Clinical Research Directory

A Study to Evaluate Adverse Events and Change in Disease Activity of Mirvetuximab Soravtansine-gynx in Adults With Folate Receptor-Alpha Positive, Platinum-Resistant Ovarian Cancer in a Real-World Setting

Sponsor: AbbVie

Summary

Epithelial ovarian cancer, which includes fallopian tube and primary peritoneal cancers, is a lethal disease with 3,221 new cases reported in 2021 in Korea. The purpose of this study is to evaluate the adverse events and change in disease activity of mirvetuximab soravtansine-gynx (MIRV) in participants with folate receptor-alpha (FRα) positive, platinum-resistant, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. This study will evaluate the patient outcome in a routine clinical practice setting in South Korea. MIRV is an antibody drug conjugate for high grade serious epithelial ovarian cancer in participants who have received one to three prior systemic treatment regimens. Participants with FRα positive platinum-resistant ovarian cancer who started treatment with MIRV according to the approved product label in Korea will be enrolled. Around 69 participants will be enrolled in the study in South Korea. Participants will receive MIRV according to the approved local label. Participants will be followed for up to 62 months. There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice.

Official title: A Post-Marketing Surveillance to Evaluate the Safety and Effectiveness of Mirvetuximab Soravtansine-gynx in Patients With Folate Receptor-Alpha Positive, Platinum-Resistant, High-grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

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