Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess the safety and efficacy of for Mirvetuximab Soravtansine in participants with platinum-resistant advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer (platinum-resistant ovarian cancer) (PROC) whose tumors express a high level of folate receptor alpha (FRα). Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to cancer cells carrying a protein called folate receptor alpha (FRα). There are 2 cohorts in this study, the Randomized Phase 2 Cohort and the Hepatic Impairment Cohort. In the Randomized Phase 2 Cohort, participants are placed in 1 of 2 groups, called treatment arms. Each treatment arm receives MIRV on a different schedule (on day 1 every 21 days or on days 1 and 15 every 28 days). The Hepatic Impairment Cohort is designed to determine the starting dose of MIRV in patients with moderately abnormal liver function. Around 110 participants will be enrolled in the study at approximately 75 sites worldwide. The total study duration will be approximately 24 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.
Age range
18 Years
Sex
FEMALE
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The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Randomized Phase 2 Cohort: Percentage of Participants with Grade >= 2 Treatment-Emergent Corneal Adverse Events (AEs)
Timeframe: Up to Approximately 24 months
Randomized Phase 2 Cohort: Percentage of Participants who Achieved Objective response rate (ORR)
Timeframe: Up to Approximately 24 months
Hepatic Impairment Cohort: Maximal Concentration (Cmax) of Mirvetuximab Soravtansine
Timeframe: Up to Approximately 24 months
Hepatic Impairment Cohort: Area Under the Plasma Concentration (AUC) of Mirvetuximab Soravtansine
Timeframe: Up to Approximately 24 months
Hepatic Impairment Cohort: Trough Concentration (Ctrough) of Mirvetuximab Soravtansine
Timeframe: Up to Approximately 24 months
Hepatic Impairment Cohort: Volume of Distribution at Steady State (Vss) of Mirvetuximab Soravtansine
Timeframe: Up to Approximately 24 months
Hepatic Impairment Cohort: Time to Maximal Concentration (Tmax) of Mirvetuximab Soravtansine
Timeframe: Up to Approximately 24 months
Hepatic Impairment Cohort: Terminal Half-Life (t1/2) of Mirvetuximab Soravtansine
Timeframe: Up to Approximately 24 months