Study of Carboplatin and Mirvetuximab Soravtansine in First-Line Treatment of Patients Receiving Neoadjuvant Chemotherapy With Advanced-Stage Ovarian, Fallopian Tube or Primary Peritoneal Cancer

The proposed study design is a single arm Phase II trial to document the feasibility of carboplatin-mirvetuximab - in patients with advanced-stage EOC. Patients with biopsy confirmed, newly diagnosed, advanced-stage serous EOC deemed appropriate for NACT will have their tumors evaluated for FRα receptor over-expression via a centralized immunohistochemical assay (IHC) and identified as appropriate for study participation if IHC staining is PS2+ in \>75% of cells (40% of all serous patients). Eligible patients will receive NACT with one cycle of carboplatin, followed by mirvetuximab + carboplat

Trial Details

NCT ID
NCT04606914
Phase
PHASE2
Sponsor
University of Alabama at Birmingham
Status
RECRUITING
Cancer Type
Ovarian Cancer
Interventions
  • mirvetuximab soravtansine (MIRV; IMGN853)
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • San Francisco, California, United States|37.77493,-122.41942
  • Minneapolis, Minnesota, United States|44.97997,-93.26384
  • Rochester, Minnesota, United States|44.02163,-92.4699
  • Oxford, Mississippi, United States|34.3665,-89.51925

Key Eligibility Criteria

  • Patients must have biopsy-confirmed high grade serous epithelial ovarian cancer.
  • Patients must present with stage III or IV disease and be appropriate to receive neoadjuvant chemotherapy
  • Patients must be willing to provide an archival tumor tissue block or slides, or undergo procedure to obtain a new biopsy using a low-risk, medical…
  • Patients must have a performance status of 0 or 1.

For full eligibility, visit ClinicalTrials.gov.

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