Phase
Condition
Ovarian Cysts
Recurrent Ovarian Cancer
Treatment
Brimonidine tartrate ophthalmic solution eye drops
Prednisolone acetate ophthalmic suspension 1% eye drops
Lubricating 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 VENTANAFOLR1 (FOLR-2.1) IUO Assay, or the VENTANA FOLR1 ( FOLR1-2.1) RxDx Assay (hereaftercollectively termed VENTANA FOLR1 Assay) (≥ 75% cells exhibit ≥ 2+ membrane stainingintensity).
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
AustraliaSite Not Available
Newcastle Private Hosptial /ID# 269306
Lambton Heights, New South Wales 2305
AustraliaSite Not Available
Blacktown Hospital /ID# 269305
Blacktown 2175411, New South Wales 2155400 2148
AustraliaSite Not Available
Monash Health - Monash Medical Centre /ID# 269304
Clayton, Victoria 3168
AustraliaSite Not Available
Monash University - Monash Medical Centre (MMC) - Clayton
Clayton, Victoria
AustraliaSite Not Available
Monash University Clayton Campus /ID# 269304
Clayton, Victoria 3168
AustraliaSite Not Available
Monash Health - Monash Medical Centre /ID# 269304
Clayton 2171400, Victoria 2145234 3168
AustraliaSite Not Available
Universitair Ziekenhuis Antwerpen (UZA) - Borstkliniek
Edegem, Antwerp
BelgiumSite Not Available
Universitair Ziekenhuis Antwerpen /ID# 269310
Edegem, Antwerpen 2650
BelgiumCompleted
Universitair Ziekenhuis Antwerpen /ID# 269310
Edegem 2799007, Antwerpen 2650
BelgiumSite Not Available
AZ Sint-Lucas - Campus Sint-Lucas - Borstkliniek
Gent, East Flanders
BelgiumSite Not Available
Universitair Ziekenhuis Gent (UZ Gent)
Gent, East Flanders
BelgiumSite Not Available
OLV Ziekenhuis Aalst /ID# 269311
Aalst, Oost-Vlaanderen 9300
BelgiumSite Not Available
Onze Lieve Vrouw Ziekenhuis Aalst /ID# 269311
Aalst, Oost-Vlaanderen 9300
BelgiumSite Not Available
OLV Ziekenhuis Aalst /ID# 269311
Aalst 2803448, Oost-Vlaanderen 9300
BelgiumSite Not Available
AZ Sint-Lucas /ID# 269307
Gent, Oost-Vlaanderen 9000
BelgiumSite Not Available
UZ Gent /ID# 269309
Gent, Oost-Vlaanderen 9000
BelgiumSite Not Available
AZ Sint-Lucas /ID# 269307
Ghent, Oost-Vlaanderen 9000
BelgiumSite Not Available
UZ Gent /ID# 269309
Ghent, Oost-Vlaanderen 9000
BelgiumCompleted
AZ Sint-Lucas /ID# 269307
Ghent 2797656, Oost-Vlaanderen 9000
BelgiumSite Not Available
UZ Gent /ID# 269309
Ghent 2797656, Oost-Vlaanderen 9000
BelgiumCompleted
UZ Leuven /ID# 269308
Leuven, Vlaams-Brabant 3000
BelgiumSite Not Available
Universitair Ziekenhuis Leuven /ID# 269308
Leuven, Vlaams-Brabant 3000
BelgiumSite Not Available
UZ Leuven /ID# 269308
Leuven 2792482, Vlaams-Brabant 3000
BelgiumSite Not Available
CHU de Liege /ID# 269312
Liege, 4000
BelgiumSite Not Available
CHU de Liege /ID# 269312
Liège, 4000
BelgiumCompleted
CHU de Liege /ID# 269312
Liège 2792413, 4000
BelgiumSite Not Available
Centre Hospitalier De L'Universite De Montreal - Hopital Saint-Luc /ID# 269314
Montreal, Quebec H2X 3E4
CanadaSite Not Available
Hospital Notre-Dame Du Centre Hospitalier De L'Universite De Montreal /ID# 269314
Montreal, Quebec H2L 4M1
CanadaSite Not Available
McGill University Health Centre (MUHC) - The Montreal General Hospital (MGH) - Cedars Cancer Centre
Montreal, Quebec
CanadaSite Not Available
McGill University Health Centre - Glen Site /ID# 269313
Montreal, Quebec H4A 3J1
CanadaSite Not Available
McGill University Health Centre - Glen Site. /ID# 269313
Montreal, Quebec H4A 3J1
CanadaSite Not Available
McGill University Health Centre /ID# 269313
Montreal, Quebec H4A 3J1
CanadaActive - Recruiting
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
CanadaSite Not Available
Centre Hospitalier De L'Universite De Montreal - Hopital Saint-Luc /ID# 269314
Montreal 6077243, Quebec 6115047 H2X 3E4
CanadaSite Not Available
McGill University Health Centre - Glen Site /ID# 269313
Montreal 6077243, Quebec 6115047 H4A 3J1
CanadaSite Not Available
McGill University Health Centre - Glen Site. /ID# 269313
Montreal 6077243, Quebec 6115047 H4A 3J1
CanadaSite Not Available
Universite de Montreal - Hopital Maisonneuve-Rosemont /ID# 268862
Montreal 6077243, Quebec 6115047 H1T 2M4
CanadaSite Not Available
Institut Paoli-Calmettes /ID# 269648
Marseille, Bouches-du-Rhone 13273
FranceSite Not Available
Institut Paoli-Calmettes /ID# 269648
Marseille 2995469, Bouches-du-Rhone 13273
FranceSite Not Available
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau /ID# 269301
Tours, Indre-et-Loire 37000
FranceSite Not Available
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau /ID# 269301
Tours 2972191, Indre-et-Loire 37000
FranceSite Not Available
Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 269330
Paris, Paris 75679
FranceSite Not Available
Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 269330
Paris 2988507, Paris 75679
FranceSite Not Available
Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 269330
Paris CEDEX 14, Paris 75679
FranceSite Not Available
Hospices Civils de Lyon - Centre Hospitalier Lyon-Sud /ID# 269327
Pierre Benite, Rhone 69310
FranceSite Not Available
Hospices Civils de Lyon - Centre Hospitalier Lyon-Sud /ID# 269327
Pierre-Bénite, Rhone 69310
FranceSite Not Available
Hospices Civils de Lyon - Centre Hospitalier Lyon-Sud /ID# 269327
Pierre-Bénite 2987314, Rhone 69310
FranceSite Not Available
Clinique Victor Hugo Le Mans /ID# 269985
Le Mans, Sarthe 72000
FranceSite Not Available
Clinique Victor Hugo Le Mans /ID# 269985
Le Mans 3003603, Sarthe 72000
FranceSite Not Available
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Cochin
Paris,
FranceSite Not Available
GH Diaconesses Croix Saint-Simon /ID# 269329
Paris, 75020
FranceSite Not Available
Groupe Hospitalier Diaconesses Croix Saint-Simon - Hopital de la Croix Saint-Simon
Paris,
FranceSite Not Available
GH Diaconesses Croix Saint-Simon /ID# 269329
Paris 2988507, 75020
FranceSite Not Available
Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud
Pierre Benite,
FranceSite Not Available
Beaumont Hospital /ID# 268864
Dublin, D09 XR63
IrelandCompleted
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
IrelandSite Not Available
Beaumont Hospital /ID# 268864
Dublin 2964574, D09 XR63
IrelandSite Not Available
Mater Misericordiae University Hospital /ID# 269334
Dublin 2964574, D07 R2WY
IrelandSite Not Available
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
SpainSite Not Available
Hospital San Pedro de Alcántara /ID# 269320
Cáceres 2520611, Caceres 10003
SpainSite Not Available
Hospital Universitario de Jaén /ID# 269319
Jaén, Jaen 23007
SpainSite Not Available
Hospital Universitario de Jaén /ID# 269319
Jaén 2516395, Jaen 23007
SpainSite Not Available
Hospital Universitario Vall d'Hebron /ID# 269315
Barcelona, 08035
SpainSite Not Available
Hospital Universitario Vall de Hebron /ID# 269315
Barcelona, 08035
SpainSite Not Available
Parc Taulí
Barcelona,
SpainSite Not Available
Usp Instituto Universitario Dexeus /ID# 269322
Barcelona, 08028
SpainSite Not Available
Vall d'Hebron Institut d'Oncologia
Barcelona,
SpainSite Not Available
Hospital Universitario Vall de Hebron /ID# 269315
Barcelona 3128760, 08035
SpainSite Not Available
Usp Instituto Universitario Dexeus /ID# 269322
Barcelona 3128760, 08028
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
SpainSite Not Available
Hospital Universitario La Paz /ID# 269302
Madrid, 28046
SpainSite Not Available
Hospital Universitario Ramon y Cajal /ID# 269318
Madrid, 28034
SpainSite Not Available
Hospital Universitario 12 de Octubre /ID# 269321
Madrid 3117735, 28041
SpainSite Not Available
Hospital Universitario La Paz /ID# 269302
Madrid 3117735, 28046
SpainSite Not Available
Hospital Universitario Ramon y Cajal /ID# 269318
Madrid 3117735, 28034
SpainSite Not Available
Hospital Universitario y Politecnico La Fe /ID# 269325
Valencia, 46026
SpainCompleted
Hospital Universitario y Politecnico La Fe /ID# 269325
Valencia 2509954, 46026
SpainSite Not Available
University of California Los Angeles /ID# 269339
Los Angeles, California 90095
United StatesActive - Recruiting
University of California Los Angeles /ID# 269339
Los Angeles 5368361, California 5332921 90095
United StatesSite Not Available
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 Cancer Institute - St. Matthews /ID# 269070
Louisville, Kentucky 40207
United StatesCompleted
Norton Healthcare /ID# 269070
Louisville, Kentucky 40207-4700
United StatesCompleted
Norton Cancer Institute - St. Matthews /ID# 269070
Louisville 4299276, Kentucky 6254925 40207
United StatesSite Not Available
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
Holy Cross Hospital - Silver Spring /ID# 269344
Silver Spring 4369596, Maryland 4361885 20910
United StatesSite Not Available
Baystate Regional Cancer Program - D'Amour Center for Cancer Care Location - Gynecologic Oncology
Springfield, Massachusetts 01107
United StatesSite Not Available
Mercy David C. Pratt Cancer Center /ID# 269350
Saint Louis, Missouri 63141
United StatesSite Not Available
Mercy David C. Pratt Cancer Center /ID# 269350
St Louis, Missouri 63141
United StatesActive - Recruiting
Mercy David C. Pratt Cancer Center /ID# 269350
St Louis 4407066, Missouri 4398678 63141
United StatesSite Not Available
The Center Of Hope /ID# 269348
Reno, Nevada 89511
United StatesSite Not Available
The Center Of Hope /ID# 269348
Reno 5511077, Nevada 5509151 89511
United StatesSite Not Available
Holy Name Medical Center
Teaneck, New Jersey 07666
United StatesActive - Recruiting
Holy Name Medical Center /ID# 269340
Teaneck, New Jersey 07666
United StatesActive - Recruiting
Holy Name Medical Center /ID# 269340
Teaneck 5105262, New Jersey 5101760 07666
United StatesSite Not Available
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 StatesCompleted
Women'S Cancer Care Associates /ID# 269980
Albany, New York 12208
United StatesCompleted
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
New York Oncology Hematology - Albany Cancer Center /ID# 269345
Albany 5106834, New York 5128638 12206-5013
United StatesSite Not Available
Women'S Cancer Care Associates /ID# 269980
Albany 5106834, New York 5128638 12208
United StatesCompleted
Duke Cancer Institute (DCI) - Duke Cancer Center
Durham, North Carolina 27710
United StatesSite Not Available
Duke Cancer Institute /ID# 269342
Durham, North Carolina 27710
United StatesActive - Recruiting
Duke Cancer Institute /ID# 269342
Durham 4464368, North Carolina 4482348 27710
United StatesSite Not Available
Summa Health /ID# 269349
Akron, Ohio 44304-1407
United StatesActive - Recruiting
Summa Health /ID# 269349
Akron 5145476, Ohio 5165418 44304-1407
United StatesSite Not Available
UT Southwestern Medical Center /ID# 269341
Dallas, Texas 75390
United StatesActive - Recruiting
University of Texas Southwestern Medical Center - Harold C. Simmons Comprehensive Cancer Center - University Hospital Gynecologic Oncology Clinic
Dallas, Texas 75235
United StatesSite Not Available
Memorial Hermann Southeast Hospital /ID# 269347
Houston, Texas 77089
United StatesActive - Recruiting
UT Southwestern Medical Center /ID# 269341
Dallas 4684888, Texas 4736286 75390
United StatesSite Not Available
Memorial Hermann Southeast Hospital /ID# 269347
Houston 4699066, Texas 4736286 77089
United StatesSite Not Available

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