Ovarian Cancer Clinical Trials

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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)

Status: Recruiting
Location: See all (188) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• 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 FIGO Stage III or IV.

• 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.

• 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.

• Has a local HRD or BRCA test result available. Participants with BRCA-wildtype will have a local HRD test results, as applicable.

• 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.

Locations
United States
California
Scripps Clinic
RECRUITING
La Jolla
Florida
Broward Health Medical Center
RECRUITING
Fort Lauderdale
Jupiter Medical Center
RECRUITING
Jupiter
Mount Sinai Medical Center
RECRUITING
Miami Beach
AdventHealth Cancer Institute
RECRUITING
Orlando
Woman's Care FL
RECRUITING
St. Petersburg
Georgia
Nancy N. & J.C Lewis Cancer & Research Pavillion- St. Josephs/ Candler Health System
RECRUITING
Savannah
Illinois
Endeavor Health Evanston Kellogg Cancer Care Center
RECRUITING
Evanston
Indiana
Indiana University
RECRUITING
Indianapolis
Louisiana
Trials365 LLC
RECRUITING
Shreveport
Massachusetts
Dana-Farber Cancer Institute
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Maryland
Greater Baltimore Medical Center
RECRUITING
Towson
Michigan
Trinity Health St. Joseph Mercy Ann Arbor
RECRUITING
Ann Arbor
Corewell Health
RECRUITING
Grand Rapids
Montana
St. Vincent Gynecologic Oncology
RECRUITING
Billings
North Carolina
UNC Hospital
RECRUITING
Chapel Hill
New Jersey
Valley Health System
RECRUITING
Paramus
New York
Columbia University
RECRUITING
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
RECRUITING
New York
Ohio
Miami Valley Hospital South
RECRUITING
Centerville
Oregon
Legacy Medical Group Gynecologic Oncology
RECRUITING
Portland
Providence Cancer Center Oncology
RECRUITING
Portland
Pennsylvania
St. Lukes University Health Network
RECRUITING
Bethlehem
Ann B Barshinger Cancer Institute
RECRUITING
Lancaster
South Dakota
Avera Medical Group Gynecologic
RECRUITING
Sioux Falls
Tennessee
Sarah Cannon Research Institute (Oncology Associates of Oregon PC)
RECRUITING
Nashville
Other Locations
Australia
Genesiscare St Andrews Hospital
RECRUITING
Adelaide
Icon Cancer Centre Wesley
RECRUITING
Auchenflower
Icon Cancer Centre Hobart
RECRUITING
Hobart
Genesis Care North Shore (Oncology)
RECRUITING
St Leonards
Westmead Hospital
RECRUITING
Sydney
Austria
Medizinische Universitat Innsbruck
RECRUITING
Innsbruck
Belgium
AZ Sint-Lucas
RECRUITING
Ghent
UZ Leuven
RECRUITING
Leuven
Groupe Sante CHC/Clinique du MontLegia
RECRUITING
Liège
CHU UCL Namur
RECRUITING
Namur
Cliniques Universitaires Saint-LUC
RECRUITING
Woluwe-saint-lambert
Brazil
Oncocentro Belo Horizonte
RECRUITING
Belo Horizonte
Centro De Pesquisas Clinica Reichow
RECRUITING
Blumenau
Fundação Doutor Amaral Carvalho
RECRUITING
Jaú
Liga Norte-Rio-Grandense Contra o Cancer
RECRUITING
Natal
Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa Hospital Mae de Deus
RECRUITING
Porto Alegre
Irmandade Da Santa Casa De Misericordia De Porto Alegre
RECRUITING
Porto Alegre
Ceon Pesquisas
RECRUITING
Santo André
Fundacao Faculdade Regional De Medicina De Sao Jose Do Rio Preto
RECRUITING
Sao Jose Rio
BP A Beneficencia Portuguesa de Sao Paulo
RECRUITING
São Paulo
Bulgaria
Complex Oncology Center- Plovdiv EOOD
RECRUITING
Plovdiv
MHAT Park Hospital EOOD
RECRUITING
Plovdiv
MHAT Serdika EOOD
RECRUITING
Sofia
UMHAT Sofiamed EOOD
RECRUITING
Sofia
UMHAT Tsaritsa Yoanna ISUL EAD
RECRUITING
Sofia
Ushato Prof Ivan Chernozemski Ead
RECRUITING
Sofia
China
Beijing Cancer Hospital
RECRUITING
Beijing
The First Hospital of Jilin University
RECRUITING
Changchun
Hunan Cancer Hospital
RECRUITING
Changsha
Sichuan University West China Second University Hospital
RECRUITING
Chengdu
Chongqing Cancer Hospital
RECRUITING
Chongqing
The Second Hospital of Dalian Medical University
RECRUITING
Dalian
Fujian Cancer Hospital
RECRUITING
Fuzhou
Sun Yat-Sen University Cancer Center
RECRUITING
Guangzhou
Harbin Medical University - Tumor Hospital
RECRUITING
Haerbing
Hainan General Hospital
RECRUITING
Haikou
Zhejiang Cancer Hospital
RECRUITING
Hangzhou
Women's Hospital School of Medicine Zhejiang University
RECRUITING
Hangzhoushi
Shandong Cancer Hospital
RECRUITING
Jinan
Yunnan Cancer Hospital
RECRUITING
Kunming
Jiangxi Maternal and Child Health Hospital
RECRUITING
Nanchang
Zhong Da Hospital, Southeast University
RECRUITING
Nanjing
Guangxi Medical University Cancer Hopstial
RECRUITING
Nanning
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai Shi
Liaoning Cancer Hospital & Institute
RECRUITING
Shenyang
Affiliated Hospital (Suzhou First People's Hospital)
RECRUITING
Suzhou
Shanxi Cancer Hospital
RECRUITING
Taiyuan
Tianjin Medical University Cancer Institute & Hospital
RECRUITING
Tianjin
Hubei Cancer Hospital
RECRUITING
Wuhan
Tongji Hospital Tongji Medical College of HUST
RECRUITING
Wuhan
The First Affiliated Hospital of Xi'an Jiaotong University
RECRUITING
Xi'an
Yantai Yuhuangding Hospital
RECRUITING
Yantai
Henan Cancer Hospital
RECRUITING
Zhengzhou
Denmark
Aarhus University Hospital
RECRUITING
Aarhus
Rigshospitalet
RECRUITING
Copenhagen
Sjællands Universitet Hospital
RECRUITING
Roskilde
France
Institut Bergonie
RECRUITING
Bordeaux
Centre Georges Francois Leclerc
RECRUITING
Dijon
Hopital Claude Huriez- CHU Lille
RECRUITING
Lille
Centre Leon Berard
RECRUITING
Lyon
CHU Montpellier, Saint Eloi
RECRUITING
Montpellier
Hopital Prive Du Confluent
RECRUITING
Nantes
Hopital Saint Joseph- Paris
RECRUITING
Paris
Hospital Europeen Georges Pompidou
RECRUITING
Paris
CRLCC Eugene Marquis
RECRUITING
Rennes
CHU Saint Etienne
RECRUITING
Saint-etienne
Hungary
Debreceni Egyetem
RECRUITING
Debrecen
India
Gujarat Cancer & Research Institute
RECRUITING
Ahmedabad
Saroj Gupta Cancer Center and Research Institute SGCC&RI
RECRUITING
Kolkata
National Cancer Institute Nagpur
RECRUITING
Nagpur
HCG Manavata Cancer Centre
RECRUITING
Nashik
Ruby Hall Clinic
RECRUITING
Pune
HCG Cancer Centre Vadodara
RECRUITING
Vadodara
King George Hospital
RECRUITING
Visakhapatnam
Israel
The Lady Davis Carmel Medical Center
RECRUITING
Haifa
Shaare Zedek
RECRUITING
Jerusalem
Meir Medical Center
RECRUITING
Kfar Saba
Rabin Medical Center-Beilinson Campus
RECRUITING
Petah Tikva
Tel Aviv Sourasky Medical Center
RECRUITING
Tel Aviv
Sheba Medical Center
RECRUITING
Tel Litwinsky
Italy
Istituto Tumori Giovanni Paolo II Irccs Ospedale Oncologico Bari
RECRUITING
Bari
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
RECRUITING
Bologna
Azienda Ospedaliera Per Lemergenza Cannizzaro
RECRUITING
Catania
Humanitas San Pio X
RECRUITING
Milan
IEO Istituto Europeo Di Oncologia
RECRUITING
Milan
Azienda Socio Sanitaria Territoriale Di Monza (Presidio San Gerardo)
RECRUITING
Monza
Istituto Nazionale Tumori Fondazione G. Pascale
RECRUITING
Naples
Azienda Ospedaliero Universitaria Pisana
RECRUITING
Pisa
Nuovo Ospedale Degli Infermi
RECRUITING
Ponderano
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
RECRUITING
Roma
Istituto Nazionale Tumori Regina Elena Irccs
RECRUITING
Roma
Japan
Hyogo Cancer Center
RECRUITING
Akashi
National Cancer Center Hospital
RECRUITING
Chūōku
Fukushima Medical University Hospital
RECRUITING
Fukushima
Saitama Medical University International Medical Center
RECRUITING
Hidaka-shi
Cancer Institute Hospital of JFCR
RECRUITING
Kōtoku
Kurume University Hospital
RECRUITING
Kurume-shi
Aichi Cancer Center Hospital
RECRUITING
Nagoya
Niigata Cancer Center Hospital
RECRUITING
Niigata
Okayama University Hosptial
RECRUITING
Okayama
Osaka International Cancer Institute
RECRUITING
Osaka
Kindai University Hospital
RECRUITING
Osakasayama-shi
NHO Hokkaido Cancer Center
RECRUITING
Sapporo
Iwate Medical University Hospital
RECRUITING
Shiwa-gun
Shizuoka Cancer Center
RECRUITING
Sunto-gun
Mie University Hospital
RECRUITING
Tsu
Yamagata University Hospital
RECRUITING
Yamagata
Malaysia
Hospital Sultan
RECRUITING
Johor Bahru
Sarawak General Hospital
RECRUITING
Kuching
HOSPITAL KUALA LUMPUR(HKL) Kuala
RECRUITING
Lumpur
National Cancer Institute / Institut Kanser Negara
RECRUITING
Putrajaya
Poland
Uniwersytecki Szpital Kliniczny w Poznaniu
RECRUITING
Poznan
Mazowiecki Szpital Wojewodzki W Siedlcach SP Zoo
RECRUITING
Siedlce
Republic of Korea
Keimyung University Dongsan Hospital
RECRUITING
Daegu
National Cancer Center
RECRUITING
Goyang-si
CHA Bundang Medical Center, CHA University
RECRUITING
Seongnam-si
Seoul National University Bundang Hospital
RECRUITING
Seongnam-si
Asan Medical Center
RECRUITING
Seoul
Gangnam Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
The Catholic University of Korea, Seoul St. Mary'S Hospital
RECRUITING
Seoul
Romania
Gral Medical S.R.L
RECRUITING
Bucharest
Medeuropa SRL
RECRUITING
Bucharest
Memorial Healthcare International SRL
RECRUITING
Bucharest
Medeuropa SRL
RECRUITING
Oradea
Singapore
National Cancer Centre Singapore
RECRUITING
Singapore
National University Hospital
RECRUITING
Singapore
Spain
Complejo Hospitalario Universitario A Coruna
RECRUITING
A Coruña
Hospital Clinic De Barcelona
RECRUITING
Barcelona
Hospital Universitari Vall D'Hebron
RECRUITING
Barcelona
Hospital Universitario Reina Sofia
RECRUITING
Córdoba
Hospital Universitario Virgen De La Arrixaca
RECRUITING
El Palmar
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Universitario Ramon y Cajal
RECRUITING
Madrid
Hospital Universitari Son Espases
RECRUITING
Palma
Clinica Universidad de Navarra (MAD)
RECRUITING
Pamplona
Hospital Universitario Donostia
RECRUITING
Planta Baja
Clinica Universidad de Navarra (Calle Marquesado de Santa Marta)
RECRUITING
San Blas-canillejas
Hospital Universitario Virgen del Rocio
RECRUITING
Seville
Hospital Clinico Universitario De Valencia
RECRUITING
Valencia
Hospital Universitari I Politecnic La Fe
RECRUITING
Valencia
Sweden
Skanes Universitetssjukhus Lund
RECRUITING
Lund
Karolinska Universitet Ssjukhuset
RECRUITING
Solna
Akademiska Sjukhuset (Uppsala University Hospital)
RECRUITING
Uppsala
Taiwan
Kaohsiung Chang Gung Memorial Hospital
RECRUITING
Kaohsiung City
Chang Gung Memorial Hospital
RECRUITING
Linkou Taoyuan
Taichung Veterans General Hospital
RECRUITING
Taichung
National Cheng Kung University Hospital
RECRUITING
Tainan
MacKay Memorial Hospital- Taipei Branch
RECRUITING
Taipei
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
United Kingdom
Addenbrooke's Hospital
RECRUITING
Cambridge
Barts Health NHS Trust
RECRUITING
London
Guys Hospital Cancer Centre
RECRUITING
London
The Christie Hospital
RECRUITING
Manchester
Genesis Care, Beaumont House
RECRUITING
Oxford
Weston Park Hospital
RECRUITING
Sheffield
Contact Information
Primary
Contact for Trial Information
CTRinfo_us@daiichisankyo.com
908-992-6400
Time Frame
Start Date: 2025-03-19
Estimated Completion Date: 2032-01-31
Participants
Target number of participants: 582
Treatments
Experimental: Treatment Arm A
Participants will receive T-DXd in combination with bevacizumab
Active_comparator: Treatment Arm B
Participants will receive bevacizumab monotherapy
Related Therapeutic Areas
Sponsors
Leads: Daiichi Sankyo

This content was sourced from clinicaltrials.gov

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