Study to Assess the Efficacy and Safety of Rina-S Compared to Treatment of Investigator's Choice in Participants With Endometrial Cancer
Start Date
11/28/2025
Completion Date
11/1/2029
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).
Detailed Description
This is a global, open-label, randomized Phase 3 study in approximately 660 participants with recurrent or progressive EC following prior therapy. Participants will be randomized in a 1:1 ratio to receive treatment with Rina-S vs investigator's choice (IC) (paclitaxel or doxorubicin). Investigators must select one of the IC treatment options for each participant prior to randomization so that this may be used for treatment assignment if the participant is randomized to the IC arm.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Rina-S
IC
Conditions
Locations
HonorHealth Research Inst
Phoenix, Arizona 85016
United States
Kaiser Permanente SoCal
Irvine, California 92618
United States
MedStar Washington Hospital
Washington D.C., District of Columbia 20010
United States
SMH - Sarasota - Main Campus
Sarasota, Florida 34239
United States
Women's Care - 9th Ave
St. Petersburg, Florida 33713
United States
Women's Care - Armenia Ave
Tampa, Florida 33603
United States
Emory Winship Cancer Inst.
Atlanta, Georgia 30308
United States
Emory Winship Cancer Inst.
Atlanta, Georgia 30322
United States
Northside Hospital Atlanta
Atlanta, Georgia 30342
United States
Emory Winship Cancer Inst./Emory Decatur Hospital
Decatur, Georgia 30033
United States
Trials365, LLC
Shreveport, Louisiana 71103
United States
Sinai Hospital
Baltimore, Maryland 21215
United States
William Kahlert Reg. Can. Ctr
Westminster, Maryland 21157
United States
Corewell Health
Grand Rapids, Michigan 49503
United States
USOR - Minnesota Oncology-Coon Rapids Clinic
Coon Rapids, Minnesota 55433
United States
USOR - Minnesota Oncology/ Coon Rapids Clinic
Coon Rapids, Minnesota 55433
United States
USOR - Minnesota Oncology - Edina Clinic
Edina, Minnesota 55435
United States
USOR - Minnesota Oncology/Edina Clinic
Edina, Minnesota 55435
United States
USOR - Minnesota Oncology/ Maple Grove Clinic
Maple Grove, Minnesota 55369
United States
USOR - Minnesota Oncology-Maplewood Clinic
Maplewood, Minnesota 55109
United States
USOR - Minnesota Oncology/ Maplewood Clinic
Maplewood, Minnesota 55109
United States
USOR - Minnesota Oncology/ Minneapolis Clinic
Minneapolis, Minnesota 55404
United States
USOR - Minnesota Oncology
Minneapolis, Minnesota 55404
United States
USOR - Minnesota Oncology/ Woodbury Clinic
Woodbury, Minnesota 55125
United States
Washington University School of Medicine
St Louis, Missouri 63110
United States
Holy Name Medical Center
Teaneck, New Jersey 07666
United States
Duke Cancer Institute
Durham, North Carolina 27710
United States
University of Cincinnati Medical Center
Cincinnati, Ohio 45219
United States
Willamette Valley Cancer Institute and Research Center - Eugene
Eugene, Oregon 97401
United States
NW Cancer Specs. P.C.
Happy Valley, Oregon 97015
United States
USOR - NW Cancer Specs P.C.
Portland, Oregon 97227
United States
USOR - NW Cancer Specs. P.C.
Tigard, Oregon 97223
United States
TX Onc - Arlington North
Arlington, Texas 76012
United States
USOR - Texas Oncology
Austin, Texas 78731
United States
USOR - Texas Oncology
Austin, Texas 78745
United States
USOR - Texas Oncology- Austin North
Austin, Texas 78758
United States
TX Onc - Bedford
Bedford, Texas 76022
United States
TX Onc - Methodist Dallas
Dallas, Texas 75203
United States
TX Onc - Presbyterian Dallas
Dallas, Texas 75231
United States
TX Onc - Methodist Charlton
Dallas, Texas 75237
United States
TX Onc - Sammons
Dallas, Texas 75246
United States
USOR - Texas Oncology - Dallas Fort Worth (DFW)
Fort Worth, Texas 76104
United States
USOR - Texas Oncology
Harlingen, Texas 78550
United States
USOR - Texas Oncology
McAllen, Texas 78503
United States
USOR - TX Oncology - SA NE
San Antonio, Texas 78217
United States
NEXT San Antonio
San Antonio, Texas 78240
United States
USOR - Texas Oncology- Horizon Circle
Waco, Texas 76712
United States
USOR - Texas Oncology- Waco
Waco, Texas 76712
United States
USOR - Texas Oncology
Weslaco, Texas 78596
United States
USOR - NW Cancer Specs P.C.
Vancouver, Washington 98684
United States
GenesisCare Campbelltown
Campbelltown, New South Wales 2560
Australia
Chris O'Brien Lifehouse
Camperdown, New South Wales 2050
Australia
Calvary Mater Newcastle
Waratah, New South Wales 2298
Australia
Antwerp University Hospital
Edegem, Antwerp 2650
Belgium
Saint-Luc University Clinics
Brussels, Brussels Capital 1200
Belgium
Universitair Ziekenhuis Leuven
Leuven, Flanders 3000
Belgium
Grand Hôpital de Charleroi
Gilly, Hainaut 6060
Belgium
CHU UCL Namur/Ste Elisabeth
Namur, Wallonia 5000
Belgium
VITAZ
Sint-Niklaas, 9100
Belgium
Arthur J E Child Cancer Comp
Calgary, Alberta T2N 5G2
Canada
MUHC - Glen Site
Montreal, Quebec H4A 3J1
Canada
Aalborg University Hospital
Aalborg, 9000
Denmark
Oulu University Hospital
Oulu, North Ostrobothnia 90220
Finland
Kuopio Univ. Hospital, PSHVA
Kuopio, Northern Savonia 70210
Finland
Hus Ccc/Ctu
Helsinki, 00250
Finland
Tampere University Hospital
Tampere, 33520
Finland
GHM Grenoble
Grenoble, Auvergne-Rhône-Alpes 38028
France
HUS Strasbourg
Strasbourg, Bas-Rhin 67200
France
CHU Brest - Cavale Blanche
Brest, Brittany Region 29609
France
Clinique Tivoli Ducos
Bordeaux, Gironde 33000
France
CHU Orléans - Pharmacie
Orléans, Loiret 45067
France
L'Hôpital Privé Nancy Lorraine
Nancy, Meurthe-Et-Moselle 54000
France
ICM Montpellier
Montpellier, Occitanie 34298
France
ICO Angers
Angers, Pays de la Loire Region 49055
France
CH de la Côte Basque
Bayonne, Pyrénées-Atlantiques 64109
France
Hôpital Foch
Suresnes, Île-de-France Region 92150
France
Klinikum Lippe GmbH Pharmacy
Lemgo, North Rhine-Westphalia 32657
Germany
Asklepios Hospital Barmbek
Hamburg, 22453
Germany
Chiba University Hospital- Center for Outpatient
Chiba, Chiba 260-8677
Japan
Gunma Prefectural Cancer Center
Ōta, Gunma 373-8550
Japan
Iwate Medical University Hosp
Shiwa-gun, Iwate 028-3695
Japan
Kitasato University Hospital
Sagamihara-shi, Kanagawa 252-0373
Japan
Kanagawa Cancer Center
Yokohama, Kanagawa 241-8515
Japan
Mie University Hospital
Tsu, Kansai 514-8507
Japan
NUC Tohoku Univ. Hospital
Sendai, Miyagi 980-8574
Japan
Osaka International Cancer Institute - Osaka - Otemae Acti
Osaka, Osaka 541-8567
Japan
Shizuoka Cancer Center
Nagaizumi-cho, Shizuoka 411-8777
Japan
Keio University Hospital
Tokyo, Tokyo 160-8582
Japan
National Cancer Center Hospital East
Chiba, 277-8577
Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1347
Japan
Fukushima Medical University Hospital
Fukushima, 960-1247
Japan
Hyogo Cancer Center
Hyōgo, 673-0021
Japan
Niigata Cancer Center Hospital
Niigata,
Japan
Saitama Medical University - International Medical Center
Saitama, 350-1298
Japan
Sapporo Medical University Hospital
Sapporo, 060-8543
Japan
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, 569-8686
Japan
Cancer Institute Hospital of JFCR
Tokyo, 135-8550
Japan
Yamagata University Hospital
Yamagata, 990-9585
Japan
LSMU Hospital Kauno klinikos
Kaunas, Central Lithuania LT-45434
Lithuania
OUH Radium Hospital
Oslo, Oslofjord 0379
Norway
Haukeland University Hospital
Bergen, Vestland NO-5021
Norway
Siedleckie Centrum Onkologii
Siedlce, Masovian Voivodeship 08-110
Poland
Białystok Onc. Ctr. (MSC), GO
Bialystok, Podlaskie Voivodeship 15-027
Poland
ICZMP
Lodz, 93-338
Poland
PR Cancer Specialists
San Juan, 00917
Puerto Rico
NUH Singapore
Singapore, 119082
Singapore
Curie Oncology (Farrer)
Singapore, 217562
Singapore
Hosp. Univ. Son Espases
Palma de Mallorca, Balearic Islands 07120
Spain
Hospital Clínic BCN
Barcelona, Catalonia 08036
Spain
CHU A Coruña
A Coruña, La Coruña 15006
Spain
CUN Pamplona
Pamplona, Navarre 31008
Spain
IVO Valencia
Valencia, Valenciana, Comunidad 46009
Spain
CUN Madrid
Madrid, 28027
Spain
Hospital La Paz
Madrid, 28046
Spain
HM Sanchinarro
Madrid, 28050
Spain
HU Virgen de la Victoria
Málaga, 29010
Spain
H.R.U. Málaga - Materno-Inf.
Málaga, 7120
Spain
HU Virgen del Rocío
Seville, 41013
Spain
HU Virgen de Valme
Seville, 41014
Spain
HU Miguel Servet
Zaragoza, 50009
Spain