A Study of Mirvetuximab Soravtansine vs. Investigator's Choice (IC) of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha (FRα) Expression

Study Identifier
IMGN853-0416
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
Not available
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Study Complete

Results Available

Protocol
Available Language(s): English
Statistical Analysis Plan
Available Language(s): English
Scientific Result Summary
Available Language(s): English
Plain Language Summary
Available Language(s): English, Bulgarian, Czech, German (Belgium), German, Spanish, French (Belgium), French, Italian, Dutch (Belgium), Dutch, Polish, Polish, Portuguese (Native), Ukrainian

Study Details

Medical Condition
  • Ovarian Cancer
  • Gynecologic Cancer - Other
  • Gynecologic Cancer - Fallopian Tube Cancer
  • Study Drug
  • Mirvetuximab Soravtansine
  • Paclitaxel
  • Topotecan
  • Pegylated liposomal doxorubicin
  • Phase
    Phase 3
    Sex
    Female
    Age
    18+ years

    Protocol Summary

    This Phase 3 study is designed to compare the efficacy and safety of mirvetuximab soravtansine (MIRV) vs. IC chemotherapy in participants with platinum-resistant high-grade epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of FRα. Participants will be, in the opinion of the Investigator, appropriate for single-agent therapy for their next line of therapy. The FRα positivity will be defined by the Ventana FOLR1 (FOLR1-2.1) CDx assay.

    Study Locations

    Location
    Status
    Location
    University of Alabama at Birmingham (UAB) GYN Oncology
    Birmingham, Alabama, United States, 35233
    Status
    Not applicable
    Location
    Alaska Women's Cancer Care
    Anchorage, Alaska, United States, 99508
    Status
    Not applicable
    Location
    Arizona Oncology Associates, PC - HAL - USOR
    Phoenix, Arizona, United States, 85016
    Status
    Not applicable
    Location
    Mayo Clinic
    Phoenix, Arizona, United States, 85054
    Status
    Not applicable
    Location
    USOR: Arizona Oncology Associates, PC - HOPE
    Tucson, Arizona, United States, 85711
    Status
    Not applicable
    Location
    University of Arizona Cancer Center
    Tucson, Arizona, United States, 85719
    Status
    Not applicable
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