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Study to Assess the Efficacy and Safety of Rina-S Compared to Treatment of Investigator's Choice in Participants With Endometrial Cancer
Sponsor: Genmab
Summary
The purpose of this study is to compare how well Rina-S (GEN1184) works compared to treatment of physician's choice (paclitaxel or doxorubicin) that are considered standard medical care for the treatment of recurrent or progressive endometrial cancer (EC) following prior therapy. There is an equal (50:50) chance of getting either Rina-S or a chemotherapy agent as treatment in this study. The study duration will be approximately 3 years. The treatment duration will be different for every participant, but an average of 4 to 6 months is expected. All participants will receive active drug; no one will be given placebo. Participation in the study will require visits to the study site(s).
Official title: A Phase 3 Randomized, Open-label Study of Rinatabart Sesutecan (Rina-S) Versus Treatment of Investigator's Choice (IC) in Patients With Endometrial Cancer After Platinum-Based Chemotherapy and PD(L)-1 Therapy
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
660
Start Date
2025-11-28
Completion Date
2029-11
Last Updated
2026-08-17
Healthy Volunteers
No
Interventions
Rina-S
Intravenous (IV) infusion.
IC
* Paclitaxel: IV infusion * Doxorubicin: IV bolus injection/infusion
Locations (160)
USAH Mitchell Cancer Inst
Mobile, Alabama, United States
HonorHealth Research Inst
Phoenix, Arizona, United States
Kaiser Permanente SoCal
Irvine, California, United States
CPMC Research Institute
San Francisco, California, United States
Norwalk Hospital
Danbury, Connecticut, United States
Norwalk Hospital
Norwalk, Connecticut, United States
MedStar Washington Hospital
Washington D.C., District of Columbia, United States
SMH - Sarasota - Main Campus
Sarasota, Florida, United States
Women's Care - 9th Ave
St. Petersburg, Florida, United States
Women's Care - Armenia Ave
Tampa, Florida, United States
Emory Winship Cancer Inst.
Atlanta, Georgia, United States
Emory Winship Cancer Inst.
Atlanta, Georgia, United States
Northside Hospital Atlanta
Atlanta, Georgia, United States
Emory Winship Cancer Inst./Emory Decatur Hospital
Decatur, Georgia, United States
Endeavor Health NorthShore
Evanston, Illinois, United States
OLOL Cancer Institute
Baton Rouge, Louisiana, United States
Trials365, LLC
Shreveport, Louisiana, United States
Sinai Hospital
Baltimore, Maryland, United States
William Kahlert Reg. Can. Ctr
Westminster, Maryland, United States
UMass Memorial Medical Ctr
Worcester, Massachusetts, United States
Corewell Health
Grand Rapids, Michigan, United States
USOR - Minnesota Oncology-Coon Rapids Clinic
Coon Rapids, Minnesota, United States
USOR - Minnesota Oncology/ Coon Rapids Clinic
Coon Rapids, Minnesota, United States
USOR - Minnesota Oncology - Edina Clinic
Edina, Minnesota, United States
USOR - Minnesota Oncology/Edina Clinic
Edina, Minnesota, United States
USOR - Minnesota Oncology/ Maple Grove Clinic
Maple Grove, Minnesota, United States
USOR - Minnesota Oncology-Maplewood Clinic
Maplewood, Minnesota, United States
USOR - Minnesota Oncology/ Maplewood Clinic
Maplewood, Minnesota, United States
USOR - Minnesota Oncology/ Minneapolis Clinic
Minneapolis, Minnesota, United States
USOR - Minnesota Oncology
Minneapolis, Minnesota, United States
USOR - Minnesota Oncology/ Woodbury Clinic
Woodbury, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Morristown Medical Center
Morristown, New Jersey, United States
Atlantic Health - Overlook MC
Summit, New Jersey, United States
Holy Name Medical Center
Teaneck, New Jersey, United States
NYU Laura and Isaac Perlmutter Cancer Center - 34th Street
New York, New York, United States
Perlmutter CC NYU Langone LI
New York, New York, United States
Duke Cancer Institute
Durham, North Carolina, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Willamette Valley Cancer Institute and Research Center - Eugene
Eugene, Oregon, United States
NW Cancer Specs. P.C.
Happy Valley, Oregon, United States
USOR - NW Cancer Specs P.C.
Portland, Oregon, United States
USOR - NW Cancer Specs. P.C.
Tigard, Oregon, United States
TX Onc - Arlington North
Arlington, Texas, United States
USOR - Texas Oncology
Austin, Texas, United States
USOR - Texas Oncology
Austin, Texas, United States
USOR - Texas Oncology- Austin North
Austin, Texas, United States
TX Onc - Bedford
Bedford, Texas, United States
TX Onc - Methodist Dallas
Dallas, Texas, United States
TX Onc - Presbyterian Dallas
Dallas, Texas, United States
TX Onc - Methodist Charlton
Dallas, Texas, United States
TX Onc - Sammons
Dallas, Texas, United States
USOR - Texas Oncology - Dallas Fort Worth (DFW)
Fort Worth, Texas, United States
USOR - Texas Oncology
Harlingen, Texas, United States
USOR - Texas Oncology
McAllen, Texas, United States
USOR - TX Oncology - SA NE
San Antonio, Texas, United States
NEXT San Antonio
San Antonio, Texas, United States
USOR - Texas Oncology- Horizon Circle
Waco, Texas, United States
USOR - Texas Oncology- Waco
Waco, Texas, United States
USOR - Texas Oncology
Weslaco, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
USOR - NW Cancer Specs P.C.
Vancouver, Washington, United States
Austin Health
Heidelberg, Heidelberg, Australia
GenesisCare Campbelltown
Campbelltown, New South Wales, Australia
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
Calvary Mater Newcastle
Waratah, New South Wales, Australia
Antwerp University Hospital
Edegem, Antwerp, Belgium
Saint-Luc University Clinics
Brussels, Brussels Capital, Belgium
Universitair Ziekenhuis Leuven
Leuven, Flanders, Belgium
Grand Hôpital de Charleroi
Gilly, Hainaut, Belgium
VITAZ
Sint-Niklaas, Sint-Niklaas, Belgium
CHU UCL Namur/Ste Elisabeth
Namur, Wallonia, Belgium
Futtura Oncologia - Hub Pesq
Porto Alegre, Rio Grande do Sul, Brazil
Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
Arthur J E Child Cancer Comp
Calgary, Alberta, Canada
BC Cancer - Vancouver
Vancouver, British Columbia, Canada
MUHC - Glen Site
Montreal, Quebec, Canada
Aalborg University Hospital
Aalborg, Denmark
Hus Ccc/Ctu
Helsinki, Helsinki, Finland
Oulu University Hospital
Oulu, North Ostrobothnia, Finland
Kuopio Univ. Hospital, PSHVA
Kuopio, Northern Savonia, Finland
Tampere University Hospital
Tampere, Pirkanmaa, Finland
Centre Jean Perrin
Clermont-Ferrand, Auvergne-Rhône-Alpes, France
GHM Grenoble
Grenoble, Auvergne-Rhône-Alpes, France
HUS Strasbourg
Strasbourg, Bas-Rhin, France
CGFL Dijon
Dijon, Bourgogne-Franche-Comté, France
CHU Brest - Cavale Blanche
Brest, Brittany Region, France
Clinique Tivoli Ducos
Bordeaux, Gironde, France
CHU Orléans - Pharmacie
Orléans, Loiret, France
Cancer Institute Jean Godinot
Reims, Marne, France
L'Hôpital Privé Nancy Lorraine
Nancy, Meurthe-Et-Moselle, France
ICM Montpellier
Montpellier, Occitanie, France
ICO Angers
Angers, Pays de la Loire Region, France
CH de la Côte Basque
Bayonne, Pyrénées-Atlantiques, France
Hôpital Foch
Suresnes, Île-de-France Region, France
Asklepios Hospital Barmbek
Hamburg, Free and Hanseatic City of Hamburg, Germany
Klinikum Lippe GmbH Pharmacy
Lemgo, North Rhine-Westphalia, Germany
Helios Hospital Berlin-Buch
Berlin, State of Berlin, Germany
UGH Patras
Pátrai, RIO, Greece
Aretaieio Hospital
Athens, Greece
Alexandra General Hospital
Athens, Greece
Rambam Medical Center
Haifa, Haifa District, Israel
CARMEL
Haifa, Haifa District, Israel
Shaare Zedek Medical Center
Jerusalem, Jerusalem, Israel
Galilee Medical Center
Nahariya, Nahariya, Israel
Irst Meldola
Meldola, FC, Italy
IRCCS San Gerardo Tintori
Monza, MB, Italy
European Institute of Oncology
Milan, MI, Italy
Humanitas San Pio X
Milan, MI, Italy
Ospedale S Stefano
Prato, PO, Italy
AUSL IRCCS Reggio Emilia
Reggio Emilia, RE, Italy
Chiba University Hospital- Center for Outpatient
Chiba, Chiba, Japan
Gunma Prefectural Cancer Center
Ōta, Gunma, Japan
Iwate Medical University Hosp
Shiwa-gun, Iwate, Japan
Kitasato University Hospital
Sagamihara-shi, Kanagawa, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan
Mie University Hospital
Tsu, Kansai, Japan
NUC Tohoku Univ. Hospital
Sendai, Miyagi, Japan
Osaka International Cancer Institute - Osaka - Otemae Acti
Osaka, Osaka, Japan
Shizuoka Cancer Center
Nagaizumi-cho, Shizuoka, Japan
Keio University Hospital
Tokyo, Tokyo, Japan
National Cancer Center Hospital East
Chiba, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, Japan
Fukushima Medical University Hospital
Fukushima, Japan
Hyogo Cancer Center
Hyōgo, Japan
Niigata Cancer Center Hospital
Niigata, Japan
Saitama Medical University - International Medical Center
Saitama, Japan
Sapporo Medical University Hospital
Sapporo, Japan
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, Japan
Cancer Institute Hospital of JFCR
Tokyo, Japan
Yamagata University Hospital
Yamagata, Japan
LSMU Hospital Kauno klinikos
Kaunas, Central Lithuania, Lithuania
Dept., VUH Santaros Clinics
Vilnius, Vilnius County, Lithuania
OUH Radium Hospital
Oslo, Oslofjord, Norway
Haukeland University Hospital
Bergen, Vestland, Norway
Centrum Onkologi Ziemi Lubelsk
Lublin, Lublin Voivodeship, Poland
Siedleckie Centrum Onkologii
Siedlce, Masovian Voivodeship, Poland
Białystok Onc. Ctr. (MSC), GO
Bialystok, Podlaskie Voivodeship, Poland
UCH No. 2, PMU Szczecin
Szczecin, West Pomeranian Voivodeship, Poland
ŚCO SPZOZ Kielce
Kielce, Poland
ICZMP
Lodz, Łódź Voivodeship, Poland
PR Cancer Specialists
San Juan, Puerto Rico
NUH Singapore
Singapore, Singapore, Singapore
Curie Oncology (Farrer)
Singapore, Singapore, Singapore
Hosp. Univ. Son Espases
Palma de Mallorca, Balearic Islands, Spain
Vall d'Hebron
Barcelona, Catalonia, Spain
Hospital Clínic BCN
Barcelona, Catalonia, Spain
Hospital Universitari de Girona Doctor Josep Trueta
Girona, GI, Spain
CHU A Coruña
A Coruña, La Coruña, Spain
CUN Madrid
Madrid, Madrid, Spain
Hospital 12 de Octubre
Madrid, Madrid, Spain
HM Sanchinarro
Madrid, Madrid, Spain
HU Virgen de la Victoria
Málaga, Málaga, Spain
CUN Pamplona
Pamplona, Navarre, Spain
IVO Valencia
Valencia, Valenciana, Comunidad, Spain
HU Miguel Servet
Zaragoza, Zaragoza, Spain
Hospital La Paz
Madrid, Spain
H.R.U. Málaga - Materno-Inf.
Málaga, Spain
HU Virgen del Rocío
Seville, Spain
HU Virgen de Valme
Seville, Spain