Trial Title:
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
NCT ID:
NCT06365853
Condition:
Recurrent Ovarian Cancer
Folate Receptor-Alpha Positive
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Toxic Optic Neuropathy
Recurrence
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Maytansine
Brimonidine Tartrate
Ophthalmic Solutions
Lubricant Eye Drops
Prednisolone hemisuccinate
Prednisolone phosphate
Mirvetuximab soravtansine
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Mirvetuximab Soravtansine
Description:
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.
Arm group label:
Primary Prophylactic Steroid Eye Drops
Arm group label:
Primary Prophylactic Vasoconstricting Eye Drops
Other name:
IMGN853
Other name:
MIRV
Intervention type:
Drug
Intervention name:
Lubricating Eye Drops
Description:
Lubricating artificial tears should be administered at least 15 minutes after
corticosteroid or brimonidine eye drop administration.
Arm group label:
Primary Prophylactic Steroid Eye Drops
Arm group label:
Primary Prophylactic Vasoconstricting Eye Drops
Intervention type:
Drug
Intervention name:
Prednisolone acetate ophthalmic suspension 1% eye drops
Description:
Self-administration of prednisolone acetate ophthalmic suspension 1% eye drops as
prescribed by the treating physician.
Arm group label:
Primary Prophylactic Steroid Eye Drops
Intervention type:
Drug
Intervention name:
Brimonidine tartrate ophthalmic solution eye drops
Description:
Self-administration of brimonidine tartrate ophthalmic solution eye drops as prescribed
by the treating physician.
Arm group label:
Primary Prophylactic Vasoconstricting Eye Drops
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.
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).
Criteria for 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 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) 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.
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
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Colorado Health - University of Colorado Cancer Center (UCCC) - Anschutz Medical Campus (Anschutz Cancer Pavilion) (ACP)
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Holy Cross Hospital
Address:
City:
Silver Spring
Zip:
20910
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Baystate Regional Cancer Program - D'Amour Center for Cancer Care Location - Gynecologic Oncology
Address:
City:
Springfield
Zip:
01107
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Holy Name Medical Center
Address:
City:
Teaneck
Zip:
07666
Country:
United States
Status:
Recruiting
Facility:
Name:
New York Oncology Hematology
Address:
City:
Albany
Zip:
12208
Country:
United States
Status:
Recruiting
Facility:
Name:
Women's Cancer Care Associates, LLC
Address:
City:
Albany
Zip:
12208
Country:
United States
Status:
Recruiting
Facility:
Name:
New York-Presbyterian/Columbia University Medical Center - Herbert Irving Comprehensive Cancer Center (HICCC) - Herbert Irving Pavilion
Address:
City:
New York
Zip:
10032
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Duke Cancer Institute (DCI) - Duke Cancer Center
Address:
City:
Durham
Zip:
27710
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
University of Texas Southwestern Medical Center - Harold C. Simmons Comprehensive Cancer Center - University Hospital Gynecologic Oncology Clinic
Address:
City:
Dallas
Zip:
75235
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Monash University - Monash Medical Centre (MMC) - Clayton
Address:
City:
Clayton
Country:
Australia
Status:
Not yet recruiting
Facility:
Name:
Universitair Ziekenhuis Antwerpen (UZA) - Borstkliniek
Address:
City:
Edegem
Country:
Belgium
Status:
Not yet recruiting
Facility:
Name:
AZ Sint-Lucas - Campus Sint-Lucas - Borstkliniek
Address:
City:
Gent
Country:
Belgium
Status:
Not yet recruiting
Facility:
Name:
Universitair Ziekenhuis Gent (UZ Gent)
Address:
City:
Gent
Country:
Belgium
Status:
Not yet recruiting
Facility:
Name:
McGill University Health Centre (MUHC) - The Montreal General Hospital (MGH) - Cedars Cancer Centre
Address:
City:
Montreal
Country:
Canada
Status:
Not yet recruiting
Facility:
Name:
Universite de Montreal - Centre Hospitalier de l'Universite de Montreal (CHUM) - Hopital Notre-Dame
Address:
City:
Montreal
Country:
Canada
Status:
Not yet recruiting
Facility:
Name:
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Cochin
Address:
City:
Paris
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Groupe Hospitalier Diaconesses Croix Saint-Simon - Hopital de la Croix Saint-Simon
Address:
City:
Paris
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud
Address:
City:
Pierre Benite
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Bon Secours Hospital - Dublin
Address:
City:
Dublin
Country:
Ireland
Status:
Not yet recruiting
Facility:
Name:
Mater Misericordiae University Hospital (MMUH) (START Dublin)
Address:
City:
Dublin
Country:
Ireland
Status:
Not yet recruiting
Facility:
Name:
Istituto Europeo di Oncologia (IEO) (European Institute of Oncology)
Address:
City:
Milan
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Institut Catala d'Oncologia (ICO) - Hospital Universitari Germans Trias i Pujol (HUGTP) Location
Address:
City:
Badalona
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Parc Taulí
Address:
City:
Barcelona
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Vall d'Hebron Institut d'Oncologia
Address:
City:
Barcelona
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Complejo Hospitalario de Jaen (University Hospital Ciudad De Jaen)
Address:
City:
Jaen
Country:
Spain
Status:
Not yet recruiting
Start date:
July 29, 2024
Completion date:
May 26, 2027
Lead sponsor:
Agency:
ImmunoGen, Inc.
Agency class:
Industry
Source:
ImmunoGen, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06365853
