Phase 3Recruiting
A Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Maintenance Treatment Versus Standard of Care in Participants With Platinum-sensitive Recurrent Ovarian Cancer (MK-2870-022/TroFuse-022/ENGOT-ov84/GOG-3103)
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)
- Sponsor
- Merck Sharp & Dohme LLC (Industry)
- Enrolment
- 770 planned
- Conditions
- Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer
- Interventions
- Sacituzumab tirumotecan; Bevacizumab; H1 receptor antagonist; H2 receptor antagonist; Acetaminophen (or equivalent); Dexamethasone (or equivalent); Steroid mouthwash (dexamethasone or equivalent)
- Ages
- adults, older adults
- Registry
- NCT06824467
From the registry
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.
Primary outcomes
- Part 1: Number of Participants With One or More Adverse Events (AEs)
- Part 1: Number of Participants Who Discontinue Study Intervention Due to an AE
- Part 2: Progression-Free Survival (PFS)