Estudo para avaliar a eficácia de Rina-S em comparação com o tratamento de escolha do investigador em participantes com câncer de ovário resistente à platina (RAINFOL-02)
2 de novembro de 2026 atualizado por: Genmab
Um estudo aberto e randomizado de fase 3 de Rinatabart Sesutecan (Rina-S) versus tratamento de escolha do investigador (IC) em pacientes com câncer de ovário resistente à platina
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.
Visão geral do estudo
Status
Ativo, não recrutando
Condições
Descrição detalhada
The China extension-study of GCT1184-02 is registered under NCT07604766.
Tipo de estudo
Intervencional
Inscrição (Real)
584
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Berlin, Alemanha, 13125
- Helios Klinikum Berlin-Buch
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Bonn, Alemanha, 53127
- University Hospital Bonn
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Dresden, Alemanha, 01307
- University Hospital Carl Gustav Carus Dresden
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Düsseldorf, Alemanha, 40225
- University Hospital of Düsseldorf
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Essen, Alemanha, 45136
- Kliniken Essen-Mitte - Evangelische Huyssens-Stiftung
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Frankfurt, Alemanha, 60596
- Klinikum der Johann Wolfgang Goethe-Universität
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Giessen, Alemanha, 35392
- Universitätsklinikum Gießen und Marburg - Gießen (UKGM)
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Hamburg, Alemanha, 20357
- Mammazentrum Hamburg am Krankenhaus Jerusalem
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Hanover, Alemanha, 30449
- MVZ Onko Medical GmbH Hanover
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Heidelberg, Alemanha, 69120
- University Hospital Heidelberg /Universitätsklinikum Heidelberg
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Homburg, Alemanha, 66421
- UniversitY Hospital of Saarland
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Munich, Alemanha, 80634
- Red Cross Hospital Munich
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Münster, Alemanha, 48149
- Universitätsklinikum Münster/University Clinic Muenster
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Wiesbaden, Alemanha, 65199
- Helios Dr. Horst Schmidt Kliniken Wiesbaden
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South Brisbane, Austrália
- Mater Misericordiae - Mater Hospital Brisbane
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Subiaco, Austrália, 6008
- Saint John of God - Subiaco Hospital
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New South Wales
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New Lambton Heights, New South Wales, Austrália
- Newcastle Private Hospital
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Queensland (qld)
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South Brisbane, Queensland (qld), Austrália, 4101
- Icon Cancer Centre
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Aalst, Bélgica, 9300
- AZORG - Onze-Lieve-Vrouwziekenhuis - Campus Aalst
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Brussels, Bélgica, 1000
- Centre Hospitalier Universitaire Saint-Pierre
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Charleroi, Bélgica, 6000
- Grand Hôpital de Charleroi - Site Les Viviers
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Leuven, Bélgica, 3000
- Universitair Ziekenhuis (UZ) Leuven - Campus Gasthuisberg
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Liège, Bélgica, 4000
- Centre Hospitalier Chretien - Clinique MontLégia
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Roeselare, Bélgica, 051237111
- Algemeen Ziekenhuis Delta - Campus Rumbeke
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Antwerp
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Turnhout, Antwerp, Bélgica, 2300
- Algemeen Ziekenhuis Turnhout - Campus Sint-Elisabeth
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Toronto, Canadá, M4Y 3M5
- Sunnybrook Health Sciences Centre - Bayview Campus
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Ontario
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Toronto, Ontario, Canadá, M5G2M9
- Princess Margaret Cancer Centre
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Quebec
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Montreal, Quebec, Canadá, H2X0C1
- Centre Hospitalier de l'Université de Montréal (CHUM)
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Changchun, China, 130021
- The First Hospital of Jilin University
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Hanzhou, China
- Zhejiang Cancer Hospital
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Shanghai, China, 200032
- Fudan University Shanghai Cancer Center
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Tianjin, China, 300060
- Tianjin Medical University Cancer Institute & Hospital
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Zhengzhou, China
- Henan Cancer Hospital - Zhengzhou University
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Guangdong
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Guangzhou, Guangdong, China, 510060
- Sun Yat-Sen University Cancer Center
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Shaanxi
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Xi'an, Shaanxi, China, 710049
- The First Affiliated Hospital of Xi'an Jiaotong University
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Aalborg, Dinamarca, 9000
- Aalborg Universitetshospital
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Copenhagen, Dinamarca
- The Royal Hospital (Rigshospitalet)
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Odense, Dinamarca, 5000
- Odense Universitets Hospital
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A Coruña, Espanha, 15006
- Hospital Universitario de A Coruña
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Donostia / San Sebastian, Espanha, 20014
- Hospital Universitario DE Donostia
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El Palmar, Espanha, 30120
- Hospital Clínico Universitario Virgen de la Arrixaca
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Madrid, Espanha, 28033
- MD Anderson Cancer Center Madrid
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Madrid, Espanha, 28029
- Hospital Universitario La Paz
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Seville, Espanha, 41013
- Virgen del Rocío University Hospital
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Valencia, Espanha, 46009
- IVO - Valencian Institute of Oncology Foundation
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Zaragoza, Espanha, 50009
- Miguel Servet Hospital
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Alaska
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Anchorage, Alaska, Estados Unidos, 99508
- Alaska Women's Cancer Care
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Arizona
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Scottsdale, Arizona, Estados Unidos, 85251
- Arizona Center for Cancer Care (ACCC) - Biltmore
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Tucson, Arizona, Estados Unidos, 85724
- University of Arizona Cancer Center - Research and Administration at Main Campus
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California
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Burbank, California, Estados Unidos, 91505
- Providence Saint Joseph Medical Center - Roy and Patricia Disney Family Cancer Center
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La Jolla, California, Estados Unidos, 92093
- University of California San Diego Moores Cancer Center
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San Francisco, California, Estados Unidos, 94158
- USCF Mission Bay
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Vallejo, California, Estados Unidos, 94589
- Kaiser Permanente - Vallejo Medical Center
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
- UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center
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Connecticut
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Hartford, Connecticut, Estados Unidos, 06106
- Hartford Hospital
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New Haven, Connecticut, Estados Unidos, 06510
- Yale School of Medicine
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Norwalk, Connecticut, Estados Unidos, 06850
- Norwalk Hospital
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Florida
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Fort Myers, Florida, Estados Unidos, 33901-8108
- SCRI - Florida Cancer Specialists - South Region Research Office
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Miami Beach, Florida, Estados Unidos, 33140
- Mount Sinai Comprehensive Cancer Center
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Orlando, Florida, Estados Unidos, 32806
- Orlando Health Cancer Institute - Downtown Orlando
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Sarasota, Florida, Estados Unidos, 34239
- Sarasota Memorial Hospital
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West Palm Beach, Florida, Estados Unidos, 33401
- SCRI - Florida Cancer Specialists - West Palm Beach
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Georgia
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Atlanta, Georgia, Estados Unidos, 30322
- Winship Cancer Institute of Emory University
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Atlanta, Georgia, Estados Unidos, 30342
- Northside Hospital Atlanta
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Augusta, Georgia, Estados Unidos, 30912
- Augusta University Georgia Cancer Center
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Hawaii
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Honolulu, Hawaii, Estados Unidos, 96826
- Kapi'olani Medical Center for Women and Children
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Indiana
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Dyer, Indiana, Estados Unidos, 46311
- Northwest Cancer Center - Dyer
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Kansas
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Kansas City, Kansas, Estados Unidos, 66160
- University of Kansas Cancer Center
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Overland Park, Kansas, Estados Unidos, 66211
- HCA Midwest Health
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Kentucky
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Edgewood, Kentucky, Estados Unidos, 41017
- St. Elizabeth Healthcare - Edgewood
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Lexington, Kentucky, Estados Unidos, 40503
- Baptist Health Lexington
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Louisiana
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New Orleans, Louisiana, Estados Unidos, 70112
- Louisiana State University Health Sciences Center (LSU Health) - New Orleans
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Shreveport, Louisiana, Estados Unidos, 71103
- Trials365, LLC (Gynecologic Oncology Associates-Shreveport)
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Maine
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Scarborough, Maine, Estados Unidos, 04074-7172
- Maine Medical Center Cancer Institute- Scarborough
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Maryland
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Silver Spring, Maryland, Estados Unidos, 20910
- Holy Cross Health - Holy Cross Hospital
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, Estados Unidos, 02215
- Dana-Farber Cancer Institute
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Michigan
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Detroit, Michigan, Estados Unidos, 48201
- Barbara Ann Karmanos Cancer Institute
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Grand Rapids, Michigan, Estados Unidos, 49503
- Corewell Health (Spectrum Health)
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Ypsilanti, Michigan, Estados Unidos, 48197
- Saint Joseph Mercy Ann Arbor Hospital
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68105
- University of Nebraska Medical Center
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Nevada
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Reno, Nevada, Estados Unidos, 89511
- Center of Hope
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New Jersey
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Teaneck, New Jersey, Estados Unidos, 07666
- Holy Name Medical Center
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New Mexico
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Albuquerque, New Mexico, Estados Unidos, 87131
- University of New Mexico Comprehensive Cancer Center
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New York
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Buffalo, New York, Estados Unidos, 14203
- Roswell Park Comprehensive Cancer Center
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New York, New York, Estados Unidos, 10032
- Herbert Irving Comprehensive Cancer Center
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New York, New York, Estados Unidos, 10065
- New York-Presbyterian - Weill Cornell Medical Center
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New York, New York, Estados Unidos, 10016
- Perlmutter Cancer Center - 38th Street
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New York, New York, Estados Unidos, 10016
- Perlmutter Cancer Center at NYU Langone Hospital - Long Island
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Rochester, New York, Estados Unidos, 14642
- James P. Wilmot Cancer Center
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North Carolina
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Durham, North Carolina, Estados Unidos, 27705
- Duke Cancer Institute
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Pinehurst, North Carolina, Estados Unidos, 28374
- FirstHealth Outpatient Cancer Center
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45219
- University of Cincinnati Medical Center
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Cleveland, Ohio, Estados Unidos, 44109
- MetroHealth Medical Center
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Cleveland, Ohio, Estados Unidos, 44106
- University Hospitals Cleveland Medical Center
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Cleveland, Ohio, Estados Unidos, 44195
- Cleveland Clinic Main Campus
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Hilliard, Ohio, Estados Unidos, 43026
- JamesCare Gynecologic Oncology at Mill Run
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Oregon
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Portland, Oregon, Estados Unidos, 97239
- Oregon Health and Science University
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Portland, Oregon, Estados Unidos, 97210
- Legacy Good Samaritan Medical Center
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Portland, Oregon, Estados Unidos, 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, Estados Unidos, 18015
- St. Luke's University Health Network
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Hershey, Pennsylvania, Estados Unidos, 17033
- Penn State Health Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, Estados Unidos, 19111
- Fox Chase Cancer Center
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Pittsburgh, Pennsylvania, Estados Unidos, 15224
- Allegheny Health Network - West Penn Hospital
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Willow Grove, Pennsylvania, Estados Unidos, 19090
- Jefferson Health - Asplundh Cancer Pavilion
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South Dakota
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Sioux Falls, South Dakota, Estados Unidos, 57105
- Avera Cancer Institute
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37203
- SCRI Oncology Partners
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Texas
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Abilene, Texas, Estados Unidos, 79606
- USOR - Texas Oncology - Dallas Fort Worth (DFW) - Abilene
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Austin, Texas, Estados Unidos, 78731
- USOR - Texas Oncology - Dallas Fort Worth (DFW) - Austin Central
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Dallas, Texas, Estados Unidos, 75390
- University of Texas Southwestern Medical Center
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Fort Worth, Texas, Estados Unidos, 76104
- USOR - Texas Oncology - Dallas Fort Worth (DFW) - Fort Worth
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Virginia
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Fairfax, Virginia, Estados Unidos, 22031
- Inova Schar Cancer Institute
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Norfolk, Virginia, Estados Unidos, 23502
- USOR - Virginia Oncology Associates - Norfolk
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Washington
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Kennewick, Washington, Estados Unidos, 99336
- Kadlec Clinic - Hematology and Oncology
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Seattle, Washington, Estados Unidos, 98109
- Fred Hutchinson Cancer Research Center
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Spokane, Washington, Estados Unidos, 99204
- Providence Sacred Heart Medical Center
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West Virginia
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Morgantown, West Virginia, Estados Unidos, 26506-9600
- West Virginia University Cancer Institute
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Wisconsin
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Madison, Wisconsin, Estados Unidos, 53706
- University of Wisconsin - Madison
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Nice, França, 6189
- Centre Antoine Lacassagne
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Paris, França, 75015
- Hôpital Européen Georges-Pompidou
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Pierre-Bénite, França, 69310
- Hospital Lyon-Sud (HCL)
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Rennes, França, 35042
- Centre Eugène Marquis
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Saint-Herblain, França, 44800
- Western Cancer Institute - Saint-Herblain - René Gauducheau Site
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Toulouse, França, 31059
- Institut Universitaire du Cancer de Toulouse (IUCT) Oncopole
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Villejuif, França, 94805
- Gustave Roussy
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Athens, Grécia, 11527
- General Hospital of Athens
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Chaïdári, Grécia, 12462
- Attikon University General Hospital/General Hospital of West Attica
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Léfkos, Grécia, 2024
- Aretaieio Hospital
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Panórama, Grécia
- Saint Luke's Hospital
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Amsterdam, Holanda, 1081 HV
- Amsterdam UMC, location VUmc
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Enschede, Holanda, 7512 AV
- Medisch Spectrum Twente - Enschede Koningsplein
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Leiden, Holanda, 2333
- Leids Universitair Medisch Centrum (LUMC)
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Maastricht, Holanda, 6229
- Maastricht (UMC) Universitair Medisch Centrum
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Rotterdam, Holanda, 3015 GD
- Erasmus MC/ Erasmus Medisch Centrum
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Milan, Itália, 20132
- Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
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Milan, Itália, 20141
- Istituto Europeo di Oncologia/ European Institute of Oncology
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Milan, Itália, 20159
- Humanitas San Pio X
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Ponderano, Itália, 13875
- Local Health Authority of Biella - Nuovo Ospedale degli Infermi
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Roma, Itália, 00168
- Agostino Gemelli University Hospital Foundation IRCCS
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Torino, Itália, 10128
- Centre Antoine Lacassagne/Azienda Ospedaliera Ordine Mau
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Apulia
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Brindisi, Apulia, Itália, 72100
- Azienda Sanitaria Locale Brindisi
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Tokyo, Japão, 104-0045
- National Cancer Center Hospital
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Tokyo, Japão, 135-8550
- Cancer Institute Hospital of JFCR
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Aichi Pref
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Nagoya, Aichi Pref, Japão, 4648681
- Aichi Cancer Center
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Fukuoka Pref
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Kurume, Fukuoka Pref, Japão, 8300011
- Kurume University Hospital
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Hokkaido
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Sapporo, Hokkaido, Japão, 0300804
- Hokkaido Cancer Center
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Kanagawa Pref
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Kawasaki, Kanagawa Pref, Japão, 2160015
- St. Marianna University Hospital
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Miyagi Pref
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Sendai, Miyagi Pref, Japão, 9808574
- Tohoku University Hospital
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Niigata Pref
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Niigata, Niigata Pref, Japão, 9518520
- Niigata University Medical and Dental Hospital
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Okayama Pref.
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Okayama, Okayama Pref., Japão, 7008558
- Okayama University Hospital
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Saitama Pref.
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Hidaka, Saitama Pref., Japão, 350-1298
- Saitama Medical University - International Medical Center
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Shizuoka Pref.
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Nagaizumi-chō, Shizuoka Pref., Japão, 4118777
- Shizuoka Cancer Center
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Tochigi Pref.
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Saitama, Tochigi Pref., Japão, 329-0498
- Jichi Medical University Hospital
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Tokyo
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Minato, Tokyo, Japão, 105-0003
- The Jikei University Hospital
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Toon City, Ehime Pref
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Shibukawa, Toon City, Ehime Pref, Japão, 791-0295
- Ehime University Hospital
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Oslo, Noruega, 0379
- Oslo Universitetssykehus - Radiumhospitalet
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Tromsø, Noruega, 9019
- University Hospital of North Norway/Universitetssykehuset Nord-Norge - Tromsø
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Bialystok, Polônia, 15-027
- Białostockie Centrum Onkologii im. Marii Skłodowskiej- Curie w Białymstoku
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Gdansk, Polônia, 80-211
- Uniwersyteckie Centrum Kliniczne w Gdańsku
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Lodz, Polônia, 93-338
- Instytut Centrum Zdrowia Matki Polki
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Poznan, Polônia, 61-867
- Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie
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Siedlce, Polônia, 08-110
- Mazowiecki Szpital Wojewódzki im. św. Jana Pawła II w Siedlcach
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Szczecin, Polônia, 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), Polônia, 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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Brno, Tcheca, 60200
- Masaryk Memorial Cancer Institute
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Hradec Králové, Tcheca, 50005
- Fakultní Nemocnice Hradec Králové
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Nový Jičín, Tcheca, 74101
- Nemocnice AGEL Nový Jičín a.s.
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Prague, Tcheca, 15000
- Fakultni nemocnice v Motole
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Prague, Tcheca, 18000
- Bulovka University Hospital
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Prague, Tcheca, 12808
- Vseobecna Fakultni Nemocnice v Praze
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Prague
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Prague, Prague, Tcheca
- University Hospital Královské Vinohrady
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Graz, Áustria, 8036
- Medizinische Universität Graz
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Vienna, Áustria, 1090
- Medizinische Universität Wien
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State of Vienna
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Vienna, State of Vienna, Áustria, 1130
- Krankenhaus Hietzing
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Tyrol
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Innsbruck, Tyrol, Áustria, 6020
- Medizinische Universität Innsbruck
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Upper Austria (Oberösterreich)
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Linz, Upper Austria (Oberösterreich), Áustria, 4010
- Ordensklinikum Linz GmbH Barmherzige Schwestern
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Escolha do Investigador
|
IV infusion IV infusion IV infusion IV infusion |
|
Experimental: Rina-S
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Intravenous (IV) infusion
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Progression-Free Survival (PFS)
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Número de Participantes com Eventos Adversos Emergentes do Tratamento (TEAEs)
Prazo: Até aproximadamente 1,5 anos
|
Até aproximadamente 1,5 anos
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|
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Overall Survival (OS)
Prazo: Up to approximately 1.5 years
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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)
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Study Official, Genmab
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
7 de fevereiro de 2025
Conclusão Primária (Real)
18 de agosto de 2026
Conclusão do estudo (Estimado)
1 de outubro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
20 de setembro de 2024
Enviado pela primeira vez que atendeu aos critérios de CQ
25 de setembro de 2024
Primeira postagem (Real)
1 de outubro de 2024
Atualizações de registro de estudo
Última Atualização Postada (Real)
3 de novembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
2 de novembro de 2026
Última verificação
1 de setembro de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças urogenitais
- Doenças Genitais
- Doenças do Sistema Endócrino
- Neoplasias urogenitais
- Neoplasias por local
- Neoplasias
- Doenças Urogenitais Femininas
- Doenças urogenitais femininas e complicações na gravidez
- Doenças Genitais Femininas
- Neoplasias das Glândulas Endócrinas
- Doenças ovarianas
- Doenças anexiais
- Neoplasias Genitais Femininas
- Distúrbios Gonadais
- Doenças das Trompas de Falópio
- Neoplasias ovarianas
- Neoplasias das Trompas de Falópio
- Produtos químicos orgânicos
- Compostos heterocíclicos, 1 anel
- Compostos heterocíclicos
- Hidrocarbonetos
- Cicloparaffinas
- Hidrocarbonetos, aliciclicos
- Hidrocarbonetos, cíclicos
- Terpenos
- Camptothecin
- Alcalóides
- Taxóides
- Ciclodecanos
- Diterpenos
- Desoxicitidina
- Citidina
- Nucleosídeos de pirimidina
- Pirimidinas
- Gemcitabina
- Paclitaxel
- Topotecano
- doxorrubicina lipossômica
Outros números de identificação do estudo
- GCT1184-02
- PRO1184-002 (Outro identificador: Other Sponsor Identifier)
- GOG-3107 (Outro identificador: Other Sponsor Identifier)
- ENGOT-OV86 (Outro identificador: Other Sponsor Identifier)
- 2024-514822-21 (Outro identificador: EU Trial (CTIS) Number)
- jRCT2031250064 (Identificador de registro: Japan Registry for Clinical Trials (jRCT))
- CTR20253987 (Identificador de registro: ChinaDrugTrials.org.cn)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .