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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06365853
Other study ID # IMGN853-0424
Secondary ID 2023-505617-24-0
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date June 30, 2024
Est. completion date May 26, 2027

Study information

Verified date April 2024
Source ImmunoGen, Inc.
Contact ImmunoGen, Inc.
Phone 781-895-0600
Email 424medical@immunogen.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 (FRĪ±) expression.


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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date May 26, 2027
Est. primary completion date May 26, 2026
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Key Inclusion Criteria: - Participants must have a confirmed diagnosis of epithelial ovarian, fallopian tube, and primary peritoneal cancer (EOC) with high FRa expression. - Participant's tumor must be FRa positive (FRa 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 FRa-targeting agents. Note: Other protocol-defined inclusion and exclusion criteria may apply.

Study Design


Intervention

Drug:
Mirvetuximab Soravtansine
Mirvetuximab soravtansine is an antibody drug conjugate designed to target folate receptor a (FRa). It consists of the humanized anti-FRa monoclonal antibody (mAb) M9346A attached via a cleavable disulfide linker to the cytotoxic maytansinoid, DM4.
Lubricating Eye Drops
Lubricating artificial tears should be administered at least 15 minutes after corticosteroid or brimonidine eye drop administration.
Prednisolone acetate ophthalmic suspension 1% eye drops
Self-administration of prednisolone acetate ophthalmic suspension 1% eye drops as prescribed by the treating physician.
Brimonidine tartrate ophthalmic solution eye drops
Self-administration of brimonidine tartrate ophthalmic solution eye drops as prescribed by the treating physician.

Locations

Country Name City State
Australia Monash University - Monash Medical Centre (MMC) - Clayton Clayton Victoria
Belgium 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
Canada 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
France 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
Ireland Bon Secours Hospital - Dublin Dublin
Ireland Mater Misericordiae University Hospital (MMUH) (START Dublin) Dublin
Italy Istituto Europeo di Oncologia (IEO) (European Institute of Oncology) Milan
Spain 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
United States New York Oncology Hematology Albany New York
United States Women's Cancer Care Associates, LLC Albany New York
United States University of Colorado Health - University of Colorado Cancer Center (UCCC) - Anschutz Medical Campus (Anschutz Cancer Pavilion) (ACP) Aurora Colorado
United States University of Texas Southwestern Medical Center - Harold C. Simmons Comprehensive Cancer Center - University Hospital Gynecologic Oncology Clinic Dallas Texas
United States Duke Cancer Institute (DCI) - Duke Cancer Center Durham North Carolina
United States Yale School of Medicine - Yale Gynecologic Oncology New Haven Connecticut
United States New York-Presbyterian/Columbia University Medical Center - Herbert Irving Comprehensive Cancer Center (HICCC) - Herbert Irving Pavilion New York New York
United States Holy Cross Hospital Silver Spring Maryland
United States Baystate Regional Cancer Program - D'Amour Center for Cancer Care Location - Gynecologic Oncology Springfield Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
ImmunoGen, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  France,  Ireland,  Italy,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With MIRV-related Corneal AEs (= Grade 2) in Asymptomatic Participants This endpoint will be assessed in the participants receiving MIRV who are asymptomatic (defined as ocular symptom assessment = Grade 1), in the 3-week period prior to the examination. 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 All Ocular TEAEs in Participants Using Corticosteroid Versus Vasoconstricting Eye Drop Primary Prophylaxis 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 MIRV-related Corneal AEs and All Ocular TEAEs in Asymptomatic Versus Symptomatic Participants 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 MIRV-related Corneal AEs and All Ocular TEAEs in Participants Using Corticosteroid Versus Vasoconstricting Eye Drop Primary Prophylaxis Cycle 1 Day 1 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)
Secondary National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) Composite Score At Cycle 5 Day 1 or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)
Secondary Area Under the Curve (AUC) of MIRV 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)
Secondary Maximum Serum Concentration (Cmax) of MIRV 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)
Secondary Trough Concentration (Ctrough) of MIRV 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)
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