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

Status: Recruiting
Location: See all (139) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

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

• Participants must have histologically or cytologically confirmed high grade serous or endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.

• Participants may be enrolled regardless of FRα expression level.

• Participants must have received 1 to 4 prior lines of therapy. Participants must have progressed radiographically on or after their most recent line of therapy.

• Participants must have received prior treatment with the following therapies:

‣ Platinum chemotherapy

⁃ Prior bevacizumab (or biosimilar) treatment is required, if labeled and available as standard of care per institutional guidelines, unless the participant has a documented contraindication or unless the participant is not eligible for treatment with bevacizumab (or biosimilar) due to precautions/intolerance

⁃ Participants with known or suspected deleterious germline or somatic breast cancer gene (BRCA) mutations and who achieved a complete or partial response to platinum-based chemotherapy must have been treated with a poly ADP-ribose polymerase (PARP) inhibitor as maintenance treatment unless the participant is not eligible for treatment with PARP inhibitor

⁃ Mirvetuximab soravtansine, if:

• Mirvetuximab soravtansine is available in the enrollment region, and

∙ The participant is eligible based on positive FRα expression per Food and Drug Administration (FDA)-approved (or local equivalent) test, and

∙ The participant does not have a documented medical exception, including chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring, such as uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, and /or monocular vision.

• Participants must have platinum-resistant disease:

‣ Participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum therapy, and must have either had a response (CR or PR) or had non-measurable disease at the start of adjuvant platinum-based therapy, and then progressed between \> 91 days and ≤ 183 days after the date of the last dose of platinum.

⁃ Participants who have received 2 to 4 lines of platinum-based therapy must have progressed on or within 183 days after the date of the last dose of platinum.

Locations
United States
Alaska
Alaska Women's Cancer Care
RECRUITING
Anchorage
Arizona
Arizona Center for Cancer Care (ACCC) - Biltmore
RECRUITING
Scottsdale
University of Arizona Cancer Center - Research and Administration at Main Campus
RECRUITING
Tucson
California
Providence Saint Joseph Medical Center - Roy and Patricia Disney Family Cancer Center
RECRUITING
Burbank
University of California San Diego Moores Cancer Center
RECRUITING
La Jolla
USCF Mission Bay
RECRUITING
San Francisco
Kaiser Permanente - Vallejo Medical Center
RECRUITING
Vallejo
Colorado
UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center
RECRUITING
Aurora
Connecticut
Hartford Hospital
RECRUITING
Hartford
Yale School of Medicine
RECRUITING
New Haven
Norwalk Hospital
RECRUITING
Norwalk
Florida
SCRI - Florida Cancer Specialists - South Region Research Office
RECRUITING
Fort Myers
Mount Sinai Comprehensive Cancer Center
RECRUITING
Miami Beach
Orlando Health Cancer Institute - Downtown Orlando
RECRUITING
Orlando
Sarasota Memorial Hospital
RECRUITING
Sarasota
SCRI - Florida Cancer Specialists - West Palm Beach
RECRUITING
West Palm Beach
Georgia
Northside Hospital Atlanta
RECRUITING
Atlanta
Winship Cancer Institute of Emory University
RECRUITING
Atlanta
Augusta University Georgia Cancer Center
RECRUITING
Augusta
Indiana
Northwest Cancer Center - Dyer
RECRUITING
Dyer
Kansas
University of Kansas Cancer Center
RECRUITING
Kansas City
HCA Midwest Health
RECRUITING
Overland Park
Kentucky
St. Elizabeth Healthcare - Edgewood
RECRUITING
Edgewood
Baptist Health Lexington
RECRUITING
Lexington
Louisiana
Louisiana State University Health Sciences Center (LSU Health) - New Orleans
RECRUITING
New Orleans
Trials365, LLC (Gynecologic Oncology Associates-Shreveport)
RECRUITING
Shreveport
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Dana-Farber Cancer Institute
RECRUITING
Boston
Maine
Maine Medical Center Cancer Institute- Scarborough
RECRUITING
Scarborough
Michigan
Barbara Ann Karmanos Cancer Institute
RECRUITING
Detroit
Corewell Health (Spectrum Health)
RECRUITING
Grand Rapids
Saint Joseph Mercy Ann Arbor Hospital
RECRUITING
Ypsilanti
North Carolina
Duke Cancer Institute
RECRUITING
Durham
FirstHealth Outpatient Cancer Center
RECRUITING
Pinehurst
Nebraska
University of Nebraska Medical Center
RECRUITING
Omaha
New Jersey
Holy Name Medical Center
RECRUITING
Teaneck
New Mexico
University of New Mexico Comprehensive Cancer Center
RECRUITING
Albuquerque
Nevada
Center of Hope
RECRUITING
Reno
New York
Roswell Park Comprehensive Cancer Center
RECRUITING
Buffalo
Herbert Irving Comprehensive Cancer Center
RECRUITING
New York
New York-Presbyterian - Weill Cornell Medical Center
RECRUITING
New York
Perlmutter Cancer Center - 38th Street
RECRUITING
New York
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
RECRUITING
New York
James P. Wilmot Cancer Center
RECRUITING
Rochester
Ohio
University of Cincinnati Medical Center
RECRUITING
Cincinnati
Cleveland Clinic Main Campus
RECRUITING
Cleveland
MetroHealth Medical Center
RECRUITING
Cleveland
University Hospitals Cleveland Medical Center
RECRUITING
Cleveland
JamesCare Gynecologic Oncology at Mill Run
RECRUITING
Hilliard
Oregon
Legacy Good Samaritan Medical Center
RECRUITING
Portland
Oregon Health and Science University
RECRUITING
Portland
USOR - Northwest Cancer Specialists, P.C. dba Compass Oncology - Rose Quarter Cancer Center
RECRUITING
Portland
Pennsylvania
St. Luke's University Health Network
RECRUITING
Bethlehem
Penn State Health Milton S. Hershey Medical Center
RECRUITING
Hershey
Fox Chase Cancer Center
RECRUITING
Philadelphia
Allegheny Health Network - West Penn Hospital
RECRUITING
Pittsburgh
Jefferson Health - Asplundh Cancer Pavilion
RECRUITING
Willow Grove
South Dakota
Avera Cancer Institute
RECRUITING
Sioux Falls
Tennessee
SCRI Oncology Partners
RECRUITING
Nashville
Texas
USOR - Texas Oncology - Dallas Fort Worth (DFW) - Abilene
RECRUITING
Abilene
USOR - Texas Oncology - Dallas Fort Worth (DFW) - Austin Central
RECRUITING
Austin
University of Texas Southwestern Medical Center
RECRUITING
Dallas
USOR - Texas Oncology - Dallas Fort Worth (DFW) - Fort Worth
RECRUITING
Fort Worth
Virginia
Inova Schar Cancer Institute
RECRUITING
Fairfax
USOR - Virginia Oncology Associates - Norfolk
RECRUITING
Norfolk
Washington
Kadlec Clinic - Hematology and Oncology
RECRUITING
Kennewick
Fred Hutchinson Cancer Research Center
RECRUITING
Seattle
Providence Sacred Heart Medical Center
RECRUITING
Spokane
Wisconsin
University of Wisconsin - Madison
RECRUITING
Madison
West Virginia
West Virginia University Cancer Institute
RECRUITING
Morgantown
Other Locations
Australia
Icon Cancer Centre
RECRUITING
South Brisbane
Austria
Medizinische Universität Graz
RECRUITING
Graz
Medizinische Universität Innsbruck
RECRUITING
Innsbruck
Ordensklinikum Linz GmbH Barmherzige Schwestern
RECRUITING
Linz
Medizinische Universität Wien
RECRUITING
Vienna
Belgium
AZORG - Onze-Lieve-Vrouwziekenhuis - Campus Aalst
RECRUITING
Aalst
Centre Hospitalier Universitaire Saint-Pierre
RECRUITING
Brussels
Universitair Ziekenhuis (UZ) Leuven - Campus Gasthuisberg
RECRUITING
Leuven
Centre Hospitalier Chretien - Clinique MontLégia
RECRUITING
Liège
Algemeen Ziekenhuis Delta - Campus Rumbeke
RECRUITING
Roeselare
Algemeen Ziekenhuis Turnhout - Campus Sint-Elisabeth
RECRUITING
Turnhout
Canada
Centre Hospitalier de l'Université de Montréal (CHUM)
RECRUITING
Montreal
Princess Margaret Cancer Centre
RECRUITING
Toronto
Sunnybrook Health Sciences Centre - Bayview Campus
RECRUITING
Toronto
Denmark
Aalborg Universitetshospital
RECRUITING
Aalborg
Odense Universitets Hospital
RECRUITING
Odense
France
Hôpital Européen Georges-Pompidou
RECRUITING
Paris
Hospital Lyon-Sud (HCL)
RECRUITING
Pierre-bénite
Centre Eugène Marquis
RECRUITING
Rennes
Institut Universitaire du Cancer de Toulouse (IUCT) Oncopole
RECRUITING
Toulouse
Gustave Roussy
RECRUITING
Villejuif
Germany
Helios Klinikum Berlin-Buch
RECRUITING
Berlin
University Hospital Bonn
RECRUITING
Bonn
University Hospital Carl Gustav Carus Dresden
RECRUITING
Dresden
Klinikum der Johann Wolfgang Goethe-Universität
RECRUITING
Frankfurt
Universitätsklinikum Gießen und Marburg - Gießen (UKGM)
RECRUITING
Giessen
Mammazentrum Hamburg am Krankenhaus Jerusalem
RECRUITING
Hamburg
MVZ Onko Medical GmbH Hanover
RECRUITING
Hanover
UniversitY Hospital of Saarland
RECRUITING
Homburg
Red Cross Hospital Munich
RECRUITING
Munich
Helios Dr. Horst Schmidt Kliniken Wiesbaden
RECRUITING
Wiesbaden
Greece
General Hospital of Athens
RECRUITING
Athens
Attikon University General Hospital/General Hospital of West Attica
RECRUITING
Chaïdári
Aretaieio Hospital
RECRUITING
Léfkos
Saint Luke's Hospital
RECRUITING
Panórama
Italy
Humanitas San Pio X
RECRUITING
Milan
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
RECRUITING
Milan
Japan
Saitama Medical University - International Medical Center
RECRUITING
Hidaka
St. Marianna University Hospital
RECRUITING
Kawasaki
Kurume University Hospital
RECRUITING
Kurume
The Jikei University Hospital
RECRUITING
Minato
Shizuoka Cancer Center
RECRUITING
Nagaizumi-chō
Aichi Cancer Center
RECRUITING
Nagoya
Niigata University Medical and Dental Hospital
RECRUITING
Niigata
Okayama University Hospital
RECRUITING
Okayama
Jichi Medical University Hospital
RECRUITING
Saitama
Hokkaido Cancer Center
RECRUITING
Sapporo
Tohoku University Hospital
RECRUITING
Sendai
Ehime University Hospital
RECRUITING
Shibukawa
Cancer Institute Hospital of JFCR
RECRUITING
Tokyo
National Cancer Center Hospital
RECRUITING
Tokyo
Netherlands
Leids Universitair Medisch Centrum (LUMC)
RECRUITING
Leiden
Maastricht (UMC) Universitair Medisch Centrum
RECRUITING
Maastricht
Norway
Oslo Universitetssykehus - Radiumhospitalet
RECRUITING
Oslo
Poland
Białostockie Centrum Onkologii im. Marii Skłodowskiej- Curie w Białymstoku
RECRUITING
Bialystok
Uniwersyteckie Centrum Kliniczne w Gdańsku
RECRUITING
Gdansk
Jagiellońskie Centrum Innowacj
RECRUITING
Krakow
Instytut Centrum Zdrowia Matki Polki
RECRUITING
Lodz
Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie
RECRUITING
Poznan
Mazowiecki Szpital Wojewódzki im. św. Jana Pawła II w Siedlcach
RECRUITING
Siedlce
Uniwersytecki Szpital Kliniczny Nr 2 PUM w Szczecinie
RECRUITING
Szczecin
Puerto Rico
UPR Comprehensive Cancer Center Hospital
RECRUITING
Monacillo
Spain
Hospital Universitario de A Coruña
RECRUITING
A Coruña
Hospital Universitario DE Donostia
RECRUITING
Donostia / San Sebastian
Hospital Universitario La Paz
RECRUITING
Madrid
MD Anderson Cancer Center Madrid
RECRUITING
Madrid
Virgen del Rocío University Hospital
RECRUITING
Seville
IVO - Valencian Institute of Oncology Foundation
RECRUITING
Valencia
Miguel Servet Hospital
RECRUITING
Zaragoza
Contact Information
Primary
Genmab Trial Information
clinicaltrials@genmab.com
+4570202728
Time Frame
Start Date: 2025-02-07
Estimated Completion Date: 2028-05-23
Participants
Target number of participants: 530
Treatments
Experimental: Rina-S
Active_comparator: Investigator's Choice
Related Therapeutic Areas
Sponsors
Leads: Genmab

This content was sourced from clinicaltrials.gov