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

NCT07318558 · Merck Sharp & Dohme LLC
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Official title
A Phase 3, Randomized, Open-label, Multicenter Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) Maintenance Treatment With or Without Bevacizumab Versus Standard of Care in Participants With Newly Diagnosed Advanced Non-HRD Positive Ovarian Cancer Following First-line Platinum-based Chemotherapy (TroFuse-021/ENGOTov85/GOG-3102)
About this study
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
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.
Study design
Enrollment target: 900 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2026-02-16
Estimated completion: 2033-02-25
Last updated: 2026-09-17
Interventions
Drug: Sacituzumab tirumotecanDrug: BevacizumabDrug: Rescue Medications
Primary outcomes
  • Progression-Free Survival (PFS) (Up to approximately 49 months)
Sponsor
Merck Sharp & Dohme LLC · industry
Contacts & investigators
ContactToll Free Number · contact · Trialsites@msd.com · 1-888-577-8839
InvestigatorMedical Director · study_director, Merck Sharp & Dohme LLC
All locations (163)
University of Alabama - Birmingham ( Site 0058)Recruiting
Birmingham, Alabama, United States
John Muir Health Cancer Center ( Site 0069)Recruiting
Walnut Creek, California, United States
Mount Sinai Cancer Center ( Site 0029)Recruiting
Miami Beach, Florida, United States
Orlando Health Winnie Palmer Hospital for Women and Babies ( Site 0085)Recruiting
Orlando, Florida, United States
Winship Cancer Institute of Emory University ( Site 0037)Recruiting
Atlanta, Georgia, United States
Illinois Cancer Specialists (ICS) ( Site 8009)Recruiting
Arlington Heights, Illinois, United States
Parkview Research Center at Parkview Regional Medical Center ( Site 0055)Recruiting
Fort Wayne, Indiana, United States
Franciscan Health Indianapolis ( Site 0081)Recruiting
Indianapolis, Indiana, United States
Women's Cancer Care ( Site 0018)Recruiting
Covington, Louisiana, United States
Maine Medical Center Research Institute-MaineHealth/Maine Medical Partners - GynOnc ( Site 0060)Recruiting
Scarborough, Maine, United States
Maryland Oncology Hematology (MOH) ( Site 8002)Recruiting
Columbia, Maryland, United States
Nebraska Methodist Hospital ( Site 0004)Recruiting
Omaha, Nebraska, United States
University Of Nebraska Medical Center ( Site 0035)Recruiting
Omaha, Nebraska, United States
The Center of Hope ( Site 0025)Recruiting
Reno, Nevada, United States
Womens Cancer Care Associates, LLC ( Site 0023)Recruiting
Albany, New York, United States
Memorial Sloan Kettering Cancer Center ( Site 0072)Recruiting
New York, New York, United States
Duke Cancer Center ( Site 0012)Recruiting
Durham, North Carolina, United States
University of Cincinnati Medical Center ( Site 0042)Recruiting
Cincinnati, Ohio, United States
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0007)Recruiting
Tulsa, Oklahoma, United States
Hospital of the University of Pennsylvania ( Site 0071)Recruiting
Philadelphia, Pennsylvania, United States
Women & Infants Hospital ( Site 0001)Recruiting
Providence, Rhode Island, United States
West Cancer Center and Research Institute ( Site 0013)Recruiting
Germantown, Tennessee, United States
University of Tennessee Medical Center ( Site 0087)Recruiting
Knoxville, Tennessee, United States
Henry-Joyce Cancer Clinic ( Site 0011)Recruiting
Nashville, Tennessee, United States
Virginia Cancer Specialists (VCS) ( Site 8012)Recruiting
Fairfax, Virginia, United States
Virginia Oncology Associates (VOA) ( Site 8013)Recruiting
Norfolk, Virginia, United States
Hospital Aleman ( Site 2903)Recruiting
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Instituto Alexander Fleming ( Site 2902)Recruiting
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Mar del Plata ( Site 2901)Recruiting
Mar del Plata, Buenos Aires, Argentina
Fundación Respirar ( Site 2912)Recruiting
Buenos Aires, Buenos Aires F.D., Argentina
Sanatorio Parque - Oncología ( Site 2911)Recruiting
Rosario, Santa Fe Province, Argentina
Instituto de Oncologia de Rosario ( Site 2909)Recruiting
Rosario, Santa Fe Province, Argentina
Hospital Britanico de Buenos Aires ( Site 2905)Recruiting
CABA, Argentina
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 2907)Recruiting
La Rioja, Argentina
Westmead Hospital ( Site 0201)Recruiting
Westmead, New South Wales, Australia
Gallipoli Medical Research Ltd ( Site 0204)Recruiting
Brisbane, Queensland, Australia
Epworth Freemasons ( Site 0207)Recruiting
East Melbourne, Victoria, Australia
Medizinische Universitat Wien ( Site 0102)Recruiting
Vienna, State of Vienna, Austria
Medizinische Universitaet Innsbruck-Univ.-Klinik f. Gynäkologie und Geburtshilfe ( Site 0101)Recruiting
Innsbruck, Tyrol, Austria
Grand Hopital de Charleroi ( Site 0303)Recruiting
Charleroi, Hainaut, Belgium
AZ Maria Middelares ( Site 0302)Recruiting
Ghent, Oost-Vlaanderen, Belgium
UZ Leuven ( Site 0301)Recruiting
Leuven, Vlaams-Brabant, Belgium
Obras Sociais Irma Dulce ( Site 0427)Recruiting
Salvador, Estado de Bahia, Brazil
Liga Norte Riograndense Contra o Cancer ( Site 0417)Recruiting
Natal, Rio Grande do Norte, Brazil
Hospital São Lucas da PUCRS ( Site 0415)Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
ANIMI - Unidade de Tratamento Oncologico ( Site 0421)Recruiting
Lages, Santa Catarina, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0414)Recruiting
São José do Rio Preto, São Paulo, Brazil
IBCC - Núcleo de Pesquisa e Ensino ( Site 0416)Recruiting
São Paulo, Brazil
CIUSSS - Saguenay-Lac-Saint-Jean ( Site 0519)Recruiting
Chicoutimi, Quebec, Canada
Centre Hospitalier de l'Université de Montréal ( Site 0518)Recruiting
Montreal, Quebec, Canada
McGill University Health Centre ( Site 0516)Recruiting
Montreal, Quebec, Canada
Clinica Puerto Montt ( Site 0606)Recruiting
Port Montt, Los Lagos Region, Chile
FALP ( Site 0607)Recruiting
Santiago, Region M. de Santiago, Chile
Clínica Alemana de Santiago ( Site 0610)Recruiting
Santiago, Region M. de Santiago, Chile
Pontificia Universidad Catolica de Chile ( Site 0602)Recruiting
Santiago, Region M. de Santiago, Chile
ONCOCENTRO APYS-ACEREY ( Site 0603)Recruiting
Viña del Mar, Valparaiso, Chile
Fundacion Colombiana de Cancerología Clinica Vida ( Site 0803)Recruiting
Medellín, Antioquia, Colombia
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0801)Recruiting
Bogotá, Bogota D.C., Colombia
Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0802)Recruiting
Valledupar, Cesar Department, Colombia
Instituto Nacional De Cancerologia ( Site 0808)Recruiting
Bogota, Cundinamarca, Colombia
Oncólogos del Occidente S.A.S. ( Site 0806)Recruiting
Pereira, Risaralda Department, Colombia
Fakultni Nemocnice Brno Bohunice ( Site 3304)Recruiting
Brno, Brno-mesto, Czechia
Fakultni nemocnice Ostrava-Gynekologicko-porodnicka klinika ( Site 3303)Recruiting
Ostrava-Poruba, Ostrava Mesto, Czechia
Fakultni nemocnice Hradec Kralove ( Site 3307)Recruiting
Hradec Králové, Czechia
Fakultni nemocnice Kralovske Vinohrady ( Site 3306)Recruiting
Prague, Czechia
Vseobecna fakultni nemocnice v Praze ( Site 3305)Recruiting
Prague, Czechia
Fakultni nemocnice motol ( Site 3302)Recruiting
Prague, Czechia
Herlev Hospital ( Site 0902)Recruiting
Herlev, Capital Region, Denmark
Aalborg Universitetshospital ( Site 0901)Recruiting
Aalborg, North Denmark, Denmark
Aarhus Universitetshospital, Skejby ( Site 0903)Recruiting
Aarhus, North Denmark, Denmark
Odense Universitets Hospital ( Site 0904)Recruiting
Odense, Region Syddanmark, Denmark
Oulun yliopistollinen sairaala ( Site 1003)Recruiting
Oulu, North Ostrobothnia, Finland
Kuopion Yliopistollinen Sairaala ( Site 1004)Recruiting
Kuopio, Northern Savonia, Finland
Tampereen yliopistollinen sairaala ( Site 1002)Recruiting
Tampere, Pirkanmaa, Finland
Turku University Hospital-Department of Obstetrics and Gynecology ( Site 1001)Recruiting
Turku, Southwest Finland, Finland
CENTRE LEON BERARD ( Site 1101)Recruiting
Lyon, Auvergne-Rhône-Alpes, France
Hopitaux Universitaires de Strasbourg ( Site 1109)Recruiting
Strasbourg, Bas-Rhin, France
Institut Paoli Calmettes ( Site 1111)Recruiting
Marseille, Bouches-du-Rhone, France
Hôpital Privé Des Côtes d'Armor ( Site 1102)Recruiting
Plérin, Cotes-d Armor, France
CHRU de Brest - Hopital de la Cavale Blanche ( Site 1104)Recruiting
Brest, Finistere, France
LBM ONCOPOLE CLAUDIUS REGAUD ( Site 1114)Recruiting
Toulouse, Haute-Garonne, France
Centre Hospitalier Universitaire Dupuytren ( Site 1112)Recruiting
Limoges, Haute-Vienne, France
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau ( Site 1105)Recruiting
Tours, Indre-et-Loire, France
Centre Oscar Lambret ( Site 1106)Recruiting
Lille, Nord, France
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 1113)Recruiting
Clermont-Ferrand, Puy-de-Dome, France
Alexandra General Hospital of Athens ( Site 0703)Recruiting
Athens, Attica, Greece
Evgenidion Clinic Agia Trias S.A ( Site 0701)Recruiting
Athens, Attica, Greece
Agios Loukas Clinic ( Site 0702)Recruiting
Thessaloniki, Greece
Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 3910)Recruiting
Kecskemét, Bács-Kiskun county, Hungary
Petz Aladar Egyetemi Oktato Korhaz-Onkológiai Osztály ( Site 3911)Recruiting
Győr, Győr-Moson-Sopron, Hungary
Semmelweis Egyetem I. Szamu Szuleszeti es Nogyogyaszati Klinika ( Site 3915)Recruiting
Budapest, Hungary
Országos Onkológiai Intézet-Ngyógyászat ( Site 3913)Recruiting
Budapest, Hungary
Debreceni Egyetem Klinikai Kozpont-Szülészeti és Nőgyógyászati Klinika ( Site 3912)Recruiting
Debrecen, Hungary
Cork University Hospital ( Site 1303)Recruiting
Cork, Ireland
St James Hospital ( Site 1302)Recruiting
Dublin, Ireland
Rambam Health Care Campus ( Site 1422)Recruiting
Haifa, Israel
Edith Wolfson Medical Center ( Site 1423)Recruiting
Holon, Israel
Sheba Medical Center ( Site 1421)Recruiting
Ramat Gan, Israel
Azienda Ospedaliera Spedali Civili di Brescia ( Site 1501)Recruiting
Brescia, Italy
ASST DI LECCO ( Site 1509)Recruiting
Lecco, Italy
Istituto Nazionale dei Tumori ( Site 1504)Recruiting
Milan, Italy
Istituto Europeo di Oncologia ( Site 1503)Recruiting
Milan, Italy
Istituto Oncologico Veneto ( Site 1506)Recruiting
Padova, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1510)Recruiting
Roma, Italy
Ospedale Mauriziano ( Site 1507)Recruiting
Torino, Italy
Aichi Cancer Center ( Site 1601)Recruiting
Nagoya, Aichi-ken, Japan
Kurume University Hospital ( Site 1615)Recruiting
Kurume, Fukuoka, Japan
Gunma Prefectural Cancer Center ( Site 1605)Recruiting
Ōta, Gunma, Japan
Hokkaido University Hospital ( Site 1609)Recruiting
Sapporo, Hokkaido, Japan
Hyogo Cancer Center ( Site 1620)Recruiting
Akashi, Hyōgo, Japan
Iwate Medical University Hospital ( Site 1610)Recruiting
Shiwa-gun, Iwate, Japan
Saitama Medical University International Medical Center ( Site 1607)Recruiting
Hidaka, Saitama, Japan
Shizuoka Cancer Center ( Site 1618)Recruiting
Sunto-gun,, Shizuoka, Japan
Cancer Institute Hospital of JFCR ( Site 1614)Recruiting
Koto, Tokyo, Japan
Keio University Hospital ( Site 1611)Recruiting
Shinjyuku, Tokyo, Japan
National Hospital Organization Kyushu Cancer Center ( Site 1603)Recruiting
Fukuoka, Japan
Kagoshima City Hospital ( Site 1613)Recruiting
Kagoshima, Japan
Niigata Cancer Center Hospital ( Site 1608)Recruiting
Niigata, Japan
Okayama University Hospital ( Site 1619)Recruiting
Okayama, Japan
Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 1604)Recruiting
Osaka, Japan
Stavanger Universitetssjukehus ( Site 2002)Recruiting
Stavanger, Rogaland, Norway
Sorlandet Sykehus Kristiansand ( Site 2003)Recruiting
Kristiansand, Vest-Agder, Norway
Oslo University Hospital ( Site 2001)Recruiting
Oslo, Norway
IPOR Instituto Peruano de Oncología & Radioterapia ( Site 3604)Recruiting
Lima, Peru
Clínica San Felipe ( Site 3603)Recruiting
Lima, Peru
Uniwersytecki Szpital Kliniczny w Poznaniu-Oddzial Ginekologii Onkologicznej ( Site 2106)Recruiting
Poznan, Greater Poland Voivodeship, Poland
Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie ( Site 2105)Recruiting
Poznan, Greater Poland Voivodeship, Poland
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2102)Recruiting
Siedlce, Masovian Voivodeship, Poland
Bialostockie Centrum Onkologii ( Site 2104)Recruiting
Bialystok, Podlaskie Voivodeship, Poland
Uniwersytecki Szpital Kliniczny nr2 PUM w Szczecinie ( Site 2103)Recruiting
Szczecin, West Pomeranian Voivodeship, Poland
Severance Hospital ( Site 2302)Recruiting
Seodaemun-Gu, Seoul, South Korea
Keimyung University Dongsan Hospital ( Site 2304)Recruiting
Daegu, Taegu-Kwangyokshi, South Korea
Seoul National University Hospital ( Site 2301)Recruiting
Seoul, South Korea
Asan Medical Center ( Site 2305)Recruiting
Seoul, South Korea
Samsung Medical Center ( Site 2303)Recruiting
Seoul, South Korea
Institut Català d'Oncologia (ICO) - Girona ( Site 2402)Recruiting
Girona, Gerona, Spain
Complejo Hospitalario Universitario A Coruna ( Site 2412)Recruiting
A Coruña, La Coruna, Spain
Clinica Universidad de Navarra ( Site 2407)Recruiting
Madrid, Madrid, Comunidad de, Spain
Instituto Valenciano de Oncologia - IVO ( Site 2411)Recruiting
Valencia, Valenciana, Comunitat, Spain
Hospital Vall D Hebron ( Site 2403)Recruiting
Barcelona, Spain
Hospital Clinic I Provincial de Barcelona ( Site 2409)Recruiting
Barcelona, Spain
ICO L Hospitalet ( Site 2408)Recruiting
Barcelona, Spain
Hospital Universitario Reina Sofia ( Site 2406)Recruiting
Córdoba, Spain
Hospital Ramon y Cajal ( Site 2405)Recruiting
Madrid, Spain
Hospital Clinico San Carlos... ( Site 2410)Recruiting
Madrid, Spain
Hospital Universitario La Paz-Oncología Médica ( Site 2404)Recruiting
Madrid, Spain
Karolinska Universitetssjukhuset Solna ( Site 2502)Recruiting
Stockholm, Stockholm County, Sweden
Inselspital Bern ( Site 3504)Recruiting
Bern, Canton of Bern, Switzerland
Ospedale Regionale Bellinzona e Valli ( Site 3501)Recruiting
Bellinzona, Canton Ticino, Switzerland
Kantonsspital Graubünden ( Site 3503)Recruiting
Chur, Kanton Graubünden, Switzerland
Hôpitaux Universitaires de Genève (HUG) ( Site 3502)Recruiting
Geneva, Switzerland
Taichung Veterans General Hospital ( Site 2603)Recruiting
Taichung, Taiwan
National Cheng Kung University Hospital ( Site 2602)Recruiting
Tainan, Taiwan
National Taiwan University Hospital ( Site 2601)Recruiting
Taipei, Taiwan
Mackay Memorial Hospital ( Site 2604)Recruiting
Taipei, Taiwan
Linkou Chang Gung Memorial Hospital ( Site 2605)Recruiting
Taoyuan, Taiwan
Ramathibodi Hospital. ( Site 3402)Recruiting
Bangkok, Bangkok, Thailand
Faculty of Medicine Siriraj Hospital ( Site 3401)Recruiting
Bangkoknoi, Bangkok, Thailand
Faculty of Medicine - Khon Kaen University ( Site 3403)Recruiting
Muang, Changwat Khon Kaen, Thailand
Addenbrookes Hospital ( Site 2802)Recruiting
Cambridge, Cambridgeshire, United Kingdom
University Hospitals of Leicester NHS Trust ( Site 2805)Recruiting
Leicester, Leicestershire, United Kingdom
University College London Hospitals ( Site 2801)Recruiting
London, London, City of, United Kingdom
The Christie NHS Foundation Trust ( Site 2804)Recruiting
Manchester, United Kingdom
A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021) · TrialPath