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

Part of paid clinical trials in Los Angeles, California.

Sponsor
AbbVie
Study ID
NCT06365853
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Folate Receptor-Alpha Positive
  • Recurrent Ovarian Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mirvetuximab Soravtansine — DRUG
    Mirvetuximab soravtansine is an antibody drug conjugate designed to target folate receptor α (FRα). It consists of the humanized anti-FRα monoclonal antibody (mAb) M9346A attached via a cleavable disulfide linker to the cytotoxic maytansinoid, DM4.
  • Lubricating Eye Drops — DRUG
    Lubricating artificial tears should be administered at least 15 minutes after corticosteroid or brimonidine eye drop administration.
  • Prednisolone acetate ophthalmic suspension 1% eye drops — DRUG
    Self-administration of prednisolone acetate ophthalmic suspension 1% eye drops as prescribed by the treating physician.
  • Brimonidine tartrate ophthalmic solution eye drops — DRUG
    Self-administration of brimonidine tartrate ophthalmic solution eye drops as prescribed by the treating physician.

Study Details

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.

Key Dates

Start date
Jul 29, 2024
Status verified
Mar 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Primary Prophylactic Steroid Eye Drops
    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.
  • Experimental: Primary Prophylactic Vasoconstricting Eye Drops
    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.

Primary Outcome Measure

Number of Participants With MIRV-related Corneal TEAEs (≥ Grade 2) in Asymptomatic Participants [ Time Frame: Cycle 1 Day 1 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days) ]

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
University of California Los Angeles /ID# 269339Los AngelesCalifornia90095-
Norton Cancer Institute - St. Matthews /ID# 269070LouisvilleKentucky40207-
Holy Cross Hospital - Silver Spring /ID# 269344Silver SpringMaryland20910-
Mercy David C. Pratt Cancer Center /ID# 269350St LouisMissouri63141-
The Center Of Hope /ID# 269348RenoNevada89511-
Holy Name Medical Center /ID# 269340TeaneckNew Jersey07666-
New York Oncology Hematology - Albany Cancer Center /ID# 269345AlbanyNew York12206-5013-
Women'S Cancer Care Associates /ID# 269980AlbanyNew York12208-
Duke Cancer Institute /ID# 269342DurhamNorth Carolina27710-
Summa Health /ID# 269349AkronOhio44304-1407-
UT Southwestern Medical Center /ID# 269341DallasTexas75390-
Memorial Hermann Southeast Hospital /ID# 269347HoustonTexas77089-

Find similar trials in Los Angeles, CA

By research site
University of California Los Angeles· Los Angeles, CANorton Cancer Institute - St. Matthews· Louisville, KYHoly Cross Hospital - Silver Spring· Silver Spring, MDMercy David C. Pratt Cancer Center· St Louis, MOThe Center Of Hope· Reno, NVHoly Name Medical Center· Teaneck, NJ

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