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IMGN853-0416 MIRASOL

Trial

Clinical Trial Title

A Randomized, Open-label, Phase 3 Study of Mirvetuximab Soravtansine vs. Investigator’s Choice of Chemotherapy in Advanced Highgrade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers with High Folate Receptor-Alpha Expression

Trial Status

Open to Enrollment

Start Date

September 1, 2020

Trial Type

Cancer - Adult Oncology

Specific Condition

Ovarian Cancer

Description

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 FRα. Patients will be, in the opinion of the Investigator, appropriate for single-agent therapy for their next line of therapy. Folate receptor alpha (FRα) positivity will be defined by the Ventana FOLR1 (FOLR1-2.1) CDx assay.

Eligibility Criteria

Inclusion Criteria

  • Patients must have a confirmed diagnosis of high-grade serous EOC, primary peritoneal cancer, or fallopian tube cancer
  • Patients must have platinum-resistant disease (defined as progression within 6 months from completion of a minimum of four cycles of platinum-containing therapy)
  • Patients must have progressed on or after their most recent line of therapy
  • Patient’s tumor must be positive for FRα expression as defined by the Ventana FOLR1 (FOLR-2.1) CDx assay
  • Patients must have received at least 1 but no more than 3 prior systemic lines of anticancer therapy, and for whom single-agent therapy is appropriate as the next line of treatment

Exclusion Criteria

  • Patients with primary platinum-refractory disease, defined as disease that did not respond to or has progressed within 3 months of the last dose of first line platinum-containing chemotherapy

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.

IRB Number

Central IRB

Principal Investigator Name

Colleen McCormick, MD

Contact Name

Oncology Clinical Research

Phone

503-413-8199

Contact Fax

503-413-6920

Contact E-Mail

oncologyresearch@lhs.org

Last Updated: Wednesday, January 27, 2021 12:56:51 PM