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ACTIVE NOT RECRUITING
NCT06619236
PHASE3

Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer

Sponsor: Genmab

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase 3 Randomized, Open-label Study of Rinatabart Sesutecan (Rina-S) Versus Treatment of Investigator's Choice (IC) in Patients With Platinum Resistant Ovarian Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

530

Start Date

2025-02-07

Completion Date

2028-05-23

Last Updated

2026-03-03

Healthy Volunteers

No

Interventions

DRUG

Rina-S

Intravenous (IV) infusion

DRUG

Paclitaxel

IV infusion

DRUG

Topotecan

IV infusion

DRUG

Pegylated liposomal doxorubicin (PLD)

IV infusion

DRUG

Gemcitabine

IV infusion

Locations (177)

Alaska Women's Cancer Care

Anchorage, Alaska, United States

Arizona Center for Cancer Care (ACCC) - Biltmore

Scottsdale, Arizona, United States

University of Arizona Cancer Center - Research and Administration at Main Campus

Tucson, Arizona, United States

Providence Saint Joseph Medical Center - Roy and Patricia Disney Family Cancer Center

Burbank, California, United States

University of California San Diego Moores Cancer Center

La Jolla, California, United States

USCF Mission Bay

San Francisco, California, United States

Kaiser Permanente - Vallejo Medical Center

Vallejo, California, United States

UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center

Aurora, Colorado, United States

Hartford Hospital

Hartford, Connecticut, United States

Yale School of Medicine

New Haven, Connecticut, United States

Norwalk Hospital

Norwalk, Connecticut, United States

SCRI - Florida Cancer Specialists - South Region Research Office

Fort Myers, Florida, United States

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, United States

Orlando Health Cancer Institute - Downtown Orlando

Orlando, Florida, United States

Sarasota Memorial Hospital

Sarasota, Florida, United States

SCRI - Florida Cancer Specialists - West Palm Beach

West Palm Beach, Florida, United States

Winship Cancer Institute of Emory University

Atlanta, Georgia, United States

Northside Hospital Atlanta

Atlanta, Georgia, United States

Augusta University Georgia Cancer Center

Augusta, Georgia, United States

Kapi'olani Medical Center for Women and Children

Honolulu, Hawaii, United States

Northwest Cancer Center - Dyer

Dyer, Indiana, United States

University of Kansas Cancer Center

Kansas City, Kansas, United States

HCA Midwest Health

Overland Park, Kansas, United States

St. Elizabeth Healthcare - Edgewood

Edgewood, Kentucky, United States

Baptist Health Lexington

Lexington, Kentucky, United States

Louisiana State University Health Sciences Center (LSU Health) - New Orleans

New Orleans, Louisiana, United States

Trials365, LLC (Gynecologic Oncology Associates-Shreveport)

Shreveport, Louisiana, United States

Maine Medical Center Cancer Institute- Scarborough

Scarborough, Maine, United States

Holy Cross Health - Holy Cross Hospital

Silver Spring, Maryland, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Corewell Health (Spectrum Health)

Grand Rapids, Michigan, United States

Saint Joseph Mercy Ann Arbor Hospital

Ypsilanti, Michigan, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Center of Hope

Reno, Nevada, United States

Holy Name Medical Center

Teaneck, New Jersey, United States

University of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico, United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

Perlmutter Cancer Center - 38th Street

New York, New York, United States

Perlmutter Cancer Center at NYU Langone Hospital - Long Island

New York, New York, United States

Herbert Irving Comprehensive Cancer Center

New York, New York, United States

New York-Presbyterian - Weill Cornell Medical Center

New York, New York, United States

James P. Wilmot Cancer Center

Rochester, New York, United States

Duke Cancer Institute

Durham, North Carolina, United States

FirstHealth Outpatient Cancer Center

Pinehurst, North Carolina, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

MetroHealth Medical Center

Cleveland, Ohio, United States

Cleveland Clinic Main Campus

Cleveland, Ohio, United States

JamesCare Gynecologic Oncology at Mill Run

Hilliard, Ohio, United States

Legacy Good Samaritan Medical Center

Portland, Oregon, United States

USOR - Northwest Cancer Specialists, P.C. dba Compass Oncology - Rose Quarter Cancer Center

Portland, Oregon, United States

Oregon Health and Science University

Portland, Oregon, United States

St. Luke's University Health Network

Bethlehem, Pennsylvania, United States

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Allegheny Health Network - West Penn Hospital

Pittsburgh, Pennsylvania, United States

Jefferson Health - Asplundh Cancer Pavilion

Willow Grove, Pennsylvania, United States

Avera Cancer Institute

Sioux Falls, South Dakota, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

USOR - Texas Oncology - Dallas Fort Worth (DFW) - Abilene

Abilene, Texas, United States

USOR - Texas Oncology - Dallas Fort Worth (DFW) - Austin Central

Austin, Texas, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

USOR - Texas Oncology - Dallas Fort Worth (DFW) - Fort Worth

Fort Worth, Texas, United States

Inova Schar Cancer Institute

Fairfax, Virginia, United States

USOR - Virginia Oncology Associates - Norfolk

Norfolk, Virginia, United States

Kadlec Clinic - Hematology and Oncology

Kennewick, Washington, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Providence Sacred Heart Medical Center

Spokane, Washington, United States

West Virginia University Cancer Institute

Morgantown, West Virginia, United States

University of Wisconsin - Madison

Madison, Wisconsin, United States

Newcastle Private Hospital

New Lambton Heights, New South Wales, Australia

Icon Cancer Centre

South Brisbane, Queensland (qld), Australia

Mater Misericordiae - Mater Hospital Brisbane

South Brisbane, Australia

Saint John of God - Subiaco Hospital

Subiaco, Australia

Medizinische Universität Innsbruck

Innsbruck, Tyrol, Austria

Ordensklinikum Linz GmbH Barmherzige Schwestern

Linz, Upper Austria (Oberösterreich), Austria

Krankenhaus Hietzing

Vienna, Vienna, Austria

Medizinische Universität Graz

Graz, Austria

Medizinische Universität Wien

Vienna, Austria

Algemeen Ziekenhuis Turnhout - Campus Sint-Elisabeth

Turnhout, Antwerp, Belgium

AZORG - Onze-Lieve-Vrouwziekenhuis - Campus Aalst

Aalst, Belgium

Centre Hospitalier Universitaire Saint-Pierre

Brussels, Belgium

Grand Hôpital de Charleroi - Site Les Viviers

Charleroi, Belgium

Universitair Ziekenhuis (UZ) Leuven - Campus Gasthuisberg

Leuven, Belgium

Centre Hospitalier Chretien - Clinique MontLégia

Liège, Belgium

Algemeen Ziekenhuis Delta - Campus Rumbeke

Roeselare, Belgium

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

Sunnybrook Health Sciences Centre - Bayview Campus

Toronto, Canada

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

The First Hospital of Jilin University

Changchun, China

Zhejiang Cancer Hospital

Hanzhou, China

Fudan University Shanghai Cancer Center

Shanghai, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

Henan Cancer Hospital - Zhengzhou University

Zhengzhou, China

University Hospital Královské Vinohrady

Prague, Prague, Czechia

Masaryk Memorial Cancer Institute

Brno, Czechia

Fakultní Nemocnice Hradec Králové

Hradec Králové, Czechia

Nemocnice AGEL Nový Jičín a.s.

Nový Jičín, Czechia

Vseobecna Fakultni Nemocnice v Praze

Prague, Czechia

Fakultni nemocnice v Motole

Prague, Czechia

Bulovka University Hospital

Prague, Czechia

Aalborg Universitetshospital

Aalborg, Denmark

The Royal Hospital (Rigshospitalet)

Copenhagen, Denmark

Odense Universitets Hospital

Odense, Denmark

Centre Antoine Lacassagne

Nice, France

Hôpital Européen Georges-Pompidou

Paris, France

Hospital Lyon-Sud (HCL)

Pierre-Bénite, France

Centre Eugène Marquis

Rennes, France

Western Cancer Institute - Saint-Herblain - René Gauducheau Site

Saint-Herblain, France

Institut Universitaire du Cancer de Toulouse (IUCT) Oncopole

Toulouse, France

Gustave Roussy

Villejuif, France

Helios Klinikum Berlin-Buch

Berlin, Germany

University Hospital Bonn

Bonn, Germany

University Hospital Carl Gustav Carus Dresden

Dresden, Germany

University Hospital of Düsseldorf

Düsseldorf, Germany

Kliniken Essen-Mitte - Evangelische Huyssens-Stiftung

Essen, Germany

Klinikum der Johann Wolfgang Goethe-Universität

Frankfurt, Germany

Universitätsklinikum Gießen und Marburg - Gießen (UKGM)

Giessen, Germany

Mammazentrum Hamburg am Krankenhaus Jerusalem

Hamburg, Germany

MVZ Onko Medical GmbH Hanover

Hanover, Germany

University Hospital Heidelberg /Universitätsklinikum Heidelberg

Heidelberg, Germany

UniversitY Hospital of Saarland

Homburg, Germany

Red Cross Hospital Munich

Munich, Germany

Universitätsklinikum Münster/University Clinic Muenster

Münster, Germany

Helios Dr. Horst Schmidt Kliniken Wiesbaden

Wiesbaden, Germany

General Hospital of Athens

Athens, Greece

Attikon University General Hospital/General Hospital of West Attica

Chaïdári, Greece

Aretaieio Hospital

Léfkos, Greece

Saint Luke's Hospital

Panórama, Greece

Azienda Sanitaria Locale Brindisi

Brindisi, Apulia, Italy

Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele

Milan, Italy

Istituto Europeo di Oncologia/ European Institute of Oncology

Milan, Italy

Humanitas San Pio X

Milan, Italy

Local Health Authority of Biella - Nuovo Ospedale degli Infermi

Ponderano, Italy

Agostino Gemelli University Hospital Foundation IRCCS

Roma, Italy

Centre Antoine Lacassagne/Azienda Ospedaliera Ordine Mau

Torino, Italy

Aichi Cancer Center

Nagoya, Aichi Pref, Japan

Kurume University Hospital

Kurume, Fukuoka Pref, Japan

Hokkaido Cancer Center

Sapporo, Hokkaido, Japan

St. Marianna University Hospital

Kawasaki, Kanagawa Pref, Japan

Tohoku University Hospital

Sendai, Miyagi Pref, Japan

Niigata University Medical and Dental Hospital

Niigata, Niigata Pref, Japan

Okayama University Hospital

Okayama, Okayama Pref., Japan

Saitama Medical University - International Medical Center

Hidaka, Saitama Pref., Japan

Shizuoka Cancer Center

Nagaizumi-chō, Shizuoka Pref., Japan

Jichi Medical University Hospital

Saitama, Tochigi Pref., Japan

The Jikei University Hospital

Minato, Tokyo, Japan

Ehime University Hospital

Shibukawa, Toon City, Ehime Pref, Japan

National Cancer Center Hospital

Tokyo, Japan

Cancer Institute Hospital of JFCR

Tokyo, Japan

Amsterdam UMC, location VUmc

Amsterdam, Netherlands

Medisch Spectrum Twente - Enschede Koningsplein

Enschede, Netherlands

Leids Universitair Medisch Centrum (LUMC)

Leiden, Netherlands

Maastricht (UMC) Universitair Medisch Centrum

Maastricht, Netherlands

Erasmus MC/ Erasmus Medisch Centrum

Rotterdam, Netherlands

Oslo Universitetssykehus - Radiumhospitalet

Oslo, Norway

University Hospital of North Norway/Universitetssykehuset Nord-Norge - Tromsø

Tromsø, Norway

Jagiellońskie Centrum Innowacj

Krakow, Lesser Poland (Małopolskie), Poland

Białostockie Centrum Onkologii im. Marii Skłodowskiej- Curie w Białymstoku

Bialystok, Poland

Uniwersyteckie Centrum Kliniczne w Gdańsku

Gdansk, Poland

Instytut Centrum Zdrowia Matki Polki

Lodz, Poland

Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie

Poznan, Poland

Mazowiecki Szpital Wojewódzki im. św. Jana Pawła II w Siedlcach

Siedlce, Poland

Uniwersytecki Szpital Kliniczny Nr 2 PUM w Szczecinie

Szczecin, Poland

UPR Comprehensive Cancer Center Hospital

Monacillo, San Juan, Puerto Rico

Hospital Universitario de A Coruña

A Coruña, Spain

Hospital Universitario DE Donostia

Donostia / San Sebastian, Spain

Hospital Clínico Universitario Virgen de la Arrixaca

El Palmar, Spain

Hospital Universitario La Paz

Madrid, Spain

MD Anderson Cancer Center Madrid

Madrid, Spain

Virgen del Rocío University Hospital

Seville, Spain

IVO - Valencian Institute of Oncology Foundation

Valencia, Spain

Miguel Servet Hospital

Zaragoza, Spain