A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan Maintenance Treatment With or Without Bevacizumab Versus Standard of Care After Second-line Platinum-based Doublet Chemotherapy in Participants With Platinum-sensitive Recurrent Ovarian Cancer (TroFuse-022/ENGOT-ov84/GOG-3103)
Merck Sharp & Dohme LLC
Summary
The main goals of this study are to learn about the safety of sacituzumab tirumotecan with bevacizumab and if people tolerate it; and if people who take sacituzumab tirumotecan with or without bevacizumab live longer without the cancer getting worse than those who receive standard of care treatment.
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Has histologically confirmed Federation of Gynecology and Obstetrics (FIGO) Stage III or IV epithelial ovarian, primary peritoneal, or fallopian tube carcinoma of certain histologies * Has received 4 or more cycles of platinum-based doublet chemotherapy in first-line and a total of 6 cycles of carboplatin-based doublet chemotherapy in second-line setting for ovarian cancer (OC) * Has platinum-sensitive epithelial OC * Has provided tissue of a tumor lesion that was not previously irradiated * Human immunodeficiency virus (HIV)-infected participants must have well controll…
Interventions
- BiologicalSacituzumab tirumotecan
IV Infusion
- BiologicalBevacizumab
IV Infusion
- DrugH1 receptor antagonist
Rescue medication taken per approved product label before sacituzumab tirumotecan
- DrugH2 receptor antagonist
Rescue medication taken per approved product label before sacituzumab tirumotecan
- DrugAcetaminophen (or equivalent)
Rescue medication taken per approved product label before sacituzumab tirumotecan
- DrugDexamethasone (or equivalent)
Rescue medication taken per approved product label before sacituzumab tirumotecan
Locations (167)
- University of Alabama at Birmingham ( Site 0006)Birmingham, Alabama
- Alaska Women's Cancer Care ( Site 0096)Anchorage, Alaska
- Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0001)New Haven, Connecticut
- Mount Sinai Cancer Center ( Site 0078)Miami Beach, Florida
- Sarasota Memorial Hospital ( Site 0075)Sarasota, Florida
- Florida Cancer Specialists East ( Site 7000)West Palm Beach, Florida