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OncoMatch/Clinical Trials/NCT06365853

A Study of Ocular Toxicity Evaluation and Mitigation During Treatment With Mirvetuximab Soravtansine in Participants With Recurrent Ovarian Cancer With High Folate Receptor-Alpha Expression

Is NCT06365853 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Mirvetuximab Soravtansine and Lubricating Eye Drops for recurrent ovarian cancer.

Phase 2RecruitingAbbVieNCT06365853Data as of Jun 2026Location: International · 7 countries

Treatment: Mirvetuximab Soravtansine · Lubricating Eye Drops · Prednisolone acetate ophthalmic suspension 1% eye drops · Brimonidine tartrate ophthalmic solution eye dropsThe 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.

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Extracted eligibility criteria

Treatments studied

Targeted therapy

Mirvetuximab Soravtansine

Other

Lubricating Eye DropsPrednisolone acetate ophthalmic suspension 1% eye dropsBrimonidine tartrate ophthalmic solution eye drops

Cancer type

Ovarian Cancer

Biomarker criteria

Required: FOLR1 high expression (≥ 75% cells with ≥ 2+ membrane staining intensity by VENTANA FOLR1 Assay) (≥ 75% cells with ≥ 2+ membrane staining intensity)

FRα positive (FRα high) as defined by either the VENTANA FOLR1 (FOLR-2.1) IUO Assay, or the VENTANA FOLR1 ( FOLR1-2.1) RxDx Assay (≥ 75% cells exhibit ≥ 2+ membrane staining intensity)

Allowed: BRCA1 mutation (tumor or germline)

Participants with known breast cancer susceptibility gene (BRCA) mutations (tumor or germline) must have received poly (ADP-ribose) polymerase inhibitors (PARPi)

Allowed: BRCA2 mutation (tumor or germline)

Participants with known breast cancer susceptibility gene (BRCA) mutations (tumor or germline) must have received poly (ADP-ribose) polymerase inhibitors (PARPi)

Demographics

Female only

Prior therapy

Must have received: poly (ADP-ribose) polymerase inhibitor

Participants with known breast cancer susceptibility gene (BRCA) mutations (tumor or germline) must have received poly (ADP-ribose) polymerase inhibitors (PARPi)

Cannot have received: FRα-targeting agent (mirvetuximab soravtansine)

Participants who received prior treatment with MIRV or other FRα-targeting agents

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of California Los Angeles /ID# 269339 · Los Angeles, California
  • Norton Cancer Institute - St. Matthews /ID# 269070 · Louisville, Kentucky
  • Holy Cross Hospital - Silver Spring /ID# 269344 · Silver Spring, Maryland
  • Mercy David C. Pratt Cancer Center /ID# 269350 · St Louis, Missouri
  • The Center Of Hope /ID# 269348 · Reno, Nevada

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See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT06365853 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior FRα-targeting agent disqualifies patients from enrollment.

Does this trial require FOLR1?

Yes, FOLR1 high expression (≥ 75% cells with ≥ 2+ membrane staining intensity by VENTANA FOLR1 Assay) is a required biomarker for enrollment.

Is this trial open to male patients?

No. This trial enrolls female patients only.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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