Phase
Condition
Ovarian Cysts
Recurrent Ovarian Cancer
Treatment
Mirvetuximab Soravtansine
Brimonidine tartrate ophthalmic solution eye drops
Prednisolone acetate ophthalmic suspension 1% eye drops
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
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 Ventanafolate receptor 1 (FOLR1) (FOLR1-2.1) CDx Assay or FOLR1-2.1 RxDx Assay (hereaftercollectively termed: Ventana FOLR1 Assay) (≥75% cells exhibit 2 or 3+membrane-staining intensity).
Participants with known breast cancer susceptibility gene (BRCA) mutations (tumor orgermline) 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 isshorter) before first dose of MIRV;
Focal radiation completed ≥ 2 weeks before the first dose of MIRV.
Participants must have stabilized or recovered (Grade 1 or baseline) from all priortherapy-related toxicities (except alopecia).
Women of childbearing potential (WOCBP) must agree to use highly effectivecontraceptive method(s) while on MIRV and for ≥ 7 months after the last dose; andmust have a negative pregnancy test ≤ 4 days before the first dose of MIRV.
Exclusion
Exclusion Criteria:
Participants with borderline ovarian tumor or non-epithelial histology or mixedhistology including borderline or non-epithelial histology will be excluded.
PROC participants with primary platinum-refractory disease, defined as disease thatdid not respond to (complete response [CR] or partial response [PR]) or progressedwithin ≤ 3 months of the last dose of first line platinum-containing chemotherapy.
Participants with > Grade 1 peripheral neuropathy per National CancerInstitute-Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAEv5.0).
Participants with significant active or chronic corneal disorders (for example,corneal dystrophies, degenerations, limbal stem cell deficiency), history of cornealtransplantation, significant ocular inflammatory conditions (for example, active orrecurrent uveitis), or other active ocular conditions requiring ongoingtreatment/monitoring, such as uncontrolled glaucoma, active diabetic retinopathywith macular edema, macular degeneration requiring treatment ≤ 90 days before firstdose, presence of papilledema, best corrected visual acuity (BCVA) worse than 20/70in either eye, or monocular vision.
Participants receiving corticosteroid or vasoconstricting eyedrops at baseline orwithin 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 Design
Study Description
Connect with a study center
Blacktown Hospital /ID# 269305
Blacktown, New South Wales 2148
AustraliaActive - Recruiting
Newcastle Private Hosptial /ID# 269306
Lambton Heights, New South Wales 2305
AustraliaActive - Recruiting
Monash University - Monash Medical Centre (MMC) - Clayton
Clayton, Victoria
AustraliaSite Not Available
Monash University Clayton Campus /ID# 269304
Clayton, Victoria 3168
AustraliaActive - Recruiting
Universitair Ziekenhuis Antwerpen (UZA) - Borstkliniek
Edegem, Antwerp
BelgiumSite Not Available
Universitair Ziekenhuis Antwerpen /ID# 269310
Edegem, Antwerpen 2650
BelgiumActive - Recruiting
AZ Sint-Lucas - Campus Sint-Lucas - Borstkliniek
Gent, East Flanders
BelgiumSite Not Available
Universitair Ziekenhuis Gent (UZ Gent)
Gent, East Flanders
BelgiumSite Not Available
Onze Lieve Vrouw Ziekenhuis Aalst /ID# 269311
Aalst, Oost-Vlaanderen 9300
BelgiumActive - Recruiting
AZ Sint-Lucas /ID# 269307
Gent, Oost-Vlaanderen 9000
BelgiumActive - Recruiting
UZ Gent /ID# 269309
Gent, Oost-Vlaanderen 9000
BelgiumActive - Recruiting
UZ Leuven /ID# 269308
Leuven, Vlaams-Brabant 3000
BelgiumActive - Recruiting
McGill University Health Centre (MUHC) - The Montreal General Hospital (MGH) - Cedars Cancer Centre
Montreal, Quebec
CanadaSite Not Available
Universite de Montreal - Centre Hospitalier de l'Universite de Montreal (CHUM) - Hopital Notre-Dame
Montreal, Quebec
CanadaSite Not Available
Universite de Montreal - Hopital Maisonneuve-Rosemont /ID# 268862
Montreal, Quebec H1T 2M4
CanadaActive - Recruiting
Institut Paoli-Calmettes /ID# 269648
Marseille, Bouches-du-Rhone 13273
FranceActive - Recruiting
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau /ID# 269301
Tours, Indre-et-Loire 37000
FranceActive - Recruiting
Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 269330
Paris CEDEX 14, Paris 75679
FranceActive - Recruiting
Hospices Civils de Lyon - Centre Hospitalier Lyon-Sud /ID# 269327
Pierre Benite, Rhone 69310
FranceActive - Recruiting
Clinique Victor Hugo Le Mans /ID# 269985
Le Mans, Sarthe 72000
FranceActive - Recruiting
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Cochin
Paris,
FranceSite Not Available
GH Diaconesses Croix Saint-Simon /ID# 269329
Paris, 75020
FranceActive - Recruiting
Groupe Hospitalier Diaconesses Croix Saint-Simon - Hopital de la Croix Saint-Simon
Paris,
FranceSite Not Available
Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud
Pierre Benite,
FranceSite Not Available
Beaumont Hospital /ID# 268864
Dublin, D09 XR63
IrelandActive - Recruiting
Bon Secours Hospital - Dublin
Dublin,
IrelandSite Not Available
Mater Misericordiae University Hospital (MMUH) (START Dublin)
Dublin,
IrelandSite Not Available
Mater Misericordiae University Hospital /ID# 269334
Dublin, D07 R2WY
IrelandActive - Recruiting
Istituto Europeo di Oncologia (IEO) (European Institute of Oncology)
Milan,
ItalySite Not Available
Institut Catala d'Oncologia (ICO) - Hospital Universitari Germans Trias i Pujol (HUGTP) Location
Badalona, Barcelona
SpainSite Not Available
Hospital San Pedro de Alcántara /ID# 269320
Cáceres, Caceres 10003
SpainActive - Recruiting
Hospital Universitario de Jaén /ID# 269319
Jaén, Jaen 23007
SpainActive - Recruiting
Hospital Universitario Vall d'Hebron /ID# 269315
Barcelona, 08035
SpainActive - Recruiting
Parc Taulí
Barcelona,
SpainSite Not Available
Usp Instituto Universitario Dexeus /ID# 269322
Barcelona, 08028
SpainActive - Recruiting
Vall d'Hebron Institut d'Oncologia
Barcelona,
SpainSite Not Available
Complejo Hospitalario de Jaen (University Hospital Ciudad De Jaen)
Jaen,
SpainSite Not Available
Hospital Universitario 12 de Octubre /ID# 269321
Madrid, 28041
SpainActive - Recruiting
Hospital Universitario La Paz /ID# 269302
Madrid, 28046
SpainActive - Recruiting
Hospital Universitario Ramon y Cajal /ID# 269318
Madrid, 28034
SpainActive - Recruiting
Hospital Universitario y Politecnico La Fe /ID# 269325
Valencia, 46026
SpainActive - Recruiting
University of Colorado Health - University of Colorado Cancer Center (UCCC) - Anschutz Medical Campus (Anschutz Cancer Pavilion) (ACP)
Aurora, Colorado 80045
United StatesSite Not Available
Yale School of Medicine - Yale Gynecologic Oncology
New Haven, Connecticut 06510
United StatesSite Not Available
Norton Healthcare /ID# 269070
Louisville, Kentucky 40207-4700
United StatesActive - Recruiting
Holy Cross Hospital
Silver Spring, Maryland 20910
United StatesSite Not Available
Holy Cross Hospital - Silver Spring /ID# 269344
Silver Spring, Maryland 20910
United StatesActive - Recruiting
Baystate Regional Cancer Program - D'Amour Center for Cancer Care Location - Gynecologic Oncology
Springfield, Massachusetts 01107
United StatesSite Not Available
The Center Of Hope /ID# 269348
Reno, Nevada 89511
United StatesActive - Recruiting
Holy Name Medical Center
Teaneck, New Jersey 07666
United StatesActive - Recruiting
Holy Name Medical Center /ID# 269340
Teaneck, New Jersey 07666
United StatesActive - Recruiting
New York Oncology Hematology
Albany, New York 12208
United StatesActive - Recruiting
New York Oncology Hematology - Albany Cancer Center /ID# 269345
Albany, New York 12206-5013
United StatesActive - Recruiting
Women'S Cancer Care Associates /ID# 269980
Albany, New York 12208
United StatesActive - Recruiting
Women's Cancer Care Associates, LLC
Albany, New York 12208
United StatesActive - Recruiting
New York-Presbyterian/Columbia University Medical Center - Herbert Irving Comprehensive Cancer Center (HICCC) - Herbert Irving Pavilion
New York, New York 10032
United StatesSite Not Available
Duke Cancer Institute (DCI) - Duke Cancer Center
Durham, North Carolina 27710
United StatesSite Not Available
University of Texas Southwestern Medical Center - Harold C. Simmons Comprehensive Cancer Center - University Hospital Gynecologic Oncology Clinic
Dallas, Texas 75235
United StatesSite Not Available
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