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A Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Maintenance Treatment Versus Standard of Care in Participants With Platinum-sensitive Recurrent Ovarian Cancer (MK-2870-022/TroFuse-022/ENGOT-ov84/GOG-3103)
Sponsor: Merck Sharp & Dohme LLC
Summary
The main goals of this study are to learn about the safety of sacituzumab tirumotecan with bevacizumab and if people tolerate it; and if people who take sacituzumab tirumotecan with or without bevacizumab live longer without the cancer getting worse than those who receive standard of care treatment.
Official title: A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan Maintenance Treatment With or Without Bevacizumab Versus Standard of Care After Second-line Platinum-based Doublet Chemotherapy in Participants With Platinum-sensitive Recurrent Ovarian Cancer (TroFuse-022/ENGOT-ov84/GOG-3103)
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
770
Start Date
2025-04-09
Completion Date
2032-11-09
Last Updated
2026-10-13
Healthy Volunteers
No
Interventions
Sacituzumab tirumotecan
IV Infusion
Bevacizumab
IV Infusion
H1 receptor antagonist
Rescue medication taken per approved product label before sacituzumab tirumotecan
H2 receptor antagonist
Rescue medication taken per approved product label before sacituzumab tirumotecan
Acetaminophen (or equivalent)
Rescue medication taken per approved product label before sacituzumab tirumotecan
Dexamethasone (or equivalent)
Rescue medication taken per approved product label before sacituzumab tirumotecan
Steroid mouthwash (dexamethasone or equivalent)
Rescue medication taken orally 2-4 times daily
Locations (198)
University of Alabama at Birmingham ( Site 0006)
Birmingham, Alabama, United States
Alaska Women's Cancer Care ( Site 0096)
Anchorage, Alaska, United States
City of Hope Lennar Foundation Cancer Center ( Site 0024)
Irvine, California, United States
UCSF Medical Center at Mission Bay ( Site 0013)
San Francisco, California, United States
John Muir Health Cancer Center ( Site 0016)
Walnut Creek, California, United States
Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0001)
New Haven, Connecticut, United States
Mount Sinai Braman Comprehensive Cancer Center ( Site 0078)
Miami Beach, Florida, United States
Sarasota Memorial Hospital ( Site 0075)
Sarasota, Florida, United States
Florida Cancer Specialists East ( Site 7000)
West Palm Beach, Florida, United States
Winship Cancer Institute of Emory University ( Site 0086)
Atlanta, Georgia, United States
Augusta University - Georgia Cancer Center ( Site 0066)
Augusta, Georgia, United States
Parkview Research Center at Parkview Regional Medical Center ( Site 0003)
Fort Wayne, Indiana, United States
The University of Kansas Cancer Center - Westwood ( Site 0002)
Westwood, Kansas, United States
Women's Cancer Care ( Site 0067)
Covington, Louisiana, United States
Maine Medical Center Research Institute-MaineHealth/Maine Medical Partners - GynOnc ( Site 0008)
Scarborough, Maine, United States
Minnesota Oncology Hematology (MNO) ( Site 8002)
Maplewood, Minnesota, United States
St. Dominic's Hospital ( Site 0064)
Jackson, Mississippi, United States
Washington University School of Medicine ( Site 0052)
St Louis, Missouri, United States
Nebraska Methodist Hospital ( Site 0053)
Omaha, Nebraska, United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0081)
Hackensack, New Jersey, United States
Rutgers Cancer Institute of New Jersey ( Site 0071)
New Brunswick, New Jersey, United States
University of New Mexico Comprehensive Cancer Center ( Site 0055)
Albuquerque, New Mexico, United States
NYU Langone Hospital - Long Island ( Site 0015)
Mineola, New York, United States
Laura and Isaac Perlmutter Cancer Center ( Site 0076)
New York, New York, United States
FirstHealth Cancer Center ( Site 0079)
Pinehurst, North Carolina, United States
University of Cincinnati Medical Center ( Site 0090)
Cincinnati, Ohio, United States
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0054)
Columbus, Ohio, United States
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0056)
Tulsa, Oklahoma, United States
Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8010)
Eugene, Oregon, United States
Allegheny Health Network West Penn Hospital ( Site 0099)
Pittsburgh, Pennsylvania, United States
Women & Infants Hospital ( Site 0050)
Providence, Rhode Island, United States
Henry-Joyce Cancer Clinic ( Site 0060)
Nashville, Tennessee, United States
Texas Oncology - Central/South Texas ( Site 8009)
Austin, Texas, United States
Texas Oncology - DFW ( Site 8001)
Fort Worth, Texas, United States
University Of Texas Health Science Center -San Antonio ( Site 0095)
San Antonio, Texas, United States
Texas Oncology - San Antonio ( Site 8005)
San Antonio, Texas, United States
Texas Oncology - Gulf Coast ( Site 8003)
Webster, Texas, United States
Virginia Cancer Specialists (VCS) ( Site 8011)
Fairfax, Virginia, United States
Instituto Alexander Fleming ( Site 2909)
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Mar del Plata ( Site 2901)
Mar del Plata, Buenos Aires, Argentina
Fundación Respirar ( Site 2912)
Buenos Aires, Buenos Aires F.D., Argentina
Instituto de Oncologia de Rosario ( Site 2910)
Rosario, Santa Fe Province, Argentina
Hospital Aleman ( Site 2903)
CABA, Argentina
Hospital Italiano de Cordoba ( Site 2908)
Córdoba, Argentina
Blacktown Hospital ( Site 0211)
Sydney, New South Wales, Australia
Gallipoli Medical Research Ltd ( Site 0214)
Brisbane, Queensland, Australia
Epworth Freemasons ( Site 0217)
East Melbourne, Victoria, Australia
Frankston Hospital ( Site 0216)
Frankston, Victoria, Australia
Medizinische Universitat Wien ( Site 0102)
Vienna, State of Vienna, Austria
Medizinische Universität Graz-Abteilung für Gynäkologie / Onkologie ( Site 0104)
Graz, Styria, Austria
Medizinische Universitaet Innsbruck-Univ.-Klinik f. Gynäkologie und Geburtshilfe ( Site 0101)
Innsbruck, Tyrol, Austria
Antwerp University Hospital ( Site 0304)
Edegem, Antwerpen, Belgium
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman ( Site 0306)
Liège, Liege, Belgium
AZ Sint-Lucas ( Site 0305)
Ghent, Oost-Vlaanderen, Belgium
UZ Leuven ( Site 0301)
Leuven, Vlaams-Brabant, Belgium
CHU UCL Namur/Site Sainte Elisabeth ( Site 0302)
Namur, Belgium
Liga Norte Riograndense Contra o Cancer ( Site 0423)
Natal, Rio Grande do Norte, Brazil
Hospital São Lucas da PUCRS ( Site 0425)
Porto Alegre, Rio Grande do Sul, Brazil
ANIMI - Unidade de Tratamento Oncologico ( Site 0419)
Lages, Santa Catarina, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto ( Site 0413)
São José do Rio Preto, São Paulo, Brazil
Instituto Nacional de Câncer - INCA ( Site 0422)
Rio de Janeiro, Brazil
Hospital Paulistano ( Site 0421)
São Paulo, Brazil
IBCC - Núcleo de Pesquisa e Ensino ( Site 0424)
São Paulo, Brazil
Arthur J.E. Child Comprehensive Cancer Centre ( Site 0512)
Calgary, Alberta, Canada
Health Sciences North Research Institute ( Site 0517)
Greater Sudbury, Ontario, Canada
Trillium Health Partners - Credit Valley Hospital ( Site 0508)
Mississauga, Ontario, Canada
Princess Margaret Cancer Centre ( Site 0518)
Toronto, Ontario, Canada
CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0505)
Montreal, Quebec, Canada
McGill University Health Centre ( Site 0502)
Montreal, Quebec, Canada
Clinica Puerto Montt ( Site 0615)
Port Montt, Los Lagos Region, Chile
Fundación Arturo López Pérez ( Site 0616)
Santiago, Region M. de Santiago, Chile
Pontificia Universidad Catolica de Chile ( Site 0611)
Santiago, Region M. de Santiago, Chile
Bradfordhill-Clinical Area ( Site 0610)
Santiago, Region M. de Santiago, Chile
ONCOCENTRO APYS-ACEREY ( Site 0612)
Viña del Mar, Valparaiso, Chile
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0806)
Bogotá, Bogota D.C., Colombia
Instituto Nacional De Cancerologia ( Site 0807)
Bogotá, Bogota D.C., Colombia
Oncologos Del Occidente ( Site 0805)
Pereira, Risaralda Department, Colombia
Fakultni Nemocnice Brno Bohunice ( Site 3324)
Brno, Brno-mesto, Czechia
Fakultni nemocnice Ostrava ( Site 3323)
Ostrava-Poruba, Ostrava Mesto, Czechia
Vseobecna fakultni nemocnice v Praze ( Site 3325)
Prague, Czechia
Fakultni nemocnice v Motole ( Site 3322)
Prague, Czechia
Rigshospitalet ( Site 0904)
Copenhagen, Capital Region, Denmark
Herlev Hospital ( Site 0903)
Herlev, Capital Region, Denmark
Aalborg Universitetshospital ( Site 0901)
Aalborg, North Denmark, Denmark
Vejle Sygehus ( Site 0902)
Vejle, Region Syddanmark, Denmark
Oulun yliopistollinen sairaala ( Site 1003)
Oulu, North Ostrobothnia, Finland
Kuopion Yliopistollinen Sairaala ( Site 1004)
Kuopio, Northern Savonia, Finland
Tampereen yliopistollinen sairaala ( Site 1002)
Tampere, Pirkanmaa, Finland
Centre Oscar Lambret ( Site 1104)
Lille, Ain, France
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 1101)
Bordeaux, Aquitaine, France
Centre Hopitalier Lyon Sud ( Site 1110)
Pierre-Bénite, Auvergne-Rhône-Alpes, France
Centre Francois Baclesse ( Site 1108)
Caen, Calvados, France
Hôpital Privé Des Côtes d'Armor ( Site 1106)
Plérin, Cotes-d Armor, France
LBM ONCOPOLE CLAUDIUS REGAUD ( Site 1109)
Toulouse, Haute-Garonne, France
Pôle Santé Léonard de Vinci ( Site 1112)
Chambray-lès-Tours, Indre-et-Loire, France
Groupe Hospitalier Broca Cochin Hotel Dieu ( Site 1111)
Paris, Paris, France
Institut De Cancerologie De L Ouest ( Site 1107)
Saint-Herblain, Pays de la Loire Region, France
Sainte Catherine Institut du Cancer Avignon Provence ( Site 1105)
Avignon, Vaucluse, France
Groupe Hospitalier Diaconesses Croix Saint Simon ( Site 1102)
Paris, France
Aretaieio Hospital ( Site 0701)
Athens, Attica, Greece