RecruitingPhase 3NCT07318558

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

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)


Sponsor

Merck Sharp & Dohme LLC

Enrollment

900 participants

Start Date

Feb 16, 2026

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called Sac-TMT (sacituzumab tirumotecan) as a maintenance therapy after first-line chemotherapy in people with advanced ovarian, fallopian tube, or peritoneal cancer that is not HRD-positive (meaning a specific DNA repair defect is not present). **You may be eligible if...** - You have confirmed advanced epithelial ovarian, primary peritoneal, or fallopian tube cancer (certain specific subtypes) - You have completed primary or interval surgery to remove the tumor - You have completed first-line platinum-based chemotherapy with a stable, partial, or complete response - You can provide a tumor tissue sample (not previously irradiated) - If you have HIV, it must be well-controlled on medication; hepatitis B/C must also be managed **You may NOT be eligible if...** - Your tumor is a non-epithelial cancer, low-grade serous, mucinous, borderline, or undifferentiated type - You have active brain metastases - You have a history of severe eye disease or active inflammatory bowel disease - You have uncontrolled cardiovascular or cerebrovascular disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSacituzumab tirumotecan

Administered via intravenous (IV) infusion at a dose of 4mg/kg

DRUGBevacizumab

Administered via IV infusion at a dose of 15mg/kg

DRUGRescue Medications

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.


Locations(99)

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

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

Fort Wayne, Indiana, United States

Women's Cancer Care ( Site 0018)

Covington, Louisiana, United States

Nebraska Methodist Hospital ( Site 0004)

Omaha, Nebraska, United States

University Of Nebraska Medical Center ( Site 0035)

Omaha, Nebraska, United States

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

Tulsa, Oklahoma, United States

West Cancer Center and Research Institute ( Site 0013)

Germantown, Tennessee, United States

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

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

Hospital São Lucas da PUCRS ( Site 0415)

Porto Alegre, Rio Grande do Sul, Brazil

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

São José do Rio Preto, São Paulo, Brazil

McGill University Health Centre ( Site 0516)

Montreal, Quebec, Canada

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

Bogotá, Bogota D.C., Colombia

Instituto Nacional De Cancerologia ( Site 0808)

Bogota, Cundinamarca, Colombia

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

Pereira, Risaralda Department, Colombia

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

Ostrava-Poruba, Ostrava Mesto, 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

Hôpital Privé Des Côtes d'Armor ( Site 1102)

Plérin, Cotes-d Armor, 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

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

Kecskemét, Bács-Kiskun county, Hungary

Országos Onkológiai Intézet-Ngyógyászat ( Site 3913)

Budapest, Hungary

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

Debrecen, Hungary

Rambam Health Care Campus ( Site 1422)

Haifa, Israel

Edith Wolfson Medical Center ( Site 1423)

Holon, Israel

Azienda Ospedaliera Spedali Civili di Brescia ( Site 1501)

Brescia, Italy

Istituto Europeo di Oncologia ( Site 1503)

Milan, Italy

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

Roma, Italy

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

Cancer Institute Hospital of JFCR ( Site 1614)

Koto, Tokyo, Japan

Kagoshima City Hospital ( Site 1613)

Kagoshima, Japan

Niigata Cancer Center Hospital ( Site 1608)

Niigata, 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

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

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

The Christie NHS Foundation Trust ( Site 2804)

Manchester, United Kingdom

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NCT07318558


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