IMGN853-0424

A Randomized Phase 2 Study of Ocular Toxicity Evaluation and Mitigation During Treatment with Mirvetuximab Soravtansine in Patients with Recurrent Ovarian Cancer with High Folate Receptor-Alpha Expression

Open
Grade
High grade, Low grade, Other / unknown
Prior lines
1, 2, 3, 4
Histology
Serous, Mucinous Endometrioid Clear-cell
Platin
Platinum sensitive
Platinum resistant
Secondary platinum refractory
Phase
II
IMP
Mirvetuximab Soravtansine
principal investigator
Prof. Dr. Toon Van Gorp

Treatment

Participants will be randomized (1:1):

  •  Mirvetuximab Soravtansine + Prednisolone acetate ophthalmic suspension 1% eye drops
  •  Mirvetuximab Soravtansine + Brimonidine tartrate ophthalmic solution eye drops
     

Treatment duration

The treatment can continue until disease progression, unacceptable toxicity or withdrawal of consent.

Eligibility

Main inclusion criteria:

  • FRα positive tumor (centrally tested)

Main exclusion criteria:

  • Grade 2 or higher peripheral neuropathy
  • Significant active or chronic corneal disorders, history of corneal transplantation, significant ocular inflammatory conditions or other active ocular conditions
  • Prior treatment with mirvetuximab Soravtansine or other FRα-targeting agents

Disclaimer: This is an overview of the main in- and exclusion criteria which can also be found on clinicaltrials.gov (NCT06365853). Criteria might change during the course of the study due to amendments. Inclusion in the trial remains the responsibility of the principal investigator of the trial and will depend on patient eligibility and slot availability.

Contact

In case you feel your patient might be eligible for this trial or in case you want to have more information about this trial, please feel free to contact us via: lgog@uzleuven.be