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RecruitingInterventionalPhase 2

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

NCT ID: NCT06365853Sponsor: AbbVieLast updated: 2026-06-12

Summary

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.

Detailed description

Participants will be randomized (1:1) to 1 of 2 ocular adverse event (AE) risk mitigation strategy arms (primary prophylactic steroid eye drops versus primary prophylactic vasoconstricting eye drops).

Arms & interventions

  • DrugMirvetuximab Soravtansine

    Mirvetuximab soravtansine 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.

  • DrugLubricating Eye Drops

    Lubricating artificial tears should be administered at least 15 minutes after corticosteroid or brimonidine eye drop administration.

  • DrugPrednisolone acetate ophthalmic suspension 1% eye drops

    Self-administration of prednisolone acetate ophthalmic suspension 1% eye drops as prescribed by the treating physician.

  • DrugBrimonidine tartrate ophthalmic solution eye drops

    Self-administration of brimonidine tartrate ophthalmic solution eye drops as prescribed by the treating physician.

Outcome measures

Primary

  • Number of Participants With MIRV-related Corneal TEAEs (≥ Grade 2) in Asymptomatic Participants

    This endpoint will be assessed in the participants receiving MIRV who are asymptomatic .

    Time frame: Cycle 1 Day 1 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)

Secondary

  • Number of Participants With Ocular symptom TEAEs in Participants Using Corticosteroid or Vasoconstricting Eye Drop Primary Prophylaxis

    Time frame: Cycle 1 Day 1 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days

  • Number of Participants With MIRV-related Corneal TEAEs in Symptomatic Participants

    Time frame: Cycle 1 Day 1 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)

  • Number of Participants With Ocular exam TEAEs in Asymptomatic Participants and Symptomatic participants

    Time frame: Cycle 1 Day 1 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)

  • Number of Participants With MIRV-related Corneal TEAEs (≥ Grade 2) in Participants Using Corticosteroid or Vasoconstricting Eye Drop Primary Prophylaxis

    Time frame: Cycle 1 Day 1 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)

  • Number of Participants with ocular exam TEAEs in Participants using corticosteroid or vasoconstricting eye drop primary prophylaxis

    Time frame: Cycle 1 Day 1 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)

  • National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) Composite Score

    Time frame: At Cycle 5 Day 1 or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)

  • Area Under the Curve (AUC) of MIRV

    Time frame: Day 1 and Day 8 of Cycles 1 through 4 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)

  • Maximum Serum Concentration (Cmax) of MIRV

    Time frame: Day 1 and Day 8 of Cycles 1 through 4 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)

  • Trough Concentration (Ctrough) of MIRV

    Time frame: Day 1 and Day 8 of Cycles 1 through 4 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)

Eligibility criteria

Sex: FemaleAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: * 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) as defined by either the VENTANA FOLR1 (FOLR-2.1) IUO Assay, or the VENTANA FOLR1 ( FOLR1-2.1) RxDx Assay (hereafter collectively termed VENTANA FOLR1 Assay) (≥ 75% cells exhibit ≥ 2+ membrane staining intensity). * Participants with known breast cancer susceptibility gene (BRCA) mutations (tumor or germline) must have received poly (ADP-ribose) polymerase inhibitors (PARPi). * Participants must have completed prior therapy within the specified times below: 1. Systemic antineoplastic therapy ≥ 5 half-lives or 4 weeks (whichever is shorter) before first dose of MIRV; 2. Focal radiation completed ≥ 2 weeks before the first dose of MIRV. * Participants must have stabilized or recovered (Grade 1 or baseline) from all prior therapy-related toxicities (except alopecia). * Women of childbearing potential (WOCBP) must agree to use highly effective contraceptive method(s) while on MIRV and for ≥ 7 months after the last dose; and must have a negative pregnancy test ≤ 4 days before the first dose of MIRV. Exclusion Criteria: * Participants with borderline ovarian tumor or non-epithelial histology or mixed histology including borderline or non-epithelial histology will be excluded. * PROC participants with primary platinum-refractory disease, defined as disease that did not respond to (complete response \[CR\] or partial response \[PR\]) or progressed within ≤ 3 months of the last dose of first line platinum-containing chemotherapy. * Participants with \> Grade 1 peripheral neuropathy per National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0). * Participants with significant active or chronic corneal disorders (for example, corneal dystrophies, degenerations, limbal stem cell deficiency), history of corneal transplantation, significant ocular inflammatory conditions (for example, active or recurrent uveitis), or other active ocular conditions requiring ongoing treatment/monitoring, such as uncontrolled glaucoma, active diabetic retinopathy with macular edema, macular degeneration requiring treatment ≤ 90 days before first dose, presence of papilledema, best corrected visual acuity (BCVA) worse than 20/70 in either eye, or monocular vision. * Participants receiving corticosteroid or vasoconstricting eyedrops at baseline or within 5 weeks of Cycle 1 Day 1. * Participants who received prior treatment with MIRV or other FRα-targeting agents. Note: Other protocol-defined inclusion and exclusion criteria may apply.

Study locations (12)

University of California Los Angeles /ID# 269339

Los Angeles, California, 90095

Recruiting

Norton Cancer Institute - St. Matthews /ID# 269070

Louisville, Kentucky, 40207

Completed

Holy Cross Hospital - Silver Spring /ID# 269344

Silver Spring, Maryland, 20910

Recruiting

Mercy David C. Pratt Cancer Center /ID# 269350

St Louis, Missouri, 63141

Recruiting

The Center Of Hope /ID# 269348

Reno, Nevada, 89511

Active Not Recruiting

Holy Name Medical Center /ID# 269340

Teaneck, New Jersey, 07666

Recruiting

New York Oncology Hematology - Albany Cancer Center /ID# 269345

Albany, New York, 12206-5013

Completed

Women'S Cancer Care Associates /ID# 269980

Albany, New York, 12208

Completed

Duke Cancer Institute /ID# 269342

Durham, North Carolina, 27710

Recruiting

Summa Health /ID# 269349

Akron, Ohio, 44304-1407

Recruiting

UT Southwestern Medical Center /ID# 269341

Dallas, Texas, 75390

Recruiting

Memorial Hermann Southeast Hospital /ID# 269347

Houston, Texas, 77089

Completed
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 | Cancerify