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 (MIRASOL)

  • STATUS
    Recruiting
  • End date
    Apr 1, 2024
  • participants needed
    430
  • sponsor
    ImmunoGen, Inc.
Updated on 1 July 2022
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 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.

Description

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

Details
Condition Epithelial Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
Treatment Topotecan, Paclitaxel, Pegylated Liposomal Doxorubicin, Mirvetuximab Soravtansine
Clinical Study IdentifierNCT04209855
SponsorImmunoGen, Inc.
Last Modified on1 July 2022

Eligibility

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note