Actively Recruiting
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
Led by AbbVie · Updated on 2026-03-25
100
Participants Needed
40
Research Sites
148 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal cancer with high folate receptor alpha (FRb1) expression
- Tumor must be FRb1 positive by VENTANA FOLR1 Assay with e7 75% cells showing e7 2+ membrane staining intensity
- Participants with known BRCA mutations must have received PARP inhibitors
- Completed prior systemic antineoplastic therapy at least 5 half-lives or 4 weeks before first MIRV dose
- Completed focal radiation at least 2 weeks before first MIRV dose
- Stabilized or recovered from all prior therapy-related toxicities except alopecia
- Women of childbearing potential must use highly effective contraception during and for at least 7 months after last MIRV dose
- Negative pregnancy test within 4 days before first MIRV dose
You will not qualify if you...
- Borderline ovarian tumor or non-epithelial or mixed histology including borderline or non-epithelial
- Platinum-resistant ovarian cancer with primary platinum-refractory disease (no response or progression c= 3 months after first-line platinum chemotherapy)
- Peripheral neuropathy greater than Grade 1 per NCI-CTCAE v5.0
- Significant active or chronic corneal disorders, history of corneal transplant, or significant ocular inflammatory conditions
- Other active eye conditions requiring ongoing treatment or monitoring, including uncontrolled glaucoma, active diabetic retinopathy with macular edema, recent macular degeneration treatment, papilledema, vision worse than 20/70 in either eye, or monocular vision
- Use of corticosteroid or vasoconstricting eye drops at baseline or within 5 weeks before Cycle 1 Day 1
- Prior treatment with MIRV or other FRb1-targeting agents
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 40 locations
1
University of California Los Angeles /ID# 269339
Los Angeles, California, United States, 90095
Actively Recruiting
2
Norton Cancer Institute - St. Matthews /ID# 269070
Louisville, Kentucky, United States, 40207
Completed
3
Holy Cross Hospital - Silver Spring /ID# 269344
Silver Spring, Maryland, United States, 20910
Actively Recruiting
4
Mercy David C. Pratt Cancer Center /ID# 269350
St Louis, Missouri, United States, 63141
Actively Recruiting
5
The Center Of Hope /ID# 269348
Reno, Nevada, United States, 89511
Active, Not Recruiting
6
Holy Name Medical Center /ID# 269340
Teaneck, New Jersey, United States, 07666
Actively Recruiting
7
New York Oncology Hematology - Albany Cancer Center /ID# 269345
Albany, New York, United States, 12206-5013
Completed
8
Women'S Cancer Care Associates /ID# 269980
Albany, New York, United States, 12208
Completed
9
Duke Cancer Institute /ID# 269342
Durham, North Carolina, United States, 27710
Actively Recruiting
10
Summa Health /ID# 269349
Akron, Ohio, United States, 44304-1407
Actively Recruiting
11
UT Southwestern Medical Center /ID# 269341
Dallas, Texas, United States, 75390
Actively Recruiting
12
Memorial Hermann Southeast Hospital /ID# 269347
Houston, Texas, United States, 77089
Actively Recruiting
13
Blacktown Hospital /ID# 269305
Blacktown, New South Wales, Australia, 2148
Active, Not Recruiting
14
Newcastle Private Hosptial /ID# 269306
Lambton Heights, New South Wales, Australia, 2305
Active, Not Recruiting
15
Monash Health - Monash Medical Centre /ID# 269304
Clayton, Victoria, Australia, 3168
Active, Not Recruiting
16
Universitair Ziekenhuis Antwerpen /ID# 269310
Edegem, Antwerpen, Belgium, 2650
Completed
17
OLV Ziekenhuis Aalst /ID# 269311
Aalst, Oost-Vlaanderen, Belgium, 9300
Active, Not Recruiting
18
AZ Sint-Lucas /ID# 269307
Ghent, Oost-Vlaanderen, Belgium, 9000
Active, Not Recruiting
19
UZ Gent /ID# 269309
Ghent, Oost-Vlaanderen, Belgium, 9000
Completed
20
Universitair Ziekenhuis Leuven /ID# 269308
Leuven, Vlaams-Brabant, Belgium, 3000
Active, Not Recruiting
21
CHU de Liege /ID# 269312
Liège, Belgium, 4000
Completed
22
Universite de Montreal - Hopital Maisonneuve-Rosemont /ID# 268862
Montreal, Quebec, Canada, H1T 2M4
Active, Not Recruiting
23
Hospital Notre-Dame Du Centre Hospitalier De L'Universite De Montreal /ID# 269314
Montreal, Quebec, Canada, H2L 4M1
Active, Not Recruiting
24
McGill University Health Centre - Glen Site. /ID# 269313
Montreal, Quebec, Canada, H4A 3J1
Active, Not Recruiting
25
Institut Paoli-Calmettes /ID# 269648
Marseille, Bouches-du-Rhone, France, 13273
Active, Not Recruiting
26
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau /ID# 269301
Tours, Indre-et-Loire, France, 37000
Active, Not Recruiting
27
Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 269330
Paris, Paris, France, 75679
Active, Not Recruiting
28
Hospices Civils de Lyon - Centre Hospitalier Lyon-Sud /ID# 269327
Pierre-Bénite, Rhone, France, 69310
Active, Not Recruiting
29
Clinique Victor Hugo Le Mans /ID# 269985
Le Mans, Sarthe, France, 72000
Active, Not Recruiting
30
GH Diaconesses Croix Saint-Simon /ID# 269329
Paris, France, 75020
Active, Not Recruiting
31
Mater Misericordiae University Hospital /ID# 269334
Dublin, Ireland, D07 R2WY
Active, Not Recruiting
32
Beaumont Hospital /ID# 268864
Dublin, Ireland, D09 XR63
Completed
33
Hospital San Pedro de Alcántara /ID# 269320
Cáceres, Caceres, Spain, 10003
Active, Not Recruiting
34
Hospital Universitario de Jaén /ID# 269319
Jaén, Jaen, Spain, 23007
Active, Not Recruiting
35
Usp Instituto Universitario Dexeus /ID# 269322
Barcelona, Spain, 08028
Active, Not Recruiting
36
Hospital Universitario Vall de Hebron /ID# 269315
Barcelona, Spain, 08035
Active, Not Recruiting
37
Hospital Universitario Ramon y Cajal /ID# 269318
Madrid, Spain, 28034
Active, Not Recruiting
38
Hospital Universitario 12 de Octubre /ID# 269321
Madrid, Spain, 28041
Active, Not Recruiting
39
Hospital Universitario La Paz /ID# 269302
Madrid, Spain, 28046
Active, Not Recruiting
40
Hospital Universitario y Politecnico La Fe /ID# 269325
Valencia, Spain, 46026
Completed
Research Team
A
ABBVIE CALL CENTER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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