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Universitair Ziekenhuis Gent | Health Innovation and Research Institute - Poli Gastro-Enterologie Department

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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

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ImmunoGen

Status and phase

Not yet enrolling
Phase 2

Conditions

Recurrent Ovarian Cancer
Folate Receptor-Alpha Positive

Treatments

Drug: Prednisolone acetate ophthalmic suspension 1% eye drops
Drug: Lubricating Eye Drops
Drug: Brimonidine tartrate ophthalmic solution eye drops
Drug: Mirvetuximab Soravtansine

Study type

Interventional

Funder types

Industry

Identifiers

NCT06365853
IMGN853-0424
2023-505617-24-00

Details and patient eligibility

About

The purpose of this study is to evaluate the incidence rate and severity of pre-specified 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.

Full 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).

Enrollment

100 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key 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 folate receptor 1 (FOLR1) (FOLR1-2.1) CDX Assay or Ventana FOLR1 (FOLR1-2.1) RxDx Assay (hereafter collectively termed: Ventana FOLR1 Assay) (≥75% cells exhibit 2 or 3+ 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) prior to first dose of MIRV;
    2. Focal radiation completed ≥ 2 weeks prior to 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 prior to the first dose of MIRV.

Key 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 ≤ 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 prior to first dose, presence of papilledema, best corrected visual acuity (BCVA) worse than 20/70, 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

Primary Prophylactic Steroid Eye Drops
Experimental group
Description:
Prednisolone acetate ophthalmic suspension 1% 6 times daily on Days -1 to 4 and 4 times daily (QID) on Days 5 to 8 of each cycle; Lubricating eye drops QID throughout the entire cycle (doses should follow steroid dosing, when given, by approximately 15 minutes); MIRV 6 milligrams (mg)/kilogram (kg) adjusted ideal body weight (AIBW) every 3 weeks (Q3W). Each cycle length = 21 days.
Treatment:
Drug: Mirvetuximab Soravtansine
Drug: Prednisolone acetate ophthalmic suspension 1% eye drops
Drug: Lubricating Eye Drops
Primary Prophylactic Vasoconstricting Eye Drops
Experimental group
Description:
Primary prophylactic brimonidine tartrate ophthalmic solution eye drops 3 times daily (TID) throughout the cycle; Lubricating eye drops QID throughout the entire cycle (doses should follow brimonidine dosing, when given, by approximately 15 minutes); MIRV 6 mg/kg AIBW Q3W. Each cycle length = 21 days.
Treatment:
Drug: Mirvetuximab Soravtansine
Drug: Brimonidine tartrate ophthalmic solution eye drops
Drug: Lubricating Eye Drops

Trial contacts and locations

25

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Central trial contact

ImmunoGen, Inc.

Data sourced from clinicaltrials.gov

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