Scores are linearly transformed on a scale of 0 to 100. A higher scale score represents better functioning.

    Measured: Baseline up to approximately 72 months

  22. Change from Baseline in Pain from EORTC QLQ-C30

    The EORTC QLQ-C30 assesses 5 functional scales, 3 symptom scales, a global health/QoL scale, and 6 single items. The pain symptom scale is scored on a 4-point scale ranging from 1 ("not at all") to 4 ("very much"). Scores are linearly transformed on a scale of 0 to 100. A higher scale score represents worse symptom.

    Measured: Baseline up to approximately 72 months

  23. Change from Baseline in Global Health Status/Overall Quality of Life (GHS/Overall QoL) Scales from EORTC QLQ-C30

    The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status.

    Measured: Baseline up to approximately 72 months

  24. Change from Baseline in Abdominal/Gastrointestinal (GI) Symptoms from EORTC Quality of Life Questionnaire Ovarian Cancer Module 28 (QLQ-OV28)

    EORTC QLQ-OV28 is an ovarian cancer-specific module to supplement the EORTC QLQ-C30. Participant responses to the 6 abdominal/GI symptoms scale questions are scored on a 4-point scale (1=not at all, 4=very much). The combined score is computed by averaging the raw scores of the 6 items and then applying a linear transformation to standardize the average score, so that the combined score ranges from 0 to 100. The change from baseline in abdominal and gastrointestinal symptoms (EORTC QLQ-OV28 Items 31-36) score will be presented. A lower score indicates a better outcome.

    Measured: Baseline up to approximately 72 months

  25. Percentage of Participants With Confirmed Deterioration for Physical function, Pain, GHS/Overall QoL scales from EORTC QLQ-C30

    The EORTC QLQ-C30 assesses 5 functional scales, 3 symptom scales, a global health/QoL scale, and 6 single items. The functional, symptom, and single items are scored on a 4-point scale ranging from 1 ("not at all") to 4 ("very much"). The final 2 global health/QoL items are scored on a 7-point scale ranging from 1 ("very poor") to 7 ("excellent"). All of the scales and single-item measure scores are linearly transformed on a scale of 0 to 100. A higher scale score represents a higher response level and worse symptoms for the symptom scales.

    Measured: Up to approximately 72 months

  26. Percentage of Participants With Confirmed Deterioration Abdominal/Gastrointestinal Symptoms from EORTC QLQ-OV28

    EORTC QLQ-OV28 is an ovarian cancer-specific module to supplement the EORTC QLQ-C30. Participant responses to the 6 abdominal/GI symptoms scale questions are scored on a 4-point scale (1=not at all, 4=very much). The combined score is computed by averaging the raw scores of the 6 items and then applying a linear transformation to standardize the average score, so that the combined score ranges from 0 to 100. The change from baseline in abdominal and gastrointestinal symptoms (EORTC QLQ-OV28 Items 31-36) score will be presented. A lower score indicates a better outcome.

    Measured: Up to approximately 72 months

  27. Time to Confirmed Deterioration for Physical Function, Pain, GHS/Overall QoL Scales from EORTC QLQ-C30

    The EORTC QLQ-C30 assesses 5 functional scales, 3 symptom scales, a global health/QoL scale, and 6 single items. The functional, symptom, and single items are scored on a 4-point scale ranging from 1 ("not at all") to 4 ("very much"). The final 2 global health/QoL items are scored on a 7-point scale ranging from 1 ("very poor") to 7 ("excellent"). All of the scales and single-item measure scores are linearly transformed on a scale of 0 to 100. A higher scale score represents a higher response level and worse symptoms for the symptom scales.

    Measured: Up to approximately 72 months

  28. Time to Confirmed Deterioration for Abdominal/Gastrointestinal Symptoms from EORTC QLQ-OV28

    EORTC QLQ-OV28 is an ovarian cancer-specific module to supplement the EORTC QLQ-C30. Participant responses to the 6 abdominal/GI symptoms scale questions are scored on a 4-point scale (1=not at all, 4=very much). The combined score is computed by averaging the raw scores of the 6 items and then applying a linear transformation to standardize the average score, so that the combined score ranges from 0 to 100. The change from baseline in abdominal and gastrointestinal symptoms (EORTC QLQ-OV28 Items 31-36) score will be presented. A lower score indicates a better outcome.

    Measured: Up to approximately 72 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2025
  2. Study start19 Mar 2025
  3. Primary completion1 Nov 2028 (estimated)
  4. Study completion31 Jan 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
582 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06819007
Sponsor's protocol ID
DS8201-772
Other IDs
ENGOT-ov89, GEICO144-O, GOG-3112, APGOT-OV13, 2024-516982-35-00
Acronym
DO-01
Status last verified
Oct 2026
First submitted
5 Feb 2025
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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/

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Trastuzumab Deruxtecan and Bevacizumab in people with Ovarian Cancer, run by Daiichi Sankyo at 232 sites in 26 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 232 sites in United States, China, Spain, Japan, Italy and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Contact for Trial Information (908-992-6400, CTRinfo_us@daiichisankyo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06819007.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.

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