RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Merck Sharp & Dohme LLC • ClinicalTrials.gov ID: NCT07318558

Registry updated: 2026-10-13

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Description

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.

Interventions

Sacituzumab tirumotecan (Drug)
Administered via intravenous (IV) infusion at a dose of 4mg/kg
Bevacizumab (Drug)
Administered via IV infusion at a dose of 15mg/kg
Rescue Medications (Drug)
Participants must receive prophylactic steroid mouthwash (dexamethasone or equivalent). It is recommended that participants receive the following rescue medications prior to sac-TMT infusion, per approved product label: histamine-1 receptor antagonist, histamine-2 receptor antagonist, acetaminophen or equivalent, and dexamethasone or equivalent.

Eligibility criteria

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.

Conditions

Ovarian Neoplasms Ovarian Cancer

Locations

University of Alabama - Birmingham ( Site 0058) — Birmingham, Alabama, United States
John Muir Health Cancer Center ( Site 0069) — Walnut Creek, California, United States
Mount Sinai Cancer Center ( Site 0029) — Miami Beach, Florida, United States
Orlando Health Winnie Palmer Hospital for Women and Babies ( Site 0085) — Orlando, Florida, United States
Winship Cancer Institute of Emory University ( Site 0037) — Atlanta, Georgia, United States
Illinois Cancer Specialists (ICS) ( Site 8009) — Arlington Heights, Illinois, United States
Parkview Research Center at Parkview Regional Medical Center ( Site 0055) — Fort Wayne, Indiana, United States
Franciscan Health Indianapolis ( Site 0081) — Indianapolis, Indiana, United States
Women's Cancer Care ( Site 0018) — Covington, Louisiana, United States
Maine Medical Center Research Institute-MaineHealth/Maine Medical Partners - GynOnc ( Site 0060) — Scarborough, Maine, United States
Maryland Oncology Hematology (MOH) ( Site 8002) — Columbia, Maryland, United States
Nebraska Methodist Hospital ( Site 0004) — Omaha, Nebraska, United States
University Of Nebraska Medical Center ( Site 0035) — Omaha, Nebraska, United States
The Center of Hope ( Site 0025) — Reno, Nevada, United States
Womens Cancer Care Associates, LLC ( Site 0023) — Albany, New York, United States
Memorial Sloan Kettering Cancer Center ( Site 0072) — New York, New York, United States
Duke Cancer Center ( Site 0012) — Durham, North Carolina, United States
University of Cincinnati Medical Center ( Site 0042) — Cincinnati, Ohio, United States
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0007) — Tulsa, Oklahoma, United States
Kaiser Permanente Interstate Medical Office - Central ( Site 0089) — Portland, Oregon, United States
Hospital of the University of Pennsylvania ( Site 0071) — Philadelphia, Pennsylvania, United States
Women & Infants Hospital ( Site 0001) — Providence, Rhode Island, United States
West Cancer Center and Research Institute ( Site 0013) — Germantown, Tennessee, United States
University of Tennessee Medical Center ( Site 0087) — Knoxville, Tennessee, United States
Henry-Joyce Cancer Clinic ( Site 0011) — Nashville, Tennessee, United States
Virginia Cancer Specialists (VCS) ( Site 8012) — Fairfax, Virginia, United States
Virginia Oncology Associates (VOA) ( Site 8013) — Norfolk, Virginia, United States
Hospital Aleman ( Site 2903) — Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Instituto Alexander Fleming ( Site 2902) — 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
Sanatorio Parque - Oncología ( Site 2911) — Rosario, Santa Fe Province, Argentina
Instituto de Oncologia de Rosario ( Site 2909) — Rosario, Santa Fe Province, Argentina
Hospital Britanico de Buenos Aires ( Site 2905) — CABA, Argentina
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 2907) — La Rioja, Argentina
Westmead Hospital ( Site 0201) — Westmead, New South Wales, Australia
Gallipoli Medical Research Ltd ( Site 0204) — Brisbane, Queensland, Australia
Epworth Freemasons ( Site 0207) — East Melbourne, Victoria, Australia
Medizinische Universitat Wien ( Site 0102) — Vienna, State of Vienna, Austria
Medizinische Universitaet Innsbruck-Univ.-Klinik f. Gynäkologie und Geburtshilfe ( Site 0101) — Innsbruck, Tyrol, Austria
Grand Hopital de Charleroi ( Site 0303) — Charleroi, Hainaut, Belgium
AZ Maria Middelares ( Site 0302) — Ghent, Oost-Vlaanderen, Belgium
UZ Leuven ( Site 0301) — Leuven, Vlaams-Brabant, Belgium
Obras Sociais Irma Dulce ( Site 0427) — Salvador, Estado de Bahia, Brazil
Liga Norte Riograndense Contra o Cancer ( Site 0417) — Natal, Rio Grande do Norte, Brazil
Hospital São Lucas da PUCRS ( Site 0415) — Porto Alegre, Rio Grande do Sul, Brazil
ANIMI - Unidade de Tratamento Oncologico ( Site 0421) — Lages, Santa Catarina, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0414) — São José do Rio Preto, São Paulo, Brazil
IBCC - Núcleo de Pesquisa e Ensino ( Site 0416) — São Paulo, Brazil
CIUSSS - Saguenay-Lac-Saint-Jean ( Site 0519) — Chicoutimi, Quebec, Canada
Centre Hospitalier de l'Université de Montréal ( Site 0518) — Montreal, Quebec, Canada
McGill University Health Centre ( Site 0516) — Montreal, Quebec, Canada
Clinica Puerto Montt ( Site 0606) — Port Montt, Los Lagos Region, Chile
Fundación Arturo López Pérez ( Site 0607) — Santiago, Region M. de Santiago, Chile
Clínica Alemana de Santiago ( Site 0610) — Santiago, Region M. de Santiago, Chile
Pontificia Universidad Catolica de Chile ( Site 0602) — Santiago, Region M. de Santiago, Chile
Bradfordhill ( Site 0601) — Santiago, Region M. de Santiago, Chile
ONCOCENTRO APYS-ACEREY ( Site 0603) — Viña del Mar, Valparaiso, Chile
Fundacion Colombiana de Cancerología Clinica Vida ( Site 0803) — Medellín, Antioquia, Colombia
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0801) — Bogotá, Bogota D.C., Colombia
Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0802) — Valledupar, Cesar Department, Colombia
Instituto Nacional De Cancerologia ( Site 0808) — Bogota, Cundinamarca, Colombia
Oncólogos del Occidente S.A.S. ( Site 0806) — Pereira, Risaralda Department, Colombia
Fakultni Nemocnice Brno Bohunice ( Site 3304) — Brno, Brno-mesto, Czechia
Fakultni nemocnice Ostrava-Gynekologicko-porodnicka klinika ( Site 3303) — Ostrava-Poruba, Ostrava Mesto, Czechia
Fakultni nemocnice Hradec Kralove ( Site 3307) — Hradec Králové, Czechia
Fakultni nemocnice Kralovske Vinohrady ( Site 3306) — Prague, Czechia
Vseobecna fakultni nemocnice v Praze ( Site 3305) — Prague, Czechia
Fakultni nemocnice motol ( Site 3302) — Prague, Czechia
Herlev Hospital ( Site 0902) — Herlev, Capital Region, Denmark
Aalborg Universitetshospital ( Site 0901) — Aalborg, North Denmark, Denmark
Aarhus Universitetshospital, Skejby ( Site 0903) — Aarhus, North Denmark, Denmark
Odense Universitets Hospital ( Site 0904) — Odense, 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
Turku University Hospital-Department of Obstetrics and Gynecology ( Site 1001) — Turku, Southwest Finland, Finland
CENTRE LEON BERARD ( Site 1101) — Lyon, Auvergne-Rhône-Alpes, France
Hopitaux Universitaires de Strasbourg ( Site 1109) — Strasbourg, Bas-Rhin, France
Institut Paoli Calmettes ( Site 1111) — Marseille, Bouches-du-Rhone, France
Hôpital Privé Des Côtes d'Armor ( Site 1102) — Plérin, Cotes-d Armor, France
CHRU de Brest - Hopital de la Cavale Blanche ( Site 1104) — Brest, Finistere, France
LBM ONCOPOLE CLAUDIUS REGAUD ( Site 1114) — Toulouse, Haute-Garonne, France
Centre Hospitalier Universitaire Dupuytren ( Site 1112) — Limoges, Haute-Vienne, France
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau ( Site 1105) — Tours, Indre-et-Loire, France
Centre Oscar Lambret ( Site 1106) — Lille, Nord, France
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 1113) — Clermont-Ferrand, Puy-de-Dome, France
Universitätsklinikum Jena ( Site 1211) — Jena, Thuringia, Germany
Alexandra General Hospital of Athens ( Site 0703) — Athens, Attica, Greece
Evgenidion Clinic Agia Trias S.A ( Site 0701) — Athens, Attica, Greece
Agios Loukas Clinic ( Site 0702) — Thessaloniki, Greece
Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 3910) — Kecskemét, Bács-Kiskun county, Hungary
Petz Aladar Egyetemi Oktato Korhaz-Onkológiai Osztály ( Site 3911) — Győr, Győr-Moson-Sopron, Hungary
Semmelweis Egyetem I. Szamu Szuleszeti es Nogyogyaszati Klinika ( Site 3915) — Budapest, Hungary
Országos Onkológiai Intézet-Ngyógyászat ( Site 3913) — Budapest, Hungary
Debreceni Egyetem Klinikai Kozpont-Szülészeti és Nőgyógyászati Klinika ( Site 3912) — Debrecen, Hungary
Cork University Hospital ( Site 1303) — Cork, Ireland
St James Hospital ( Site 1302) — Dublin, Ireland
Rambam Health Care Campus ( Site 1422) — Haifa, Israel
Edith Wolfson Medical Center ( Site 1423) — Holon, Israel
Sheba Medical Center ( Site 1421) — Ramat Gan, Israel
Azienda Ospedaliera Spedali Civili di Brescia ( Site 1501) — Brescia, Italy
ASST DI LECCO ( Site 1509) — Lecco, Italy
Istituto Nazionale dei Tumori ( Site 1504) — Milan, Italy
Istituto Europeo di Oncologia ( Site 1503) — Milan, Italy
Istituto Oncologico Veneto ( Site 1506) — Padova, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1510) — Roma, Italy
Ospedale Mauriziano ( Site 1507) — Torino, Italy
Aichi Cancer Center ( Site 1601) — Nagoya, Aichi-ken, Japan
Kurume University Hospital ( Site 1615) — Kurume, Fukuoka, Japan
Gunma Prefectural Cancer Center ( Site 1605) — Ōta, Gunma, Japan
Hokkaido University Hospital ( Site 1609) — Sapporo, Hokkaido, Japan
Hyogo Cancer Center ( Site 1620) — Akashi, Hyōgo, Japan
Iwate Medical University Hospital ( Site 1610) — Shiwa-gun, Iwate, Japan
Saitama Medical University International Medical Center ( Site 1607) — Hidaka, Saitama, Japan
Shizuoka Cancer Center ( Site 1618) — Sunto-gun,, Shizuoka, Japan
Cancer Institute Hospital of JFCR ( Site 1614) — Koto, Tokyo, Japan
Keio University Hospital ( Site 1611) — Shinjyuku, Tokyo, Japan
National Hospital Organization Kyushu Cancer Center ( Site 1603) — Fukuoka, Japan
Kagoshima City Hospital ( Site 1613) — Kagoshima, Japan
Niigata Cancer Center Hospital ( Site 1608) — Niigata, Japan
Okayama University Hospital ( Site 1619) — Okayama, Japan
Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 1604) — Osaka, Japan
Stavanger Universitetssjukehus ( Site 2002) — Stavanger, Rogaland, Norway
Sorlandet Sykehus Kristiansand ( Site 2003) — Kristiansand, Vest-Agder, Norway
Oslo University Hospital ( Site 2001) — Oslo, Norway
IPOR Instituto Peruano de Oncología & Radioterapia ( Site 3604) — Lima, Peru
Clínica San Felipe ( Site 3603) — Lima, Peru
Uniwersytecki Szpital Kliniczny w Poznaniu-Oddzial Ginekologii Onkologicznej ( Site 2106) — Poznan, Greater Poland Voivodeship, Poland
Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie ( Site 2105) — Poznan, Greater Poland Voivodeship, Poland
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2102) — Siedlce, Masovian Voivodeship, Poland
Bialostockie Centrum Onkologii ( Site 2104) — Bialystok, Podlaskie Voivodeship, Poland
Uniwersytecki Szpital Kliniczny nr2 PUM w Szczecinie ( Site 2103) — Szczecin, West Pomeranian Voivodeship, Poland
Severance Hospital ( Site 2302) — Seodaemun-Gu, Seoul, South Korea
Keimyung University Dongsan Hospital ( Site 2304) — Daegu, Taegu-Kwangyokshi, South Korea
Seoul National University Hospital ( Site 2301) — Seoul, South Korea
Asan Medical Center ( Site 2305) — Seoul, South Korea
Samsung Medical Center ( Site 2303) — Seoul, South Korea
Institut Català d'Oncologia (ICO) - Girona ( Site 2402) — Girona, Gerona, Spain
Complejo Hospitalario Universitario A Coruna ( Site 2412) — A Coruña, La Coruna, Spain
Clinica Universidad de Navarra ( Site 2407) — Madrid, Madrid, Comunidad de, Spain
Instituto Valenciano de Oncologia - IVO ( Site 2411) — 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 La Paz-Oncología Médica ( Site 2404) — Madrid, Spain
Karolinska Universitetssjukhuset Solna ( Site 2502) — Stockholm, Stockholm County, Sweden
Inselspital Bern ( Site 3504) — Bern, Canton of Bern, Switzerland
Ospedale Regionale Bellinzona e Valli ( Site 3501) — Bellinzona, Canton Ticino, Switzerland
Kantonsspital Graubünden ( Site 3503) — Chur, Kanton Graubünden, Switzerland
Hôpitaux Universitaires de Genève (HUG) ( Site 3502) — Geneva, Switzerland
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
Linkou Chang Gung Memorial Hospital ( Site 2605) — Taoyuan, Taiwan
Ramathibodi Hospital. ( Site 3402) — Bangkok, Bangkok, Thailand
Faculty of Medicine Siriraj Hospital ( Site 3401) — Bangkoknoi, Bangkok, Thailand
Faculty of Medicine - Khon Kaen University ( Site 3403) — Muang, Changwat Khon Kaen, Thailand
Royal United Hospital Bath NHS Foundation Trust ( Site 2808) — Bath, Bath And North East Somerset, United Kingdom
Addenbrookes Hospital ( Site 2802) — Cambridge, Cambridgeshire, United Kingdom
University Hospitals of Leicester NHS Trust ( Site 2805) — Leicester, Leicestershire, United Kingdom
University College London Hospitals ( Site 2801) — London, London, City of, United Kingdom
The Christie NHS Foundation Trust ( Site 2804) — Manchester, United Kingdom

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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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