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RECRUITING

NCT07318558

PHASE3

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

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

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)

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

900

Start Date

2026-02-16

Completion Date

2033-02-25

Last Updated

2026-05-29

Healthy Volunteers

Conditions

Ovarian Neoplasms Ovarian Cancer

Interventions

DRUG

Sacituzumab tirumotecan

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

DRUG

Bevacizumab

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

DRUG

Rescue 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.

The main inclusion criteria include but are not limited to the following: * Has histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube carcinoma of certain histologies. * 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. * If human immunodeficiency virus (HIV) infected, has well-controlled HIV on antiretroviral therapy. * 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, or has current pneumonitis/ILD. * 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. * Has active or ongoing stomatitis of any grade.

Locations (77)

Mount Sinai Cancer Center ( Site 0029)

Miami Beach, Florida, 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

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

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

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

São José do Rio Preto, São Paulo, Brazil

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

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

Hôpital Privé Des Côtes d'Armor ( Site 1102)

Plérin, Cotes-d Armor, 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

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 Clinic I Provincial de Barcelona ( Site 2409)

Barcelona, Spain

ICO L Hospitalet ( Site 2408)

Barcelona, Spain

Hospital Clinico San Carlos... ( Site 2410)

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

Faculty of Medicine - Khon Kaen University ( Site 3403)

Muang, Changwat Khon Kaen, Thailand

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (77)