Studio per valutare l'efficacia di Rina-S rispetto al trattamento scelto dallo sperimentatore in partecipanti con cancro ovarico resistente al platino (RAINFOL-02)
2 novembre 2026 aggiornato da: Genmab
Uno studio di fase 3, randomizzato, in aperto, su Rinatabart Sesutecan (Rina-S) rispetto al trattamento scelto dallo sperimentatore (IC) in pazienti con cancro ovarico resistente al platino
This phase 3 study will be conducted in different countries all over the world.
The purpose of this study is to compare how well Rina-S works against platinum-resistant ovarian cancer compared to chemotherapy drugs that are already approved and used for platinum-resistant ovarian cancer.
Treatment in this study could be Rina-S or it could be 1 of 4 indicated chemotherapy agents that are considered standard medical care. There is an equal (50:50) chance of getting Rina-S or an approved chemotherapy agent as treatment in this study. No one will know what treatment they are assigned to until the first dose.
All participants will receive active drug; no one will be given placebo.
Panoramica dello studio
Stato
Attivo, non reclutante
Condizioni
Intervento / Trattamento
Descrizione dettagliata
The China extension-study of GCT1184-02 is registered under NCT07604766.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
584
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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South Brisbane, Australia
- Mater Misericordiae - Mater Hospital Brisbane
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Subiaco, Australia, 6008
- Saint John of God - Subiaco Hospital
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New South Wales
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New Lambton Heights, New South Wales, Australia
- Newcastle Private Hospital
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Queensland (qld)
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South Brisbane, Queensland (qld), Australia, 4101
- Icon Cancer Centre
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Graz, Austria, 8036
- Medizinische Universität Graz
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Vienna, Austria, 1090
- Medizinische Universität Wien
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State of Vienna
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Vienna, State of Vienna, Austria, 1130
- Krankenhaus Hietzing
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Tyrol
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Innsbruck, Tyrol, Austria, 6020
- Medizinische Universität Innsbruck
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Upper Austria (Oberösterreich)
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Linz, Upper Austria (Oberösterreich), Austria, 4010
- Ordensklinikum Linz GmbH Barmherzige Schwestern
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Aalst, Belgio, 9300
- AZORG - Onze-Lieve-Vrouwziekenhuis - Campus Aalst
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Brussels, Belgio, 1000
- Centre Hospitalier Universitaire Saint-Pierre
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Charleroi, Belgio, 6000
- Grand Hôpital de Charleroi - Site Les Viviers
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Leuven, Belgio, 3000
- Universitair Ziekenhuis (UZ) Leuven - Campus Gasthuisberg
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Liège, Belgio, 4000
- Centre Hospitalier Chretien - Clinique MontLégia
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Roeselare, Belgio, 051237111
- Algemeen Ziekenhuis Delta - Campus Rumbeke
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Antwerp
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Turnhout, Antwerp, Belgio, 2300
- Algemeen Ziekenhuis Turnhout - Campus Sint-Elisabeth
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Toronto, Canada, M4Y 3M5
- Sunnybrook Health Sciences Centre - Bayview Campus
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Ontario
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Toronto, Ontario, Canada, M5G2M9
- Princess Margaret Cancer Centre
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Quebec
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Montreal, Quebec, Canada, H2X0C1
- Centre Hospitalier de l'Université de Montréal (CHUM)
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Brno, Cechia, 60200
- Masaryk Memorial Cancer Institute
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Hradec Králové, Cechia, 50005
- Fakultní Nemocnice Hradec Králové
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Nový Jičín, Cechia, 74101
- Nemocnice AGEL Nový Jičín a.s.
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Prague, Cechia, 15000
- Fakultni nemocnice v Motole
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Prague, Cechia, 18000
- Bulovka University Hospital
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Prague, Cechia, 12808
- Vseobecna Fakultni Nemocnice v Praze
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Prague
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Prague, Prague, Cechia
- University Hospital Královské Vinohrady
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Changchun, Cina, 130021
- The First Hospital of Jilin University
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Hanzhou, Cina
- Zhejiang Cancer Hospital
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Shanghai, Cina, 200032
- Fudan University Shanghai Cancer Center
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Tianjin, Cina, 300060
- Tianjin Medical University Cancer Institute & Hospital
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Zhengzhou, Cina
- Henan Cancer Hospital - Zhengzhou University
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Guangdong
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Guangzhou, Guangdong, Cina, 510060
- Sun Yat-Sen University Cancer Center
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Shaanxi
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Xi'an, Shaanxi, Cina, 710049
- The First Affiliated Hospital of Xi'an Jiaotong University
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Aalborg, Danimarca, 9000
- Aalborg Universitetshospital
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Copenhagen, Danimarca
- The Royal Hospital (Rigshospitalet)
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Odense, Danimarca, 5000
- Odense Universitets Hospital
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Nice, Francia, 6189
- Centre Antoine Lacassagne
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Paris, Francia, 75015
- Hôpital Européen Georges-Pompidou
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Pierre-Bénite, Francia, 69310
- Hospital Lyon-Sud (HCL)
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Rennes, Francia, 35042
- Centre Eugène Marquis
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Saint-Herblain, Francia, 44800
- Western Cancer Institute - Saint-Herblain - René Gauducheau Site
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Toulouse, Francia, 31059
- Institut Universitaire du Cancer de Toulouse (IUCT) Oncopole
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Villejuif, Francia, 94805
- Gustave Roussy
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Berlin, Germania, 13125
- Helios Klinikum Berlin-Buch
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Bonn, Germania, 53127
- University Hospital Bonn
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Dresden, Germania, 01307
- University Hospital Carl Gustav Carus Dresden
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Düsseldorf, Germania, 40225
- University Hospital of Düsseldorf
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Essen, Germania, 45136
- Kliniken Essen-Mitte - Evangelische Huyssens-Stiftung
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Frankfurt, Germania, 60596
- Klinikum der Johann Wolfgang Goethe-Universität
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Giessen, Germania, 35392
- Universitätsklinikum Gießen und Marburg - Gießen (UKGM)
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Hamburg, Germania, 20357
- Mammazentrum Hamburg am Krankenhaus Jerusalem
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Hanover, Germania, 30449
- MVZ Onko Medical GmbH Hanover
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Heidelberg, Germania, 69120
- University Hospital Heidelberg /Universitätsklinikum Heidelberg
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Homburg, Germania, 66421
- UniversitY Hospital of Saarland
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Munich, Germania, 80634
- Red Cross Hospital Munich
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Münster, Germania, 48149
- Universitätsklinikum Münster/University Clinic Muenster
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Wiesbaden, Germania, 65199
- Helios Dr. Horst Schmidt Kliniken Wiesbaden
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Tokyo, Giappone, 104-0045
- National Cancer Center Hospital
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Tokyo, Giappone, 135-8550
- Cancer Institute Hospital of JFCR
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Aichi Pref
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Nagoya, Aichi Pref, Giappone, 4648681
- Aichi Cancer Center
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Fukuoka Pref
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Kurume, Fukuoka Pref, Giappone, 8300011
- Kurume University Hospital
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Hokkaido
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Sapporo, Hokkaido, Giappone, 0300804
- Hokkaido Cancer Center
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Kanagawa Pref
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Kawasaki, Kanagawa Pref, Giappone, 2160015
- St. Marianna University Hospital
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Miyagi Pref
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Sendai, Miyagi Pref, Giappone, 9808574
- Tohoku University Hospital
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Niigata Pref
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Niigata, Niigata Pref, Giappone, 9518520
- Niigata University Medical and Dental Hospital
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Okayama Pref.
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Okayama, Okayama Pref., Giappone, 7008558
- Okayama University Hospital
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Saitama Pref.
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Hidaka, Saitama Pref., Giappone, 350-1298
- Saitama Medical University - International Medical Center
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Shizuoka Pref.
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Nagaizumi-chō, Shizuoka Pref., Giappone, 4118777
- Shizuoka Cancer Center
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Tochigi Pref.
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Saitama, Tochigi Pref., Giappone, 329-0498
- Jichi Medical University Hospital
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Tokyo
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Minato, Tokyo, Giappone, 105-0003
- The Jikei University Hospital
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Toon City, Ehime Pref
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Shibukawa, Toon City, Ehime Pref, Giappone, 791-0295
- Ehime University Hospital
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Athens, Grecia, 11527
- General Hospital of Athens
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Chaïdári, Grecia, 12462
- Attikon University General Hospital/General Hospital of West Attica
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Léfkos, Grecia, 2024
- Aretaieio Hospital
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Panórama, Grecia
- Saint Luke's Hospital
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Milan, Italia, 20132
- Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
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Milan, Italia, 20141
- Istituto Europeo di Oncologia/ European Institute of Oncology
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Milan, Italia, 20159
- Humanitas San Pio X
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Ponderano, Italia, 13875
- Local Health Authority of Biella - Nuovo Ospedale degli Infermi
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Roma, Italia, 00168
- Agostino Gemelli University Hospital Foundation IRCCS
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Torino, Italia, 10128
- Centre Antoine Lacassagne/Azienda Ospedaliera Ordine Mau
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Apulia
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Brindisi, Apulia, Italia, 72100
- Azienda Sanitaria Locale Brindisi
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Oslo, Norvegia, 0379
- Oslo Universitetssykehus - Radiumhospitalet
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Tromsø, Norvegia, 9019
- University Hospital of North Norway/Universitetssykehuset Nord-Norge - Tromsø
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Amsterdam, Olanda, 1081 HV
- Amsterdam UMC, location VUmc
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Enschede, Olanda, 7512 AV
- Medisch Spectrum Twente - Enschede Koningsplein
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Leiden, Olanda, 2333
- Leids Universitair Medisch Centrum (LUMC)
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Maastricht, Olanda, 6229
- Maastricht (UMC) Universitair Medisch Centrum
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Rotterdam, Olanda, 3015 GD
- Erasmus MC/ Erasmus Medisch Centrum
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Bialystok, Polonia, 15-027
- Białostockie Centrum Onkologii im. Marii Skłodowskiej- Curie w Białymstoku
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Gdansk, Polonia, 80-211
- Uniwersyteckie Centrum Kliniczne w Gdańsku
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Lodz, Polonia, 93-338
- Instytut Centrum Zdrowia Matki Polki
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Poznan, Polonia, 61-867
- Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie
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Siedlce, Polonia, 08-110
- Mazowiecki Szpital Wojewódzki im. św. Jana Pawła II w Siedlcach
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Szczecin, Polonia, 70-111
- Uniwersytecki Szpital Kliniczny Nr 2 PUM w Szczecinie
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Lesser Poland (Małopolskie)
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Krakow, Lesser Poland (Małopolskie), Polonia, 30-348
- Jagiellońskie Centrum Innowacj
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San Juan
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Monacillo, San Juan, Porto Rico, 00927
- UPR Comprehensive Cancer Center Hospital
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A Coruña, Spagna, 15006
- Hospital Universitario de A Coruña
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Donostia / San Sebastian, Spagna, 20014
- Hospital Universitario DE Donostia
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El Palmar, Spagna, 30120
- Hospital Clínico Universitario Virgen de la Arrixaca
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Madrid, Spagna, 28033
- MD Anderson Cancer Center Madrid
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Madrid, Spagna, 28029
- Hospital Universitario La Paz
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Seville, Spagna, 41013
- Virgen del Rocío University Hospital
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Valencia, Spagna, 46009
- IVO - Valencian Institute of Oncology Foundation
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Zaragoza, Spagna, 50009
- Miguel Servet Hospital
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Alaska
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Anchorage, Alaska, Stati Uniti, 99508
- Alaska Women's Cancer Care
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Arizona
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Scottsdale, Arizona, Stati Uniti, 85251
- Arizona Center for Cancer Care (ACCC) - Biltmore
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Tucson, Arizona, Stati Uniti, 85724
- University of Arizona Cancer Center - Research and Administration at Main Campus
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California
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Burbank, California, Stati Uniti, 91505
- Providence Saint Joseph Medical Center - Roy and Patricia Disney Family Cancer Center
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La Jolla, California, Stati Uniti, 92093
- University of California San Diego Moores Cancer Center
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San Francisco, California, Stati Uniti, 94158
- USCF Mission Bay
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Vallejo, California, Stati Uniti, 94589
- Kaiser Permanente - Vallejo Medical Center
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Colorado
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Aurora, Colorado, Stati Uniti, 80045
- UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center
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Connecticut
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Hartford, Connecticut, Stati Uniti, 06106
- Hartford Hospital
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New Haven, Connecticut, Stati Uniti, 06510
- Yale School of Medicine
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Norwalk, Connecticut, Stati Uniti, 06850
- Norwalk Hospital
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Florida
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Fort Myers, Florida, Stati Uniti, 33901-8108
- SCRI - Florida Cancer Specialists - South Region Research Office
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Miami Beach, Florida, Stati Uniti, 33140
- Mount Sinai Comprehensive Cancer Center
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Orlando, Florida, Stati Uniti, 32806
- Orlando Health Cancer Institute - Downtown Orlando
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Sarasota, Florida, Stati Uniti, 34239
- Sarasota Memorial Hospital
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West Palm Beach, Florida, Stati Uniti, 33401
- SCRI - Florida Cancer Specialists - West Palm Beach
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Georgia
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Atlanta, Georgia, Stati Uniti, 30322
- Winship Cancer Institute of Emory University
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Atlanta, Georgia, Stati Uniti, 30342
- Northside Hospital Atlanta
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Augusta, Georgia, Stati Uniti, 30912
- Augusta University Georgia Cancer Center
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Hawaii
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Honolulu, Hawaii, Stati Uniti, 96826
- Kapi'olani Medical Center for Women and Children
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Indiana
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Dyer, Indiana, Stati Uniti, 46311
- Northwest Cancer Center - Dyer
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Kansas
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Kansas City, Kansas, Stati Uniti, 66160
- University of Kansas Cancer Center
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Overland Park, Kansas, Stati Uniti, 66211
- HCA Midwest Health
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Kentucky
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Edgewood, Kentucky, Stati Uniti, 41017
- St. Elizabeth Healthcare - Edgewood
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Lexington, Kentucky, Stati Uniti, 40503
- Baptist Health Lexington
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Louisiana
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New Orleans, Louisiana, Stati Uniti, 70112
- Louisiana State University Health Sciences Center (LSU Health) - New Orleans
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Shreveport, Louisiana, Stati Uniti, 71103
- Trials365, LLC (Gynecologic Oncology Associates-Shreveport)
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Maine
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Scarborough, Maine, Stati Uniti, 04074-7172
- Maine Medical Center Cancer Institute- Scarborough
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Maryland
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Silver Spring, Maryland, Stati Uniti, 20910
- Holy Cross Health - Holy Cross Hospital
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, Stati Uniti, 02215
- Dana-Farber Cancer Institute
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Michigan
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Detroit, Michigan, Stati Uniti, 48201
- Barbara Ann Karmanos Cancer Institute
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Grand Rapids, Michigan, Stati Uniti, 49503
- Corewell Health (Spectrum Health)
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Ypsilanti, Michigan, Stati Uniti, 48197
- Saint Joseph Mercy Ann Arbor Hospital
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Nebraska
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Omaha, Nebraska, Stati Uniti, 68105
- University of Nebraska Medical Center
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Nevada
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Reno, Nevada, Stati Uniti, 89511
- Center of Hope
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New Jersey
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Teaneck, New Jersey, Stati Uniti, 07666
- Holy Name Medical Center
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New Mexico
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Albuquerque, New Mexico, Stati Uniti, 87131
- University of New Mexico Comprehensive Cancer Center
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New York
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Buffalo, New York, Stati Uniti, 14203
- Roswell Park Comprehensive Cancer Center
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New York, New York, Stati Uniti, 10032
- Herbert Irving Comprehensive Cancer Center
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New York, New York, Stati Uniti, 10065
- New York-Presbyterian - Weill Cornell Medical Center
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New York, New York, Stati Uniti, 10016
- Perlmutter Cancer Center - 38th Street
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New York, New York, Stati Uniti, 10016
- Perlmutter Cancer Center at NYU Langone Hospital - Long Island
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Rochester, New York, Stati Uniti, 14642
- James P. Wilmot Cancer Center
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North Carolina
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Durham, North Carolina, Stati Uniti, 27705
- Duke Cancer Institute
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Pinehurst, North Carolina, Stati Uniti, 28374
- FirstHealth Outpatient Cancer Center
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Ohio
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Cincinnati, Ohio, Stati Uniti, 45219
- University of Cincinnati Medical Center
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Cleveland, Ohio, Stati Uniti, 44109
- MetroHealth Medical Center
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Cleveland, Ohio, Stati Uniti, 44106
- University Hospitals Cleveland Medical Center
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Cleveland, Ohio, Stati Uniti, 44195
- Cleveland Clinic Main Campus
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Hilliard, Ohio, Stati Uniti, 43026
- JamesCare Gynecologic Oncology at Mill Run
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Oregon
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Portland, Oregon, Stati Uniti, 97239
- Oregon Health and Science University
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Portland, Oregon, Stati Uniti, 97210
- Legacy Good Samaritan Medical Center
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Portland, Oregon, Stati Uniti, 97227
- USOR - Northwest Cancer Specialists, P.C. dba Compass Oncology - Rose Quarter Cancer Center
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Pennsylvania
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Bethlehem, Pennsylvania, Stati Uniti, 18015
- St. Luke's University Health Network
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Hershey, Pennsylvania, Stati Uniti, 17033
- Penn State Health Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, Stati Uniti, 19111
- Fox Chase Cancer Center
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Pittsburgh, Pennsylvania, Stati Uniti, 15224
- Allegheny Health Network - West Penn Hospital
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Willow Grove, Pennsylvania, Stati Uniti, 19090
- Jefferson Health - Asplundh Cancer Pavilion
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South Dakota
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Sioux Falls, South Dakota, Stati Uniti, 57105
- Avera Cancer Institute
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Tennessee
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Nashville, Tennessee, Stati Uniti, 37203
- SCRI Oncology Partners
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Texas
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Abilene, Texas, Stati Uniti, 79606
- USOR - Texas Oncology - Dallas Fort Worth (DFW) - Abilene
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Austin, Texas, Stati Uniti, 78731
- USOR - Texas Oncology - Dallas Fort Worth (DFW) - Austin Central
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Dallas, Texas, Stati Uniti, 75390
- University of Texas Southwestern Medical Center
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Fort Worth, Texas, Stati Uniti, 76104
- USOR - Texas Oncology - Dallas Fort Worth (DFW) - Fort Worth
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Virginia
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Fairfax, Virginia, Stati Uniti, 22031
- Inova Schar Cancer Institute
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Norfolk, Virginia, Stati Uniti, 23502
- USOR - Virginia Oncology Associates - Norfolk
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Washington
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Kennewick, Washington, Stati Uniti, 99336
- Kadlec Clinic - Hematology and Oncology
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Seattle, Washington, Stati Uniti, 98109
- Fred Hutchinson Cancer Research Center
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Spokane, Washington, Stati Uniti, 99204
- Providence Sacred Heart Medical Center
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West Virginia
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Morgantown, West Virginia, Stati Uniti, 26506-9600
- West Virginia University Cancer Institute
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Wisconsin
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Madison, Wisconsin, Stati Uniti, 53706
- University of Wisconsin - Madison
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Femmina
Descrizione
Key Inclusion Criteria:
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Participants must have histologically or cytologically confirmed high grade serous or endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
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Participants may be enrolled regardless of FRα expression level.
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Participants must have received 1 to 4 prior lines of therapy. Participants must have progressed radiographically on or after their most recent line of therapy.
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Participants must have received prior treatment with the following therapies:
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Platinum chemotherapy
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Prior bevacizumab (or biosimilar) treatment is required, if labeled and available as standard of care per institutional guidelines, unless the participant has a documented contraindication or unless the participant is not eligible for treatment with bevacizumab (or biosimilar) due to precautions/intolerance
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Participants with known or suspected deleterious germline or somatic breast cancer gene (BRCA) mutations and who achieved a complete or partial response to platinum-based chemotherapy must have been treated with a poly ADP-ribose polymerase (PARP) inhibitor as maintenance treatment unless the participant is not eligible for treatment with PARP inhibitor
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Mirvetuximab soravtansine, if:
- Mirvetuximab soravtansine is available in the enrollment region, and
- The participant is eligible, and
- The participant does not have a documented medical exception, including chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring, such as uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, and /or monocular vision.
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Participants must have platinum-resistant disease:
- Participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum therapy, and must have either had a response (CR or PR) or had non-measurable disease at the start of adjuvant platinum-based therapy, and then progressed between > 91 days and ≤ 183 days after the date of the last dose of platinum.
- Participants who have received a protocol defined number of lines of platinum-based therapy must have progressed on or within 183 days after the date of the last dose of platinum.
Key Exclusion Criteria:
- Prior therapy with an antibody-drug conjugate containing a topoisomerase 1 inhibitor.
- Have primary platinum-refractory disease, defined as ovarian cancer that did not respond (CR or PR) to or progressed ≤ 91 days after the last dose of a first-line platinum-containing regimen.
- History of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (e.g., 5-year OS ≥90%), including, but not limited to, adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, ductal carcinoma in situ, or Stage I uterine cancer.
- Known active central nervous system metastases or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment, they have no new or enlarging brain metastases, and are off corticosteroids and anticonvulsants prescribed for symptoms associated with brain metastases for at least 7 days prior to the first dose of study drug. Participants with suspected brain metastases at screening should undergo a computed tomography (CT)/magnetic resonance imaging (MRI) of the brain prior to study entry.
- Hospitalization or clinical symptoms due to gastrointestinal obstruction within the past 91 days or radiographic evidence of gastrointestinal obstruction at the time of screening. Enrollment of participants who currently require parenteral nutrition must be discussed with the study medical monitor to determine eligibility.
- Participant has clinically significant ascites/pleural effusion. Enrollment of participants with an indwelling catheter flush/drain is not allowed. Note: Clinically significant is defined as (1) symptomatic, or (2) requires therapeutic paracentesis/thoracentesis within 8 weeks of the first dose, or (3) recurrent ascites/pleural effusion that necessitates multiple paracentesis/thoracocentesis procedures more often than approximately every 4 weeks.
NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: La scelta dell'investigatore
|
IV infusion IV infusion IV infusion IV infusion |
|
Sperimentale: Rina-S
|
Intravenous (IV) infusion
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Progression-Free Survival (PFS)
Lasso di tempo: Up to approximately 1.5 years
|
PFS is defined as the time from the date of randomization to the date of the first documented progression or death (PD) due to any cause, whichever occurs first based on response evaluation criteria in solid tumors (RECIST) version 1.1 as assessed by the investigator. |
Up to approximately 1.5 years
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Numero di Partecipanti con Eventi Avversi Emergenti dal Trattamento (TEAE)
Lasso di tempo: Fino a circa 1.5 anni
|
Fino a circa 1.5 anni
|
|
|
Overall Survival (OS)
Lasso di tempo: Up to approximately 1.5 years
|
OS is defined as the time from date of randomization to date of death due to any cause. |
Up to approximately 1.5 years
|
|
Objective Response Rate (ORR)
Lasso di tempo: Up to approximately 1.5 years
|
ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) based on RECIST v1.1 as assessed by the investigator. |
Up to approximately 1.5 years
|
|
PFS as Determined by BICR
Lasso di tempo: Up to approximately 1.5 years
|
PFS is defined as the time from the date of randomization to the date of the first documented progression or death (PD) due to any cause, whichever occurs first based on RECIST version 1.1 as determined by BICR. |
Up to approximately 1.5 years
|
|
ORR as Determined by BICR
Lasso di tempo: Up to approximately 1.5 years
|
ORR is defined as the percentage of participants with BOR of CR or PR based on RECIST v1.1 as determined by BICR. |
Up to approximately 1.5 years
|
|
Duration of Response (DOR)
Lasso di tempo: Up to approximately 1.5 years
|
DOR is defined as the time from the onset date of response to the date of the first documented progression or death due to any cause based on RECIST v1.1 as assessed by the investigator and by blinded independent central review (BICR). |
Up to approximately 1.5 years
|
|
Percentage of Participants Who Achieved Cancer Antigen-125 (CA-125) Response per Gynecologic Cancer Intergroup (GCIG) Criteria
Lasso di tempo: Up to approximately 1.5 years
|
A CA-125 response per the GCIG criteria is defined as a ≥ 50% reduction in CA-125 levels from baseline. |
Up to approximately 1.5 years
|
|
Time to Second Disease Progression or Death From any Cause (PFS2)
Lasso di tempo: Up to approximately 1.5 years
|
PFS2 is defined as the time from randomization to the date of the second PD (i.e., the first PD reported in subsequent anti-cancer therapies, or long-term follow up) or death. |
Up to approximately 1.5 years
|
|
Overall Change From Baseline in Global Health Status/Quality of Life (GHS/Qol)
Lasso di tempo: Baseline, up to approximately 1.5 years
|
Overall change from baseline in GHS/Qol score (items 29 and 30) will be calculated using the European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC-QLQ-C30) questionnaire. The score ranges from 0 to 100. A high scale score represents a higher response level. |
Baseline, up to approximately 1.5 years
|
|
Time to Deterioration (TTD) in the GHS/Qol Score
Lasso di tempo: Up to approximately 1.5 years
|
TTD in the GHS/Qol score is defined as the time from baseline to the first onset of a ≥10-point negative change (decrease) in GHS/QoL score. A longer TTD indicates a better outcome. |
Up to approximately 1.5 years
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Direttore dello studio: Study Official, Genmab
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
7 febbraio 2025
Completamento primario (Effettivo)
18 agosto 2026
Completamento dello studio (Stimato)
1 ottobre 2027
Date di iscrizione allo studio
Primo inviato
20 settembre 2024
Primo inviato che soddisfa i criteri di controllo qualità
25 settembre 2024
Primo Inserito (Effettivo)
1 ottobre 2024
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
3 novembre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
2 novembre 2026
Ultimo verificato
1 settembre 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie urogenitali
- Malattie genitali
- Malattie del sistema endocrino
- Neoplasie urogenitali
- Neoplasie per sede
- Neoplasie
- Malattie urogenitali femminili
- Malattie urogenitali femminili e complicanze della gravidanza
- Malattie genitali, femmina
- Neoplasie delle ghiandole endocrine
- Malattie ovariche
- Malattie annessiali
- Neoplasie genitali, femmina
- Disturbi gonadici
- Malattie delle tube di Falloppio
- Neoplasie ovariche
- Neoplasie delle tube di Falloppio
- Prodotti chimici organici
- Composti eterociclici, 1-anello
- Composti eterociclici
- Idrocarburi
- Cicloparaffins
- Idrocarburi, aliciclici
- Idrocarburi, ciclici
- Terpeni
- Camptothecin
- Alcaloidi
- Taxoidi
- Ciclodecani
- Diterpenes
- Deossictidina
- Citidina
- Nucleosidi di pirimidina
- Pirimidine
- Gemcitabina
- Paclitaxel
- Topotecan
- doxorubicina liposomiale
Altri numeri di identificazione dello studio
- GCT1184-02
- PRO1184-002 (Altro identificatore: Other Sponsor Identifier)
- GOG-3107 (Altro identificatore: Other Sponsor Identifier)
- ENGOT-OV86 (Altro identificatore: Other Sponsor Identifier)
- 2024-514822-21 (Altro identificatore: EU Trial (CTIS) Number)
- jRCT2031250064 (Identificatore di registro: Japan Registry for Clinical Trials (jRCT))
- CTR20253987 (Identificatore di registro: ChinaDrugTrials.org.cn)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .