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NCT06824467PHASE3Recruiting

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)

Merck Sharp & Dohme LLC

Start Date

4/9/2025

Completion Date

11/9/2032

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Has histologically confirmed Federation of Gynecology and Obstetrics (FIGO) Stage III or IV epithelial ovarian, primary peritoneal, or fallopian tube carcinoma of certain histologies * Has received 4 or more cycles of platinum-based doublet chemotherapy in first-line and a total of 6 cycles of carboplatin-based doublet chemotherapy in second-line setting for ovarian cancer (OC) * Has platinum-sensitive epithelial OC * Has provided tissue of a tumor lesion that was not previously irradiated * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy * Participants who are hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation (Part 1) or randomization (Part 2) * Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening * Has an ECOG performance status of 0 or 1 assessed within 7 days before allocation (Part 1) or randomization (Part 2) Exclusion Criteria: * Has nonepithelial cancers (germ cell tumors and sex cord-stromal tumors), low-grade serous tumors, low-grade endometrioid tumors, borderline tumors (low malignant potential), mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor and undifferentiated carcinoma * Has platinum-resistant OC or platinum-refractory OC * Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing * Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis, or chronic diarrhea) * Has uncontrolled, significant cardiovascular disease or cerebrovascular disease * Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Has received more than 2 prior lines of systemic therapy for OC * Has received prior systemic anticancer therapy within 3 weeks or 5 half-lives (whichever is shorter) before allocation (Part 1) or randomization (Part 2) * Has received prior radiotherapy within 2 weeks of allocation (Part 1) or randomization (Part 2), or has radiation related toxicities, requiring corticosteroids * Has an additional malignancy that is progressing or has required active treatment within the past 3 years * Has active central nervous system (CNS) metastases and/or carcinomatous meningitis * Has an active infection requiring systemic therapy * Has active or ongoing stomatitis

Interventions

BIOLOGICAL

Sacituzumab tirumotecan

BIOLOGICAL

Bevacizumab

DRUG

H1 receptor antagonist

DRUG

H2 receptor antagonist

DRUG

Acetaminophen (or equivalent)

DRUG

Dexamethasone (or equivalent)

DRUG

Steroid mouthwash (dexamethasone or equivalent)

Interested in This Trial?

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Conditions

Ovarian CancerFallopian Tube CancerPrimary Peritoneal Cancer

Locations

University of Alabama at Birmingham ( Site 0006)

Birmingham, Alabama 35249

United States

Alaska Women's Cancer Care ( Site 0096)

Anchorage, Alaska 99508

United States

UCSF Medical Center at Mission Bay ( Site 0013)

San Francisco, California 94158

United States

John Muir Health Cancer Center ( Site 0016)

Walnut Creek, California 94598

United States

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

New Haven, Connecticut 06510

United States

Mount Sinai Braman Comprehensive Cancer Center ( Site 0078)

Miami Beach, Florida 33140

United States

Sarasota Memorial Hospital ( Site 0075)

Sarasota, Florida 34239

United States

Florida Cancer Specialists East ( Site 7000)

West Palm Beach, Florida 33401

United States

Winship Cancer Institute of Emory University ( Site 0086)

Atlanta, Georgia 30322

United States

Augusta University - Georgia Cancer Center ( Site 0066)

Augusta, Georgia 30912

United States

Parkview Research Center at Parkview Regional Medical Center ( Site 0003)

Fort Wayne, Indiana 46845

United States

Women's Cancer Care ( Site 0067)

Covington, Louisiana 70433

United States

Maine Medical Center Research Institute-MaineHealth/Maine Medical Partners - GynOnc ( Site 0008)

Scarborough, Maine 04074

United States

St. Dominic's Hospital ( Site 0064)

Jackson, Mississippi 39216

United States

Washington University School of Medicine ( Site 0052)

St Louis, Missouri 63110

United States

Nebraska Methodist Hospital ( Site 0053)

Omaha, Nebraska 68114

United States

John Theurer Cancer Center at Hackensack University Medical Center ( Site 0081)

Hackensack, New Jersey 07601

United States

Rutgers Cancer Institute of New Jersey ( Site 0071)

New Brunswick, New Jersey 08901

United States

University of New Mexico Comprehensive Cancer Center ( Site 0055)

Albuquerque, New Mexico 87131

United States

NYU Langone Hospital - Long Island ( Site 0015)

Mineola, New York 11501

United States

Laura and Isaac Perlmutter Cancer Center ( Site 0076)

New York, New York 10016

United States

FirstHealth Cancer Center ( Site 0079)

Pinehurst, North Carolina 28374

United States

University of Cincinnati Medical Center ( Site 0090)

Cincinnati, Ohio 45219

United States

The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0054)

Columbus, Ohio 43210

United States

Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0056)

Tulsa, Oklahoma 74146

United States

Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8010)

Eugene, Oregon 97401

United States

Allegheny Health Network West Penn Hospital ( Site 0099)

Pittsburgh, Pennsylvania 15224

United States

Women & Infants Hospital ( Site 0050)

Providence, Rhode Island 02905

United States

Henry-Joyce Cancer Clinic ( Site 0060)

Nashville, Tennessee 37232

United States

Texas Oncology - Central/South Texas ( Site 8009)

Austin, Texas 78758

United States

Texas Oncology - DFW ( Site 8001)

Fort Worth, Texas 76104

United States

Texas Oncology - San Antonio ( Site 8005)

San Antonio, Texas 78240

United States

Texas Oncology - Gulf Coast ( Site 8003)

Webster, Texas 77598

United States

Virginia Cancer Specialists (VCS) ( Site 8011)

Fairfax, Virginia 22031

United States

Instituto Alexander Fleming ( Site 2909)

Ciudad Autónoma de Buenos Aires, Buenos Aires C1426ANZ

Argentina

Instituto de Investigaciones Clinicas Mar del Plata ( Site 2901)

Mar del Plata, Buenos Aires B7600FZO

Argentina

Fundación Respirar ( Site 2912)

Buenos Aires, Buenos Aires F.D. C1426AAL

Argentina

Instituto de Oncologia de Rosario ( Site 2910)

Rosario, Santa Fe Province S2000KZE

Argentina

Hospital Aleman ( Site 2903)

CABA, C1118AAT

Argentina

Hospital Italiano de Cordoba ( Site 2908)

Córdoba, 5000

Argentina

Blacktown Hospital ( Site 0211)

Sydney, New South Wales 2148

Australia

Gallipoli Medical Research Ltd ( Site 0214)

Brisbane, Queensland 4120

Australia

Epworth Freemasons ( Site 0217)

East Melbourne, Victoria 3002

Australia

Frankston Hospital ( Site 0216)

Frankston, Victoria 3199

Australia

Antwerp University Hospital ( Site 0304)

Edegem, Antwerpen 2650

Belgium

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

Liège, Liege 4000

Belgium

AZ Sint-Lucas ( Site 0305)

Ghent, Oost-Vlaanderen 9000

Belgium

UZ Leuven ( Site 0301)

Leuven, Vlaams-Brabant 3000

Belgium

CHU UCL Namur/Site Sainte Elisabeth ( Site 0302)

Namur, 5000

Belgium

Liga Norte Riograndense Contra o Cancer ( Site 0423)

Natal, Rio Grande do Norte 59062-000

Brazil

Hospital São Lucas da PUCRS ( Site 0425)

Porto Alegre, Rio Grande do Sul 90610000

Brazil

ANIMI - Unidade de Tratamento Oncologico ( Site 0419)

Lages, Santa Catarina 88501-001

Brazil

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto ( Site 0413)

São José do Rio Preto, São Paulo 15090-000

Brazil

Instituto Nacional de Câncer - INCA ( Site 0422)

Rio de Janeiro, 20220-410

Brazil

Hospital Paulistano ( Site 0421)

São Paulo, 01321-001

Brazil

IBCC - Núcleo de Pesquisa e Ensino ( Site 0424)

São Paulo, 04014-002

Brazil

Arthur J.E. Child Comprehensive Cancer Centre ( Site 0512)

Calgary, Alberta T2N 5G2

Canada

Trillium Health Partners - Credit Valley Hospital ( Site 0508)

Mississauga, Ontario L5M 2N1

Canada

Princess Margaret Cancer Centre ( Site 0518)

Toronto, Ontario M5G 2M9

Canada

CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0505)

Montreal, Quebec H1T 2M4

Canada

McGill University Health Centre ( Site 0502)

Montreal, Quebec H4A 3J1

Canada

Clinica Puerto Montt ( Site 0615)

Port Montt, Los Lagos Region 5507642

Chile

Pontificia Universidad Catolica de Chile ( Site 0611)

Santiago, Region M. de Santiago 8330032

Chile

Bradfordhill-Clinical Area ( Site 0610)

Santiago, Region M. de Santiago 8420383

Chile

ONCOCENTRO APYS-ACEREY ( Site 0612)

Viña del Mar, Valparaiso 2520598

Chile

FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0806)

Bogotá, Bogota D.C. 110131

Colombia

Instituto Nacional De Cancerologia ( Site 0807)

Bogotá, Bogota D.C. 111511

Colombia

Oncologos Del Occidente ( Site 0805)

Pereira, Risaralda Department 660001

Colombia

Fakultni Nemocnice Brno Bohunice ( Site 3324)

Brno, Brno-mesto 602 00

Czechia

Fakultni nemocnice Ostrava ( Site 3323)

Ostrava-Poruba, Ostrava Mesto 708 52

Czechia

Vseobecna fakultni nemocnice v Praze ( Site 3325)

Prague, 128 08

Czechia

Fakultni nemocnice v Motole ( Site 3322)

Prague, 150 06

Czechia

Rigshospitalet ( Site 0904)

Copenhagen, Capital Region 2100

Denmark

Herlev Hospital ( Site 0903)

Herlev, Capital Region 2730

Denmark

Aalborg Universitetshospital ( Site 0901)

Aalborg, North Denmark 9000

Denmark

Vejle Sygehus ( Site 0902)

Vejle, Region Syddanmark 7100

Denmark

Oulun yliopistollinen sairaala ( Site 1003)

Oulu, North Ostrobothnia 90220

Finland

Kuopion Yliopistollinen Sairaala ( Site 1004)

Kuopio, Northern Savonia 70200

Finland

Tampereen yliopistollinen sairaala ( Site 1002)

Tampere, Pirkanmaa 33520

Finland

Centre Oscar Lambret ( Site 1104)

Lille, Ain 59020

France

Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 1101)

Bordeaux, Aquitaine 33076

France

Centre Hopitalier Lyon Sud ( Site 1110)

Pierre-Bénite, Auvergne-Rhône-Alpes 69310

France

Centre Francois Baclesse ( Site 1108)

Caen, Calvados 14076

France

Hôpital Privé Des Côtes d'Armor ( Site 1106)

Plérin, Cotes-d Armor 22190

France

LBM ONCOPOLE CLAUDIUS REGAUD ( Site 1109)

Toulouse, Haute-Garonne 31059

France

Pôle Santé Léonard de Vinci ( Site 1112)

Chambray-lès-Tours, Indre-et-Loire 37170

France

Groupe Hospitalier Broca Cochin Hotel Dieu ( Site 1111)

Paris, Paris 75014

France

Institut De Cancerologie De L Ouest ( Site 1107)

Saint-Herblain, Pays de la Loire Region 44805

France

Sainte Catherine Institut du Cancer Avignon Provence ( Site 1105)

Avignon, Vaucluse 84918

France

Groupe Hospitalier Diaconesses Croix Saint Simon ( Site 1102)

Paris, 75020

France

Aretaieio Hospital ( Site 0701)

Athens, Attica 115 28

Greece

ATTIKON GENERAL UNIVERSITY HOSPITAL-Oncology ( Site 0702)

Chaïdári, Attica 12462

Greece

Bacs-Kiskun Megyei Korhaz ( Site 3920)

Kecskemét, Bács-Kiskun county 6000

Hungary

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

Szeged, Csongrád megye 6720

Hungary

Debreceni Egyetem Klinikai Kozpont ( Site 3922)

Debrecen, Hajdú-Bihar 4032

Hungary

Semmelweis Egyetem ( Site 3925)

Budapest, Pest County 1088

Hungary

Országos Onkológiai Intézet-Ngyógyászat ( Site 3923)

Budapest, Pest County 1122

Hungary

St James Hospital ( Site 1301)

Dublin, DO8 NHY1

Ireland

Hillel Yaffe Medical Center ( Site 1404)

Hadera, 3810101

Israel

Rambam Health Care Campus ( Site 1402)

Haifa, 3109601

Israel

Shaare Zedek Medical Center ( Site 1405)

Jerusalem, 9103102

Israel

Meir Medical Center. ( Site 1403)

Kfar Saba, 4428164

Israel

Sheba Medical Center ( Site 1401)

Ramat Gan, 5265601

Israel

CRO-IRCCS ( Site 1510)

Aviano, Friuli Venezia Giulia 33081

Italy

Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1507)

Milan, Milano 20133

Italy

Azienda Ospedaliero Universitaria Pisana ( Site 1504)

Pisa, Tuscany 56126

Italy

Instituto Tumori Giovanni Paolo II ( Site 1505)

Bari, 70124

Italy

Istituto Ospedaliero,Fondazione Poliambulanza ( Site 1511)

Brescia, 25124

Italy

Istituto Europeo di Oncologia ( Site 1506)

Milan, 20141

Italy

Humanitas San Pio X Hospital ( Site 1503)

Milan, 20159

Italy

Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1501)

Naples, 80131

Italy

Istituto Oncologico Veneto IRCCS ( Site 1508)

Padova, 35128

Italy

Fondazione Policlinico Universitario Agostino Gemelli ( Site 1502)

Roma, 00168

Italy

Ospedale Mauriziano ( Site 1509)

Torino, 10128

Italy

Aichi Cancer Center ( Site 1626)

Nagoya, Aichi-ken 464-8681

Japan

National Cancer Center Hospital East ( Site 1641)

Kashiwa, Chiba 277-8577

Japan

National Hospital Organization Shikoku Cancer Center ( Site 1631)

Matsuyama, Ehime 791-0280

Japan

Ehime University Hospital ( Site 1637)

Tōon, Ehime 791-0295

Japan

Kurume University Hospital ( Site 1640)

Kurume, Fukuoka 830-0011

Japan

Gunma Prefectural Cancer Center ( Site 1630)

Ōta, Gunma 373-8550

Japan

Hokkaido University Hospital ( Site 1634)

Sapporo, Hokkaido 060-8648

Japan

Iwate Medical University Hospital ( Site 1635)

Shiwa-gun, Iwate 028-3695

Japan

Saitama Medical University International Medical Center ( Site 1632)

Hidaka, Saitama 350-1298

Japan

Shizuoka Cancer Center ( Site 1643)

Sunto-gun,, Shizuoka 411-8777

Japan

Cancer Institute Hospital of JFCR ( Site 1639)

Koto, Tokyo 135-8550

Japan

Keio University Hospital ( Site 1636)

Shinjyuku, Tokyo 160-8582

Japan

National Hospital Organization Kyushu Cancer Center ( Site 1628)

Fukuoka, 811-1395

Japan

Kagoshima City Hospital ( Site 1638)

Kagoshima, 890-8760

Japan

Niigata Cancer Center Hospital ( Site 1633)

Niigata, 951-8566

Japan

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

Osaka, 541-8567

Japan

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

Guadalajara, Jalisco 44630

Mexico

Higiea Oncologia ( Site 1713)

Mexico City, Mexico City 11819

Mexico

Laboratorio de Patología Clínica del Hospital Universitario "Dr. José Eleuterio González" ( Site 1711)

Monterrey, Nuevo León 64460

Mexico

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

Monterrey, Nuevo León 64710

Mexico

Servicios de Oncología Médica Integral - Monterrey ( Site 1712)

Monterrey, Nuevo León 66220

Mexico

Centro de Investigación Oncológica Galerías SC ( Site 1720)

Aguascalientes, 20124

Mexico

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

Cuauhtémoc, 6100

Mexico

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

Mexico City, 04700

Mexico

Centro de Investigacion Clinica de Oaxaca ( Site 1714)

Oaxaca City, 68020

Mexico

Unidad de Investigacion Oncologia Clínica Piura ( Site 3606)

Castilla, Piura 20001

Peru

Hospital Guillermo Almenara Irigoyen ( Site 3608)

Lima, 15001

Peru

IPOR Instituto Peruano de Oncología & Radioterapia ( Site 3604)

Lima, 15036

Peru

INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS ( Site 3601)

Lima, 15038

Peru

Clínica San Felipe ( Site 3603)

Lima, 15072

Peru

Hospital Cayetano Heredia ( Site 3607)

Lima, 15102

Peru

Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 2106)

Poznan, Greater Poland Voivodeship 61-848

Poland

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Ginekologii Onkologicznej ( Site 2101)

Warsaw, Masovian Voivodeship 02-781

Poland

Bialostockie Centrum Onkologii ( Site 2104)

Bialystok, Podlaskie Voivodeship 15-027

Poland

Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie ( Site 2103)

Szczecin, West Pomeranian Voivodeship 70-111

Poland

Swietokrzyskie Centrum Onkologii. ( Site 2105)

Kielce, Świętokrzyskie Voivodeship 25-734

Poland

Hospital da Luz ( Site 3802)

Lisbon, 1500-650

Portugal

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

Porto, 4200-072

Portugal

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

Cluj-Napoca, Cluj 400015

Romania

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

Craiova, Dolj 200746

Romania

Cabinet Medical Oncomed ( Site 2217)

Timișoara, Timiș County 300239

Romania

Spitalul Clinic Filantropia ( Site 2213)

Bucharest, 011132

Romania

National Cancer Center ( Site 2305)

Goyang-si, Kyonggi-do 10408

South Korea

Severance Hospital ( Site 2302)

Seodaemun-Gu, Seoul 03722

South Korea

Asan Medical Center ( Site 2304)

Songpa-gu, Seoul 05505

South Korea

Seoul National University Hospital ( Site 2301)

Seoul, 03080

South Korea

Samsung Medical Center ( Site 2303)

Seoul, 06351

South Korea

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

Girona, Gerona 17007

Spain

Hospital General Gregorio Maranon de Madrid ( Site 2412)

Madrid, Madrid, Comunidad de 28007

Spain

Clinica Universidad de Navarra ( Site 2407)

Madrid, Madrid, Comunidad de 28027

Spain

Hosp Clinico Universitario de Valencia ( Site 2401)

Valencia, Valenciana, Comunitat 46010

Spain

Hospital Vall D Hebron ( Site 2403)

Barcelona, 08035

Spain

Hospital Clinic I Provincial de Barcelona ( Site 2409)

Barcelona, 08036

Spain

ICO L Hospitalet ( Site 2408)

Barcelona, 08907

Spain

Hospital Universitario Reina Sofia ( Site 2406)

Córdoba, 14004

Spain

Hospital Ramon y Cajal ( Site 2405)

Madrid, 28034

Spain

Hospital Clinico San Carlos... ( Site 2410)

Madrid, 28040

Spain

Hospital Universitario 12 de Octubre ( Site 2411)

Madrid, 28041

Spain

Hospital Universitario La Paz ( Site 2404)

Madrid, 28046

Spain

Taichung Veterans General Hospital ( Site 2603)

Taichung, 40705

Taiwan

National Cheng Kung University Hospital ( Site 2602)

Tainan, 704302

Taiwan

National Taiwan University Hospital ( Site 2601)

Taipei, 10002

Taiwan

Mackay Memorial Hospital ( Site 2604)

Taipei, 104

Taiwan

Chang Gung Memorial Hospital - Linkou Branch ( Site 2605)

Taoyuan, 333

Taiwan

Ramathibodi Hospital ( Site 3402)

Bangkok, Bangkok 10400

Thailand

Faculty of Medicine Siriraj Hospital ( Site 3401)

Bangkok, Bangkok 10700

Thailand

Cambridge University Hospital ( Site 2803)

Cambridge, Cambridgeshire CB2 2QQ

United Kingdom

Western General Hospital ( Site 2806)

Edinburgh, Edinburgh, City of EH4 2XU

United Kingdom

Royal Preston Hospital ( Site 2807)

Preston, Lancashire PR2 9HT

United Kingdom

ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 2801)

London, London, City of SW3 6JJ

United Kingdom

Royal Marsden Hospital (Sutton) ( Site 2802)

Sutton, London, City of SM2 5PT

United Kingdom

Leicester Royal Infirmary ( Site 2808)

Leicester, LE1 5WW

United Kingdom