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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
544
Start Date
2025-11-28
Completion Date
2029-02
Last Updated
2026-03-03
Healthy Volunteers
No
Interventions
Rina-S
Intravenous (IV) infusion.
IC
* Paclitaxel: IV infusion * Doxorubicin: IV bolus injection/infusion
Locations (51)
SMH - Sarasota - Main Campus
Sarasota, Florida, United States
Emory Winship Cancer Inst.
Atlanta, Georgia, United States
Emory Winship Cancer Inst.
Atlanta, Georgia, United States
Emory Winship Cancer Inst./Emory Decatur Hospital
Decatur, Georgia, United States
Trials365, LLC
Shreveport, Louisiana, United States
Sinai Hospital
Baltimore, Maryland, United States
William Kahlert Reg. Can. Ctr
Westminster, Maryland, 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/ Maple Grove Clinic
Maple Grove, Minnesota, United States
USOR - Minnesota Oncology/ Maplewood Clinic
Maplewood, Minnesota, United States
USOR - Minnesota Oncology/ Minneapolis Clinic
Minneapolis, Minnesota, United States
USOR - Minnesota Oncology/ Woodbury Clinic
Woodbury, Minnesota, 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
USOR - NW Cancer Specs P.C.
Vancouver, Washington, United States
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
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