RecruitingPhase 3NCT06819007

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

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)

Sponsor

Daiichi Sankyo

Enrollment

582 participants

Start Date

Mar 19, 2025

Study Type

INTERVENTIONAL

Conditions

Ovarian Cancer

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial (DESTINY-Ovarian01) tests whether adding a targeted antibody-drug combination (trastuzumab deruxtecan, or T-DXd) to a standard maintenance drug (bevacizumab) is better than bevacizumab alone for women with HER2-expressing ovarian, fallopian tube, or peritoneal cancer who have responded to first-line chemotherapy. **You may be eligible if...** - You are 18 or older - You have been diagnosed with high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer - Your tumor tests positive for HER2 expression - You have responded to standard platinum-based chemotherapy - You are in good enough health to continue treatment **You may NOT be eligible if...** - Your tumor does not express HER2 - You have had prior treatment with T-DXd or similar antibody-drug conjugates - You have serious lung, heart, or liver conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTrastuzumab Deruxtecan

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

DRUGBevacizumab

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

Locations(180)

Scripps Clinic

La Jolla, 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

Indiana University

Indianapolis, Indiana, United States

Trials365 LLC

Shreveport, Louisiana, United States

Greater Baltimore Medical Center

Towson, Maryland, 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

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

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

Genesiscare St Andrews Hospital

Adelaide, Australia

Icon Cancer Centre Wesley

Auchenflower, Australia

Icon Cancer Centre Hobart

Hobart, Australia

Genesis Care North Shore (Oncology)

St Leonards, Australia

Westmead Hospital

Sydney, Australia

Medizinische Universitat Innsbruck

Innsbruck, Austria

AZ Sint-Lucas

Ghent, Belgium

UZ Leuven

Leuven, Belgium

Groupe Sante CHC/Clinique du MontLegia

Liège, Belgium

CHU UCL Namur

Namur, Belgium

Cliniques Universitaires Saint-LUC

Woluwe-Saint-Lambert, Belgium

Oncocentro Belo Horizonte

Belo Horizonte, Brazil

Centro De Pesquisas Clinica Reichow

Blumenau, Brazil

Fundação Doutor Amaral Carvalho

Jaú, Brazil

Liga Norte-Rio-Grandense Contra o Cancer

Natal, Brazil

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

Porto Alegre, Brazil

Irmandade Da Santa Casa De Misericordia De Porto Alegre

Porto Alegre, Brazil

Ceon Pesquisas

Santo André, Brazil

Fundacao Faculdade Regional De Medicina De Sao Jose Do Rio Preto

Sao Jose Rio, Brazil

BP A Beneficencia Portuguesa de Sao Paulo

São Paulo, Brazil

Complex Oncology Center- Plovdiv EOOD

Plovdiv, Bulgaria

MHAT Park Hospital EOOD

Plovdiv, Bulgaria

MHAT Serdika EOOD

Sofia, Bulgaria

UMHAT Sofiamed EOOD

Sofia, Bulgaria

UMHAT Tsaritsa Yoanna ISUL EAD

Sofia, Bulgaria

Ushato Prof Ivan Chernozemski Ead

Sofia, Bulgaria

Beijing Cancer Hospital

Beijing, China

The First Hospital of Jilin University

Changchun, China

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

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

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

National Cancer Center Hospital

Chūōku, Japan

Fukushima Medical University Hospital

Fukushima, Japan

Saitama Medical University International Medical Center

Hidaka-Shi, Japan

Cancer Institute Hospital of JFCR

Kōtoku, Japan

Kurume University Hospital

Kurume-shi, Japan

Aichi Cancer Center Hospital

Nagoya, Japan

Niigata Cancer Center Hospital

Niigata, Japan

Okayama University Hosptial

Okayama, Japan

Osaka International Cancer Institute

Osaka, Japan

Kindai University Hospital

Osakasayama-shi, Japan

NHO Hokkaido Cancer Center

Sapporo, Japan

Iwate Medical University Hospital

Shiwa-Gun, Japan

Shizuoka Cancer Center

Sunto-gun, Japan

Mie University Hospital

Tsu, Japan

Yamagata University Hospital

Yamagata, Japan

Hospital Sultan

Johor Bahru, Malaysia

Sarawak General Hospital

Kuching, Malaysia

HOSPITAL KUALA LUMPUR(HKL) Kuala

Lumpur, Malaysia

National Cancer Institute / Institut Kanser Negara

Putrajaya, Malaysia

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

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