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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

2026-04-02

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 (152)

University of Alabama at Birmingham ( Site 0006)

Birmingham, Alabama, United States

Alaska Women's Cancer Care ( Site 0096)

Anchorage, Alaska, United States

Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0001)

New Haven, Connecticut, United States

Mount Sinai 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

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

St. Dominic's Hospital ( Site 0064)

Jackson, Mississippi, 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

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

Women & Infants Hospital ( Site 0050)

Providence, Rhode Island, United States

Texas Oncology - Central/South Texas ( Site 8009)

Austin, Texas, United States

Texas Oncology - DFW ( Site 8001)

Fort Worth, 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

Antwerp University Hospital ( Site 0304)

Edegem, Antwerpen, Belgium

Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman ( Site 0306)

Liège, Liege, Belgium

CHU UCL Namur/Site Sainte Elisabeth ( Site 0302)

Ghent, Oost-Vlaanderen, Belgium

UZ Leuven ( Site 0301)

Leuven, Vlaams-Brabant, Belgium

Liga Norte Riograndense Contra o Cancer ( Site 0423)

Natal, Rio Grande do Norte, Brazil

ANIMI - Unidade de Tratamento Oncologico ( Site 0419)

Lages, Santa Catarina, Brazil

Hospital Paulistano ( Site 0421)

São Paulo, Brazil

IBCC - Núcleo de Pesquisa e Ensino ( Site 0424)

São Paulo, Brazil

Princess Margaret Cancer Centre ( Site 0518)

Toronto, Ontario, Canada

McGill University Health Centre ( Site 0502)

Montreal, Quebec, Canada

Clinica Puerto Montt ( Site 0615)

Port Montt, Los Lagos Region, Chile

ONCOCENTRO APYS-ACEREY ( Site 0612)

Viña del Mar, Región de Valparaíso, 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 Ostrava ( Site 3323)

Ostrava-Poruba, Ostrava Mesto, Czechia

Vseobecna fakultni nemocnice v Praze ( Site 3325)

Prague, Czechia

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

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

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

Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Onkoterapias Klinika ( Site 3924)

Szeged, Csongrád megye, Hungary

Debreceni Egyetem Klinikai Kozpont ( Site 3922)

Debrecen, Hajdú-Bihar, Hungary

Hillel Yaffe Medical Center ( Site 1404)

Hadera, Israel

Rambam Health Care Campus ( Site 1402)

Haifa, Israel

Shaare Zedek Medical Center ( Site 1405)

Jerusalem, Israel

Meir Medical Center. ( Site 1403)

Kfar Saba, Israel

CRO-IRCCS ( Site 1510)

Aviano, Friuli Venezia Giulia, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1507)

Milan, Milano, Italy

Azienda Ospedaliero Universitaria Pisana ( Site 1504)

Pisa, Tuscany, Italy

Instituto Tumori Giovanni Paolo II ( Site 1505)

Bari, Italy

Istituto Europeo di Oncologia ( Site 1506)

Milan, Italy

Humanitas San Pio X Hospital ( Site 1503)

Milan, Italy

Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1501)

Naples, Italy

Istituto Oncologico Veneto IRCCS ( Site 1508)

Padova, Italy

Fondazione Policlinico Universitario Agostino Gemelli ( Site 1502)

Roma, Italy

Ospedale Mauriziano ( Site 1509)

Torino, Italy

Aichi Cancer Center ( Site 1626)

Nagoya, Aichi-ken, Japan

National Hospital Organization Shikoku Cancer Center ( Site 1631)

Matsuyama, Ehime, Japan

Ehime University Hospital ( Site 1637)

Tōon, Ehime, Japan

Kurume University Hospital ( Site 1640)

Kurume, Fukuoka, Japan

Gunma Prefectural Cancer Center ( Site 1630)

Ōta, Gunma, Japan

Hokkaido University Hospital ( Site 1634)

Sapporo, Hokkaido, Japan

Iwate Medical University Hospital ( Site 1635)

Shiwa-gun, Iwate, Japan

Saitama Medical University International Medical Center ( Site 1632)

Hidaka, Saitama, Japan

Cancer Institute Hospital of JFCR ( Site 1639)

Koto, Tokyo, Japan

Keio University Hospital ( Site 1636)

Shinjyuku, Tokyo, Japan

National Hospital Organization Kyushu Cancer Center ( Site 1628)

Fukuoka, Japan

Kagoshima City Hospital ( Site 1638)

Kagoshima, Japan

Niigata Cancer Center Hospital ( Site 1633)

Niigata, Japan

Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 1629)

Osaka, Japan

CIO - Centro de Inmuno-Oncología de Occidente ( Site 1719)

Guadalajara, Jalisco, Mexico

Higiea Oncologia ( Site 1713)

Mexico City, Mexico City, Mexico

Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 1711)

Monterrey, Nuevo León, Mexico

I CAN ONCOLOGY CENTER S.A. DE C.V. ( Site 1716)

Monterrey, Nuevo León, Mexico

Servicios de Oncología Médica Integral - Monterrey ( Site 1712)

Monterrey, Nuevo León, Mexico

Centro de Investigación Oncológica Galerías SC ( Site 1720)

Aguascalientes, Mexico

Cryptex Investigación Clínica S.A. de C.V. ( Site 1715)

Cuauhtémoc, Mexico

COI Centro Oncologico Internacional S.A.P.I. de C.V. ( Site 1717)

Mexico City, Mexico

Centro de Investigacion Clinica de Oaxaca ( Site 1714)

Oaxaca City, Mexico

Hospital Guillermo Almenara Irigoyen ( Site 3608)

Lima, Peru

IPOR Instituto Peruano de Oncología & Radioterapia ( Site 3604)

Lima, Peru

INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS ( Site 3601)

Lima, Peru

Clínica San Felipe ( Site 3603)

Lima, Peru

Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 2106)

Poznan, Greater Poland Voivodeship, Poland

Bialostockie Centrum Onkologii ( Site 2104)

Bialystok, Podlaskie Voivodeship, Poland

Swietokrzyskie Centrum Onkologii. ( Site 2105)

Kielce, Świętokrzyskie Voivodeship, Poland

Hospital da Luz ( Site 3802)

Lisbon, Portugal

Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 3801)

Porto, Portugal

Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 2215)

Cluj-Napoca, Cluj, Romania

S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2211)

Craiova, Dolj, Romania

Cabinet Medical Oncomed ( Site 2217)

Timișoara, Timiș County, Romania

Spitalul Clinic Filantropia ( Site 2213)

Bucharest, Romania

National Cancer Center ( Site 2305)

Goyang-si, Kyonggi-do, South Korea

Severance Hospital ( Site 2302)

Seodaemun-Gu, Seoul, South Korea

Asan Medical Center ( Site 2304)

Songpa-gu, Seoul, South Korea

Seoul National University Hospital ( Site 2301)

Seoul, South Korea

Samsung Medical Center ( Site 2303)

Seoul, South Korea

Institut Català d'Oncologia (ICO) - Girona ( Site 2402)

Girona, Gerona, Spain

Hospital General Gregorio Maranon de Madrid ( Site 2412)

Madrid, Madrid, Comunidad de, Spain

Clinica Universidad de Navarra ( Site 2407)

Madrid, Madrid, Comunidad de, Spain

Hosp Clinico Universitario de Valencia ( Site 2401)

Valencia, Valenciana, Comunitat, Spain

Hospital Vall D Hebron ( Site 2403)

Barcelona, Spain

Hospital Clinic I Provincial de Barcelona ( Site 2409)

Barcelona, Spain

ICO L Hospitalet ( Site 2408)

Barcelona, Spain

Hospital Universitario Reina Sofia ( Site 2406)

Córdoba, Spain

Hospital Ramon y Cajal ( Site 2405)

Madrid, Spain

Hospital Clinico San Carlos... ( Site 2410)

Madrid, Spain

Hospital Universitario 12 de Octubre ( Site 2411)

Madrid, Spain

Hospital Universitario La Paz ( Site 2404)

Madrid, Spain

Taichung Veterans General Hospital ( Site 2603)

Taichung, Taiwan

National Cheng Kung University Hospital ( Site 2602)

Tainan, Taiwan

National Taiwan University Hospital ( Site 2601)

Taipei, Taiwan

Mackay Memorial Hospital ( Site 2604)

Taipei, Taiwan

Chang Gung Memorial Hospital - Linkou Branch ( Site 2605)

Taoyuan District, Taiwan

Ramathibodi Hospital ( Site 3402)

Bangkok, Bangkok, Thailand

Faculty of Medicine Siriraj Hospital ( Site 3401)

Bangkok, Bangkok, Thailand

Western General Hospital ( Site 2806)

Edinburgh, Edinburgh, City of, United Kingdom

ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 2801)

London, London, City of, United Kingdom

Royal Marsden Hospital (Sutton) ( Site 2802)

Sutton, London, City of, United Kingdom

Leicester Royal Infirmary ( Site 2808)

Leicester, United Kingdom