Endometrial Cancer Clinical Trials

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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

Status: Recruiting
Location: See all (160) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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).

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Participants must have histologically or cytologically confirmed recurrent or progressive endometrial cancer (EC; any subtype excluding neuroendocrine tumors, carcinosarcoma, or endometrial sarcoma) following prior therapy.

• Participants must have received at least 1, but not more than 3, prior lines of therapy:

‣ Participants must have received prior platinum-based chemotherapy and a programmed death (ligand)-1 (PD(L)-1) inhibitor, either separately or in combination

⁃ If the tumor recurred more than 12 months after completion of platinum-based chemotherapy, additional platinum-based chemotherapy must be administered for recurrent disease unless the participant is ineligible for further platinum-based chemotherapy, in which case the reason for ineligibility must be documented.

∙ Note: If Immunotherapy-based treatment is administered in the advanced/recurrent setting, then platinum rechallenge is not required, regardless of the duration of the platinum-free interval from prior platinum-based chemotherapy. In such cases, the reason for ineligibility for platinum-based chemotherapy must be documented.

⁃ Prior induction plus maintenance is considered 1 line of therapy

⁃ Hormonal therapy alone (i.e., without chemotherapy) will not be counted as a separate line of therapy.

⁃ Therapy changed due to toxicity in the absence of progression will be considered part of the same line of therapy (i.e., will not be counted independently as a separate line of therapy)

• Participants must have progressed radiographically on or after their most recent line of therapy

Locations
United States
Alabama
USAH Mitchell Cancer Inst
RECRUITING
Mobile
Arizona
HonorHealth Research Inst
RECRUITING
Phoenix
California
Kaiser Permanente SoCal
RECRUITING
Irvine
CPMC Research Institute
RECRUITING
San Francisco
Connecticut
Norwalk Hospital
RECRUITING
Danbury
Norwalk Hospital
RECRUITING
Norwalk
Washington, D.c.
MedStar Washington Hospital
RECRUITING
Washington D.c.
Florida
SMH - Sarasota - Main Campus
RECRUITING
Sarasota
Women's Care - 9th Ave
RECRUITING
St. Petersburg
Women's Care - Armenia Ave
RECRUITING
Tampa
Georgia
Emory Winship Cancer Inst.
RECRUITING
Atlanta
Emory Winship Cancer Inst.
RECRUITING
Atlanta
Northside Hospital Atlanta
RECRUITING
Atlanta
Emory Winship Cancer Inst./Emory Decatur Hospital
RECRUITING
Decatur
Illinois
Endeavor Health NorthShore
RECRUITING
Evanston
Louisiana
OLOL Cancer Institute
RECRUITING
Baton Rouge
Trials365, LLC
RECRUITING
Shreveport
Massachusetts
UMass Memorial Medical Ctr
RECRUITING
Worcester
Maryland
Sinai Hospital
RECRUITING
Baltimore
William Kahlert Reg. Can. Ctr
RECRUITING
Westminster
Michigan
Corewell Health
RECRUITING
Grand Rapids
Minnesota
USOR - Minnesota Oncology-Coon Rapids Clinic
RECRUITING
Coon Rapids
USOR - Minnesota Oncology/ Coon Rapids Clinic
RECRUITING
Coon Rapids
USOR - Minnesota Oncology - Edina Clinic
RECRUITING
Edina
USOR - Minnesota Oncology/Edina Clinic
RECRUITING
Edina
USOR - Minnesota Oncology/ Maple Grove Clinic
RECRUITING
Maple Grove
USOR - Minnesota Oncology-Maplewood Clinic
RECRUITING
Maplewood
USOR - Minnesota Oncology/ Maplewood Clinic
RECRUITING
Maplewood
USOR - Minnesota Oncology
RECRUITING
Minneapolis
USOR - Minnesota Oncology/ Minneapolis Clinic
RECRUITING
Minneapolis
USOR - Minnesota Oncology/ Woodbury Clinic
RECRUITING
Woodbury
Missouri
Washington University School of Medicine
RECRUITING
St Louis
North Carolina
Duke Cancer Institute
RECRUITING
Durham
New Jersey
Morristown Medical Center
RECRUITING
Morristown
Atlantic Health - Overlook MC
RECRUITING
Summit
Holy Name Medical Center
RECRUITING
Teaneck
New York
NYU Laura and Isaac Perlmutter Cancer Center - 34th Street
RECRUITING
New York
Perlmutter CC NYU Langone LI
RECRUITING
New York
Ohio
University of Cincinnati Medical Center
RECRUITING
Cincinnati
Oregon
Willamette Valley Cancer Institute and Research Center - Eugene
RECRUITING
Eugene
NW Cancer Specs. P.C.
RECRUITING
Happy Valley
USOR - NW Cancer Specs P.C.
RECRUITING
Portland
USOR - NW Cancer Specs. P.C.
RECRUITING
Tigard
Texas
TX Onc - Arlington North
RECRUITING
Arlington
USOR - Texas Oncology
RECRUITING
Austin
USOR - Texas Oncology
RECRUITING
Austin
USOR - Texas Oncology- Austin North
RECRUITING
Austin
TX Onc - Bedford
RECRUITING
Bedford
TX Onc - Methodist Charlton
RECRUITING
Dallas
TX Onc - Methodist Dallas
RECRUITING
Dallas
TX Onc - Presbyterian Dallas
RECRUITING
Dallas
TX Onc - Sammons
RECRUITING
Dallas
USOR - Texas Oncology - Dallas Fort Worth (DFW)
RECRUITING
Fort Worth
USOR - Texas Oncology
RECRUITING
Harlingen
USOR - Texas Oncology
RECRUITING
Mcallen
NEXT San Antonio
RECRUITING
San Antonio
USOR - TX Oncology - SA NE
RECRUITING
San Antonio
USOR - Texas Oncology- Horizon Circle
RECRUITING
Waco
USOR - Texas Oncology- Waco
RECRUITING
Waco
USOR - Texas Oncology
RECRUITING
Weslaco
Virginia
University of Virginia
RECRUITING
Charlottesville
Washington
USOR - NW Cancer Specs P.C.
RECRUITING
Vancouver
Other Locations
Australia
GenesisCare Campbelltown
RECRUITING
Campbelltown
Chris O'Brien Lifehouse
RECRUITING
Camperdown
Austin Health
RECRUITING
Heidelberg
Calvary Mater Newcastle
RECRUITING
Waratah
Belgium
Saint-Luc University Clinics
RECRUITING
Brussels
Antwerp University Hospital
RECRUITING
Edegem
Grand Hôpital de Charleroi
RECRUITING
Gilly
Universitair Ziekenhuis Leuven
RECRUITING
Leuven
CHU UCL Namur/Ste Elisabeth
RECRUITING
Namur
VITAZ
RECRUITING
Sint-niklaas
Brazil
Futtura Oncologia - Hub Pesq
RECRUITING
Porto Alegre
Hospital São Lucas da PUCRS
RECRUITING
Porto Alegre
Canada
Arthur J E Child Cancer Comp
RECRUITING
Calgary
MUHC - Glen Site
RECRUITING
Montreal
BC Cancer - Vancouver
RECRUITING
Vancouver
Denmark
Aalborg University Hospital
RECRUITING
Aalborg
Finland
Hus Ccc/Ctu
RECRUITING
Helsinki
Kuopio Univ. Hospital, PSHVA
RECRUITING
Kuopio
Oulu University Hospital
RECRUITING
Oulu
Tampere University Hospital
RECRUITING
Tampere
France
ICO Angers
RECRUITING
Angers
CH de la Côte Basque
RECRUITING
Bayonne
Clinique Tivoli Ducos
RECRUITING
Bordeaux
CHU Brest - Cavale Blanche
RECRUITING
Brest
Centre Jean Perrin
RECRUITING
Clermont-ferrand
CGFL Dijon
RECRUITING
Dijon
GHM Grenoble
RECRUITING
Grenoble
ICM Montpellier
RECRUITING
Montpellier
L'Hôpital Privé Nancy Lorraine
RECRUITING
Nancy
CHU Orléans - Pharmacie
RECRUITING
Orléans
Cancer Institute Jean Godinot
RECRUITING
Reims
HUS Strasbourg
RECRUITING
Strasbourg
Hôpital Foch
RECRUITING
Suresnes
Germany
Helios Hospital Berlin-Buch
RECRUITING
Berlin
Asklepios Hospital Barmbek
RECRUITING
Hamburg
Klinikum Lippe GmbH Pharmacy
RECRUITING
Lemgo
Greece
Alexandra General Hospital
RECRUITING
Athens
Aretaieio Hospital
RECRUITING
Athens
UGH Patras
RECRUITING
Pátrai
Israel
CARMEL
RECRUITING
Haifa
Rambam Medical Center
RECRUITING
Haifa
Shaare Zedek Medical Center
RECRUITING
Jerusalem
Galilee Medical Center
RECRUITING
Nahariya
Italy
Irst Meldola
RECRUITING
Meldola
European Institute of Oncology
RECRUITING
Milan
Humanitas San Pio X
RECRUITING
Milan
IRCCS San Gerardo Tintori
RECRUITING
Monza
Ospedale S Stefano
RECRUITING
Prato
AUSL IRCCS Reggio Emilia
RECRUITING
Reggio Emilia
Japan
Chiba University Hospital- Center for Outpatient
RECRUITING
Chiba
National Cancer Center Hospital East
RECRUITING
Chiba
National Hospital Organization Kyushu Cancer Center
RECRUITING
Fukuoka
Fukushima Medical University Hospital
RECRUITING
Fukushima
Hyogo Cancer Center
RECRUITING
Hyōgo
Shizuoka Cancer Center
RECRUITING
Nagaizumi-cho
Niigata Cancer Center Hospital
RECRUITING
Niigata
Osaka International Cancer Institute - Osaka - Otemae Acti
RECRUITING
Osaka
Gunma Prefectural Cancer Center
RECRUITING
Ōta
Kitasato University Hospital
RECRUITING
Sagamihara-shi
Saitama Medical University - International Medical Center
RECRUITING
Saitama
Sapporo Medical University Hospital
RECRUITING
Sapporo
NUC Tohoku Univ. Hospital
RECRUITING
Sendai
Iwate Medical University Hosp
RECRUITING
Shiwa-gun
Osaka Medical and Pharmaceutical University Hospital
RECRUITING
Takatsuki
Cancer Institute Hospital of JFCR
RECRUITING
Tokyo
Keio University Hospital
RECRUITING
Tokyo
Mie University Hospital
RECRUITING
Tsu
Yamagata University Hospital
RECRUITING
Yamagata
Kanagawa Cancer Center
RECRUITING
Yokohama
Lithuania
LSMU Hospital Kauno klinikos
RECRUITING
Kaunas
Dept., VUH Santaros Clinics
RECRUITING
Vilnius
Norway
Haukeland University Hospital
RECRUITING
Bergen
OUH Radium Hospital
RECRUITING
Oslo
Poland
Białystok Onc. Ctr. (MSC), GO
RECRUITING
Bialystok
ŚCO SPZOZ Kielce
RECRUITING
Kielce
ICZMP
RECRUITING
Lodz
Centrum Onkologi Ziemi Lubelsk
RECRUITING
Lublin
Siedleckie Centrum Onkologii
RECRUITING
Siedlce
UCH No. 2, PMU Szczecin
RECRUITING
Szczecin
Puerto Rico
PR Cancer Specialists
RECRUITING
San Juan
Singapore
Curie Oncology (Farrer)
RECRUITING
Singapore
NUH Singapore
RECRUITING
Singapore
Spain
CHU A Coruña
RECRUITING
A Coruña
Hospital Clínic BCN
RECRUITING
Barcelona
Vall d'Hebron
RECRUITING
Barcelona
Hospital Universitari de Girona Doctor Josep Trueta
RECRUITING
Girona
CUN Madrid
RECRUITING
Madrid
HM Sanchinarro
RECRUITING
Madrid
Hospital 12 de Octubre
RECRUITING
Madrid
Hospital La Paz
RECRUITING
Madrid
H.R.U. Málaga - Materno-Inf.
RECRUITING
Málaga
HU Virgen de la Victoria
RECRUITING
Málaga
Hosp. Univ. Son Espases
RECRUITING
Palma De Mallorca
CUN Pamplona
RECRUITING
Pamplona
HU Virgen de Valme
RECRUITING
Seville
HU Virgen del Rocío
RECRUITING
Seville
IVO Valencia
RECRUITING
Valencia
HU Miguel Servet
RECRUITING
Zaragoza
Contact Information
Primary
Genmab Trial Information
clinicaltrials@genmab.com
+4570202728
Time Frame
Start Date: 2025-11-28
Estimated Completion Date: 2029-11
Participants
Target number of participants: 660
Treatments
Experimental: Rina-S
Participants will receive Rina-S on Day 1 once every 3 weeks (Q3W).
Active_comparator: IC
Participants will receive one of the following chemotherapies at the discretion of the investigator:~* Paclitaxel on Days 1, 8, and 15 every 4 weeks (Q4W).~* Doxorubicin on Day 1 Q3W.
Related Therapeutic Areas
Sponsors
Leads: Genmab

This content was sourced from clinicaltrials.gov