A Phase 3, Randomized, Open-label, Multicenter Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) Maintenance Treatment With or Without Bevacizumab Versus Standard of Care in Participants With Newly Diagnosed Advanced Non-HRD Positive Ovarian Cancer Following First-line Platinum-based Chemotherapy (TroFuse-021/ENGOTov85/GOG-3102)
Status: Recruiting
Location: See all (155) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
Researchers are looking for new ways to treat ovarian cancer (OC). Current treatment for OC may start with surgery to remove as much of the cancer as possible. After surgery, people may receive chemotherapy. After chemotherapy, standard care options may include: * Maintenance treatment, which is used after another therapy to keep the cancer from growing, spreading, or coming back. Bevacizumab is a targeted therapy used as standard maintenance treatment. Targeted therapy works to control how specific types of cancer cells grow and spread. * Observation, which is watching to see if cancer grows or worsens The study medicine, sacituzumab tirumotecan (also called sac-TMT), is a targeted therapy. The goal of this study is to learn if people who receive sac-TMT maintenance treatment with or without bevacizumab live longer without the cancer getting worse than people who receive standard care.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• Has diagnosis of FIGO 2014 Stage III or Stage IV, histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube carcinoma with one of the following histologies: high-grade serous, high-grade endometrioid, clear cell carcinoma, or malignant mixed Müllerian tumour with a high-grade serous component. Tumors reported as Grade 2 may be enrolled only if predominately (\>50%) Grade 3 features are present.
• Has completed primary debulking surgery or interval debulking surgery.
• Has completed first-line (1L) platinum-based chemotherapy, with a response of stable disease, partial response, complete response or no evidence of disease per protocol.
• Has provided tumor tissue that is not previously irradiated.
• Has well-controlled human immunodeficiency virus (HIV) on antiretroviral therapy if diagnosed with HIV
• Has undetectable hepatitis B virus (HBV) viral load and received HBV antiviral therapy if hepatitis B surface antigen (HBsAg)-positive.
• Has undetectable hepatitis C virus (HCV) viral load if has a history of HCV infection.
Locations
United States
Alabama
University of Alabama - Birmingham ( Site 0058)
RECRUITING
Birmingham
California
John Muir Health Cancer Center ( Site 0069)
RECRUITING
Walnut Creek
Florida
Mount Sinai Cancer Center ( Site 0029)
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Miami Beach
Orlando Health Winnie Palmer Hospital for Women and Babies ( Site 0085)
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Orlando
Georgia
Winship Cancer Institute of Emory University ( Site 0037)
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Atlanta
Illinois
Illinois Cancer Specialists (ICS) ( Site 8009)
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Arlington Heights
Indiana
Parkview Research Center at Parkview Regional Medical Center ( Site 0055)
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Fort Wayne
Franciscan Health Indianapolis ( Site 0081)
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Indianapolis
Louisiana
Women's Cancer Care ( Site 0018)
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Covington
Maryland
Maryland Oncology Hematology, P.A. ( Site 8002)
RECRUITING
Columbia
Maine
Maine Medical Center Research Institute-MaineHealth/Maine Medical Partners - GynOnc ( Site 0060)
RECRUITING
Scarborough
North Carolina
Duke Cancer Center ( Site 0012)
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Durham
Nebraska
Nebraska Methodist Hospital ( Site 0004)
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Omaha
University Of Nebraska Medical Center ( Site 0035)
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Omaha
Nevada
The Center of Hope ( Site 0025)
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Reno
New York
Womens Cancer Care Associates, LLC ( Site 0023)
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Albany
Memorial Sloan Kettering Cancer Center ( Site 0072)
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New York
Ohio
University of Cincinnati Medical Center ( Site 0042)
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Cincinnati
Oklahoma
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0007)
RECRUITING
Tulsa
Pennsylvania
Hospital of the University of Pennsylvania ( Site 0071)
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Philadelphia
Rhode Island
Women & Infants Hospital ( Site 0001)
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Providence
Tennessee
West Cancer Center and Research Institute ( Site 0013)
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Germantown
University of Tennessee Medical Center ( Site 0087)
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Knoxville
Henry-Joyce Cancer Clinic ( Site 0011)
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Nashville
Virginia
Virginia Cancer Specialists (VCS) ( Site 8012)
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Fairfax
Virginia Oncology Associates (VOA) ( Site 8013)
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Norfolk
Other Locations
Argentina
Fundación Respirar ( Site 2912)
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Buenos Aires
Hospital Britanico de Buenos Aires ( Site 2905)
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Caba
Hospital Aleman ( Site 2903)
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Ciudad Autonoma De Buenos Aires
Instituto Alexander Fleming ( Site 2902)
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Ciudad Autónoma De Buenos Aires
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 2907)
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La Rioja
Instituto de Investigaciones Clinicas Mar del Plata ( Site 2901)
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Mar Del Plata
Instituto de Oncologia de Rosario ( Site 2909)
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Rosario
Sanatorio Parque - Oncología ( Site 2911)
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Rosario
Australia
Gallipoli Medical Research Ltd ( Site 0204)
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Brisbane
Epworth Freemasons ( Site 0207)
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East Melbourne
Westmead Hospital ( Site 0201)
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Westmead
Austria
Medizinische Universitaet Innsbruck-Univ.-Klinik f. Gynäkologie und Geburtshilfe ( Site 0101)
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Innsbruck
Medizinische Universitat Wien ( Site 0102)
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Vienna
Belgium
Grand Hopital de Charleroi ( Site 0303)
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Charleroi
AZ Maria Middelares ( Site 0302)
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Ghent
UZ Leuven ( Site 0301)
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Leuven
Brazil
ANIMI - Unidade de Tratamento Oncologico ( Site 0421)
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Lages
Liga Norte Riograndense Contra o Cancer ( Site 0417)
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Natal
Hospital São Lucas da PUCRS ( Site 0415)
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Porto Alegre
Obras Sociais Irma Dulce ( Site 0427)
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Salvador
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0414)
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São José Do Rio Preto
IBCC - Núcleo de Pesquisa e Ensino ( Site 0416)
RECRUITING
São Paulo
Canada
CIUSSS - Saguenay-Lac-Saint-Jean ( Site 0519)
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Chicoutimi
Centre Hospitalier de l'Université de Montréal ( Site 0518)
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Montreal
McGill University Health Centre ( Site 0516)
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Montreal
Chile
Clinica Puerto Montt ( Site 0606)
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Port Montt
Clínica Alemana de Santiago ( Site 0610)
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Santiago
FALP ( Site 0607)
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Santiago
Pontificia Universidad Catolica de Chile ( Site 0602)
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Santiago
ONCOCENTRO APYS-ACEREY ( Site 0603)
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Viña Del Mar
Colombia
Instituto Nacional De Cancerologia ( Site 0808)
RECRUITING
Bogota
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0801)
RECRUITING
Bogotá
Fundacion Colombiana de Cancerología Clinica Vida ( Site 0803)
RECRUITING
Medellín
Oncólogos del Occidente S.A.S. ( Site 0806)
RECRUITING
Pereira
Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0802)
RECRUITING
Valledupar
Denmark
Aalborg Universitetshospital ( Site 0901)
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Aalborg
Aarhus Universitetshospital, Skejby ( Site 0903)
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Aarhus
Herlev Hospital ( Site 0902)
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Herlev
Odense Universitets Hospital ( Site 0904)
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Odense
Finland
Kuopion Yliopistollinen Sairaala ( Site 1004)
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Kuopio
Oulun yliopistollinen sairaala ( Site 1003)
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Oulu
Tampereen yliopistollinen sairaala ( Site 1002)
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Tampere
Turku University Hospital-Department of Obstetrics and Gynecology ( Site 1001)
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Turku
France
CHRU de Brest - Hopital de la Cavale Blanche ( Site 1104)
RECRUITING
Brest
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 1113)
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Clermont-ferrand
Centre Oscar Lambret ( Site 1106)
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Lille
Centre Hospitalier Universitaire Dupuytren ( Site 1112)
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Limoges
CENTRE LEON BERARD ( Site 1101)
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Lyon
Institut Paoli Calmettes ( Site 1111)
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Marseille
Hôpital Privé Des Côtes d'Armor ( Site 1102)
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Plérin
Hopitaux Universitaires de Strasbourg ( Site 1109)
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Strasbourg
LBM ONCOPOLE CLAUDIUS REGAUD ( Site 1114)
RECRUITING
Toulouse
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau ( Site 1105)
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Tours
Greece
Alexandra General Hospital of Athens ( Site 0703)
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Athens
Evgenidion Clinic Agia Trias S.A ( Site 0701)
RECRUITING
Athens
Agios Loukas Clinic ( Site 0702)
RECRUITING
Thessaloniki
Hungary
Országos Onkológiai Intézet-Ngyógyászat ( Site 3913)
RECRUITING
Budapest
Semmelweis Egyetem I. Szamu Szuleszeti es Nogyogyaszati Klinika ( Site 3915)
RECRUITING
Budapest
Debreceni Egyetem Klinikai Kozpont-Szülészeti és Nőgyógyászati Klinika ( Site 3912)
RECRUITING
Debrecen
Petz Aladar Egyetemi Oktato Korhaz-Onkológiai Osztály ( Site 3911)
RECRUITING
Győr
Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 3910)
RECRUITING
Kecskemét
Ireland
St James Hospital ( Site 1302)
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Dublin
Israel
Rambam Health Care Campus ( Site 1422)
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Haifa
Edith Wolfson Medical Center ( Site 1423)
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Holon
Sheba Medical Center ( Site 1421)
RECRUITING
Ramat Gan
Italy
Azienda Ospedaliera Spedali Civili di Brescia ( Site 1501)
RECRUITING
Brescia
ASST DI LECCO ( Site 1509)
RECRUITING
Lecco
Istituto Europeo di Oncologia ( Site 1503)
RECRUITING
Milan
Istituto Nazionale dei Tumori ( Site 1504)
RECRUITING
Milan
Istituto Oncologico Veneto ( Site 1506)
RECRUITING
Padova
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1510)
RECRUITING
Roma
Ospedale Mauriziano ( Site 1507)
RECRUITING
Torino
Japan
Hyogo Cancer Center ( Site 1620)
RECRUITING
Akashi
National Hospital Organization Kyushu Cancer Center ( Site 1603)
RECRUITING
Fukuoka
Saitama Medical University International Medical Center ( Site 1607)
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Hidaka
Kagoshima City Hospital ( Site 1613)
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Kagoshima
Cancer Institute Hospital of JFCR ( Site 1614)
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Koto
Kurume University Hospital ( Site 1615)
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Kurume
Niigata Cancer Center Hospital ( Site 1608)
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Niigata
Okayama University Hospital ( Site 1619)
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Okayama
Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 1604)
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Osaka
Gunma Prefectural Cancer Center ( Site 1605)
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Ōta
Hokkaido University Hospital ( Site 1609)
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Sapporo
Keio University Hospital ( Site 1611)
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Shinjyuku
Iwate Medical University Hospital ( Site 1610)
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Shiwa-gun
Shizuoka Cancer Center ( Site 1618)
RECRUITING
Sunto-gun,
Norway
Sorlandet Sykehus Kristiansand ( Site 2003)
RECRUITING
Kristiansand
Oslo University Hospital ( Site 2001)
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Oslo
Stavanger Universitetssjukehus ( Site 2002)
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Stavanger
Peru
Clínica San Felipe ( Site 3603)
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Lima
IPOR Instituto Peruano de Oncología & Radioterapia ( Site 3604)
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Lima
Poland
Bialostockie Centrum Onkologii ( Site 2104)
RECRUITING
Bialystok
Uniwersytecki Szpital Kliniczny w Poznaniu-Oddzial Ginekologii Onkologicznej ( Site 2106)
RECRUITING
Poznan
Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie ( Site 2105)
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Poznan
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2102)
RECRUITING
Siedlce
Uniwersytecki Szpital Kliniczny nr2 PUM w Szczecinie ( Site 2103)
RECRUITING
Szczecin
Republic of Korea
Keimyung University Dongsan Hospital ( Site 2304)
RECRUITING
Daegu
Severance Hospital ( Site 2302)
RECRUITING
Seodaemun-gu
Asan Medical Center ( Site 2305)
RECRUITING
Seoul
Samsung Medical Center ( Site 2303)
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Seoul
Seoul National University Hospital ( Site 2301)
RECRUITING
Seoul
Spain
Complejo Hospitalario Universitario A Coruna ( Site 2412)
RECRUITING
A Coruña
Hospital Clinic I Provincial de Barcelona ( Site 2409)
RECRUITING
Barcelona
Hospital Vall D Hebron ( Site 2403)
RECRUITING
Barcelona
ICO L Hospitalet ( Site 2408)
RECRUITING
Barcelona
Hospital Universitario Reina Sofia ( Site 2406)
RECRUITING
Córdoba
Institut Català d'Oncologia (ICO) - Girona ( Site 2402)
RECRUITING
Girona
Clinica Universidad de Navarra ( Site 2407)
RECRUITING
Madrid
Hospital Clinico San Carlos... ( Site 2410)
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Madrid
Hospital Ramon y Cajal ( Site 2405)
RECRUITING
Madrid
Hospital Universitario La Paz-Oncología Médica ( Site 2404)
RECRUITING
Madrid
Instituto Valenciano de Oncologia - IVO ( Site 2411)
RECRUITING
Valencia
Sweden
Karolinska Universitetssjukhuset Solna ( Site 2502)
RECRUITING
Stockholm
Switzerland
Ospedale Regionale Bellinzona e Valli ( Site 3501)
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Bellinzona
Inselspital Bern ( Site 3504)
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Bern
Kantonsspital Graubünden ( Site 3503)
RECRUITING
Chur
Hôpitaux Universitaires de Genève (HUG) ( Site 3502)
RECRUITING
Geneva
Taiwan
Taichung Veterans General Hospital ( Site 2603)
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Taichung
National Cheng Kung University Hospital ( Site 2602)
RECRUITING
Tainan
Mackay Memorial Hospital ( Site 2604)
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Taipei
National Taiwan University Hospital ( Site 2601)
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Taipei
Linkou Chang Gung Memorial Hospital ( Site 2605)
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Taoyuan
Thailand
Ramathibodi Hospital. ( Site 3402)
RECRUITING
Bangkok
Faculty of Medicine Siriraj Hospital ( Site 3401)
RECRUITING
Bangkoknoi
Faculty of Medicine - Khon Kaen University ( Site 3403)
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Muang
United Kingdom
Addenbrookes Hospital ( Site 2802)
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Cambridge
University Hospitals of Leicester NHS Trust ( Site 2805)
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Leicester
University College London Hospitals ( Site 2801)
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London
The Christie NHS Foundation Trust ( Site 2804)
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Manchester
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2026-02-16
Estimated Completion Date: 2033-02-25
Participants
Target number of participants: 900
Treatments
Experimental: Sac-TMT +/- Bevacizumab
Participants will receive sac-TMT on days 1, 15, and 29 (q2W) of every 6-week cycle, until disease progression, prohibitive toxicity, or other protocol-defined reason for discontinuation. Participants receive optional bevacizumab at investigator's discretion on Days 1 and 22 (q3w) of every 6-week cycle, for up to 22 courses.
Active_comparator: Standard of Care
Participants will either receive bevacizumab q3w of every 6-week cycle for up to 22 courses until disease progression, prohibitive toxicity, or other protocol-defined reason for discontinuation of study intervention, or will be observed only and actively followed if not receiving bevacizumab.
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC