Studie for å vurdere effekten av Rina-S sammenlignet med behandling av etterforskers valg hos deltakere med platinaresistent eggstokkreft (RAINFOL-02)
2. november 2026 oppdatert av: Genmab
En fase 3 randomisert, åpen studie av Rinatabart Sesutecan (Rina-S) versus behandling av etterforskers valg (IC) hos pasienter med platinaresistent eggstokkreft
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.
Studieoversikt
Status
Aktiv, ikke rekrutterende
Forhold
Detaljert beskrivelse
The China extension-study of GCT1184-02 is registered under NCT07604766.
Studietype
Intervensjonell
Registrering (Faktiske)
584
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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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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Aalst, Belgia, 9300
- AZORG - Onze-Lieve-Vrouwziekenhuis - Campus Aalst
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Brussels, Belgia, 1000
- Centre Hospitalier Universitaire Saint-Pierre
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Charleroi, Belgia, 6000
- Grand Hôpital de Charleroi - Site Les Viviers
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Leuven, Belgia, 3000
- Universitair Ziekenhuis (UZ) Leuven - Campus Gasthuisberg
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Liège, Belgia, 4000
- Centre Hospitalier Chretien - Clinique MontLégia
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Roeselare, Belgia, 051237111
- Algemeen Ziekenhuis Delta - Campus Rumbeke
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Antwerp
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Turnhout, Antwerp, Belgia, 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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Aalborg, Danmark, 9000
- Aalborg Universitetshospital
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Copenhagen, Danmark
- The Royal Hospital (Rigshospitalet)
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Odense, Danmark, 5000
- Odense Universitets Hospital
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Alaska
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Anchorage, Alaska, Forente stater, 99508
- Alaska Women's Cancer Care
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Arizona
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Scottsdale, Arizona, Forente stater, 85251
- Arizona Center for Cancer Care (ACCC) - Biltmore
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Tucson, Arizona, Forente stater, 85724
- University of Arizona Cancer Center - Research and Administration at Main Campus
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California
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Burbank, California, Forente stater, 91505
- Providence Saint Joseph Medical Center - Roy and Patricia Disney Family Cancer Center
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La Jolla, California, Forente stater, 92093
- University of California San Diego Moores Cancer Center
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San Francisco, California, Forente stater, 94158
- USCF Mission Bay
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Vallejo, California, Forente stater, 94589
- Kaiser Permanente - Vallejo Medical Center
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Colorado
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Aurora, Colorado, Forente stater, 80045
- UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center
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Connecticut
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Hartford, Connecticut, Forente stater, 06106
- Hartford Hospital
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New Haven, Connecticut, Forente stater, 06510
- Yale School of Medicine
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Norwalk, Connecticut, Forente stater, 06850
- Norwalk Hospital
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Florida
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Fort Myers, Florida, Forente stater, 33901-8108
- SCRI - Florida Cancer Specialists - South Region Research Office
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Miami Beach, Florida, Forente stater, 33140
- Mount Sinai Comprehensive Cancer Center
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Orlando, Florida, Forente stater, 32806
- Orlando Health Cancer Institute - Downtown Orlando
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Sarasota, Florida, Forente stater, 34239
- Sarasota Memorial Hospital
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West Palm Beach, Florida, Forente stater, 33401
- SCRI - Florida Cancer Specialists - West Palm Beach
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Georgia
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Atlanta, Georgia, Forente stater, 30322
- Winship Cancer Institute of Emory University
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Atlanta, Georgia, Forente stater, 30342
- Northside Hospital Atlanta
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Augusta, Georgia, Forente stater, 30912
- Augusta University Georgia Cancer Center
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Hawaii
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Honolulu, Hawaii, Forente stater, 96826
- Kapi'olani Medical Center for Women and Children
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Indiana
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Dyer, Indiana, Forente stater, 46311
- Northwest Cancer Center - Dyer
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Kansas
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Kansas City, Kansas, Forente stater, 66160
- University of Kansas Cancer Center
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Overland Park, Kansas, Forente stater, 66211
- HCA Midwest Health
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Kentucky
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Edgewood, Kentucky, Forente stater, 41017
- St. Elizabeth Healthcare - Edgewood
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Lexington, Kentucky, Forente stater, 40503
- Baptist Health Lexington
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Louisiana
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New Orleans, Louisiana, Forente stater, 70112
- Louisiana State University Health Sciences Center (LSU Health) - New Orleans
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Shreveport, Louisiana, Forente stater, 71103
- Trials365, LLC (Gynecologic Oncology Associates-Shreveport)
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Maine
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Scarborough, Maine, Forente stater, 04074-7172
- Maine Medical Center Cancer Institute- Scarborough
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Maryland
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Silver Spring, Maryland, Forente stater, 20910
- Holy Cross Health - Holy Cross Hospital
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Massachusetts
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Boston, Massachusetts, Forente stater, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, Forente stater, 02215
- Dana-Farber Cancer Institute
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Michigan
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Detroit, Michigan, Forente stater, 48201
- Barbara Ann Karmanos Cancer Institute
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Grand Rapids, Michigan, Forente stater, 49503
- Corewell Health (Spectrum Health)
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Ypsilanti, Michigan, Forente stater, 48197
- Saint Joseph Mercy Ann Arbor Hospital
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Nebraska
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Omaha, Nebraska, Forente stater, 68105
- University of Nebraska Medical Center
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Nevada
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Reno, Nevada, Forente stater, 89511
- Center of Hope
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New Jersey
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Teaneck, New Jersey, Forente stater, 07666
- Holy Name Medical Center
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New Mexico
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Albuquerque, New Mexico, Forente stater, 87131
- University of New Mexico Comprehensive Cancer Center
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New York
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Buffalo, New York, Forente stater, 14203
- Roswell Park Comprehensive Cancer Center
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New York, New York, Forente stater, 10032
- Herbert Irving Comprehensive Cancer Center
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New York, New York, Forente stater, 10065
- New York-Presbyterian - Weill Cornell Medical Center
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New York, New York, Forente stater, 10016
- Perlmutter Cancer Center - 38th Street
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New York, New York, Forente stater, 10016
- Perlmutter Cancer Center at NYU Langone Hospital - Long Island
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Rochester, New York, Forente stater, 14642
- James P. Wilmot Cancer Center
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North Carolina
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Durham, North Carolina, Forente stater, 27705
- Duke Cancer Institute
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Pinehurst, North Carolina, Forente stater, 28374
- FirstHealth Outpatient Cancer Center
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Ohio
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Cincinnati, Ohio, Forente stater, 45219
- University of Cincinnati Medical Center
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Cleveland, Ohio, Forente stater, 44109
- MetroHealth Medical Center
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Cleveland, Ohio, Forente stater, 44106
- University Hospitals Cleveland Medical Center
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Cleveland, Ohio, Forente stater, 44195
- Cleveland Clinic Main Campus
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Hilliard, Ohio, Forente stater, 43026
- JamesCare Gynecologic Oncology at Mill Run
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Oregon
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Portland, Oregon, Forente stater, 97239
- Oregon Health and Science University
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Portland, Oregon, Forente stater, 97210
- Legacy Good Samaritan Medical Center
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Portland, Oregon, Forente stater, 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, Forente stater, 18015
- St. Luke's University Health Network
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Hershey, Pennsylvania, Forente stater, 17033
- Penn State Health Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, Forente stater, 19111
- Fox Chase Cancer Center
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Pittsburgh, Pennsylvania, Forente stater, 15224
- Allegheny Health Network - West Penn Hospital
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Willow Grove, Pennsylvania, Forente stater, 19090
- Jefferson Health - Asplundh Cancer Pavilion
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South Dakota
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Sioux Falls, South Dakota, Forente stater, 57105
- Avera Cancer Institute
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Tennessee
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Nashville, Tennessee, Forente stater, 37203
- SCRI Oncology Partners
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Texas
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Abilene, Texas, Forente stater, 79606
- USOR - Texas Oncology - Dallas Fort Worth (DFW) - Abilene
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Austin, Texas, Forente stater, 78731
- USOR - Texas Oncology - Dallas Fort Worth (DFW) - Austin Central
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Dallas, Texas, Forente stater, 75390
- University of Texas Southwestern Medical Center
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Fort Worth, Texas, Forente stater, 76104
- USOR - Texas Oncology - Dallas Fort Worth (DFW) - Fort Worth
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Virginia
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Fairfax, Virginia, Forente stater, 22031
- Inova Schar Cancer Institute
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Norfolk, Virginia, Forente stater, 23502
- USOR - Virginia Oncology Associates - Norfolk
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Washington
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Kennewick, Washington, Forente stater, 99336
- Kadlec Clinic - Hematology and Oncology
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Seattle, Washington, Forente stater, 98109
- Fred Hutchinson Cancer Research Center
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Spokane, Washington, Forente stater, 99204
- Providence Sacred Heart Medical Center
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West Virginia
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Morgantown, West Virginia, Forente stater, 26506-9600
- West Virginia University Cancer Institute
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Wisconsin
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Madison, Wisconsin, Forente stater, 53706
- University of Wisconsin - Madison
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Nice, Frankrike, 6189
- Centre Antoine Lacassagne
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Paris, Frankrike, 75015
- Hôpital Européen Georges-Pompidou
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Pierre-Bénite, Frankrike, 69310
- Hospital Lyon-Sud (HCL)
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Rennes, Frankrike, 35042
- Centre Eugène Marquis
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Saint-Herblain, Frankrike, 44800
- Western Cancer Institute - Saint-Herblain - René Gauducheau Site
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Toulouse, Frankrike, 31059
- Institut Universitaire du Cancer de Toulouse (IUCT) Oncopole
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Villejuif, Frankrike, 94805
- Gustave Roussy
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Athens, Hellas, 11527
- General Hospital of Athens
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Chaïdári, Hellas, 12462
- Attikon University General Hospital/General Hospital of West Attica
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Léfkos, Hellas, 2024
- Aretaieio Hospital
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Panórama, Hellas
- 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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Tokyo, Japan, 104-0045
- National Cancer Center Hospital
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Tokyo, Japan, 135-8550
- Cancer Institute Hospital of JFCR
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Aichi Pref
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Nagoya, Aichi Pref, Japan, 4648681
- Aichi Cancer Center
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Fukuoka Pref
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Kurume, Fukuoka Pref, Japan, 8300011
- Kurume University Hospital
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Hokkaido
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Sapporo, Hokkaido, Japan, 0300804
- Hokkaido Cancer Center
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Kanagawa Pref
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Kawasaki, Kanagawa Pref, Japan, 2160015
- St. Marianna University Hospital
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Miyagi Pref
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Sendai, Miyagi Pref, Japan, 9808574
- Tohoku University Hospital
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Niigata Pref
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Niigata, Niigata Pref, Japan, 9518520
- Niigata University Medical and Dental Hospital
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Okayama Pref.
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Okayama, Okayama Pref., Japan, 7008558
- Okayama University Hospital
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Saitama Pref.
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Hidaka, Saitama Pref., Japan, 350-1298
- Saitama Medical University - International Medical Center
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Shizuoka Pref.
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Nagaizumi-chō, Shizuoka Pref., Japan, 4118777
- Shizuoka Cancer Center
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Tochigi Pref.
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Saitama, Tochigi Pref., Japan, 329-0498
- Jichi Medical University Hospital
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Tokyo
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Minato, Tokyo, Japan, 105-0003
- The Jikei University Hospital
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Toon City, Ehime Pref
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Shibukawa, Toon City, Ehime Pref, Japan, 791-0295
- Ehime University Hospital
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Changchun, Kina, 130021
- The First Hospital of Jilin University
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Hanzhou, Kina
- Zhejiang Cancer Hospital
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Shanghai, Kina, 200032
- Fudan University Shanghai Cancer Center
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Tianjin, Kina, 300060
- Tianjin Medical University Cancer Institute & Hospital
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Zhengzhou, Kina
- Henan Cancer Hospital - Zhengzhou University
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Guangdong
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Guangzhou, Guangdong, Kina, 510060
- Sun Yat-Sen University Cancer Center
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Shaanxi
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Xi'an, Shaanxi, Kina, 710049
- The First Affiliated Hospital of Xi'an Jiaotong University
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Amsterdam, Nederland, 1081 HV
- Amsterdam UMC, location VUmc
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Enschede, Nederland, 7512 AV
- Medisch Spectrum Twente - Enschede Koningsplein
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Leiden, Nederland, 2333
- Leids Universitair Medisch Centrum (LUMC)
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Maastricht, Nederland, 6229
- Maastricht (UMC) Universitair Medisch Centrum
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Rotterdam, Nederland, 3015 GD
- Erasmus MC/ Erasmus Medisch Centrum
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Oslo, Norge, 0379
- Oslo Universitetssykehus - Radiumhospitalet
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Tromsø, Norge, 9019
- University Hospital of North Norway/Universitetssykehuset Nord-Norge - Tromsø
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Bialystok, Polen, 15-027
- Białostockie Centrum Onkologii im. Marii Skłodowskiej- Curie w Białymstoku
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Gdansk, Polen, 80-211
- Uniwersyteckie Centrum Kliniczne w Gdańsku
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Lodz, Polen, 93-338
- Instytut Centrum Zdrowia Matki Polki
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Poznan, Polen, 61-867
- Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie
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Siedlce, Polen, 08-110
- Mazowiecki Szpital Wojewódzki im. św. Jana Pawła II w Siedlcach
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Szczecin, Polen, 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), Polen, 30-348
- Jagiellońskie Centrum Innowacj
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San Juan
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Monacillo, San Juan, Puerto Rico, 00927
- UPR Comprehensive Cancer Center Hospital
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A Coruña, Spania, 15006
- Hospital Universitario de A Coruña
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Donostia / San Sebastian, Spania, 20014
- Hospital Universitario DE Donostia
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El Palmar, Spania, 30120
- Hospital Clínico Universitario Virgen de la Arrixaca
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Madrid, Spania, 28033
- MD Anderson Cancer Center Madrid
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Madrid, Spania, 28029
- Hospital Universitario La Paz
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Seville, Spania, 41013
- Virgen del Rocío University Hospital
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Valencia, Spania, 46009
- IVO - Valencian Institute of Oncology Foundation
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Zaragoza, Spania, 50009
- Miguel Servet Hospital
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Brno, Tsjekkia, 60200
- Masaryk Memorial Cancer Institute
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Hradec Králové, Tsjekkia, 50005
- Fakultní Nemocnice Hradec Králové
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Nový Jičín, Tsjekkia, 74101
- Nemocnice AGEL Nový Jičín a.s.
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Prague, Tsjekkia, 15000
- Fakultni nemocnice v Motole
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Prague, Tsjekkia, 18000
- Bulovka University Hospital
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Prague, Tsjekkia, 12808
- Vseobecna Fakultni Nemocnice v Praze
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Prague
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Prague, Prague, Tsjekkia
- University Hospital Královské Vinohrady
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Berlin, Tyskland, 13125
- Helios Klinikum Berlin-Buch
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Bonn, Tyskland, 53127
- University Hospital Bonn
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Dresden, Tyskland, 01307
- University Hospital Carl Gustav Carus Dresden
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Düsseldorf, Tyskland, 40225
- University Hospital of Düsseldorf
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Essen, Tyskland, 45136
- Kliniken Essen-Mitte - Evangelische Huyssens-Stiftung
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Frankfurt, Tyskland, 60596
- Klinikum der Johann Wolfgang Goethe-Universität
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Giessen, Tyskland, 35392
- Universitätsklinikum Gießen und Marburg - Gießen (UKGM)
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Hamburg, Tyskland, 20357
- Mammazentrum Hamburg am Krankenhaus Jerusalem
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Hanover, Tyskland, 30449
- MVZ Onko Medical GmbH Hanover
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Heidelberg, Tyskland, 69120
- University Hospital Heidelberg /Universitätsklinikum Heidelberg
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Homburg, Tyskland, 66421
- UniversitY Hospital of Saarland
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Munich, Tyskland, 80634
- Red Cross Hospital Munich
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Münster, Tyskland, 48149
- Universitätsklinikum Münster/University Clinic Muenster
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Wiesbaden, Tyskland, 65199
- Helios Dr. Horst Schmidt Kliniken Wiesbaden
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Graz, Østerrike, 8036
- Medizinische Universität Graz
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Vienna, Østerrike, 1090
- Medizinische Universität Wien
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State of Vienna
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Vienna, State of Vienna, Østerrike, 1130
- Krankenhaus Hietzing
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Tyrol
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Innsbruck, Tyrol, Østerrike, 6020
- Medizinische Universität Innsbruck
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Upper Austria (Oberösterreich)
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Linz, Upper Austria (Oberösterreich), Østerrike, 4010
- Ordensklinikum Linz GmbH Barmherzige Schwestern
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Etterforskerens valg
|
IV infusion IV infusion IV infusion IV infusion |
|
Eksperimentell: Rina-S
|
Intravenous (IV) infusion
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression-Free Survival (PFS)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Antall deltakere med behandlingsrelaterte bivirkninger (TEAE)
Tidsramme: Opptil omtrent 1.5 år
|
Opptil omtrent 1.5 år
|
|
|
Overall Survival (OS)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Study Official, Genmab
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
7. februar 2025
Primær fullføring (Faktiske)
18. august 2026
Studiet fullført (Antatt)
1. oktober 2027
Datoer for studieregistrering
Først innsendt
20. september 2024
Først innsendt som oppfylte QC-kriteriene
25. september 2024
Først lagt ut (Faktiske)
1. oktober 2024
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
3. november 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. november 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Kjønnssykdommer
- Sykdommer i det endokrine systemet
- Urogenitale neoplasmer
- Neoplasmer etter nettsted
- Neoplasmer
- Kvinnelige urogenitale sykdommer
- Kvinnelige urogenitale sykdommer og graviditetskomplikasjoner
- Kjønnssykdommer, kvinner
- Neoplasmer i endokrine kjertel
- Sykdommer i eggstokkene
- Adnexal sykdommer
- Genitale neoplasmer, kvinnelige
- Gonadal lidelser
- Eggledersykdommer
- Neoplasmer i eggstokkene
- Egglederneoplasmer
- Organiske kjemikalier
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Hydrokarboner
- Cycloparaffins
- Hydrokarboner, alicyklisk
- Hydrokarboner, syklisk
- Terpener
- Camptothecin
- Alkaloider
- Taxoider
- Cyclodecanes
- Diterpenes
- Deoxycytidine
- Cytidin
- Pyrimidin -nukleosider
- Pyrimidiner
- Gemcitabin
- Paclitaxel
- Topotekan
- Liposomal doxorubicin
Andre studie-ID-numre
- GCT1184-02
- PRO1184-002 (Annen identifikator: Other Sponsor Identifier)
- GOG-3107 (Annen identifikator: Other Sponsor Identifier)
- ENGOT-OV86 (Annen identifikator: Other Sponsor Identifier)
- 2024-514822-21 (Annen identifikator: EU Trial (CTIS) Number)
- jRCT2031250064 (Registeridentifikator: Japan Registry for Clinical Trials (jRCT))
- CTR20253987 (Registeridentifikator: ChinaDrugTrials.org.cn)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .