Ovarian Cancer Clinical Trial

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

Summary

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.

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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).

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Eligibility 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:

Systemic antineoplastic therapy ≥ 5 half-lives or 4 weeks (whichever is shorter) prior to first dose of MIRV;
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.

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

100

Study ID:

NCT06365853

Recruitment Status:

Not yet recruiting

Sponsor:

ImmunoGen, Inc.

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There are 8 Locations for this study

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University of Colorado Health - University of Colorado Cancer Center (UCCC) - Anschutz Medical Campus (Anschutz Cancer Pavilion) (ACP)
Aurora Colorado, 80045, United States
Yale School of Medicine - Yale Gynecologic Oncology
New Haven Connecticut, 06510, United States
Holy Cross Hospital
Silver Spring Maryland, 20910, United States
Baystate Regional Cancer Program - D'Amour Center for Cancer Care Location - Gynecologic Oncology
Springfield Massachusetts, 01107, United States
New York Oncology Hematology
Albany New York, 12208, United States
Women's Cancer Care Associates, LLC
Albany New York, 12208, United States
New York-Presbyterian/Columbia University Medical Center - Herbert Irving Comprehensive Cancer Center (HICCC) - Herbert Irving Pavilion
New York New York, 10032, United States
Duke Cancer Institute (DCI) - Duke Cancer Center
Durham North Carolina, 27710, United States
University of Texas Southwestern Medical Center - Harold C. Simmons Comprehensive Cancer Center - University Hospital Gynecologic Oncology Clinic
Dallas Texas, 75235, United States
Monash University - Monash Medical Centre (MMC) - Clayton
Clayton Victoria, , Australia
Universitair Ziekenhuis Antwerpen (UZA) - Borstkliniek
Edegem Antwerp, , Belgium
AZ Sint-Lucas - Campus Sint-Lucas - Borstkliniek
Gent East Flanders, , Belgium
Universitair Ziekenhuis Gent (UZ Gent)
Gent East Flanders, , Belgium
McGill University Health Centre (MUHC) - The Montreal General Hospital (MGH) - Cedars Cancer Centre
Montreal Quebec, , Canada
Universite de Montreal - Centre Hospitalier de l'Universite de Montreal (CHUM) - Hopital Notre-Dame
Montreal Quebec, , Canada
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Cochin
Paris , , France
Groupe Hospitalier Diaconesses Croix Saint-Simon - Hopital de la Croix Saint-Simon
Paris , , France
Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud
Pierre Benite , , France
Bon Secours Hospital - Dublin
Dublin , , Ireland
Mater Misericordiae University Hospital (MMUH) (START Dublin)
Dublin , , Ireland
Istituto Europeo di Oncologia (IEO) (European Institute of Oncology)
Milan , , Italy
Institut Catala d'Oncologia (ICO) - Hospital Universitari Germans Trias i Pujol (HUGTP) Location
Badalona Barcelona, , Spain
Parc Taulí
Barcelona , , Spain
Vall d'Hebron Institut d'Oncologia
Barcelona , , Spain
Complejo Hospitalario de Jaen (University Hospital Ciudad De Jaen)
Jaen , , Spain

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

100

Study ID:

NCT06365853

Recruitment Status:

Not yet recruiting

Sponsor:


ImmunoGen, Inc.

How clear is this clinincal trial information?

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