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NCT07318558PHASE3Recruiting

A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021)

Merck Sharp & Dohme LLC

Start Date

2/16/2026

Completion Date

2/25/2033

Summary

Researchers are looking for new ways to treat ovarian cancer (OC). Current treatment for OC may start with surgery to remove as much of the cancer as possible. After surgery, people may receive chemotherapy. After chemotherapy, standard care options may include: * Maintenance treatment, which is used after another therapy to keep the cancer from growing, spreading, or coming back. Bevacizumab is a targeted therapy used as standard maintenance treatment. Targeted therapy works to control how specific types of cancer cells grow and spread. * Observation, which is watching to see if cancer grows or worsens The study medicine, sacituzumab tirumotecan (also called sac-TMT), is a targeted therapy. The goal of this study is to learn if people who receive sac-TMT maintenance treatment with or without bevacizumab live longer without the cancer getting worse than people who receive standard care.

Eligibility Criteria

Age Range: 18 years to No maximum

The main inclusion criteria include but are not limited to the following: * Has diagnosis of FIGO 2014 Stage III or Stage IV, histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube carcinoma with one of the following histologies: high-grade serous, high-grade endometrioid, clear cell carcinoma, or malignant mixed Müllerian tumour with a high-grade serous component. Tumors reported as Grade 2 may be enrolled only if predominately (\>50%) Grade 3 features are present. * Has completed primary debulking surgery or interval debulking surgery. * Has completed first-line (1L) platinum-based chemotherapy, with a response of stable disease, partial response, complete response or no evidence of disease per protocol. * Has provided tumor tissue that is not previously irradiated. * Has well-controlled human immunodeficiency virus (HIV) on antiretroviral therapy if diagnosed with HIV * Has undetectable hepatitis B virus (HBV) viral load and received HBV antiviral therapy if hepatitis B surface antigen (HBsAg)-positive. * Has undetectable hepatitis C virus (HCV) viral load if has a history of HCV infection. The main exclusion criteria include but are not limited to the following: * Has nonepithelial cancers, low-grade serous tumors, low-grade endometrioid tumors, borderline tumors mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor, and undifferentiated carcinoma. * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. * Has a history of severe eye disease. * Has active inflammatory bowel disease requiring immunosuppressive medication or a previous history of inflammatory bowel disease. * Has uncontrolled, significant cardiovascular disease or cerebrovascular disease. * Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD), which required steroids, has current pneumonitis/ILD, or has suspected ILD, or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening. * Received prior systemic anticancer therapy, with the exception of the first-line platinum-based chemotherapy required by the inclusion criteria. * Had a live or live-attenuated vaccine within 30 days of randomization. * Has a known additional malignancy that is progressing or required active treatment within the past 3 years. * Has active infection requiring systemic therapy. * Has concurrent and active HBV and HCV infections. * Has HIV infection and a history of Kaposi's sarcoma and/or multicentric Castleman's disease. * Has not recovered from major surgery or has ongoing surgical complications. * Has a homologous recombination deficiency (HRD)-positive, unknown, or inconclusive tumor status as determined by the central laboratory. * Active or ongoing stomatitis of any grade.

Interventions

DRUG

Sacituzumab tirumotecan

DRUG

Bevacizumab

DRUG

Rescue Medications

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Conditions

Ovarian NeoplasmsOvarian Cancer

Locations

Mount Sinai Cancer Center ( Site 0029)

Miami Beach, Florida 33140

United States

Orlando Health Winnie Palmer Hospital for Women and Babies ( Site 0085)

Orlando, Florida 32806

United States

Winship Cancer Institute of Emory University ( Site 0037)

Atlanta, Georgia 30308

United States

Illinois Cancer Specialists (ICS) ( Site 8009)

Arlington Heights, Illinois 60005

United States

Parkview Research Center at Parkview Regional Medical Center ( Site 0055)

Fort Wayne, Indiana 46845

United States

Women's Cancer Care ( Site 0018)

Covington, Louisiana 70433

United States

Maine Medical Center Research Institute-MaineHealth/Maine Medical Partners - GynOnc ( Site 0060)

Scarborough, Maine 04074

United States

Nebraska Methodist Hospital ( Site 0004)

Omaha, Nebraska 68114

United States

University Of Nebraska Medical Center ( Site 0035)

Omaha, Nebraska 68198

United States

University of Cincinnati Medical Center ( Site 0042)

Cincinnati, Ohio 45219

United States

Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0007)

Tulsa, Oklahoma 74146

United States

Women & Infants Hospital ( Site 0001)

Providence, Rhode Island 02905

United States

West Cancer Center and Research Institute ( Site 0013)

Germantown, Tennessee 38138

United States

University of Tennessee Medical Center ( Site 0087)

Knoxville, Tennessee 37920

United States

Hospital Aleman ( Site 2903)

Ciudad Autonoma de Buenos Aires, Buenos Aires C1119ACN

Argentina

Instituto Alexander Fleming ( Site 2902)

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

Sanatorio Parque - Oncología ( Site 2911)

Rosario, Santa Fe Province S2000DVC

Argentina

Instituto de Oncologia de Rosario ( Site 2909)

Rosario, Santa Fe Province S2000KZE

Argentina

Hospital Britanico de Buenos Aires ( Site 2905)

CABA, C1280AEB

Argentina

Fundación CORI para la Investigación y Prevención del Cáncer ( Site 2907)

La Rioja, F5300COE

Argentina

Gallipoli Medical Research Ltd ( Site 0204)

Brisbane, Queensland 4120

Australia

Epworth Freemasons ( Site 0207)

East Melbourne, Victoria 3002

Australia

Medizinische Universitat Wien ( Site 0102)

Vienna, State of Vienna 1090

Austria

Medizinische Universitaet Innsbruck-Univ.-Klinik f. Gynäkologie und Geburtshilfe ( Site 0101)

Innsbruck, Tyrol 6020

Austria

Grand Hopital de Charleroi ( Site 0303)

Charleroi, Hainaut 6000

Belgium

AZ Maria Middelares ( Site 0302)

Ghent, Oost-Vlaanderen 9000

Belgium

UZ Leuven ( Site 0301)

Leuven, Vlaams-Brabant 3000

Belgium

Liga Norte Riograndense Contra o Cancer ( Site 0417)

Natal, Rio Grande do Norte 59062-000

Brazil

Hospital São Lucas da PUCRS ( Site 0415)

Porto Alegre, Rio Grande do Sul 90610000

Brazil

ANIMI - Unidade de Tratamento Oncologico ( Site 0421)

Lages, Santa Catarina 88501-001

Brazil

Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0414)

São José do Rio Preto, São Paulo 15090-000

Brazil

CIUSSS - Saguenay-Lac-Saint-Jean ( Site 0519)

Chicoutimi, Quebec G7H 5H6

Canada

McGill University Health Centre ( Site 0516)

Montreal, Quebec H4A 3J1

Canada

Clinica Puerto Montt ( Site 0606)

Port Montt, Los Lagos Region 5507642

Chile

FALP ( Site 0607)

Santiago, Region M. de Santiago 7500921

Chile

Pontificia Universidad Catolica de Chile ( Site 0602)

Santiago, Region M. de Santiago 8330073

Chile

ONCOCENTRO APYS-ACEREY ( Site 0603)

Viña del Mar, Valparaiso 2520598

Chile

Fundacion Colombiana de Cancerología Clinica Vida ( Site 0803)

Medellín, Antioquia 050030

Colombia

FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0801)

Bogotá, Bogota D.C. 110131

Colombia

Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0802)

Valledupar, Cesar Department 200001

Colombia

Instituto Nacional De Cancerologia ( Site 0808)

Bogota, Cundinamarca 111151

Colombia

Oncólogos del Occidente S.A.S. ( Site 0806)

Pereira, Risaralda Department 660001

Colombia

Fakultni Nemocnice Brno Bohunice ( Site 3304)

Brno, Brno-mesto 602 00

Czechia

Fakultni nemocnice Ostrava-Gynekologicko-porodnicka klinika ( Site 3303)

Ostrava-Poruba, Ostrava Mesto 708 52

Czechia

Fakultni nemocnice Hradec Kralove ( Site 3307)

Hradec Králové, 500 05

Czechia

Fakultni nemocnice Kralovske Vinohrady ( Site 3306)

Prague, 100 34

Czechia

Vseobecna fakultni nemocnice v Praze ( Site 3305)

Prague, 128 08

Czechia

Fakultni nemocnice motol ( Site 3302)

Prague, 150 06

Czechia

Herlev Hospital ( Site 0902)

Herlev, Capital Region 2730

Denmark

Aalborg Universitetshospital ( Site 0901)

Aalborg, North Denmark 9000

Denmark

Aarhus Universitetshospital, Skejby ( Site 0903)

Aarhus, North Denmark 8200

Denmark

Odense Universitets Hospital ( Site 0904)

Odense, Region Syddanmark 9000

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

Turku University Hospital-Department of Obstetrics and Gynecology ( Site 1001)

Turku, Southwest Finland 20520

Finland

CENTRE LEON BERARD ( Site 1101)

Lyon, Auvergne-Rhône-Alpes 69008

France

Hopitaux Universitaires de Strasbourg ( Site 1109)

Strasbourg, Bas-Rhin 67000

France

Hôpital Privé Des Côtes d'Armor ( Site 1102)

Plérin, Cotes-d Armor 22190

France

CHRU de Brest - Hopital de la Cavale Blanche ( Site 1104)

Brest, Finistere 29200

France

Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau ( Site 1105)

Tours, Indre-et-Loire 37044

France

Centre Oscar Lambret ( Site 1106)

Lille, Nord 59020

France

Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 1113)

Clermont-Ferrand, Puy-de-Dome 63003

France

Alexandra General Hospital of Athens ( Site 0703)

Athens, Attica 115 28

Greece

Aretaieio Hospital ( Site 0701)

Athens, Attica 115 28

Greece

Agios Loukas Clinic ( Site 0702)

Thessaloniki, 552 36

Greece

Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 3910)

Kecskemét, Bács-Kiskun county 6000

Hungary

Petz Aladar Egyetemi Oktato Korhaz-Onkológiai Osztály ( Site 3911)

Győr, Győr-Moson-Sopron 9024

Hungary

Országos Onkológiai Intézet-Ngyógyászat ( Site 3913)

Budapest, 1122

Hungary

Debreceni Egyetem Klinikai Kozpont-Szülészeti és Nőgyógyászati Klinika ( Site 3912)

Debrecen, 4032

Hungary

St James Hospital ( Site 1302)

Dublin, D08 E9P6

Ireland

Rambam Health Care Campus ( Site 1422)

Haifa, 3109601

Israel

Edith Wolfson Medical Center ( Site 1423)

Holon, 5810001

Israel

Sheba Medical Center ( Site 1421)

Ramat Gan, 5265601

Israel

Azienda Ospedaliera Spedali Civili di Brescia ( Site 1501)

Brescia, 25123

Italy

ASST DI LECCO ( Site 1509)

Lecco, 23900

Italy

Istituto Nazionale dei Tumori ( Site 1504)

Milan, 20133

Italy

Istituto Europeo di Oncologia ( Site 1503)

Milan, 20141

Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1510)

Roma, 00168

Italy

Kurume University Hospital ( Site 1615)

Kurume, Fukuoka 830-0011

Japan

Gunma Prefectural Cancer Center ( Site 1605)

Ōta, Gunma 373-8550

Japan

Hokkaido University Hospital ( Site 1609)

Sapporo, Hokkaido 060-8648

Japan

Hyogo Cancer Center ( Site 1620)

Akashi, Hyōgo 673-8558

Japan

Iwate Medical University Hospital ( Site 1610)

Shiwa-gun, Iwate 028-3695

Japan

Saitama Medical University International Medical Center ( Site 1607)

Hidaka, Saitama 350-1298

Japan

Shizuoka Cancer Center ( Site 1618)

Sunto-gun,, Shizuoka 411-8777

Japan

Cancer Institute Hospital of JFCR ( Site 1614)

Koto, Tokyo 135-8550

Japan

Keio University Hospital ( Site 1611)

Shinjyuku, Tokyo 160-8582

Japan

National Hospital Organization Kyushu Cancer Center ( Site 1603)

Fukuoka, 811-1395

Japan

Kagoshima City Hospital ( Site 1613)

Kagoshima, 890-8760

Japan

Niigata Cancer Center Hospital ( Site 1608)

Niigata, 951-8566

Japan

Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 1604)

Osaka, 541-8567

Japan

Stavanger Universitetssjukehus ( Site 2002)

Stavanger, Rogaland 4068

Norway

Sorlandet Sykehus Kristiansand ( Site 2003)

Kristiansand, Vest-Agder 4615

Norway

Oslo University Hospital ( Site 2001)

Oslo, 0424

Norway

Uniwersytecki Szpital Kliniczny w Poznaniu-Oddzial Ginekologii Onkologicznej ( Site 2106)

Poznan, Greater Poland Voivodeship 60-569

Poland

Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie ( Site 2105)

Poznan, Greater Poland Voivodeship 61-866

Poland

Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2102)

Siedlce, Masovian Voivodeship 08-110

Poland

Bialostockie Centrum Onkologii ( Site 2104)

Bialystok, Podlaskie Voivodeship 15-027

Poland

Uniwersytecki Szpital Kliniczny nr2 PUM w Szczecinie ( Site 2103)

Szczecin, West Pomeranian Voivodeship 70-111

Poland

Severance Hospital ( Site 2302)

Seodaemun-Gu, Seoul 03722

South Korea

Keimyung University Dongsan Hospital ( Site 2304)

Daegu, Taegu-Kwangyokshi 42601

South Korea

Seoul National University Hospital ( Site 2301)

Seoul, 03080

South Korea

Asan Medical Center ( Site 2305)

Seoul, 05505

South Korea

Samsung Medical Center ( Site 2303)

Seoul, 06351

South Korea

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

Girona, Gerona 17007

Spain

Complejo Hospitalario Universitario A Coruna ( Site 2412)

A Coruña, La Coruna 15006

Spain

Clinica Universidad de Navarra ( Site 2407)

Madrid, Madrid, Comunidad de 28027

Spain

Instituto Valenciano de Oncologia - IVO ( Site 2411)

Valencia, Valenciana, Comunitat 46009

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 La Paz-Oncología Médica ( Site 2404)

Madrid, 28046

Spain

Karolinska Universitetssjukhuset Solna ( Site 2502)

Stockholm, Stockholm County 171 76

Sweden

Inselspital Bern ( Site 3504)

Bern, Canton of Bern 3010

Switzerland

Ospedale Regionale Bellinzona e Valli ( Site 3501)

Bellinzona, Canton Ticino 6500

Switzerland

Kantonsspital Graubünden ( Site 3503)

Chur, Kanton Graubünden 7000

Switzerland

Hôpitaux Universitaires de Genève (HUG) ( Site 3502)

Geneva, 1205

Switzerland

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

Linkou Chang Gung Memorial Hospital ( Site 2605)

Taoyuan, 333

Taiwan

Ramathibodi Hospital. ( Site 3402)

Bangkok, Bangkok 10400

Thailand

Faculty of Medicine Siriraj Hospital ( Site 3401)

Bangkoknoi, Bangkok 10700

Thailand

Faculty of Medicine - Khon Kaen University ( Site 3403)

Muang, Changwat Khon Kaen 40002

Thailand

Addenbrookes Hospital ( Site 2802)

Cambridge, Cambridgeshire CB2 2QQ

United Kingdom

University Hospitals of Leicester NHS Trust ( Site 2805)

Leicester, Leicestershire LE3 9QP

United Kingdom

University College London Hospitals ( Site 2801)

London, London, City of NW1 2PG

United Kingdom

The Christie NHS Foundation Trust ( Site 2804)

Manchester, m20 4bx

United Kingdom