Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Onderzoek om de werkzaamheid van Rina-S te beoordelen in vergelijking met een behandeling naar keuze van de onderzoeker bij deelnemers met platinaresistente eierstokkanker (RAINFOL-02)

2 november 2026 bijgewerkt door: Genmab

Een fase 3 gerandomiseerde, open-label studie van Rinatabart Sesutecan (Rina-S) versus behandeling naar keuze van de onderzoeker (IC) bij patiënten met platina-resistente eierstokkanker

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.

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

The China extension-study of GCT1184-02 is registered under NCT07604766.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

584

Fase

  • Fase 3

Contacten en locaties

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

Studie Locaties

  • Australië
      • South Brisbane, Australië
        • Mater Misericordiae - Mater Hospital Brisbane
      • Subiaco, Australië, 6008
        • Saint John of God - Subiaco Hospital
    • New South Wales
      • New Lambton Heights, New South Wales, Australië
        • Newcastle Private Hospital
    • Queensland (qld)
      • South Brisbane, Queensland (qld), Australië, 4101
        • Icon Cancer Centre
  • België
      • Aalst, België, 9300
        • AZORG - Onze-Lieve-Vrouwziekenhuis - Campus Aalst
      • Brussels, België, 1000
        • Centre Hospitalier Universitaire Saint-Pierre
      • Charleroi, België, 6000
        • Grand Hôpital de Charleroi - Site Les Viviers
      • Leuven, België, 3000
        • Universitair Ziekenhuis (UZ) Leuven - Campus Gasthuisberg
      • Liège, België, 4000
        • Centre Hospitalier Chretien - Clinique MontLégia
      • Roeselare, België, 051237111
        • Algemeen Ziekenhuis Delta - Campus Rumbeke
    • Antwerp
      • Turnhout, Antwerp, België, 2300
        • Algemeen Ziekenhuis Turnhout - Campus Sint-Elisabeth
  • Canada
      • Toronto, Canada, M4Y 3M5
        • Sunnybrook Health Sciences Centre - Bayview Campus
    • Ontario
      • Toronto, Ontario, Canada, M5G2M9
        • Princess Margaret Cancer Centre
    • Quebec
      • Montreal, Quebec, Canada, H2X0C1
        • Centre Hospitalier de l'Université de Montréal (CHUM)
  • China
      • Changchun, China, 130021
        • The First Hospital of Jilin University
      • Hanzhou, China
        • Zhejiang Cancer Hospital
      • Shanghai, China, 200032
        • Fudan University Shanghai Cancer Center
      • Tianjin, China, 300060
        • Tianjin Medical University Cancer Institute & Hospital
      • Zhengzhou, China
        • Henan Cancer Hospital - Zhengzhou University
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-Sen University Cancer Center
    • Shaanxi
      • Xi'an, Shaanxi, China, 710049
        • The First Affiliated Hospital of Xi'an Jiaotong University
  • Denemarken
      • Aalborg, Denemarken, 9000
        • Aalborg Universitetshospital
      • Copenhagen, Denemarken
        • The Royal Hospital (Rigshospitalet)
      • Odense, Denemarken, 5000
        • Odense Universitets Hospital
  • Duitsland
      • Berlin, Duitsland, 13125
        • Helios Klinikum Berlin-Buch
      • Bonn, Duitsland, 53127
        • University Hospital Bonn
      • Dresden, Duitsland, 01307
        • University Hospital Carl Gustav Carus Dresden
      • Düsseldorf, Duitsland, 40225
        • University Hospital of Düsseldorf
      • Essen, Duitsland, 45136
        • Kliniken Essen-Mitte - Evangelische Huyssens-Stiftung
      • Frankfurt, Duitsland, 60596
        • Klinikum der Johann Wolfgang Goethe-Universität
      • Giessen, Duitsland, 35392
        • Universitätsklinikum Gießen und Marburg - Gießen (UKGM)
      • Hamburg, Duitsland, 20357
        • Mammazentrum Hamburg am Krankenhaus Jerusalem
      • Hanover, Duitsland, 30449
        • MVZ Onko Medical GmbH Hanover
      • Heidelberg, Duitsland, 69120
        • University Hospital Heidelberg /Universitätsklinikum Heidelberg
      • Homburg, Duitsland, 66421
        • UniversitY Hospital of Saarland
      • Munich, Duitsland, 80634
        • Red Cross Hospital Munich
      • Münster, Duitsland, 48149
        • Universitätsklinikum Münster/University Clinic Muenster
      • Wiesbaden, Duitsland, 65199
        • Helios Dr. Horst Schmidt Kliniken Wiesbaden
  • Frankrijk
      • Nice, Frankrijk, 6189
        • Centre Antoine Lacassagne
      • Paris, Frankrijk, 75015
        • Hôpital Européen Georges-Pompidou
      • Pierre-Bénite, Frankrijk, 69310
        • Hospital Lyon-Sud (HCL)
      • Rennes, Frankrijk, 35042
        • Centre Eugène Marquis
      • Saint-Herblain, Frankrijk, 44800
        • Western Cancer Institute - Saint-Herblain - René Gauducheau Site
      • Toulouse, Frankrijk, 31059
        • Institut Universitaire du Cancer de Toulouse (IUCT) Oncopole
      • Villejuif, Frankrijk, 94805
        • Gustave Roussy
  • Griekenland
      • Athens, Griekenland, 11527
        • General Hospital of Athens
      • Chaïdári, Griekenland, 12462
        • Attikon University General Hospital/General Hospital of West Attica
      • Léfkos, Griekenland, 2024
        • Aretaieio Hospital
      • Panórama, Griekenland
        • Saint Luke's Hospital
  • Italië
      • Milan, Italië, 20132
        • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
      • Milan, Italië, 20141
        • Istituto Europeo di Oncologia/ European Institute of Oncology
      • Milan, Italië, 20159
        • Humanitas San Pio X
      • Ponderano, Italië, 13875
        • Local Health Authority of Biella - Nuovo Ospedale degli Infermi
      • Roma, Italië, 00168
        • Agostino Gemelli University Hospital Foundation IRCCS
      • Torino, Italië, 10128
        • Centre Antoine Lacassagne/Azienda Ospedaliera Ordine Mau
    • Apulia
      • Brindisi, Apulia, Italië, 72100
        • Azienda Sanitaria Locale Brindisi
  • Japan
      • Tokyo, Japan, 104-0045
        • National Cancer Center Hospital
      • Tokyo, Japan, 135-8550
        • Cancer Institute Hospital of JFCR
    • Aichi Pref
      • Nagoya, Aichi Pref, Japan, 4648681
        • Aichi Cancer Center
    • Fukuoka Pref
      • Kurume, Fukuoka Pref, Japan, 8300011
        • Kurume University Hospital
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 0300804
        • Hokkaido Cancer Center
    • Kanagawa Pref
      • Kawasaki, Kanagawa Pref, Japan, 2160015
        • St. Marianna University Hospital
    • Miyagi Pref
      • Sendai, Miyagi Pref, Japan, 9808574
        • Tohoku University Hospital
    • Niigata Pref
      • Niigata, Niigata Pref, Japan, 9518520
        • Niigata University Medical and Dental Hospital
    • Okayama Pref.
      • Okayama, Okayama Pref., Japan, 7008558
        • Okayama University Hospital
    • Saitama Pref.
      • Hidaka, Saitama Pref., Japan, 350-1298
        • Saitama Medical University - International Medical Center
    • Shizuoka Pref.
      • Nagaizumi-chō, Shizuoka Pref., Japan, 4118777
        • Shizuoka Cancer Center
    • Tochigi Pref.
      • Saitama, Tochigi Pref., Japan, 329-0498
        • Jichi Medical University Hospital
    • Tokyo
      • Minato, Tokyo, Japan, 105-0003
        • The Jikei University Hospital
    • Toon City, Ehime Pref
      • Shibukawa, Toon City, Ehime Pref, Japan, 791-0295
        • Ehime University Hospital
  • Nederland
      • Amsterdam, Nederland, 1081 HV
        • Amsterdam UMC, location VUmc
      • Enschede, Nederland, 7512 AV
        • Medisch Spectrum Twente - Enschede Koningsplein
      • Leiden, Nederland, 2333
        • Leids Universitair Medisch Centrum (LUMC)
      • Maastricht, Nederland, 6229
        • Maastricht (UMC) Universitair Medisch Centrum
      • Rotterdam, Nederland, 3015 GD
        • Erasmus MC/ Erasmus Medisch Centrum
  • Noorwegen
      • Oslo, Noorwegen, 0379
        • Oslo Universitetssykehus - Radiumhospitalet
      • Tromsø, Noorwegen, 9019
        • University Hospital of North Norway/Universitetssykehuset Nord-Norge - Tromsø
  • Oostenrijk
      • Graz, Oostenrijk, 8036
        • Medizinische Universität Graz
      • Vienna, Oostenrijk, 1090
        • Medizinische Universität Wien
    • State of Vienna
      • Vienna, State of Vienna, Oostenrijk, 1130
        • Krankenhaus Hietzing
    • Tyrol
      • Innsbruck, Tyrol, Oostenrijk, 6020
        • Medizinische Universität Innsbruck
    • Upper Austria (Oberösterreich)
      • Linz, Upper Austria (Oberösterreich), Oostenrijk, 4010
        • Ordensklinikum Linz GmbH Barmherzige Schwestern
  • Polen
      • Bialystok, Polen, 15-027
        • Białostockie Centrum Onkologii im. Marii Skłodowskiej- Curie w Białymstoku
      • Gdansk, Polen, 80-211
        • Uniwersyteckie Centrum Kliniczne w Gdańsku
      • Lodz, Polen, 93-338
        • Instytut Centrum Zdrowia Matki Polki
      • Poznan, Polen, 61-867
        • Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie
      • Siedlce, Polen, 08-110
        • Mazowiecki Szpital Wojewódzki im. św. Jana Pawła II w Siedlcach
      • Szczecin, Polen, 70-111
        • Uniwersytecki Szpital Kliniczny Nr 2 PUM w Szczecinie
    • Lesser Poland (Małopolskie)
      • Krakow, Lesser Poland (Małopolskie), Polen, 30-348
        • Jagiellońskie Centrum Innowacj
  • Puerto Rico
    • San Juan
      • Monacillo, San Juan, Puerto Rico, 00927
        • UPR Comprehensive Cancer Center Hospital
  • Spanje
      • A Coruña, Spanje, 15006
        • Hospital Universitario de A Coruña
      • Donostia / San Sebastian, Spanje, 20014
        • Hospital Universitario DE Donostia
      • El Palmar, Spanje, 30120
        • Hospital Clínico Universitario Virgen de la Arrixaca
      • Madrid, Spanje, 28033
        • MD Anderson Cancer Center Madrid
      • Madrid, Spanje, 28029
        • Hospital Universitario La Paz
      • Seville, Spanje, 41013
        • Virgen del Rocío University Hospital
      • Valencia, Spanje, 46009
        • IVO - Valencian Institute of Oncology Foundation
      • Zaragoza, Spanje, 50009
        • Miguel Servet Hospital
  • Tsjechië
      • Brno, Tsjechië, 60200
        • Masaryk Memorial Cancer Institute
      • Hradec Králové, Tsjechië, 50005
        • Fakultní Nemocnice Hradec Králové
      • Nový Jičín, Tsjechië, 74101
        • Nemocnice AGEL Nový Jičín a.s.
      • Prague, Tsjechië, 15000
        • Fakultni nemocnice v Motole
      • Prague, Tsjechië, 18000
        • Bulovka University Hospital
      • Prague, Tsjechië, 12808
        • Vseobecna Fakultni Nemocnice v Praze
    • Prague
      • Prague, Prague, Tsjechië
        • University Hospital Královské Vinohrady
  • Verenigde Staten
    • Alaska
      • Anchorage, Alaska, Verenigde Staten, 99508
        • Alaska Women's Cancer Care
    • Arizona
      • Scottsdale, Arizona, Verenigde Staten, 85251
        • Arizona Center for Cancer Care (ACCC) - Biltmore
      • Tucson, Arizona, Verenigde Staten, 85724
        • University of Arizona Cancer Center - Research and Administration at Main Campus
    • California
      • Burbank, California, Verenigde Staten, 91505
        • Providence Saint Joseph Medical Center - Roy and Patricia Disney Family Cancer Center
      • La Jolla, California, Verenigde Staten, 92093
        • University of California San Diego Moores Cancer Center
      • San Francisco, California, Verenigde Staten, 94158
        • USCF Mission Bay
      • Vallejo, California, Verenigde Staten, 94589
        • Kaiser Permanente - Vallejo Medical Center
    • Colorado
      • Aurora, Colorado, Verenigde Staten, 80045
        • UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center
    • Connecticut
      • Hartford, Connecticut, Verenigde Staten, 06106
        • Hartford Hospital
      • New Haven, Connecticut, Verenigde Staten, 06510
        • Yale School of Medicine
      • Norwalk, Connecticut, Verenigde Staten, 06850
        • Norwalk Hospital
    • Florida
      • Fort Myers, Florida, Verenigde Staten, 33901-8108
        • SCRI - Florida Cancer Specialists - South Region Research Office
      • Miami Beach, Florida, Verenigde Staten, 33140
        • Mount Sinai Comprehensive Cancer Center
      • Orlando, Florida, Verenigde Staten, 32806
        • Orlando Health Cancer Institute - Downtown Orlando
      • Sarasota, Florida, Verenigde Staten, 34239
        • Sarasota Memorial Hospital
      • West Palm Beach, Florida, Verenigde Staten, 33401
        • SCRI - Florida Cancer Specialists - West Palm Beach
    • Georgia
      • Atlanta, Georgia, Verenigde Staten, 30322
        • Winship Cancer Institute of Emory University
      • Atlanta, Georgia, Verenigde Staten, 30342
        • Northside Hospital Atlanta
      • Augusta, Georgia, Verenigde Staten, 30912
        • Augusta University Georgia Cancer Center
    • Hawaii
      • Honolulu, Hawaii, Verenigde Staten, 96826
        • Kapi'olani Medical Center for Women and Children
    • Indiana
      • Dyer, Indiana, Verenigde Staten, 46311
        • Northwest Cancer Center - Dyer
    • Kansas
      • Kansas City, Kansas, Verenigde Staten, 66160
        • University of Kansas Cancer Center
      • Overland Park, Kansas, Verenigde Staten, 66211
        • HCA Midwest Health
    • Kentucky
      • Edgewood, Kentucky, Verenigde Staten, 41017
        • St. Elizabeth Healthcare - Edgewood
      • Lexington, Kentucky, Verenigde Staten, 40503
        • Baptist Health Lexington
    • Louisiana
      • New Orleans, Louisiana, Verenigde Staten, 70112
        • Louisiana State University Health Sciences Center (LSU Health) - New Orleans
      • Shreveport, Louisiana, Verenigde Staten, 71103
        • Trials365, LLC (Gynecologic Oncology Associates-Shreveport)
    • Maine
      • Scarborough, Maine, Verenigde Staten, 04074-7172
        • Maine Medical Center Cancer Institute- Scarborough
    • Maryland
      • Silver Spring, Maryland, Verenigde Staten, 20910
        • Holy Cross Health - Holy Cross Hospital
    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, Verenigde Staten, 02215
        • Dana-Farber Cancer Institute
    • Michigan
      • Detroit, Michigan, Verenigde Staten, 48201
        • Barbara Ann Karmanos Cancer Institute
      • Grand Rapids, Michigan, Verenigde Staten, 49503
        • Corewell Health (Spectrum Health)
      • Ypsilanti, Michigan, Verenigde Staten, 48197
        • Saint Joseph Mercy Ann Arbor Hospital
    • Nebraska
      • Omaha, Nebraska, Verenigde Staten, 68105
        • University of Nebraska Medical Center
    • Nevada
      • Reno, Nevada, Verenigde Staten, 89511
        • Center of Hope
    • New Jersey
      • Teaneck, New Jersey, Verenigde Staten, 07666
        • Holy Name Medical Center
    • New Mexico
      • Albuquerque, New Mexico, Verenigde Staten, 87131
        • University of New Mexico Comprehensive Cancer Center
    • New York
      • Buffalo, New York, Verenigde Staten, 14203
        • Roswell Park Comprehensive Cancer Center
      • New York, New York, Verenigde Staten, 10032
        • Herbert Irving Comprehensive Cancer Center
      • New York, New York, Verenigde Staten, 10065
        • New York-Presbyterian - Weill Cornell Medical Center
      • New York, New York, Verenigde Staten, 10016
        • Perlmutter Cancer Center - 38th Street
      • New York, New York, Verenigde Staten, 10016
        • Perlmutter Cancer Center at NYU Langone Hospital - Long Island
      • Rochester, New York, Verenigde Staten, 14642
        • James P. Wilmot Cancer Center
    • North Carolina
      • Durham, North Carolina, Verenigde Staten, 27705
        • Duke Cancer Institute
      • Pinehurst, North Carolina, Verenigde Staten, 28374
        • FirstHealth Outpatient Cancer Center
    • Ohio
      • Cincinnati, Ohio, Verenigde Staten, 45219
        • University of Cincinnati Medical Center
      • Cleveland, Ohio, Verenigde Staten, 44109
        • MetroHealth Medical Center
      • Cleveland, Ohio, Verenigde Staten, 44106
        • University Hospitals Cleveland Medical Center
      • Cleveland, Ohio, Verenigde Staten, 44195
        • Cleveland Clinic Main Campus
      • Hilliard, Ohio, Verenigde Staten, 43026
        • JamesCare Gynecologic Oncology at Mill Run
    • Oregon
      • Portland, Oregon, Verenigde Staten, 97239
        • Oregon Health and Science University
      • Portland, Oregon, Verenigde Staten, 97210
        • Legacy Good Samaritan Medical Center
      • Portland, Oregon, Verenigde Staten, 97227
        • USOR - Northwest Cancer Specialists, P.C. dba Compass Oncology - Rose Quarter Cancer Center
    • Pennsylvania
      • Bethlehem, Pennsylvania, Verenigde Staten, 18015
        • St. Luke's University Health Network
      • Hershey, Pennsylvania, Verenigde Staten, 17033
        • Penn State Health Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, Verenigde Staten, 19111
        • Fox Chase Cancer Center
      • Pittsburgh, Pennsylvania, Verenigde Staten, 15224
        • Allegheny Health Network - West Penn Hospital
      • Willow Grove, Pennsylvania, Verenigde Staten, 19090
        • Jefferson Health - Asplundh Cancer Pavilion
    • South Dakota
      • Sioux Falls, South Dakota, Verenigde Staten, 57105
        • Avera Cancer Institute
    • Tennessee
      • Nashville, Tennessee, Verenigde Staten, 37203
        • SCRI Oncology Partners
    • Texas
      • Abilene, Texas, Verenigde Staten, 79606
        • USOR - Texas Oncology - Dallas Fort Worth (DFW) - Abilene
      • Austin, Texas, Verenigde Staten, 78731
        • USOR - Texas Oncology - Dallas Fort Worth (DFW) - Austin Central
      • Dallas, Texas, Verenigde Staten, 75390
        • University of Texas Southwestern Medical Center
      • Fort Worth, Texas, Verenigde Staten, 76104
        • USOR - Texas Oncology - Dallas Fort Worth (DFW) - Fort Worth
    • Virginia
      • Fairfax, Virginia, Verenigde Staten, 22031
        • Inova Schar Cancer Institute
      • Norfolk, Virginia, Verenigde Staten, 23502
        • USOR - Virginia Oncology Associates - Norfolk
    • Washington
      • Kennewick, Washington, Verenigde Staten, 99336
        • Kadlec Clinic - Hematology and Oncology
      • Seattle, Washington, Verenigde Staten, 98109
        • Fred Hutchinson Cancer Research Center
      • Spokane, Washington, Verenigde Staten, 99204
        • Providence Sacred Heart Medical Center
    • West Virginia
      • Morgantown, West Virginia, Verenigde Staten, 26506-9600
        • West Virginia University Cancer Institute
    • Wisconsin
      • Madison, Wisconsin, Verenigde Staten, 53706
        • University of Wisconsin - Madison

Deelname Criteria

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

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

Key Inclusion Criteria:

  • Participants must have histologically or cytologically confirmed high grade serous or endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.

  • Participants may be enrolled regardless of FRα expression level.

  • 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.

  • Participants must have received prior treatment with the following therapies:

    • Platinum chemotherapy

    • 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

    • 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

    • 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.

  • 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.

Studie plan

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

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Keuze van de onderzoeker
Geneesmiddel: Paclitaxel

IV infusion

Geneesmiddel: Topotecan

IV infusion

Geneesmiddel: Pegylated liposomal doxorubicin (PLD)

IV infusion

Geneesmiddel: Gemcitabine

IV infusion
Experimenteel: Rina-S
Geneesmiddel: Rina-S

Intravenous (IV) infusion

Andere namen:
  • PRO1184
  • Rinatabart Sesutecan
  • GEN1184

Wat meet het onderzoek?

Primaire uitkomstmaten

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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Aantal deelnemers met tijdens de behandeling optredende bijwerkingen (TEAEs)
Tijdsspanne: Tot ongeveer 1,5 jaar
Tot ongeveer 1,5 jaar
Overall Survival (OS)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

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

Sponsor

Genmab

Onderzoekers

  • Studie directeur: Study Official, Genmab

Studie record data

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

Bestudeer belangrijke data

Studie start (Werkelijk)

7 februari 2025

Primaire voltooiing (Werkelijk)

18 augustus 2026

Studie voltooiing (Geschat)

1 oktober 2027

Studieregistratiedata

Eerst ingediend

20 september 2024

Eerst ingediend dat voldeed aan de QC-criteria

25 september 2024

Eerst geplaatst (Werkelijk)

1 oktober 2024

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 november 2026

Laatste update ingediend die voldeed aan QC-criteria

2 november 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • GCT1184-02
  • PRO1184-002 (Andere identificatie: Other Sponsor Identifier)
  • GOG-3107 (Andere identificatie: Other Sponsor Identifier)
  • ENGOT-OV86 (Andere identificatie: Other Sponsor Identifier)
  • 2024-514822-21 (Andere identificatie: EU Trial (CTIS) Number)
  • jRCT2031250064 (Register-ID: Japan Registry for Clinical Trials (jRCT))
  • CTR20253987 (Register-ID: ChinaDrugTrials.org.cn)

Plan Individuele Deelnemersgegevens (IPD)

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

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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

Abonneren