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.
Participants will be randomized (1:1) to 1 of 2 ocular adverse event (AE) risk mitigation strategy arms (primary prophylactic steroid eye drops versus primary prophylactic vasoconstricting eye drops).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
108
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 artificial tears should be administered at least 15 minutes after corticosteroid or brimonidine eye drop administration.
Self-administration of prednisolone acetate ophthalmic suspension 1% eye drops as prescribed by the treating physician.
Self-administration of brimonidine tartrate ophthalmic solution eye drops as prescribed by the treating physician.
University of California Los Angeles /ID# 269339
Los Angeles, California, United States
UCSF Medical Center /ID# 280425
San Francisco, California, United States
Norton Cancer Institute - St. Matthews /ID# 269070
Louisville, Kentucky, United States
Holy Cross Hospital - Silver Spring /ID# 269344
Silver Spring, Maryland, United States
Mercy David C. Pratt Cancer Center /ID# 269350
St Louis, Missouri, United States
Number of Participants With MIRV-related Corneal TEAEs (≥ Grade 2) in Asymptomatic Participants
This endpoint will be assessed in the participants receiving MIRV who are asymptomatic .
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)
Number of Participants With Ocular symptom TEAEs in Participants Using Corticosteroid or Vasoconstricting Eye Drop Primary Prophylaxis
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
Number of Participants With MIRV-related Corneal TEAEs in Symptomatic 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)
Number of Participants With Ocular exam TEAEs in Asymptomatic Participants and Symptomatic 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)
Number of Participants With MIRV-related Corneal TEAEs (≥ Grade 2) in Participants Using Corticosteroid or Vasoconstricting Eye Drop Primary Prophylaxis
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)
Number of Participants with ocular exam TEAEs in Participants using corticosteroid or vasoconstricting eye drop primary prophylaxis
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)
National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) Composite Score
Time frame: At Cycle 5 Day 1 or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)
Area Under the Curve (AUC) of MIRV
Time frame: Day 1 and Day 8 of Cycles 1 through 4 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)
Maximum Serum Concentration (Cmax) of MIRV
Time frame: Day 1 and Day 8 of Cycles 1 through 4 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)
Trough Concentration (Ctrough) of MIRV
Time frame: Day 1 and Day 8 of Cycles 1 through 4 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)
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The Center Of Hope /ID# 269348
Reno, Nevada, United States
Holy Name Medical Center /ID# 269340
Teaneck, New Jersey, United States
New York Oncology Hematology - Albany Cancer Center /ID# 269345
Albany, New York, United States
Women'S Cancer Care Associates /ID# 269980
Albany, New York, United States
Duke Cancer Institute /ID# 269342
Durham, North Carolina, United States
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