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)
Status: Recruiting
Location: See all (19) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Florida
Mount Sinai Cancer Center ( Site 0029)
RECRUITING
Miami Beach
Other Locations
Australia
Gallipoli Medical Research Ltd ( Site 0204)
RECRUITING
Brisbane
Epworth Freemasons ( Site 0207)
RECRUITING
East Melbourne
Israel
Rambam Health Care Campus ( Site 1422)
RECRUITING
Haifa
Edith Wolfson Medical Center ( Site 1423)
RECRUITING
Holon
Japan
Saitama Medical University International Medical Center ( Site 1607)
RECRUITING
Hidaka
Cancer Institute Hospital of JFCR ( Site 1614)
RECRUITING
Koto
Niigata Cancer Center Hospital ( Site 1608)
RECRUITING
Niigata
Hokkaido University Hospital ( Site 1609)
RECRUITING
Sapporo
Iwate Medical University Hospital ( Site 1610)
RECRUITING
Shiwa-gun
Republic of Korea
Keimyung University Dongsan Hospital ( Site 2304)
RECRUITING
Daegu
Severance Hospital ( Site 2302)
RECRUITING
Seodaemun-gu
Asan Medical Center ( Site 2305)
RECRUITING
Seoul
Samsung Medical Center ( Site 2303)
RECRUITING
Seoul
Seoul National University Hospital ( Site 2301)
RECRUITING
Seoul
Switzerland
Ospedale Regionale Bellinzona e Valli ( Site 3501)
RECRUITING
Bellinzona
Inselspital Bern ( Site 3504)
RECRUITING
Bern
Kantonsspital Graubünden ( Site 3503)
RECRUITING
Chur
Taiwan
Linkou Chang Gung Memorial Hospital ( Site 2605)
RECRUITING
Taoyuan District
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date:2026-02-16
Estimated Completion Date:2033-02-25
Participants
Target number of participants:900
Treatments
Experimental: Sac-TMT +/- Bevacizumab
Participants will receive sac-TMT on days 1, 15, and 29 (q2W) of every 6-week cycle, until disease progression, prohibitive toxicity, or other protocol-defined reason for discontinuation. Participants receive optional bevacizumab at investigator's discretion on Days 1 and 22 (q3w) of every 6-week cycle, for up to 22 courses.
Active_comparator: Standard of Care
Participants will either receive bevacizumab q3w of every 6-week cycle for up to 22 courses until disease progression, prohibitive toxicity, or other protocol-defined reason for discontinuation of study intervention, or will be observed only and actively followed if not receiving bevacizumab.