A Single-Arm, Phase 2 Study of Neoadjuvant Carboplatin and Mirvetuximab Soravtansine in Subjects with FRa-Expressing Advanced-Stage Serous Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
The primary objective of the study is to evaluate the anti-tumor activity of carboplatin + MIRV in newly diagnosed subjects with advanced-stage (= 75%, = 2+) serous EOC as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 imaging response. The primary endpoint is objective response (OR) by Independent Central Review (ICR), defined as best overall response of radiographic complete response (CR) or partial response (PR) as assessed by the ICR per RECIST Version 1.1 prior to subsequent anticancer therapy including interval debulking surgery (IDS). The safety objective is to evaluate the safety and tolerability of neoadjuvant carboplatin + MIRV in newly diagnosed subjects with advanced-stage FRa-expressing (= 75%, = 2+) serous EOC. Safety evaluations include adverse event (AE) monitoring, physical examinations including periodic ophthalmic examinations by an eye care professional, vital sign measurements, and clinical laboratory testing (hematology and chemistry) as measures of safety and tolerability for the entire study duration.