A Study to Assess Adverse Events and Change in Disease Activity of Multiple Treatment Combinations With Intravenous Mirvetuximab Soravtansine in Adult Participants With Ovarian Cancer

Study Identifier
M25-709
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
2025-521606-18
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Study Details

Medical Condition
  • Ovarian Cancer
  • Study Drug
  • Mirvetuximab Soravtansine
  • Bevacizumab
  • Carboplatin
  • Phase
    Phase 2
    Sex
    Female
    Age
    18+ years

    Protocol Summary

    Ovarian cancer is a lethal disease with an estimated 310,000 new cases and 200,000 deaths experienced worldwide in 2020. The purpose of this study is to assess the adverse events and change in disease activity of mirvetuximab soravtansine with carboplatin, or bevacizumab (Bev), or bev alone in participants with ovarian cancer (OC). Participants must have confirmation of folate receptor alpha (FRa) positivity by the Ventana folate receptor 1 (FOLR1) Assay.

    Mirvetuximab Soravtansine (MIRV) is an investigational drug for the treatment of OC. Participants will be assigned to 1 of 3 substudies and further into groups called treatment arms. In substudy 1, arms A-C, participants will receive 1 of 2 doses of MIRV with Bev, or Bev alone. In substudy 2, arms D and E, participants will receive 1 of 2 doses of MIRV with carboplatin, followed by MIRV alone. In substudy 3, arms F and G, participants will receive one of two doses of MIRV with BEV and carboplatin, followed by MIRV with BEV. Approximately 400 participants will be enrolled in the study at 100 sites around the world.

    Participants will receive intravenously (IV) infused MIRV with IV infused carboplatin, or IV infused Bev, or IV infused carboplatin and Bev, or IV infused Bev alone. The total study duration will be approximately 40 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.

    Study Locations

    Location
    Status
    Location
    UC San Diego Health - Moores Cancer Center /ID# 277574
    La Jolla, California, United States, 92037
    Status
    Recruiting
    Location
    Sansum Clinic - Solvang /ID# 277712
    Solvang, California, United States, 93463
    Status
    Active, Not Recruiting
    Location
    University of Florida College of Medicine /ID# 278348
    Gainesville, Florida, United States, 32610
    Status
    Recruiting
    Location
    Orlando Health Cancer Institute Gynecologic Cancer Center - Orlando /ID# 278623
    Orlando, Florida, United States, 32806
    Status
    Recruiting
    Location
    Florida Cancer Specialists - North /ID# 278626
    St. Petersburg, Florida, United States, 33705
    Status
    Recruiting
    Location
    Florida Cancer Specialists - East /ID# 278605
    West Palm Beach, Florida, United States, 33401
    Status
    Recruiting
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