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RECRUITING
NCT06824467
PHASE3

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

View on ClinicalTrials.gov

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

BIOLOGICAL

Sacituzumab tirumotecan

IV Infusion

BIOLOGICAL

Bevacizumab

IV Infusion

DRUG

H1 receptor antagonist

Rescue medication taken per approved product label before sacituzumab tirumotecan

DRUG

H2 receptor antagonist

Rescue medication taken per approved product label before sacituzumab tirumotecan

DRUG

Acetaminophen (or equivalent)

Rescue medication taken per approved product label before sacituzumab tirumotecan

DRUG

Dexamethasone (or equivalent)

Rescue medication taken per approved product label before sacituzumab tirumotecan

DRUG

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

And 98 more locations on ClinicalTrials.gov