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 (96) 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 histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube carcinoma of certain histologies.
• 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.
• If human immunodeficiency virus (HIV) infected, has well-controlled HIV on antiretroviral therapy.
• 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
Florida
Mount Sinai Cancer Center ( Site 0029)
RECRUITING
Miami Beach
Orlando Health Winnie Palmer Hospital for Women and Babies ( Site 0085)
RECRUITING
Orlando
Georgia
Winship Cancer Institute of Emory University ( Site 0037)
RECRUITING
Atlanta
Indiana
Parkview Research Center at Parkview Regional Medical Center ( Site 0055)
RECRUITING
Fort Wayne
Louisiana
Women's Cancer Care ( Site 0018)
RECRUITING
Covington
Nebraska
Nebraska Methodist Hospital ( Site 0004)
RECRUITING
Omaha
University Of Nebraska Medical Center ( Site 0035)
RECRUITING
Omaha
Oklahoma
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0007)
RECRUITING
Tulsa
Tennessee
West Cancer Center and Research Institute ( Site 0013)
RECRUITING
Germantown
Other Locations
Argentina
Fundación Respirar ( Site 2912)
RECRUITING
Buenos Aires
Hospital Britanico de Buenos Aires ( Site 2905)
RECRUITING
Caba
Instituto Alexander Fleming ( Site 2902)
RECRUITING
Ciudad Autónoma De Buenos Aires
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 2907)
RECRUITING
La Rioja
Instituto de Investigaciones Clinicas Mar del Plata ( Site 2901)
RECRUITING
Mar Del Plata
Instituto de Oncologia de Rosario ( Site 2909)
RECRUITING
Rosario
Sanatorio Parque - Oncología ( Site 2911)
RECRUITING
Rosario
Australia
Gallipoli Medical Research Ltd ( Site 0204)
RECRUITING
Brisbane
Epworth Freemasons ( Site 0207)
RECRUITING
East Melbourne
Austria
Medizinische Universitaet Innsbruck-Univ.-Klinik f. Gynäkologie und Geburtshilfe ( Site 0101)
RECRUITING
Innsbruck
Medizinische Universitat Wien ( Site 0102)
RECRUITING
Vienna
Belgium
Grand Hopital de Charleroi ( Site 0303)
RECRUITING
Charleroi
AZ Maria Middelares ( Site 0302)
RECRUITING
Ghent
UZ Leuven ( Site 0301)
RECRUITING
Leuven
Brazil
Hospital São Lucas da PUCRS ( Site 0415)
RECRUITING
Porto Alegre
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0414)
RECRUITING
São José Do Rio Preto
Canada
McGill University Health Centre ( Site 0516)
RECRUITING
Montreal
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
Oncólogos del Occidente S.A.S. ( Site 0806)
RECRUITING
Pereira
Denmark
Aalborg Universitetshospital ( Site 0901)
RECRUITING
Aalborg
Aarhus Universitetshospital, Skejby ( Site 0903)
RECRUITING
Aarhus
Herlev Hospital ( Site 0902)
RECRUITING
Herlev
Odense Universitets Hospital ( Site 0904)
RECRUITING
Odense
Finland
Kuopion Yliopistollinen Sairaala ( Site 1004)
RECRUITING
Kuopio
Oulun yliopistollinen sairaala ( Site 1003)
RECRUITING
Oulu
Tampereen yliopistollinen sairaala ( Site 1002)
RECRUITING
Tampere
Turku University Hospital-Department of Obstetrics and Gynecology ( Site 1001)
RECRUITING
Turku
France
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 1113)
RECRUITING
Clermont-ferrand
Centre Oscar Lambret ( Site 1106)
RECRUITING
Lille
CENTRE LEON BERARD ( Site 1101)
RECRUITING
Lyon
Hôpital Privé Des Côtes d'Armor ( Site 1102)
RECRUITING
Plérin
Hopitaux Universitaires de Strasbourg ( Site 1109)
RECRUITING
Strasbourg
Hungary
Országos Onkológiai Intézet-Ngyógyászat ( Site 3913)
RECRUITING
Budapest
Debreceni Egyetem Klinikai Kozpont-Szülészeti és Nőgyógyászati Klinika ( Site 3912)
RECRUITING
Debrecen
Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 3910)
RECRUITING
Kecskemét
Israel
Rambam Health Care Campus ( Site 1422)
RECRUITING
Haifa
Edith Wolfson Medical Center ( Site 1423)
RECRUITING
Holon
Italy
Azienda Ospedaliera Spedali Civili di Brescia ( Site 1501)
RECRUITING
Brescia
Istituto Europeo di Oncologia ( Site 1503)
RECRUITING
Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1510)
RECRUITING
Roma
Japan
Hyogo Cancer Center ( Site 1620)
RECRUITING
Akashi
Saitama Medical University International Medical Center ( Site 1607)
RECRUITING
Hidaka
Kagoshima City Hospital ( Site 1613)
RECRUITING
Kagoshima
Cancer Institute Hospital of JFCR ( Site 1614)
RECRUITING
Koto
Niigata Cancer Center Hospital ( Site 1608)
RECRUITING
Niigata
Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 1604)
RECRUITING
Osaka
Gunma Prefectural Cancer Center ( Site 1605)
RECRUITING
Ōta
Hokkaido University Hospital ( Site 1609)
RECRUITING
Sapporo
Iwate Medical University Hospital ( Site 1610)
RECRUITING
Shiwa-gun
Norway
Sorlandet Sykehus Kristiansand ( Site 2003)
RECRUITING
Kristiansand
Oslo University Hospital ( Site 2001)
RECRUITING
Oslo
Stavanger Universitetssjukehus ( Site 2002)
RECRUITING
Stavanger
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)
RECRUITING
Poznan
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2102)
RECRUITING
Siedlce
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)
RECRUITING
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)
RECRUITING
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)
RECRUITING
Bellinzona
Inselspital Bern ( Site 3504)
RECRUITING
Bern
Kantonsspital Graubünden ( Site 3503)
RECRUITING
Chur
Hôpitaux Universitaires de Genève (HUG) ( Site 3502)
RECRUITING
Geneva
Taiwan
Taichung Veterans General Hospital ( Site 2603)
RECRUITING
Taichung
National Cheng Kung University Hospital ( Site 2602)
RECRUITING
Tainan
Mackay Memorial Hospital ( Site 2604)
RECRUITING
Taipei
National Taiwan University Hospital ( Site 2601)
RECRUITING
Taipei
Linkou Chang Gung Memorial Hospital ( Site 2605)
RECRUITING
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)
RECRUITING
Muang
United Kingdom
The Christie NHS Foundation Trust ( Site 2804)
RECRUITING
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