IMGN-858-0424

About this trial

Mirvetuximab soravtansine (MIRV) is an antibody drug conjugate designed to target folate receptor α (FRα). It consists of the humanized anti-FRα monoclonal antibody (mAb) M9346A attached via a cleavable disulfide linker to the cytotoxic maytansinoid, DM4. Patients often develop issues with their eyes after receiving this treatment.

The purpose of this study is to evaluate the incidence rate and severity of prespecified mirvetuximab soravtansine (MIRV)-related ocular treatment-emergent adverse events (TEAEs) and assess prophylaxis strategies in all participants (symptomatic and asymptomatic) undergoing prospective ophthalmic evaluation with recurrent ovarian cancer (participants with either platinum-sensitive ovarian cancer [PSOC] or platinum-resistant ovarian cancer [PROC]) with high folate receptor alpha (FRα) expression.

These patients will be monitored for any TEAES post receiving MIRV.

Patient Profile

* Participants must have a confirmed diagnosis of epithelial ovarian, fallopian tube, and primary peritoneal cancer (EOC) with high FRα expression.
* Participant’s tumor must be FRα positive (FRα high)
* Participants with known breast cancer susceptibility gene (BRCA) mutations (tumor or germline) must have received poly (ADP-ribose) polymerase inhibitors (PARPi).
* Participants with known breast cancer susceptibility gene (BRCA) mutations (tumor or germline) must have received poly (ADP-ribose) polymerase inhibitors (PARPi).

Where’s this trial being run?

Beaumont Hospital and Mater Misericordiae University Hospital

Can I join this study / trial?

The first thing you do is to talk to your doctor and/or the cancer trials research team in your hospital. The contact details for the cancer trials research units in Ireland is here.

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Questions?

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Questions

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Summary Data

Name:	IMGN-858-0424
Number:	24-116
Full Title:	IMGN-858-0424 / 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

Principal Investigator:	Prof. Austin Duffy
Type:	Industry Sponsored
Sponsor:	AbbVie
Recruitment Started:	Global: July 2024 Ireland:

Global Recruitment Target:	100
Ireland Recruitment Target: