En klinisk studie av Sacituzumab Tirumotecan hos personer med eggstokkreft (MK-2870-021) (TroFuse-021)
12. oktober 2026 oppdatert av: Merck Sharp & Dohme LLC
En fase 3, randomisert, åpen, multikenterstudie av vedlikeholdsbehandling med Sacituzumab Tirumotecan (Sac-TMT, MK-2870) med eller uten Bevacizumab versus standardbehandling hos deltakere med nyoppdaget avansert HRD-negativ eggstokkreft etter første linje platina-basert kjemoterapi (TroFuse-021/ENGOTov85/GOG-3102)
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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
900
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
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- Telefonnummer: 1-888-577-8839
- E-post: Trialsites@msd.com
Studiesteder
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CABA, Argentina, C1280AEB
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- Hospital Britanico de Buenos Aires ( Site 2905)
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- Telefonnummer: +5411 4309 4469
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La Rioja, Argentina, F5300COE
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- Fundación CORI para la Investigación y Prevención del Cáncer ( Site 2907)
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- Telefonnummer: +54 380 4336443
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Buenos Aires
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1119ACN
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- Hospital Aleman ( Site 2903)
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Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1426ANZ
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- Instituto Alexander Fleming ( Site 2902)
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Mar del Plata, Buenos Aires, Argentina, B7600FZO
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- Instituto de Investigaciones Clinicas Mar del Plata ( Site 2901)
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Buenos Aires F.D.
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Buenos Aires, Buenos Aires F.D., Argentina, C1426AAL
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- Fundación Respirar ( Site 2912)
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Santa Fe Province
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Rosario, Santa Fe Province, Argentina, S2000DVC
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- Sanatorio Parque - Oncología ( Site 2911)
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Rosario, Santa Fe Province, Argentina, S2000KZE
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New South Wales
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Westmead, New South Wales, Australia, 2145
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- Westmead Hospital ( Site 0201)
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Queensland
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Brisbane, Queensland, Australia, 4120
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- Gallipoli Medical Research Ltd ( Site 0204)
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Victoria
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East Melbourne, Victoria, Australia, 3002
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Hainaut
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Charleroi, Hainaut, Belgia, 6000
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Oost-Vlaanderen
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Ghent, Oost-Vlaanderen, Belgia, 9000
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- AZ Maria Middelares ( Site 0302)
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Vlaams-Brabant
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Leuven, Vlaams-Brabant, Belgia, 3000
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- UZ Leuven ( Site 0301)
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São Paulo, Brasil, 04014-002
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- IBCC - Núcleo de Pesquisa e Ensino ( Site 0416)
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Estado de Bahia
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Salvador, Estado de Bahia, Brasil, 41680-430
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- Obras Sociais Irma Dulce ( Site 0427)
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Rio Grande do Norte
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Natal, Rio Grande do Norte, Brasil, 59062-000
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- Liga Norte Riograndense Contra o Cancer ( Site 0417)
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasil, 90610000
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- Hospital São Lucas da PUCRS ( Site 0415)
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Santa Catarina
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Lages, Santa Catarina, Brasil, 88501-001
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- ANIMI - Unidade de Tratamento Oncologico ( Site 0421)
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São Paulo
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São José do Rio Preto, São Paulo, Brasil, 15090-000
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Quebec
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Chicoutimi, Quebec, Canada, G7H 5H6
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- CIUSSS - Saguenay-Lac-Saint-Jean ( Site 0519)
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Montreal, Quebec, Canada, H4A 3J1
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- McGill University Health Centre ( Site 0516)
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Montreal, Quebec, Canada, H2X 3H8
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- Centre Hospitalier de l'Université de Montréal ( Site 0518)
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Los Lagos Region
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Port Montt, Los Lagos Region, Chile, 5507642
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- Clinica Puerto Montt ( Site 0606)
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Region M. de Santiago
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Santiago, Region M. de Santiago, Chile, 8330073
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- Pontificia Universidad Catolica de Chile ( Site 0602)
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Santiago, Region M. de Santiago, Chile, 7650568
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Santiago, Region M. de Santiago, Chile, 7500921
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- Fundación Arturo López Pérez ( Site 0607)
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Santiago, Region M. de Santiago, Chile, 8420383
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- Bradfordhill ( Site 0601)
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Valparaiso
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Viña del Mar, Valparaiso, Chile, 2520598
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Antioquia
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Medellín, Antioquia, Colombia, 050030
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- Fundacion Colombiana de Cancerología Clinica Vida ( Site 0803)
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Bogota D.C.
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Bogotá, Bogota D.C., Colombia, 110131
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- FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0801)
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Cesar Department
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Valledupar, Cesar Department, Colombia, 200001
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- Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0802)
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Ta kontakt med:
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- Telefonnummer: 605 5804141
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Cundinamarca
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Bogota, Cundinamarca, Colombia, 111151
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- Instituto Nacional De Cancerologia ( Site 0808)
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- Telefonnummer: +5714320160
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Risaralda Department
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Pereira, Risaralda Department, Colombia, 660001
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- Oncólogos del Occidente S.A.S. ( Site 0806)
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- Telefonnummer: +573002558656
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Capital Region
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Herlev, Capital Region, Danmark, 2730
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- Herlev Hospital ( Site 0902)
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North Denmark
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Aalborg, North Denmark, Danmark, 9000
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- Aalborg Universitetshospital ( Site 0901)
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Aarhus, North Denmark, Danmark, 8200
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Region Syddanmark
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Odense, Region Syddanmark, Danmark, 9000
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- Odense Universitets Hospital ( Site 0904)
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North Ostrobothnia
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Oulu, North Ostrobothnia, Finland, 90220
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Northern Savonia
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Kuopio, Northern Savonia, Finland, 70200
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- Kuopion Yliopistollinen Sairaala ( Site 1004)
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Pirkanmaa
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Tampere, Pirkanmaa, Finland, 33520
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- Tampereen yliopistollinen sairaala ( Site 1002)
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Southwest Finland
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Turku, Southwest Finland, Finland, 20520
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- Turku University Hospital-Department of Obstetrics and Gynecology ( Site 1001)
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Alabama
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Birmingham, Alabama, Forente stater, 35233
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- University of Alabama - Birmingham ( Site 0058)
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California
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Walnut Creek, California, Forente stater, 94598
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- John Muir Health Cancer Center ( Site 0069)
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- Telefonnummer: 925-692-5603
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Florida
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Miami Beach, Florida, Forente stater, 33140
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- Mount Sinai Cancer Center ( Site 0029)
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Orlando, Florida, Forente stater, 32806
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- Orlando Health Winnie Palmer Hospital for Women and Babies ( Site 0085)
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Georgia
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Atlanta, Georgia, Forente stater, 30308
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- Winship Cancer Institute of Emory University ( Site 0037)
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Illinois
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Arlington Heights, Illinois, Forente stater, 60005
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Indiana
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Fort Wayne, Indiana, Forente stater, 46845
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- Parkview Research Center at Parkview Regional Medical Center ( Site 0055)
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Indianapolis, Indiana, Forente stater, 46237
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- Franciscan Health Indianapolis ( Site 0081)
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Louisiana
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Covington, Louisiana, Forente stater, 70433
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- Women's Cancer Care ( Site 0018)
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Maine
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Scarborough, Maine, Forente stater, 04074
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- Maine Medical Center Research Institute-MaineHealth/Maine Medical Partners - GynOnc ( Site 0060)
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Maryland
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Columbia, Maryland, Forente stater, 21044
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- Maryland Oncology Hematology (MOH) ( Site 8002)
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Nebraska
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Omaha, Nebraska, Forente stater, 68114
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- Nebraska Methodist Hospital ( Site 0004)
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- Telefonnummer: 402-354-7939
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Omaha, Nebraska, Forente stater, 68198
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- University Of Nebraska Medical Center ( Site 0035)
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- Telefonnummer: 402-559-2000
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Nevada
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Reno, Nevada, Forente stater, 89511
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- The Center of Hope ( Site 0025)
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- Telefonnummer: 775-327-4673
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New York
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Albany, New York, Forente stater, 12208-1743
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- Womens Cancer Care Associates, LLC ( Site 0023)
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- Telefonnummer: 518-458-1390
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New York, New York, Forente stater, 10022
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- Memorial Sloan Kettering Cancer Center ( Site 0072)
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- Telefonnummer: 347-923-8746
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North Carolina
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Durham, North Carolina, Forente stater, 27710
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- Duke Cancer Center ( Site 0012)
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- Telefonnummer: 919-681-6900
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Ohio
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Cincinnati, Ohio, Forente stater, 45219
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- University of Cincinnati Medical Center ( Site 0042)
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- Telefonnummer: 513-584-1000
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Oklahoma
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Tulsa, Oklahoma, Forente stater, 74146
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- Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0007)
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- Telefonnummer: 918-505-3200
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Oregon
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Portland, Oregon, Forente stater, 97227
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19104
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- Hospital of the University of Pennsylvania ( Site 0071)
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Rhode Island
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Providence, Rhode Island, Forente stater, 02905
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- Women & Infants Hospital ( Site 0001)
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- Telefonnummer: 401-274-1122x48181
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Tennessee
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Germantown, Tennessee, Forente stater, 38138
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- West Cancer Center and Research Institute ( Site 0013)
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Knoxville, Tennessee, Forente stater, 37920
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- University of Tennessee Medical Center ( Site 0087)
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- Telefonnummer: 865-305-9000
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Nashville, Tennessee, Forente stater, 37232
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- Henry-Joyce Cancer Clinic ( Site 0011)
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- Telefonnummer: 615-936-4585
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Virginia
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Fairfax, Virginia, Forente stater, 22031
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- Virginia Cancer Specialists (VCS) ( Site 8012)
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- Telefonnummer: 703-280-5390
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Norfolk, Virginia, Forente stater, 23502
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- Virginia Oncology Associates (VOA) ( Site 8013)
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- Telefonnummer: 757-466-8663
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Auvergne-Rhône-Alpes
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Lyon, Auvergne-Rhône-Alpes, Frankrike, 69008
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- CENTRE LEON BERARD ( Site 1101)
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- Telefonnummer: +33478782888
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Bas-Rhin
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Strasbourg, Bas-Rhin, Frankrike, 67000
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- Hopitaux Universitaires de Strasbourg ( Site 1109)
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- Telefonnummer: 0368767141
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Bouches-du-Rhone
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Marseille, Bouches-du-Rhone, Frankrike, 13273
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- Institut Paoli Calmettes ( Site 1111)
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- Telefonnummer: +33491223333
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Cotes-d Armor
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Plérin, Cotes-d Armor, Frankrike, 22190
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- Hôpital Privé Des Côtes d'Armor ( Site 1102)
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- Telefonnummer: +33296752216
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Finistere
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Brest, Finistere, Frankrike, 29200
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- CHRU de Brest - Hopital de la Cavale Blanche ( Site 1104)
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- Study Coordinator
- Telefonnummer: +33230338161
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Haute-Garonne
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Toulouse, Haute-Garonne, Frankrike, 31059
- Rekruttering
- LBM ONCOPOLE CLAUDIUS REGAUD ( Site 1114)
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- Telefonnummer: +33531155101
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Haute-Vienne
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Limoges, Haute-Vienne, Frankrike, 87042
- Rekruttering
- Centre Hospitalier Universitaire Dupuytren ( Site 1112)
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- Study Coordinator
- Telefonnummer: +33555056268
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Indre-et-Loire
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Tours, Indre-et-Loire, Frankrike, 37044
- Rekruttering
- Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau ( Site 1105)
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- Study Coordinator
- Telefonnummer: +33247478261
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Nord
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Lille, Nord, Frankrike, 59020
- Rekruttering
- Centre Oscar Lambret ( Site 1106)
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- Study Coordinator
- Telefonnummer: +33320295606
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Puy-de-Dome
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Clermont-Ferrand, Puy-de-Dome, Frankrike, 63003
- Rekruttering
- Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 1113)
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- Telefonnummer: +33473278080
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Thessaloniki, Hellas, 552 36
- Rekruttering
- Agios Loukas Clinic ( Site 0702)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +302310390972
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Attica
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Athens, Attica, Hellas, 115 28
- Rekruttering
- Alexandra General Hospital of Athens ( Site 0703)
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- Study Coordinator
- Telefonnummer: +302132162543
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Athens, Attica, Hellas, 115 28
- Rekruttering
- Evgenidion Clinic Agia Trias S.A ( Site 0701)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +302107286444
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Cork, Irland, T12 DC4A
- Rekruttering
- Cork University Hospital ( Site 1303)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +350214922000
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Dublin, Irland, D08 E9P6
- Rekruttering
- St James Hospital ( Site 1302)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +353014103000
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Haifa, Israel, 3109601
- Rekruttering
- Rambam Health Care Campus ( Site 1422)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +97247772688
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Holon, Israel, 5810001
- Rekruttering
- Edith Wolfson Medical Center ( Site 1423)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +97235028211
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Ramat Gan, Israel, 5265601
- Rekruttering
- Sheba Medical Center ( Site 1421)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +97235303030
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Brescia, Italia, 25123
- Rekruttering
- Azienda Ospedaliera Spedali Civili di Brescia ( Site 1501)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +390303998428
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Lecco, Italia, 23900
- Rekruttering
- ASST DI LECCO ( Site 1509)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 0039 0341489167
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Milan, Italia, 20141
- Rekruttering
- Istituto Europeo di Oncologia ( Site 1503)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 390257489543
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Milan, Italia, 20133
- Rekruttering
- Istituto Nazionale dei Tumori ( Site 1504)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +390223903619
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Padova, Italia, 35128
- Rekruttering
- Istituto Oncologico Veneto ( Site 1506)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 0039 0498215729
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Roma, Italia, 00168
- Rekruttering
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1510)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +390630157004
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Torino, Italia, 10128
- Rekruttering
- Ospedale Mauriziano ( Site 1507)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 0039 0115082764
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-
-
-
-
Fukuoka, Japan, 811-1395
- Rekruttering
- National Hospital Organization Kyushu Cancer Center ( Site 1603)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-92-541-3231
-
Kagoshima, Japan, 890-8760
- Rekruttering
- Kagoshima City Hospital ( Site 1613)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-99-230-7000
-
Niigata, Japan, 951-8566
- Rekruttering
- Niigata Cancer Center Hospital ( Site 1608)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-25-266-5111
-
Okayama, Japan, 700-8558
- Rekruttering
- Okayama University Hospital ( Site 1619)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-86-223-7151
-
Osaka, Japan, 541-8567
- Rekruttering
- Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 1604)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-6-6945-1181
-
-
Aichi-ken
-
Nagoya, Aichi-ken, Japan, 464-8681
- Rekruttering
- Aichi Cancer Center ( Site 1601)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-52-762-6111
-
-
Fukuoka
-
Kurume, Fukuoka, Japan, 830-0011
- Rekruttering
- Kurume University Hospital ( Site 1615)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-942-35-3311
-
-
Gunma
-
Ōta, Gunma, Japan, 373-8550
- Rekruttering
- Gunma Prefectural Cancer Center ( Site 1605)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-276-38-0771
-
-
Hokkaido
-
Sapporo, Hokkaido, Japan, 060-8648
- Rekruttering
- Hokkaido University Hospital ( Site 1609)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-11-716-1161
-
-
Hyōgo
-
Akashi, Hyōgo, Japan, 673-8558
- Rekruttering
- Hyogo Cancer Center ( Site 1620)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-78-929-1151
-
-
Iwate
-
Shiwa-gun, Iwate, Japan, 028-3695
- Rekruttering
- Iwate Medical University Hospital ( Site 1610)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-19-613-7111
-
-
Saitama
-
Hidaka, Saitama, Japan, 350-1298
- Rekruttering
- Saitama Medical University International Medical Center ( Site 1607)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-42-984-4111
-
-
Shizuoka
-
Sunto-gun,, Shizuoka, Japan, 411-8777
- Rekruttering
- Shizuoka Cancer Center ( Site 1618)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-55-989-5222
-
-
Tokyo
-
Koto, Tokyo, Japan, 135-8550
- Rekruttering
- Cancer Institute Hospital of JFCR ( Site 1614)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-3-3520-0111
-
Shinjyuku, Tokyo, Japan, 160-8582
- Rekruttering
- Keio University Hospital ( Site 1611)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-3-3353-1211
-
-
-
-
-
Oslo, Norge, 0424
- Rekruttering
- Oslo University Hospital ( Site 2001)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +47-48512384
-
-
Rogaland
-
Stavanger, Rogaland, Norge, 4068
- Rekruttering
- Stavanger Universitetssjukehus ( Site 2002)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 4751518000
-
-
Vest-Agder
-
Kristiansand, Vest-Agder, Norge, 4615
- Rekruttering
- Sorlandet Sykehus Kristiansand ( Site 2003)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +4738073070
-
-
-
-
-
Lima, Peru, 15036
- Rekruttering
- IPOR Instituto Peruano de Oncología & Radioterapia ( Site 3604)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +51 951 881 870
-
Lima, Peru, 15072
- Rekruttering
- Clínica San Felipe ( Site 3603)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +5112190000 Ext 8327
-
-
-
-
Greater Poland Voivodeship
-
Poznan, Greater Poland Voivodeship, Polen, 61-866
- Rekruttering
- Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie ( Site 2105)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +48 61 8850 557
-
Poznan, Greater Poland Voivodeship, Polen, 60-569
- Rekruttering
- Uniwersytecki Szpital Kliniczny w Poznaniu-Oddzial Ginekologii Onkologicznej ( Site 2106)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +48618549014
-
-
Masovian Voivodeship
-
Siedlce, Masovian Voivodeship, Polen, 08-110
- Rekruttering
- Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2102)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +48256403485
-
-
Podlaskie Voivodeship
-
Bialystok, Podlaskie Voivodeship, Polen, 15-027
- Rekruttering
- Bialostockie Centrum Onkologii ( Site 2104)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +48856646732
-
-
West Pomeranian Voivodeship
-
Szczecin, West Pomeranian Voivodeship, Polen, 70-111
- Rekruttering
- Uniwersytecki Szpital Kliniczny nr2 PUM w Szczecinie ( Site 2103)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +48 91 466 10 00
-
-
-
-
-
Barcelona, Spania, 08035
- Rekruttering
- Hospital Vall D Hebron ( Site 2403)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +34934894350
-
Barcelona, Spania, 08907
- Rekruttering
- ICO L Hospitalet ( Site 2408)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +34932607744
-
Barcelona, Spania, 08036
- Rekruttering
- Hospital Clinic I Provincial de Barcelona ( Site 2409)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +34932275402
-
Córdoba, Spania, 14004
- Rekruttering
- Hospital Universitario Reina Sofia ( Site 2406)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +34957011456
-
Madrid, Spania, 28034
- Rekruttering
- Hospital Ramon y Cajal ( Site 2405)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +34913368263
-
Madrid, Spania, 28040
- Rekruttering
- Hospital Clinico San Carlos... ( Site 2410)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 34913303000 x484811
-
Madrid, Spania, 28046
- Rekruttering
- Hospital Universitario La Paz-Oncología Médica ( Site 2404)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +34679927508
-
-
Gerona
-
Girona, Gerona, Spania, 17007
- Rekruttering
- Institut Català d'Oncologia (ICO) - Girona ( Site 2402)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +34972225834
-
-
La Coruna
-
A Coruña, La Coruna, Spania, 15006
- Rekruttering
- Complejo Hospitalario Universitario A Coruna ( Site 2412)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 34981178353
-
-
Madrid, Comunidad de
-
Madrid, Madrid, Comunidad de, Spania, 28027
- Rekruttering
- Clinica Universidad de Navarra ( Site 2407)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +34913531920/ 7513
-
-
Valenciana, Comunitat
-
Valencia, Valenciana, Comunitat, Spania, 46009
- Rekruttering
- Instituto Valenciano de Oncologia - IVO ( Site 2411)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +34961114229
-
-
-
-
-
Manchester, Storbritannia, m20 4bx
- Rekruttering
- The Christie NHS Foundation Trust ( Site 2804)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 0161 918 7690
-
-
Bath And North East Somerset
-
Bath, Bath And North East Somerset, Storbritannia, BA1 3NG
- Rekruttering
- Royal United Hospital Bath NHS Foundation Trust ( Site 2808)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +441225821778
-
-
Cambridgeshire
-
Cambridge, Cambridgeshire, Storbritannia, CB2 2QQ
- Rekruttering
- Addenbrookes Hospital ( Site 2802)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +441223805000
-
-
Leicestershire
-
Leicester, Leicestershire, Storbritannia, LE3 9QP
- Rekruttering
- University Hospitals of Leicester NHS Trust ( Site 2805)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +443003031573
-
-
London, City of
-
London, London, City of, Storbritannia, NW1 2PG
- Rekruttering
- University College London Hospitals ( Site 2801)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +4402034477807
-
-
-
-
-
Geneva, Sveits, 1205
- Rekruttering
- Hôpitaux Universitaires de Genève (HUG) ( Site 3502)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +41795534976
-
-
Canton Ticino
-
Bellinzona, Canton Ticino, Sveits, 6500
- Rekruttering
- Ospedale Regionale Bellinzona e Valli ( Site 3501)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 41918118194
-
-
Canton of Bern
-
Bern, Canton of Bern, Sveits, 3010
- Rekruttering
- Inselspital Bern ( Site 3504)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 41316326416
-
-
Kanton Graubünden
-
Chur, Kanton Graubünden, Sveits, 7000
- Rekruttering
- Kantonsspital Graubünden ( Site 3503)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +41 81 256 6646
-
-
-
-
Stockholm County
-
Stockholm, Stockholm County, Sverige, 171 76
- Rekruttering
- Karolinska Universitetssjukhuset Solna ( Site 2502)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +460812370000
-
-
-
-
-
Seoul, Sør -Korea, 03080
- Rekruttering
- Seoul National University Hospital ( Site 2301)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +82260724984
-
Seoul, Sør -Korea, 06351
- Rekruttering
- Samsung Medical Center ( Site 2303)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +82234101382
-
Seoul, Sør -Korea, 05505
- Rekruttering
- Asan Medical Center ( Site 2305)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +82230103640
-
-
Seoul
-
Seodaemun-Gu, Seoul, Sør -Korea, 03722
- Rekruttering
- Severance Hospital ( Site 2302)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +82222277969
-
-
Taegu-Kwangyokshi
-
Daegu, Taegu-Kwangyokshi, Sør -Korea, 42601
- Rekruttering
- Keimyung University Dongsan Hospital ( Site 2304)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +82532586671
-
-
-
-
-
Taichung, Taiwan, 40705
- Rekruttering
- Taichung Veterans General Hospital ( Site 2603)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 886-4-23592525x5822
-
Tainan, Taiwan, 704302
- Rekruttering
- National Cheng Kung University Hospital ( Site 2602)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +8862353535
-
Taipei, Taiwan, 104
- Rekruttering
- Mackay Memorial Hospital ( Site 2604)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +886225433535
-
Taipei, Taiwan, 10002
- Rekruttering
- National Taiwan University Hospital ( Site 2601)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 886-223123456x271563
-
Taoyuan, Taiwan, 333
- Rekruttering
- Linkou Chang Gung Memorial Hospital ( Site 2605)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 886-33281200x8258
-
-
-
-
Bangkok
-
Bangkok, Bangkok, Thailand, 10400
- Rekruttering
- Ramathibodi Hospital. ( Site 3402)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +6622011451
-
Bangkoknoi, Bangkok, Thailand, 10700
- Rekruttering
- Faculty of Medicine Siriraj Hospital ( Site 3401)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +6624194488
-
-
Changwat Khon Kaen
-
Muang, Changwat Khon Kaen, Thailand, 40002
- Rekruttering
- Faculty of Medicine - Khon Kaen University ( Site 3403)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +6643348382
-
-
-
-
-
Hradec Králové, Tsjekkia, 500 05
- Rekruttering
- Fakultni nemocnice Hradec Kralove ( Site 3307)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +420 495 831 111
-
Prague, Tsjekkia, 128 08
- Rekruttering
- Vseobecna fakultni nemocnice v Praze ( Site 3305)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +420224967451
-
Prague, Tsjekkia, 150 06
- Rekruttering
- Fakultni nemocnice motol ( Site 3302)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +420224431111
-
Prague, Tsjekkia, 100 34
- Rekruttering
- Fakultni nemocnice Kralovske Vinohrady ( Site 3306)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +420267161111
-
-
Brno-mesto
-
Brno, Brno-mesto, Tsjekkia, 602 00
- Rekruttering
- Fakultni Nemocnice Brno Bohunice ( Site 3304)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 420532233843
-
-
Ostrava Mesto
-
Ostrava-Poruba, Ostrava Mesto, Tsjekkia, 708 52
- Rekruttering
- Fakultni nemocnice Ostrava-Gynekologicko-porodnicka klinika ( Site 3303)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +420597371804
-
-
-
-
Thuringia
-
Jena, Thuringia, Tyskland, 07747
- Rekruttering
- Universitätsklinikum Jena ( Site 1211)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +49 36419329101
-
-
-
-
-
Budapest, Ungarn, 1122
- Rekruttering
- Országos Onkológiai Intézet-Ngyógyászat ( Site 3913)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +3612248600
-
Budapest, Ungarn, 1088
- Rekruttering
- Semmelweis Egyetem I. Szamu Szuleszeti es Nogyogyaszati Klinika ( Site 3915)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +36 1 266 0473
-
Debrecen, Ungarn, 4032
- Rekruttering
- Debreceni Egyetem Klinikai Kozpont-Szülészeti és Nőgyógyászati Klinika ( Site 3912)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 0652255705
-
-
Bács-Kiskun county
-
Kecskemét, Bács-Kiskun county, Ungarn, 6000
- Rekruttering
- Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 3910)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +3676516719
-
-
Győr-Moson-Sopron
-
Győr, Győr-Moson-Sopron, Ungarn, 9024
- Rekruttering
- Petz Aladar Egyetemi Oktato Korhaz-Onkológiai Osztály ( Site 3911)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +3696418244
-
-
-
-
State of Vienna
-
Vienna, State of Vienna, Østerrike, 1090
- Rekruttering
- Medizinische Universitat Wien ( Site 0102)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +43 1 4040061030
-
-
Tyrol
-
Innsbruck, Tyrol, Østerrike, 6020
- Rekruttering
- Medizinische Universitaet Innsbruck-Univ.-Klinik f. Gynäkologie und Geburtshilfe ( Site 0101)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +4351250483105
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
The main inclusion criteria include but are not limited to the following:
- 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.
The main exclusion criteria include but are not limited to the following:
- Has nonepithelial cancers, low-grade serous tumors, low-grade endometrioid tumors, borderline tumors mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor, and undifferentiated carcinoma.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has a history of severe eye disease.
- Has active inflammatory bowel disease requiring immunosuppressive medication or a previous history of inflammatory bowel disease.
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.
- Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD), which required steroids, has current pneumonitis/ILD, or has suspected ILD, or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening.
- Received prior systemic anticancer therapy, with the exception of the first-line platinum-based chemotherapy required by the inclusion criteria.
- Had a live or live-attenuated vaccine within 30 days of randomization.
- Has a known additional malignancy that is progressing or required active treatment within the past 3 years.
- Has active infection requiring systemic therapy.
- Has concurrent and active HBV and HCV infections.
- Has HIV infection and a history of Kaposi's sarcoma and/or multicentric Castleman's disease.
- Has not recovered from major surgery or has ongoing surgical complications.
- Has a homologous recombination deficiency (HRD)-positive, unknown, or inconclusive tumor status as determined by the central laboratory.
- Active or ongoing stomatitis of any grade.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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. |
Administered via intravenous (IV) infusion at a dose of 4mg/kg
Andre navn:
Administered via IV infusion at a dose of 15mg/kg
Andre navn:
Participants must receive prophylactic steroid mouthwash (dexamethasone or equivalent). It is recommended that participants receive the following rescue medications prior to sac-TMT infusion, per approved product label: histamine-1 receptor antagonist, histamine-2 receptor antagonist, acetaminophen or equivalent, and dexamethasone or equivalent. |
|
Aktiv komparator: 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. |
Administered via IV infusion at a dose of 15mg/kg
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression-Free Survival (PFS)
Tidsramme: Up to approximately 49 months
|
PFS is defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 by blinded independent central review (BICR) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. |
Up to approximately 49 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Survival (OS)
Tidsramme: Up to approximately 78 months
|
OS is defined as the time from randomization to death due to any cause. |
Up to approximately 78 months
|
|
Progression-Free Survival 2 (PFS2)
Tidsramme: Up to approximately 78 months
|
PFS2 as assessed by investigator is defined as the time from randomization to the documented subsequent objective disease progression after initiation of new anticancer therapy or death due to any cause, whichever occurs first. |
Up to approximately 78 months
|
|
Number of Participants Who Experience an Adverse Event (AE)
Tidsramme: Up to approximately 78 months
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. |
Up to approximately 78 months
|
|
Number of Participants Who Discontinue Study Treatment Due to an AE
Tidsramme: Up to approximately 78 months
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. |
Up to approximately 78 months
|
|
Change From Baseline in Global Health Status/Quality of Life (GHS/QoL) Combined Score (Items 29 and 30) Using the European Organisation for Research and Treatment of Cancer QoL Questionnaire-Core 30 (EORTC QLQ-C30)
Tidsramme: Baseline and up to approximately 78 months
|
EORTC QLQ-C30 is a questionnaire to assess the overall quality of life (QoL) of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7- point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score will be presented. |
Baseline and up to approximately 78 months
|
|
Change From Baseline in Physical Functioning Combined Score (Items 1 to 5) Using EORTC QLQ-C30
Tidsramme: Baseline and up to approximately 78 months
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EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1 = Not at All to 4 = Very Much). The combined score is computed by averaging the raw scores of the 5 questions and then applying a linear transformation to standardize the average score, so that the combined score ranges from 0 to 100. A higher score indicates a better outcome. The change from baseline in the EORTC QLQ-C30 physical functioning combined score will be presented. |
Baseline and up to approximately 78 months
|
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Change From Baseline in Role Functioning Combined Score (Items 6 and 7) Using EORTC QLQ-C30
Tidsramme: Baseline and up to approximately 78 months
|
EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 2 questions about their role functioning are scored on a 4-point scale (1 = Not at All to 4 = Very Much). The combined score is computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined score ranges from 0 to 100. A higher score indicates a better outcome. The change from baseline in the EORTC QLQ-C30 role functioning combined score will be presented. |
Baseline and up to approximately 78 months
|
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Change From Baseline in Abdominal/Gastrointestinal (GI) Symptoms Combined Score Using the EORTC QLQ-Ovarian Cancer Module 28 (OV28)
Tidsramme: Baseline and up to approximately 78 months
|
EORTC QLQ-OV28 is an OC-specific module to supplement the EORTC QLQ-C30. Participant responses to the 6 abdominal/GI symptoms scale questions are scored on a 4-point scale (1=not at all, 4=very much). The combined score is computed by averaging the raw scores of the 6 items and then applying a linear transformation to standardize the average score, so that the combined score ranges from 0 to 100. The change from baseline in abdominal and gastrointestinal symptoms (EORTC QLQ-OC28 Items 31-36) score will be presented. A lower score indicates a better outcome. |
Baseline and up to approximately 78 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Medical Director, Merck Sharp & Dohme LLC
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
16. februar 2026
Primær fullføring (Antatt)
25. februar 2033
Studiet fullført (Antatt)
25. februar 2033
Datoer for studieregistrering
Først innsendt
2. januar 2026
Først innsendt som oppfylte QC-kriteriene
2. januar 2026
Først lagt ut (Faktiske)
6. januar 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
13. oktober 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. oktober 2026
Sist bekreftet
1. oktober 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Kjønnssykdommer
- Sykdommer i det endokrine systemet
- Urogenitale neoplasmer
- Neoplasmer etter nettsted
- Neoplasmer
- Kvinnelige urogenitale sykdommer
- Kvinnelige urogenitale sykdommer og graviditetskomplikasjoner
- Kjønnssykdommer, kvinner
- Neoplasmer i endokrine kjertel
- Sykdommer i eggstokkene
- Adnexal sykdommer
- Genitale neoplasmer, kvinnelige
- Gonadal lidelser
- Neoplasmer i eggstokkene
- Aminosyrer, peptider og proteiner
- Proteiner
- Antistoffer, monoklonalt, humanisert
- Antistoffer, monoklonalt
- Antistoffer
- Immunoglobuliner
- Immunoproteiner
- Blodproteiner
- Serumglobuliner
- Globuliner
- Bevacizumab
Andre studie-ID-numre
- 2870-021
- MK-2870-021 (Annen identifikator: MSD)
- GOG-3102 (Annen identifikator: Gynecologic Oncology Group)
- ENGOT-ov85 (Annen identifikator: European Network for Gynaecological Oncological Trial groups)
- U1111-1297-5158 (Registeridentifikator: WHO/UTN)
- 2023-508047-40-00 (Registeridentifikator: EU CT)
- jRCT2031250647 (Registeridentifikator: Japan Registry of Clinical Trial (jRCT))
- 2023 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .