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A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021)
Sponsor: Merck Sharp & Dohme LLC
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
2026-04-02
Healthy Volunteers
No
Conditions
Interventions
Sacituzumab tirumotecan
Administered via intravenous (IV) infusion at a dose of 4mg/kg
Bevacizumab
Administered via IV infusion at a dose of 15mg/kg
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.
Locations (13)
Mount Sinai Cancer Center ( Site 0029)
Miami Beach, Florida, United States
Rambam Health Care Campus ( Site 1422)
Haifa, Israel
Edith Wolfson Medical Center ( Site 1423)
Holon, Israel
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
Niigata Cancer Center Hospital ( Site 1608)
Niigata, Japan
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
Linkou Chang Gung Memorial Hospital ( Site 2605)
Taoyuan District, Taiwan