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Recruiting Phase 3 NCT07318558

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

Phase 3 – large-scale trial before approval
Conditions: Ovarian Neoplasms Ovarian Cancer

Sponsor: Merck Sharp & Dohme LLC

trial.available_in: БГ
Overview
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.
Who can participate
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.
Interventions
Sacituzumab tirumotecan
DRUG
Bevacizumab
DRUG
Rescue Medications
DRUG
Locations 24
Australia (2)
Gallipoli Medical Research Ltd ( Site 0204)
Brisbane , Queensland
Study Coordinator
Epworth Freemasons ( Site 0207)
East Melbourne , Victoria
Study Coordinator
Israel (2)
Rambam Health Care Campus ( Site 1422)
Haifa
Study Coordinator
Edith Wolfson Medical Center ( Site 1423)
Holon
Study Coordinator
Japan (5)
Saitama Medical University International Medical Center ( Site 1607)
Hidaka , Saitama
Study Coordinator
Cancer Institute Hospital of JFCR ( Site 1614)
Koto , Tokyo
Study Coordinator
Niigata Cancer Center Hospital ( Site 1608)
Niigata
Study Coordinator
Hokkaido University Hospital ( Site 1609)
Sapporo , Hokkaido
Study Coordinator
Iwate Medical University Hospital ( Site 1610)
Shiwa-gun , Iwate
Study Coordinator
South Korea (5)
Keimyung University Dongsan Hospital ( Site 2304)
Daegu , Taegu-Kwangyokshi
Study Coordinator
Severance Hospital ( Site 2302)
Seodaemun-Gu , Seoul
Study Coordinator
Seoul National University Hospital ( Site 2301)
Seoul
Study Coordinator
Asan Medical Center ( Site 2305)
Seoul
Study Coordinator
Samsung Medical Center ( Site 2303)
Seoul
Study Coordinator
Switzerland (4)
Ospedale Regionale Bellinzona e Valli ( Site 3501)
Bellinzona , Canton Ticino
Study Coordinator
Inselspital Bern ( Site 3504)
Bern , Canton of Bern
Study Coordinator
Kantonsspital Graubünden ( Site 3503)
Chur , Kanton Graubünden
Study Coordinator
Hôpitaux Universitaires de Genève (HUG) ( Site 3502)
Geneva
Study Coordinator
Taiwan (2)
Taichung Veterans General Hospital ( Site 2603)
Taichung
Study Coordinator
Linkou Chang Gung Memorial Hospital ( Site 2605)
Taoyuan District
Study Coordinator
United States (4)
Women's Cancer Care ( Site 0018)
Covington , Louisiana
Study Coordinator
Mount Sinai Cancer Center ( Site 0029)
Miami Beach , Florida
Study Coordinator
Nebraska Methodist Hospital ( Site 0004)
Omaha , Nebraska
Study Coordinator
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0007)
Tulsa , Oklahoma
Study Coordinator
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Female only
Minimum age
18 Years
Healthy volunteers
No
Start date
16.02.2026
Completion date
25.02.2033
Registry ID
NCT07318558
Source
clinicaltrials.gov
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