Study of Mirvetuximab Soravtansine for Women With Advanced Platinum-Resistant High-Grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancers High in Folate Receptor-Alpha

What this Trial Is About

This research aims to evaluate the safety and effectiveness of Mirvetuximab Soravtansine in female participants aged 18 years and older who have platinum-resistant advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers with high levels of folate receptor alpha FR. The study includes two groups a randomized Phase 2 group and a hepatic impairment group, with about 110 participants expected worldwide. The purpose is to better understand how this investigational antibody drug conjugate works by targeting cancer cells carrying FR to deliver a cell-killing drug. Participants in the randomized Phase 2 group receive Mirvetuximab Soravtansine intravenously on one of two schedules either a standard dose on day 1 every 21 days or a lower dose on days 1 and 15 every 28 days. The hepatic impairment group evaluates the starting dose for participants with moderately abnormal liver function, receiving different doses on day 1 of a 21-day cycle. Treatment and monitoring continue for up to about 24 months, including dose optimization and safety assessments. During the study, participants will visit the hospital or clinic regularly for medical exams, blood tests, and scans to track treatment effects and side effects. Researchers will measure responses including corneal adverse events, tumor response rates, drug concentrations in the body, and survival outcomes. Safety is closely monitored through assessments of vital signs, laboratory values, and physical exams. The total participation time is approximately 24 months, with ongoing evaluations to determine how well the treatment works and its safety profile.

A Study to Assess Adverse Events and Change in Disease Activity in Participants With Platinum-Resistant Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression Treated With Intravenously (IV) Infused Mirvetuximab Soravtansine