Phase 3 Study of Sacituzumab Tirumotecan With or Without Bevacizumab Compared to Standard Treatment in Women With Platinum-sensitive Recurrent Ovarian Cancer After Second-line Chemotherapy

What this Trial Is About

This trial focuses on people with platinum-sensitive recurrent ovarian cancer, including certain types of ovarian, primary peritoneal, or fallopian tube cancers. It aims to study the safety and tolerance of sacituzumab tirumotecan combined with bevacizumab and compare how long participants live without their cancer worsening when treated with sacituzumab tirumotecan, with or without bevacizumab, versus standard care. The study is a Phase 3, randomized, open-label trial designed to evaluate these treatments after second-line platinum-based chemotherapy. Participants are assigned to one of three groups one group receives sacituzumab tirumotecan plus bevacizumab through intravenous infusions every 2 and 3 weeks respectively for 6 weeks another group receives sacituzumab tirumotecan alone every 2 weeks for up to about 2 years or until the disease progresses, with optional bevacizumab at the doctors choice the third group follows the local standard care until progression, with optional bevacizumab as determined by the physician. The study includes rescue medications such as H1 and H2 receptor antagonists, acetaminophen, dexamethasone, and steroid mouthwash taken as needed according to approved guidelines. During the study, participants will be monitored for adverse events up to 6 weeks in Part 1 and for progression-free survival for up to about 4 years in Part 2. Additional assessments include overall survival for up to 6 years and quality of life measures through questionnaires at baseline and periodically up to approximately 4 years. Safety and treatment tolerability will be closely tracked, and participants will have intravenous infusions and follow-up visits throughout the study period, which may last several years depending on disease progression and treatment continuation.

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)