Actively Recruiting
Ocular Toxicity Evaluation and Mitigation During Treatment With Mirvetuximab Soravtansine in Recurrent Ovarian Cancer With High Folate Receptor-Alpha Expression
Led by AbbVie · Updated on 2026-03-25
100
Participants Needed
40
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the rate and severity of eye-related side effects caused by mirvetuximab soravtansine (MIRV) in women with recurrent ovarian cancer that has high folate receptor alpha expression. The study focuses on participants with either platinum-sensitive or platinum-resistant ovarian cancer and aims to assess strategies to prevent these eye side effects. This is a randomized phase 2 trial sponsored by AbbVie. Participants are randomly assigned to one of two groups, each receiving a different eye drop treatment to reduce the risk of eye side effects. One group uses prednisolone acetate ophthalmic suspension 1% eye drops along with lubricating eye drops, while the other group uses brimonidine tartrate ophthalmic solution eye drops plus lubricating eye drops. Both groups also receive mirvetuximab soravtansine at 6 mg per kilogram adjusted ideal body weight every three weeks in 21-day cycles. Throughout the study, participants undergo regular eye exams and monitoring to evaluate the occurrence and severity of ocular treatment-emergent adverse events. Researchers will assess eye-related symptoms, visual function using questionnaires, and blood levels of MIRV. The main outcome is the number of participants with corneal eye side effects of grade 2 or higher over approximately 18 weeks. Safety and eye health are closely followed during treatment and up to 30 days after the last dose.
CONDITIONS
Brief 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...
- Women aged 18 years or older
- Confirmed diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal cancer with high folate receptor alpha expression
- Tumor must show at least 75% of cells with 2+ or higher membrane staining intensity for folate receptor alpha
- Participants with BRCA mutations must have received PARP inhibitors
- Prior systemic therapy completed at least 4 weeks or 5 half-lives before starting study drug
- Focal radiation completed at least 2 weeks before starting study drug
- Stabilized or recovered from prior therapy-related toxicities (except alopecia)
- Women of childbearing potential must use effective contraception and have a negative pregnancy test within 4 days before first dose
You will not qualify if you...
- Borderline ovarian tumor or non-epithelial or mixed histology including borderline/non-epithelial tumors
- Platinum-refractory disease in platinum-resistant participants
- Peripheral neuropathy greater than grade 1
- Significant active or chronic corneal disorders or history of corneal transplantation
- Significant ocular inflammatory conditions or other active eye diseases needing treatment or monitoring
- Best corrected visual acuity worse than 20/70 in either eye or monocular vision
- Use of corticosteroid or vasoconstricting eye drops at baseline or within 5 weeks before starting study drug
- Prior treatment with mirvetuximab soravtansine or other folate receptor alpha-targeting agents
- Other protocol-defined criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 18 weeks
Participants receive Mirvetuximab Soravtansine every 3 weeks with assigned ocular adverse event risk mitigation eye drops throughout each 21-day treatment cycle.
Up to 6 visits every 3 weeks corresponding to treatment cycles
Duration - 30 days after last treatment
Participants are monitored for ocular adverse events and overall safety after completing treatment.
1 follow-up visit
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
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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