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RECRUITING
NCT06819007
PHASE3

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

Sponsor: Daiichi Sankyo

View on ClinicalTrials.gov

Summary

This clinical trial is designed to evaluate the efficacy and safety of T-DXd in combination with bevacizumab versus bevacizumab monotherapy as first-line maintenance therapy, in participants with human epidermal growth factor 2 (HER2)-expressing (immunohistochemistry \[IHC\] 3+/2+/1+) advanced high-grade epithelial ovarian cancer.

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)

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

582

Start Date

2025-03-19

Completion Date

2032-01-31

Last Updated

2026-10-28

Healthy Volunteers

No

Conditions

Interventions

DRUG

Trastuzumab Deruxtecan

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

DRUG

Bevacizumab

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

Locations (232)

Disney Family Cancer Center

Burbank, California, United States

Scripps Clinic

La Jolla, California, United States

Palo Alto Medical Foundation

Palo Alto, California, United States

Broward Health Medical Center

Fort Lauderdale, Florida, United States

Jupiter Medical Center

Jupiter, Florida, United States

Mount Sinai Medical Center

Miami Beach, Florida, United States

AdventHealth Cancer Institute

Orlando, Florida, United States

Woman's Care FL

St. Petersburg, Florida, United States

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

Savannah, Georgia, United States

Endeavor Health Evanston Kellogg Cancer Care Center

Evanston, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

Trials365 LLC

Shreveport, Louisiana, United States

Greater Baltimore Medical Center

Towson, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Trinity Health St. Joseph Mercy Ann Arbor

Ann Arbor, Michigan, United States

Corewell Health

Grand Rapids, Michigan, United States

Minnesota Oncology Hematology PA

Minneapolis, Minnesota, United States

St. Vincent Gynecologic Oncology

Billings, Montana, United States

Valley Health System

Paramus, New Jersey, United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Columbia University

New York, New York, United States

UNC Hospital

Chapel Hill, North Carolina, United States

Miami Valley Hospital South

Centerville, Ohio, United States

Legacy Medical Group Gynecologic Oncology

Portland, Oregon, United States

Providence Cancer Center Oncology

Portland, Oregon, United States

St. Lukes University Health Network

Bethlehem, Pennsylvania, United States

Ann B Barshinger Cancer Institute

Lancaster, Pennsylvania, United States

Avera Medical Group Gynecologic

Sioux Falls, South Dakota, United States

Sarah Cannon Research Institute (Oncology Associates of Oregon PC)

Nashville, Tennessee, United States

Utah Cancer Specialists Network

Salt Lake City, Utah, United States

University of Wisconsin

Madison, Wisconsin, United States

Genesiscare St Andrews Hospital

Adelaide, Australia

Icon Cancer Centre Wesley

Auchenflower, Australia

Icon Cancer Centre Hobart

Hobart, Australia

Sir Charles Gairdner Hospital

Perth, Australia

Epworth Healthcare

Richmond, Australia

Genesis Care North Shore (Oncology)

St Leonards, Australia

Westmead Hospital

Sydney, Australia

Townsville University Hospital Cancer Centre

Townsville, 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

São José do Rio Preto, Brazil

BP A Beneficencia Portuguesa de Sao Paulo

São Paulo, Brazil

Complex Oncology Center- Plovdiv EOOD

Plovdiv, Bulgaria

MHAT Park Hospital EOOD

Plovdiv, Bulgaria

MHAT Serdika EOOD

Sofia, Bulgaria

UMHAT Sofiamed EOOD

Sofia, Bulgaria

UMHAT Tsaritsa Yoanna ISUL EAD

Sofia, Bulgaria

Ushato Prof Ivan Chernozemski Ead

Sofia, Bulgaria

Beijing Cancer Hospital

Beijing, China

The First Hospital of Jilin University

Changchun, China

Hunan Cancer Hospital

Changsha, 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

Hainan General Hospital

Haikou, China

Women's Hospital School of Medicine Zhejiang University

Hangzhou, China

Zhejiang Cancer Hospital

Hangzhou, China

Harbin Medical University - Tumor Hospital

Harbin, 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, China

Liaoning Cancer Hospital & Institute

Shenyang, China

Affiliated Hospital (Suzhou First People's Hospital)

Suzhou, China

Shanxi Cancer Hospital

Taiyuan, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

Hubei Cancer Hospital

Wuhan, China

Tongji Hospital Tongji Medical College of HUST

Wuhan, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

Yantai Yuhuangding Hospital

Yantai, China

Henan Cancer Hospital

Zhengzhou, China

Fakultni Nemocnice Ostrava

Ostrava-Poruba, Czechia

Fakultni Nemocnice Bulovka

Prague, Czechia

Fakultni Nemocnice Kralovske Vinohrady

Prague, Czechia

Fakultni Nemocnice V Motole

Prague, Czechia

Vseobecna Fakultni Nemocnice V Praze

Prague, Czechia

Aarhus University Hospital

Aarhus, Denmark

Rigshospitalet

Copenhagen, Denmark

Sjællands Universitet Hospital

Roskilde, Denmark

Institut Bergonie

Bordeaux, France

Centre Georges Francois Leclerc

Dijon, France

Hopital Claude Huriez- CHU Lille

Lille, France

And 132 more locations on ClinicalTrials.gov