A Randomized Phase 2 Study of Ocular Toxicity Evaluation and Mitigation During Treatment With Mirvetuximab Soravtansine in Patients With Recurrent Ovarian Cancer With High Folate Receptor-Alpha Expression
Status: Recruiting
Location: See all (40) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The purpose of this study is to evaluate the incidence rate and severity of prespecified 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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• 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 FOLR1 (FOLR-2.1) IUO Assay, or the VENTANA FOLR1 ( FOLR1-2.1) RxDx Assay (hereafter collectively termed VENTANA FOLR1 Assay) (≥ 75% cells exhibit ≥ 2+ 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) 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 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.
Locations
United States
California
University of California Los Angeles /ID# 269339
RECRUITING
Los Angeles
Kentucky
Norton Cancer Institute - St. Matthews /ID# 269070
COMPLETED
Louisville
Maryland
Holy Cross Hospital - Silver Spring /ID# 269344
RECRUITING
Silver Spring
Missouri
Mercy David C. Pratt Cancer Center /ID# 269350
RECRUITING
St Louis
North Carolina
Duke Cancer Institute /ID# 269342
RECRUITING
Durham
New Jersey
Holy Name Medical Center /ID# 269340
RECRUITING
Teaneck
Nevada
The Center Of Hope /ID# 269348
ACTIVE_NOT_RECRUITING
Reno
New York
New York Oncology Hematology - Albany Cancer Center /ID# 269345
COMPLETED
Albany
Women'S Cancer Care Associates /ID# 269980
COMPLETED
Albany
Ohio
Summa Health /ID# 269349
RECRUITING
Akron
Texas
UT Southwestern Medical Center /ID# 269341
RECRUITING
Dallas
Memorial Hermann Southeast Hospital /ID# 269347
RECRUITING
Houston
Other Locations
Australia
Blacktown Hospital /ID# 269305
ACTIVE_NOT_RECRUITING
Blacktown
Monash Health - Monash Medical Centre /ID# 269304
ACTIVE_NOT_RECRUITING
Clayton
Newcastle Private Hosptial /ID# 269306
ACTIVE_NOT_RECRUITING
Lambton Heights
Belgium
OLV Ziekenhuis Aalst /ID# 269311
ACTIVE_NOT_RECRUITING
Aalst
Universitair Ziekenhuis Antwerpen /ID# 269310
COMPLETED
Edegem
AZ Sint-Lucas /ID# 269307
ACTIVE_NOT_RECRUITING
Ghent
UZ Gent /ID# 269309
COMPLETED
Ghent
UZ Leuven /ID# 269308
ACTIVE_NOT_RECRUITING
Leuven
CHU de Liege /ID# 269312
COMPLETED
Liège
Canada
Centre Hospitalier De L'Universite De Montreal - Hopital Saint-Luc /ID# 269314
ACTIVE_NOT_RECRUITING
Montreal
McGill University Health Centre - Glen Site. /ID# 269313
ACTIVE_NOT_RECRUITING
Montreal
Universite de Montreal - Hopital Maisonneuve-Rosemont /ID# 268862
ACTIVE_NOT_RECRUITING
Montreal
France
Clinique Victor Hugo Le Mans /ID# 269985
ACTIVE_NOT_RECRUITING
Le Mans
Institut Paoli-Calmettes /ID# 269648
ACTIVE_NOT_RECRUITING
Marseille
GH Diaconesses Croix Saint-Simon /ID# 269329
ACTIVE_NOT_RECRUITING
Paris
Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 269330
ACTIVE_NOT_RECRUITING
Paris
Hospices Civils de Lyon - Centre Hospitalier Lyon-Sud /ID# 269327
ACTIVE_NOT_RECRUITING
Pierre-bénite
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau /ID# 269301
ACTIVE_NOT_RECRUITING
Tours
Ireland
Beaumont Hospital /ID# 268864
COMPLETED
Dublin
Mater Misericordiae University Hospital /ID# 269334
ACTIVE_NOT_RECRUITING
Dublin
Spain
Hospital Universitario Vall de Hebron /ID# 269315
ACTIVE_NOT_RECRUITING
Barcelona
Usp Instituto Universitario Dexeus /ID# 269322
ACTIVE_NOT_RECRUITING
Barcelona
Hospital San Pedro de Alcántara /ID# 269320
ACTIVE_NOT_RECRUITING
Cáceres
Hospital Universitario de Jaén /ID# 269319
ACTIVE_NOT_RECRUITING
Jaén
Hospital Universitario 12 de Octubre /ID# 269321
ACTIVE_NOT_RECRUITING
Madrid
Hospital Universitario La Paz /ID# 269302
ACTIVE_NOT_RECRUITING
Madrid
Hospital Universitario Ramon y Cajal /ID# 269318
ACTIVE_NOT_RECRUITING
Madrid
Hospital Universitario y Politecnico La Fe /ID# 269325
Prednisolone acetate ophthalmic suspension 1% 6 times daily on Days -1 to 4 and 4 times daily (QID) on Days 5 to 8 of each cycle; Lubricating eye drops QID throughout the entire cycle (doses should follow steroid dosing, when given, by approximately 15 minutes); MIRV 6 milligrams (mg)/kilogram (kg) adjusted ideal body weight (AIBW) every 3 weeks (Q3W) on Day 1 of each cycle. Each cycle length = 21 days.
Primary prophylactic brimonidine tartrate ophthalmic solution eye drops 3 times daily (TID) on Days 1 to 8 of each cycle (vasoconstricting drops should be started on the day of first infusion and should begin before the first infusion on Cycle 1 Day 1); Lubricating eye drops QID throughout the entire cycle (doses should follow brimonidine dosing, when given, by approximately 15 minutes); MIRV 6 mg/kg AIBW Q3W on Day 1 of each cycle. Each cycle length = 21 days.