A Phase III Non-Randomized Study of Mirvetuximab Soravtansine in Women with Ovarian, Peritoneal, or Fallopian Tube Cancers

Share
Print

Full Title

A Phase 3, Single Arm Study of Mirvetuximab Soravtansine in Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers with High Folate Receptor-Alpha Expression

Purpose

The purpose of this study is to assess the effectiveness of the investigational treatment mirvetuximab soravtansine (MIRV) in women with metastatic ovarian, peritoneal, or fallopian tube cancers that persist or came back despite prior therapies and contain high levels of a protein called FR-alpha.

 MIRV is called an “antibody-drug conjugate.” The antibody part binds to FR-alpha and then releases the chemotherapy (a drug called DM4), which kills cancer cells. Researchers hope MIRV can shrink tumors and slow down the return or worsening of a patient’s cancer. MIRV is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have metastatic high-grade serous ovarian, peritoneal, or fallopian tube cancer that persists or came back despite prior therapies.
  • Patients will need to have testing to determine if their tumor cells have high levels of the FR-alpha protein.
  • Patients must have received at least one but no more than three prior regimens of chemotherapy, including platinum-containing medication and bevacizumab.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for women age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Jason Konner at 848-225-6530.

Protocol

20-469

Phase

III

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators