Phase III clinical trial - Gynécologie - Ovaires

MIRASOL
Gynécologie - Ovaires
Ouvert depuis le: 09.19.2021
Site: Saint-Cloud
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Adulte
MIRASOL: A Randomized, Open-label, Phase 3 Study of Mirvetuximab Soravtansine vs. Investigator's Choice of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression.
Description de l'essai

This Phase 3 study is designed to compare the efficacy and safety of mirvetuximab soravtansine vs. investigator's choice chemotherapy in patients with platinum-resistant high-grade epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of FR¦Á. Patients will be, in the opinion of the Investigator, appropriate for single-agent therapy for their next line of therapy. Folate receptor alpha (FR¦Á) positivity will be defined by the Ventana FOLR1 (FOLR1-2.1) CDx assay.