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Een klinische studie van Sacituzumab Tirumotecan bij mensen met eierstokkanker (MK-2870-021) (TroFuse-021)

6 november 2026 bijgewerkt door: Merck Sharp & Dohme LLC

Een fase 3, gerandomiseerde, open-label, multicenterstudie van sacituzumab tirumotecan (Sac-TMT, MK-2870) als onderhoudsbehandeling met of zonder bevacizumab versus de standaardzorg bij deelnemers met nieuw gediagnosticeerd gevorderd HRD-negatief ovariumcarcinoom na eerstelijns platinumbased chemotherapie (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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

900

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Argentinië
      • CABA, Argentinië, C1280AEB
        • Werving
        • Hospital Britanico de Buenos Aires ( Site 2905)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +5411 4309 4469
      • La Rioja, Argentinië, F5300COE
        • Werving
        • Fundación CORI para la Investigación y Prevención del Cáncer ( Site 2907)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +54 380 4336443
    • Buenos Aires
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentinië, C1119ACN
        • Werving
        • Hospital Aleman ( Site 2903)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +5491148277000
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentinië, C1426ANZ
        • Werving
        • Instituto Alexander Fleming ( Site 2902)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 5411 3221 8900
      • Mar del Plata, Buenos Aires, Argentinië, B7600FZO
        • Werving
        • Instituto de Investigaciones Clinicas Mar del Plata ( Site 2901)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +54 223 496 3224
    • Buenos Aires F.D.
      • Buenos Aires, Buenos Aires F.D., Argentinië, C1426AAL
        • Werving
        • Fundación Respirar ( Site 2912)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +541147815331
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentinië, S2000DVC
        • Werving
        • Sanatorio Parque - Oncología ( Site 2911)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +543412987413
      • Rosario, Santa Fe Province, Argentinië, S2000KZE
        • Werving
        • Instituto de Oncologia de Rosario ( Site 2909)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +543414218909
  • Australië
    • New South Wales
      • Westmead, New South Wales, Australië, 2145
        • Werving
        • Westmead Hospital ( Site 0201)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 0288909518
    • Queensland
      • Brisbane, Queensland, Australië, 4120
        • Werving
        • Gallipoli Medical Research Ltd ( Site 0204)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +610733947807
    • Victoria
      • East Melbourne, Victoria, Australië, 3002
        • Werving
        • Epworth Freemasons ( Site 0207)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +61385595000
  • België
    • Hainaut
      • Charleroi, Hainaut, België, 6000
        • Werving
        • Grand Hopital de Charleroi ( Site 0303)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +3260 11 06 04
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, België, 9000
        • Werving
        • AZ Maria Middelares ( Site 0302)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +32 9 246 95 19
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, België, 3000
        • Werving
        • UZ Leuven ( Site 0301)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +32 16 34 74 19
  • Brazilië
      • Rio de Janeiro, Brazilië, 20220-410
        • Werving
        • Instituto Nacional de Câncer - INCA ( Site 0418)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +552132072985
      • São Paulo, Brazilië, 04014-002
        • Werving
        • IBCC - Núcleo de Pesquisa e Ensino ( Site 0416)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +551144500360
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazilië, 41680-430
        • Werving
        • Obras Sociais Irma Dulce ( Site 0427)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +55 71 3310-1978
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brazilië, 59062-000
        • Werving
        • Liga Norte Riograndense Contra o Cancer ( Site 0417)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +558440095595
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazilië, 90610000
        • Werving
        • Hospital São Lucas da PUCRS ( Site 0415)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +555133396039
    • Santa Catarina
      • Lages, Santa Catarina, Brazilië, 88501-001
        • Werving
        • ANIMI - Unidade de Tratamento Oncologico ( Site 0421)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +554933805200
    • São Paulo
      • São José do Rio Preto, São Paulo, Brazilië, 15090-000
        • Werving
        • Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0414)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 55 17 32015054
  • Canada
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
        • Werving
        • CIUSSS - Saguenay-Lac-Saint-Jean ( Site 0519)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 418 541-1000
      • Montreal, Quebec, Canada, H4A 3J1
        • Werving
        • McGill University Health Centre ( Site 0516)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 514-934-1934 x31975
      • Montreal, Quebec, Canada, H2X 3H8
        • Werving
        • Centre Hospitalier de l'Université de Montréal ( Site 0518)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 514-890-8000
  • Chili
    • Los Lagos Region
      • Port Montt, Los Lagos Region, Chili, 5507642
        • Werving
        • Clinica Puerto Montt ( Site 0606)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 56961687093
    • Region M. de Santiago
      • Santiago, Region M. de Santiago, Chili, 8330073
        • Werving
        • Pontificia Universidad Catolica de Chile ( Site 0602)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +56934331806
      • Santiago, Region M. de Santiago, Chili, 7650568
        • Werving
        • Clínica Alemana de Santiago ( Site 0610)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +56996197211
      • Santiago, Region M. de Santiago, Chili, 7500921
        • Werving
        • Fundación Arturo López Pérez ( Site 0607)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 56224205098
      • Santiago, Region M. de Santiago, Chili, 8420383
        • Werving
        • Bradfordhill ( Site 0601)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +5622949070
    • Valparaiso
      • Viña del Mar, Valparaiso, Chili, 2520598
        • Werving
        • ONCOCENTRO APYS-ACEREY ( Site 0603)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +56323320850
  • Colombia
    • Antioquia
      • Medellín, Antioquia, Colombia, 050030
        • Werving
        • Fundacion Colombiana de Cancerología Clinica Vida ( Site 0803)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +576044480016
    • Bogota D.C.
      • Bogotá, Bogota D.C., Colombia, 110131
        • Werving
        • FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0801)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +573044921963
    • Cesar Department
      • Valledupar, Cesar Department, Colombia, 200001
        • Werving
        • Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0802)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 605 5804141
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia, 111151
        • Werving
        • Instituto Nacional De Cancerologia ( Site 0808)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +5714320160
    • Risaralda Department
      • Pereira, Risaralda Department, Colombia, 660001
        • Werving
        • Oncólogos del Occidente S.A.S. ( Site 0806)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +573002558656
  • Denemarken
    • Capital Region
      • Herlev, Capital Region, Denemarken, 2730
        • Werving
        • Herlev Hospital ( Site 0902)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +4538689255
    • North Denmark
      • Aalborg, North Denmark, Denemarken, 9000
        • Werving
        • Aalborg Universitetshospital ( Site 0901)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +4597660000
      • Aarhus, North Denmark, Denemarken, 8200
        • Werving
        • Aarhus Universitetshospital, Skejby ( Site 0903)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +4578450000
    • Region Syddanmark
      • Odense, Region Syddanmark, Denemarken, 9000
        • Werving
        • Odense Universitets Hospital ( Site 0904)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +4523604974
  • Duitsland
    • Hesse
      • Kassel, Hesse, Duitsland, 34125
        • Werving
        • Klinikum Kassel GmbH ( Site 1212)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +4956198017547
    • Thuringia
      • Jena, Thuringia, Duitsland, 07747
        • Werving
        • Universitätsklinikum Jena ( Site 1211)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +49 36419329101
  • Finland
    • North Ostrobothnia
      • Oulu, North Ostrobothnia, Finland, 90220
        • Werving
        • Oulun yliopistollinen sairaala ( Site 1003)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +358 8 3153108
    • Northern Savonia
      • Kuopio, Northern Savonia, Finland, 70200
        • Werving
        • Kuopion Yliopistollinen Sairaala ( Site 1004)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +35844 7176780
    • Pirkanmaa
      • Tampere, Pirkanmaa, Finland, 33520
        • Werving
        • Tampereen yliopistollinen sairaala ( Site 1002)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +358331166203
    • Southwest Finland
      • Turku, Southwest Finland, Finland, 20520
        • Werving
        • Turku University Hospital-Department of Obstetrics and Gynecology ( Site 1001)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +358 2 313 0000
  • Frankrijk
    • Auvergne-Rhône-Alpes
      • Lyon, Auvergne-Rhône-Alpes, Frankrijk, 69008
        • Werving
        • CENTRE LEON BERARD ( Site 1101)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +33478782888
    • Bas-Rhin
      • Strasbourg, Bas-Rhin, Frankrijk, 67000
        • Werving
        • Hopitaux Universitaires de Strasbourg ( Site 1109)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 0368767141
    • Bouches-du-Rhone
      • Marseille, Bouches-du-Rhone, Frankrijk, 13273
        • Werving
        • Institut Paoli Calmettes ( Site 1111)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +33491223333
    • Cotes-d Armor
      • Plérin, Cotes-d Armor, Frankrijk, 22190
        • Werving
        • Hôpital Privé Des Côtes d'Armor ( Site 1102)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +33296752216
    • Finistere
      • Brest, Finistere, Frankrijk, 29200
        • Werving
        • CHRU de Brest - Hopital de la Cavale Blanche ( Site 1104)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +33230338161
    • Haute-Garonne
      • Toulouse, Haute-Garonne, Frankrijk, 31059
        • Werving
        • LBM ONCOPOLE CLAUDIUS REGAUD ( Site 1114)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +33531155101
    • Haute-Vienne
      • Limoges, Haute-Vienne, Frankrijk, 87042
        • Werving
        • Centre Hospitalier Universitaire Dupuytren ( Site 1112)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +33555056268
    • Indre-et-Loire
      • Tours, Indre-et-Loire, Frankrijk, 37044
        • Werving
        • Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau ( Site 1105)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +33247478261
    • Nord
      • Lille, Nord, Frankrijk, 59020
        • Werving
        • Centre Oscar Lambret ( Site 1106)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +33320295606
    • Puy-de-Dome
      • Clermont-Ferrand, Puy-de-Dome, Frankrijk, 63003
        • Werving
        • Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 1113)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +33473278080
  • Griekenland
      • Thessaloniki, Griekenland, 552 36
        • Werving
        • Agios Loukas Clinic ( Site 0702)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +302310390972
    • Attica
      • Athens, Attica, Griekenland, 115 28
        • Werving
        • Alexandra General Hospital of Athens ( Site 0703)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +302132162543
      • Athens, Attica, Griekenland, 115 28
        • Werving
        • Evgenidion Clinic Agia Trias S.A ( Site 0701)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +302107286444
  • Hongarije
      • Budapest, Hongarije, 1122
        • Werving
        • Országos Onkológiai Intézet-Ngyógyászat ( Site 3913)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +3612248600
      • Budapest, Hongarije, 1088
        • Werving
        • Semmelweis Egyetem I. Szamu Szuleszeti es Nogyogyaszati Klinika ( Site 3915)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +36 1 266 0473
      • Debrecen, Hongarije, 4032
        • Werving
        • Debreceni Egyetem Klinikai Kozpont-Szülészeti és Nőgyógyászati Klinika ( Site 3912)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 0652255705
    • Bács-Kiskun county
      • Kecskemét, Bács-Kiskun county, Hongarije, 6000
        • Werving
        • Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 3910)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +3676516719
    • Győr-Moson-Sopron
      • Győr, Győr-Moson-Sopron, Hongarije, 9024
        • Werving
        • Petz Aladar Egyetemi Oktato Korhaz-Onkológiai Osztály ( Site 3911)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +3696418244
  • Ierland
      • Cork, Ierland, T12 DC4A
        • Werving
        • Cork University Hospital ( Site 1303)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +350214922000
      • Dublin, Ierland, D08 E9P6
        • Werving
        • St James Hospital ( Site 1302)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +353014103000
  • Israël
      • Haifa, Israël, 3109601
        • Werving
        • Rambam Health Care Campus ( Site 1422)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +97247772688
      • Holon, Israël, 5810001
        • Werving
        • Edith Wolfson Medical Center ( Site 1423)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +97235028211
      • Ramat Gan, Israël, 5265601
        • Werving
        • Sheba Medical Center ( Site 1421)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +97235303030
  • Italië
      • Brescia, Italië, 25123
        • Werving
        • Azienda Ospedaliera Spedali Civili di Brescia ( Site 1501)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +390303998428
      • Lecco, Italië, 23900
        • Werving
        • ASST DI LECCO ( Site 1509)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 0039 0341489167
      • Milan, Italië, 20141
        • Werving
        • Istituto Europeo di Oncologia ( Site 1503)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 390257489543
      • Milan, Italië, 20133
        • Werving
        • Istituto Nazionale dei Tumori ( Site 1504)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +390223903619
      • Padova, Italië, 35128
        • Werving
        • Istituto Oncologico Veneto ( Site 1506)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 0039 0498215729
      • Roma, Italië, 00168
        • Werving
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1510)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +390630157004
      • Torino, Italië, 10128
        • Werving
        • Ospedale Mauriziano ( Site 1507)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 0039 0115082764
  • Japan
      • Fukuoka, Japan, 811-1395
        • Werving
        • National Hospital Organization Kyushu Cancer Center ( Site 1603)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81-92-541-3231
      • Kagoshima, Japan, 890-8760
        • Werving
        • Kagoshima City Hospital ( Site 1613)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81-99-230-7000
      • Niigata, Japan, 951-8566
        • Werving
        • Niigata Cancer Center Hospital ( Site 1608)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81-25-266-5111
      • Okayama, Japan, 700-8558
        • Werving
        • Okayama University Hospital ( Site 1619)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81-86-223-7151
      • Osaka, Japan, 541-8567
        • Werving
        • Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 1604)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81-6-6945-1181
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 464-8681
        • Werving
        • Aichi Cancer Center ( Site 1601)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81-52-762-6111
    • Fukuoka
      • Kurume, Fukuoka, Japan, 830-0011
        • Werving
        • Kurume University Hospital ( Site 1615)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81-942-35-3311
    • Gunma
      • Ōta, Gunma, Japan, 373-8550
        • Werving
        • Gunma Prefectural Cancer Center ( Site 1605)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81-276-38-0771
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Werving
        • Hokkaido University Hospital ( Site 1609)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81-11-716-1161
    • Hyōgo
      • Akashi, Hyōgo, Japan, 673-8558
        • Werving
        • Hyogo Cancer Center ( Site 1620)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81-78-929-1151
    • Iwate
      • Shiwa-gun, Iwate, Japan, 028-3695
        • Werving
        • Iwate Medical University Hospital ( Site 1610)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81-19-613-7111
    • Saitama
      • Hidaka, Saitama, Japan, 350-1298
        • Werving
        • Saitama Medical University International Medical Center ( Site 1607)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81-42-984-4111
    • Shizuoka
      • Sunto-gun,, Shizuoka, Japan, 411-8777
        • Werving
        • Shizuoka Cancer Center ( Site 1618)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81-55-989-5222
    • Tokyo
      • Koto, Tokyo, Japan, 135-8550
        • Werving
        • Cancer Institute Hospital of JFCR ( Site 1614)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81-3-3520-0111
      • Shinjyuku, Tokyo, Japan, 160-8582
        • Werving
        • Keio University Hospital ( Site 1611)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81-3-3353-1211
  • Noorwegen
      • Oslo, Noorwegen, 0424
        • Werving
        • Oslo University Hospital ( Site 2001)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +47-48512384
    • Rogaland
      • Stavanger, Rogaland, Noorwegen, 4068
        • Werving
        • Stavanger Universitetssjukehus ( Site 2002)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 4751518000
    • Vest-Agder
      • Kristiansand, Vest-Agder, Noorwegen, 4615
        • Werving
        • Sorlandet Sykehus Kristiansand ( Site 2003)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +4738073070
  • Oostenrijk
    • State of Vienna
      • Vienna, State of Vienna, Oostenrijk, 1090
        • Werving
        • Medizinische Universitat Wien ( Site 0102)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +43 1 4040061030
    • Tyrol
      • Innsbruck, Tyrol, Oostenrijk, 6020
        • Werving
        • Medizinische Universitaet Innsbruck-Univ.-Klinik f. Gynäkologie und Geburtshilfe ( Site 0101)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +4351250483105
    • Upper Austria
      • Linz, Upper Austria, Oostenrijk, 4021
        • Werving
        • Keppler Universitatsklinikum ( Site 0103)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +43 5 7680 83 78899
  • Peru
      • Lima, Peru, 15036
        • Werving
        • IPOR Instituto Peruano de Oncología & Radioterapia ( Site 3604)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +51 951 881 870
      • Lima, Peru, 15072
        • Werving
        • Clínica San Felipe ( Site 3603)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +5112190000 Ext 8327
      • Lima, Peru, 15102
        • Werving
        • Hospital Cayetano Heredia ( Site 3607)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +51 953 838 268
  • Polen
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Polen, 61-866
        • Werving
        • Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie ( Site 2105)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +48 61 8850 557
      • Poznan, Greater Poland Voivodeship, Polen, 60-569
        • Werving
        • Uniwersytecki Szpital Kliniczny w Poznaniu-Oddzial Ginekologii Onkologicznej ( Site 2106)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +48618549014
    • Masovian Voivodeship
      • Siedlce, Masovian Voivodeship, Polen, 08-110
        • Werving
        • Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2102)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +48256403485
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Polen, 15-027
        • Werving
        • Bialostockie Centrum Onkologii ( Site 2104)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +48856646732
    • West Pomeranian Voivodeship
      • Szczecin, West Pomeranian Voivodeship, Polen, 70-111
        • Werving
        • Uniwersytecki Szpital Kliniczny nr2 PUM w Szczecinie ( Site 2103)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +48 91 466 10 00
  • Spanje
      • Barcelona, Spanje, 08035
        • Werving
        • Hospital Vall D Hebron ( Site 2403)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +34934894350
      • Barcelona, Spanje, 08907
        • Werving
        • ICO L Hospitalet ( Site 2408)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +34932607744
      • Barcelona, Spanje, 08036
        • Werving
        • Hospital Clinic I Provincial de Barcelona ( Site 2409)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +34932275402
      • Córdoba, Spanje, 14004
        • Werving
        • Hospital Universitario Reina Sofia ( Site 2406)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +34957011456
      • Madrid, Spanje, 28034
        • Werving
        • Hospital Ramon y Cajal ( Site 2405)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +34913368263
      • Madrid, Spanje, 28040
        • Werving
        • Hospital Clinico San Carlos... ( Site 2410)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 34913303000 x484811
      • Madrid, Spanje, 28046
        • Werving
        • Hospital Universitario La Paz-Oncología Médica ( Site 2404)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +34679927508
    • Gerona
      • Girona, Gerona, Spanje, 17007
        • Werving
        • Institut Català d'Oncologia (ICO) - Girona ( Site 2402)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +34972225834
    • La Coruna
      • A Coruña, La Coruna, Spanje, 15006
        • Werving
        • Complejo Hospitalario Universitario A Coruna ( Site 2412)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 34981178353
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spanje, 28027
        • Werving
        • Clinica Universidad de Navarra ( Site 2407)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +34913531920/ 7513
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spanje, 46009
        • Werving
        • Instituto Valenciano de Oncologia - IVO ( Site 2411)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +34961114229
  • Taiwan
      • Taichung, Taiwan, 40705
        • Werving
        • Taichung Veterans General Hospital ( Site 2603)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 886-4-23592525x5822
      • Tainan, Taiwan, 704302
        • Werving
        • National Cheng Kung University Hospital ( Site 2602)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +8862353535
      • Taipei, Taiwan, 104
        • Werving
        • Mackay Memorial Hospital ( Site 2604)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +886225433535
      • Taipei, Taiwan, 10002
        • Werving
        • National Taiwan University Hospital ( Site 2601)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 886-223123456x271563
      • Taoyuan, Taiwan, 333
        • Werving
        • Linkou Chang Gung Memorial Hospital ( Site 2605)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 886-33281200x8258
  • Thailand
    • Bangkok
      • Bangkok, Bangkok, Thailand, 10400
        • Werving
        • Ramathibodi Hospital. ( Site 3402)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +6622011451
      • Bangkoknoi, Bangkok, Thailand, 10700
        • Werving
        • Faculty of Medicine Siriraj Hospital ( Site 3401)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +6624194488
    • Changwat Khon Kaen
      • Muang, Changwat Khon Kaen, Thailand, 40002
        • Werving
        • Faculty of Medicine - Khon Kaen University ( Site 3403)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +6643348382
  • Tsjechië
      • Hradec Králové, Tsjechië, 500 05
        • Werving
        • Fakultni nemocnice Hradec Kralove ( Site 3307)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +420 495 831 111
      • Prague, Tsjechië, 128 08
        • Werving
        • Vseobecna fakultni nemocnice v Praze ( Site 3305)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +420224967451
      • Prague, Tsjechië, 100 34
        • Werving
        • Fakultni nemocnice Kralovske Vinohrady ( Site 3306)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +420267161111
      • Prague, Tsjechië, 150 06
        • Werving
        • Fakultní nemocnice Motol a Homolka ( Site 3302)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +420224431111
    • Brno-mesto
      • Brno, Brno-mesto, Tsjechië, 602 00
        • Werving
        • Fakultni Nemocnice Brno Bohunice ( Site 3304)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 420532233843
    • Ostrava Mesto
      • Ostrava-Poruba, Ostrava Mesto, Tsjechië, 708 52
        • Werving
        • Fakultni nemocnice Ostrava-Gynekologicko-porodnicka klinika ( Site 3303)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +420597371804
  • Verenigd Koninkrijk
      • Manchester, Verenigd Koninkrijk, m20 4bx
        • Werving
        • The Christie NHS Foundation Trust ( Site 2804)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 0161 918 7690
    • Bath And North East Somerset
      • Bath, Bath And North East Somerset, Verenigd Koninkrijk, BA1 3NG
        • Werving
        • Royal United Hospital Bath NHS Foundation Trust ( Site 2808)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +441225821778
    • Cambridgeshire
      • Cambridge, Cambridgeshire, Verenigd Koninkrijk, CB2 2QQ
        • Werving
        • Addenbrookes Hospital ( Site 2802)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +441223805000
    • Leicestershire
      • Leicester, Leicestershire, Verenigd Koninkrijk, LE3 9QP
        • Werving
        • University Hospitals of Leicester NHS Trust ( Site 2805)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +443003031573
    • London, City of
      • London, London, City of, Verenigd Koninkrijk, NW1 2PG
        • Werving
        • University College London Hospitals ( Site 2801)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +4402034477807
  • Verenigde Staten
    • Alabama
      • Birmingham, Alabama, Verenigde Staten, 35233
        • Werving
        • University of Alabama - Birmingham ( Site 0058)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 205-934-4986
    • California
      • La Jolla, California, Verenigde Staten, 92093
        • Werving
        • UCSD Moores Cancer Center ( Site 0038)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 858-822-6100
      • Walnut Creek, California, Verenigde Staten, 94598
        • Werving
        • John Muir Health Cancer Center ( Site 0069)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 925-692-5603
    • Colorado
      • Aurora, Colorado, Verenigde Staten, 80045
        • Werving
        • Anschutz Cancer Pavilion ( Site 0049)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 303-724-2066
      • Highlands Ranch, Colorado, Verenigde Staten, 80129
        • Werving
        • University of Colorado Health - Highlands Ranch Hospital ( Site 0094)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 303-724-2066
    • Florida
      • Miami Beach, Florida, Verenigde Staten, 33140
        • Werving
        • Mount Sinai Cancer Center ( Site 0029)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 305-674-2625
      • Orlando, Florida, Verenigde Staten, 32806
        • Werving
        • Orlando Health Winnie Palmer Hospital for Women and Babies ( Site 0085)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 321-841-8393
    • Georgia
      • Atlanta, Georgia, Verenigde Staten, 30308
        • Werving
        • Winship Cancer Institute of Emory University ( Site 0037)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 404-778-1900
    • Illinois
      • Arlington Heights, Illinois, Verenigde Staten, 60005
        • Werving
        • Illinois Cancer Specialists (ICS) ( Site 8009)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 847-259-4482
    • Indiana
      • Fort Wayne, Indiana, Verenigde Staten, 46845
        • Werving
        • Parkview Research Center at Parkview Regional Medical Center ( Site 0055)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 206-266-7701
      • Indianapolis, Indiana, Verenigde Staten, 46237
        • Werving
        • Franciscan Health Indianapolis ( Site 0081)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 317-528-5000
    • Louisiana
      • Covington, Louisiana, Verenigde Staten, 70433
        • Werving
        • Women's Cancer Care ( Site 0018)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 985-892-2252
    • Maine
      • Scarborough, Maine, Verenigde Staten, 04074
        • Werving
        • Maine Medical Center Research Institute-MaineHealth/Maine Medical Partners - GynOnc ( Site 0060)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 207-883-0069
    • Maryland
      • Columbia, Maryland, Verenigde Staten, 21044
        • Werving
        • Maryland Oncology Hematology (MOH) ( Site 8002)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 410-964-2212
    • Nebraska
      • Omaha, Nebraska, Verenigde Staten, 68114
        • Werving
        • Nebraska Methodist Hospital ( Site 0004)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 402-354-7939
      • Omaha, Nebraska, Verenigde Staten, 68198
        • Werving
        • University Of Nebraska Medical Center ( Site 0035)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 402-559-2000
    • Nevada
      • Reno, Nevada, Verenigde Staten, 89511
        • Werving
        • The Center of Hope ( Site 0025)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 775-327-4673
    • New York
      • Albany, New York, Verenigde Staten, 12208-1743
        • Werving
        • Womens Cancer Care Associates, LLC ( Site 0023)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 518-458-1390
      • New York, New York, Verenigde Staten, 10022
        • Werving
        • Memorial Sloan Kettering Cancer Center ( Site 0072)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 347-923-8746
    • North Carolina
      • Durham, North Carolina, Verenigde Staten, 27710
        • Werving
        • Duke Cancer Center ( Site 0012)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 919-681-6900
    • Ohio
      • Cincinnati, Ohio, Verenigde Staten, 45219
        • Werving
        • University of Cincinnati Medical Center ( Site 0042)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 513-584-1000
      • Hilliard, Ohio, Verenigde Staten, 43026
        • Werving
        • The Ohio State University ( Site 0005)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 614-293-3300
    • Oklahoma
      • Tulsa, Oklahoma, Verenigde Staten, 74146
        • Werving
        • Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0007)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 918-505-3200
    • Oregon
      • Portland, Oregon, Verenigde Staten, 97227
        • Werving
        • Kaiser Permanente Interstate Medical Office - Central ( Site 0089)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 503-335-2400
    • Pennsylvania
      • Philadelphia, Pennsylvania, Verenigde Staten, 19104
        • Werving
        • Hospital of the University of Pennsylvania ( Site 0071)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 215-662-4000
      • Pittsburgh, Pennsylvania, Verenigde Staten, 15224
        • Werving
        • AHN West Penn Hospital ( Site 0051)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 412-578-4517
    • Rhode Island
      • Providence, Rhode Island, Verenigde Staten, 02905
        • Werving
        • Women & Infants Hospital ( Site 0001)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 401-274-1122x48181
    • Tennessee
      • Germantown, Tennessee, Verenigde Staten, 38138
        • Werving
        • West Cancer Center and Research Institute ( Site 0013)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 901-683-0055
      • Knoxville, Tennessee, Verenigde Staten, 37920
        • Werving
        • University of Tennessee Medical Center ( Site 0087)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 865-305-9000
      • Nashville, Tennessee, Verenigde Staten, 37232
        • Werving
        • Henry-Joyce Cancer Clinic ( Site 0011)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 615-936-4585
    • Texas
      • Fort Worth, Texas, Verenigde Staten, 76104
        • Werving
        • JPS Health Network ( Site 0084)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 817-702-7001
    • Virginia
      • Fairfax, Virginia, Verenigde Staten, 22031
        • Werving
        • Virginia Cancer Specialists (VCS) ( Site 8012)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 703-280-5390
      • Norfolk, Virginia, Verenigde Staten, 23502
        • Werving
        • Virginia Oncology Associates (VOA) ( Site 8013)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 757-466-8663
  • Zuid -Korea
      • Seoul, Zuid -Korea, 03080
        • Werving
        • Seoul National University Hospital ( Site 2301)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +82260724984
      • Seoul, Zuid -Korea, 06351
        • Werving
        • Samsung Medical Center ( Site 2303)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +82234101382
      • Seoul, Zuid -Korea, 05505
        • Werving
        • Asan Medical Center ( Site 2305)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +82230103640
    • Seoul
      • Seodaemun-Gu, Seoul, Zuid -Korea, 03722
        • Werving
        • Severance Hospital ( Site 2302)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +82222277969
    • Taegu-Kwangyokshi
      • Daegu, Taegu-Kwangyokshi, Zuid -Korea, 42601
        • Werving
        • Keimyung University Dongsan Hospital ( Site 2304)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +82532586671
  • Zweden
    • Stockholm County
      • Stockholm, Stockholm County, Zweden, 171 76
        • Werving
        • Karolinska Universitetssjukhuset Solna ( Site 2502)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +460812370000
  • Zwitserland
      • Geneva, Zwitserland, 1205
        • Werving
        • Hôpitaux Universitaires de Genève (HUG) ( Site 3502)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +41795534976
    • Canton Ticino
      • Bellinzona, Canton Ticino, Zwitserland, 6500
        • Werving
        • Ospedale Regionale Bellinzona e Valli ( Site 3501)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 41918118194
    • Canton of Bern
      • Bern, Canton of Bern, Zwitserland, 3010
        • Werving
        • Inselspital Bern ( Site 3504)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 41316326416
    • Kanton Graubünden
      • Chur, Kanton Graubünden, Zwitserland, 7000
        • Werving
        • Kantonsspital Graubünden ( Site 3503)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +41 81 256 6646

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Geneesmiddel: Sacituzumab tirumotecan

Administered via intravenous (IV) infusion at a dose of 4mg/kg

Andere namen:
  • SKB264
  • MK-2870
  • zak-TMT
Geneesmiddel: Bevacizumab

Administered via IV infusion at a dose of 15mg/kg

Andere namen:
  • Avastin
  • MVASI
  • Altuzan
Geneesmiddel: Rescue Medications

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.
Actieve vergelijker: 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.
Geneesmiddel: Bevacizumab

Administered via IV infusion at a dose of 15mg/kg

Andere namen:
  • Avastin
  • MVASI
  • Altuzan

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Progression-Free Survival (PFS)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Overall Survival (OS)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: Baseline and up to approximately 78 months

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
Change From Baseline in Role Functioning Combined Score (Items 6 and 7) Using EORTC QLQ-C30
Tijdsspanne: 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
Change From Baseline in Abdominal/Gastrointestinal (GI) Symptoms Combined Score Using the EORTC QLQ-Ovarian Cancer Module 28 (OV28)
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Merck Sharp & Dohme LLC

Onderzoekers

  • Studie directeur: Medical Director, Merck Sharp & Dohme LLC

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

16 februari 2026

Primaire voltooiing (Geschat)

25 februari 2033

Studie voltooiing (Geschat)

25 februari 2033

Studieregistratiedata

Eerst ingediend

2 januari 2026

Eerst ingediend dat voldeed aan de QC-criteria

2 januari 2026

Eerst geplaatst (Werkelijk)

6 januari 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 november 2026

Laatste update ingediend die voldeed aan QC-criteria

6 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2870-021
  • MK-2870-021 (Andere identificatie: MSD)
  • GOG-3102 (Andere identificatie: Gynecologic Oncology Group)
  • ENGOT-ov85 (Andere identificatie: European Network for Gynaecological Oncological Trial groups)
  • U1111-1297-5158 (Register-ID: WHO/UTN)
  • 2023-508047-40-00 (Register-ID: EU CT)
  • jRCT2031250647 (Register-ID: Japan Registry of Clinical Trial (jRCT))
  • 2023 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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