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

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 2 substudies and

Trial Details

NCT ID
NCT07059845
Phase
PHASE2
Sponsor
AbbVie
Status
RECRUITING
Cancer Type
Ovarian Cancer
Interventions
  • Mirvetuximab Soravtansine
  • Bevacizumab
  • Carboplatin
Locations (sample)
  • Kogarah, New South Wales, Australia|-33.9681,151.13564
  • Auchenflower, Queensland, Australia|-27.47443,152.99213
  • Adelaide, South Australia, Australia|-34.92866,138.59863
  • Hobart, Tasmania, Australia|-42.87936,147.32941
  • Clayton, Victoria, Australia|-37.91667,145.11667

Key Eligibility Criteria

  • Substudy 1 and 2: Confirmed high or medium folate receptor alpha (FRa) expression by Ventana folate receptor 1 (FOLR1) Assay.
  • Substudy 1 and 2: Participants must have an Eastern Cooperative Oncology Group performance status of 0 or 1.
  • Substudy 1: Participants must have a confirmed diagnosis of Federation of Gynecology and Obstetrics (FIGO) Stage III or IV high-grade serous ovaria…
  • Substudy 1: Tumor must be confirmed HRD test negative (HRP), determined by a local homologous recombination deficient (HRD) test.

For full eligibility, visit ClinicalTrials.gov.

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