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)
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.
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
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 th…
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 (41)
- Mount Sinai Cancer Center ( Site 0029)Miami Beach, Florida
- Parkview Research Center at Parkview Regional Medical Center ( Site 0055)Fort Wayne, Indiana
- Women's Cancer Care ( Site 0018)Covington, Louisiana
- Nebraska Methodist Hospital ( Site 0004)Omaha, Nebraska
- Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0007)Tulsa, Oklahoma
- West Cancer Center and Research Institute ( Site 0013)Germantown, Tennessee