A Study of Mirvetuximab Soravtansine vs. Investigator's Choice of Chemotherapy in Platinum-Resistant Advanced High-Grade Epithelial Ovarian Primary Peritoneal or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression

  • STATUS
    Recruiting
  • End date
    Sep 10, 2023
  • participants needed
    430
  • sponsor
    ImmunoGen, Inc.
Updated on 10 July 2021
platelet count
paclitaxel
cancer
monoclonal antibodies
measurable disease
endocrine therapy
maintenance therapy
doxorubicin
serum bilirubin level
cytotoxic chemotherapy
neutrophil count
hormone therapy
blood transfusion
bevacizumab
hormonal therapy
folic acid
cancer chemotherapy
antineoplastic
parp inhibitor
ovarian cancer
fallopian tube
taxane
mirvetuximab soravtansine
immunostimulant
ovarian epithelial cancer
topotecan
cancer antigen 125
peritoneal cancer
primary peritoneal carcinoma
ovarian epithelial carcinoma
cancer of the ovary
fallopian tube cancer
epithelial ovarian cancer
immunological adjuvant
plat

Summary

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

Description

Patients will be randomized to either mirvetuximab soravtansine (MIRV) or Investigator's Choice chemotherapy (paclitaxel, PEGylated liposomal doxorubicin, or topotecan).

Details
Condition Fallopian Tube Cancer, Peritoneal Cancer, Ovarian Epithelial Cancer, Epithelial Ovarian Cancer, Primary Peritoneal Cavity Cancer, Epithelial Ovarian Carcinoma, ovarian epithelial carcinoma, carcinoma of the ovary, fallopian tube cancers
Treatment Topotecan, Paclitaxel, Pegylated Liposomal Doxorubicin, Mirvetuximab Soravtansine
Clinical Study IdentifierNCT04209855
SponsorImmunoGen, Inc.
Last Modified on10 July 2021

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