Phase 2 Study Evaluating Intravenous Mirvetuximab Soravtansine with Bevacizumab andor Carboplatin in Women with Ovarian Cancer Assessing Safety and Disease Activity

What this Trial Is About

Ovarian cancer is a serious disease with a high number of new cases and deaths worldwide. This study evaluates the safety and disease activity changes of mirvetuximab soravtansine combined with carboplatin, bevacizumab, or bevacizumab alone in female participants with ovarian cancer confirmed to express folate receptor alpha FR. The trial is a Phase 2 study involving approximately 400 participants worldwide, assessing different treatment combinations given by intravenous infusion. Participants will be assigned to one of three substudies and receive treatment in groups called arms. Substudy 1 includes arms where participants receive one of two doses of mirvetuximab soravtansine with bevacizumab or bevacizumab alone. Substudy 2 involves mirvetuximab soravtansine with carboplatin followed by mirvetuximab soravtansine alone. Substudy 3 combines mirvetuximab soravtansine, bevacizumab, and carboplatin followed by mirvetuximab soravtansine with bevacizumab. Treatments are given by intravenous infusion, and the study duration ranges up to approximately 40 months depending on the substudy. Participants will attend regular visits at hospitals or clinics where they will receive infusions and undergo medical assessments including blood tests and scans. Researchers will monitor treatment-emergent adverse events, ocular events, overall response, progression-free survival, and other outcomes up to about 40 months. The study includes careful safety monitoring and evaluation of disease activity during and after treatment to assess the effects and safety of these drug combinations.

A Study to Assess Adverse Events and Change in Disease Activity of Multiple Treatment Combinations With Intravenous Mirvetuximab Soravtansine in Adult Participants With Ovarian Cancer