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
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.
Detailed description
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).
Arms & interventions
- DrugMirvetuximab Soravtansine
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.
- DrugLubricating Eye Drops
Lubricating artificial tears should be administered at least 15 minutes after corticosteroid or brimonidine eye drop administration.
- DrugPrednisolone acetate ophthalmic suspension 1% eye drops
Self-administration of prednisolone acetate ophthalmic suspension 1% eye drops as prescribed by the treating physician.
- DrugBrimonidine tartrate ophthalmic solution eye drops
Self-administration of brimonidine tartrate ophthalmic solution eye drops as prescribed by the treating physician.
Outcome measures
Primary
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)
Secondary
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)
Eligibility criteria
Study locations (12)
University of California Los Angeles /ID# 269339
Los Angeles, California, 90095
Norton Cancer Institute - St. Matthews /ID# 269070
Louisville, Kentucky, 40207
Holy Cross Hospital - Silver Spring /ID# 269344
Silver Spring, Maryland, 20910
Mercy David C. Pratt Cancer Center /ID# 269350
St Louis, Missouri, 63141
The Center Of Hope /ID# 269348
Reno, Nevada, 89511
Holy Name Medical Center /ID# 269340
Teaneck, New Jersey, 07666
New York Oncology Hematology - Albany Cancer Center /ID# 269345
Albany, New York, 12206-5013
Women'S Cancer Care Associates /ID# 269980
Albany, New York, 12208
Duke Cancer Institute /ID# 269342
Durham, North Carolina, 27710
Summa Health /ID# 269349
Akron, Ohio, 44304-1407
UT Southwestern Medical Center /ID# 269341
Dallas, Texas, 75390
Memorial Hermann Southeast Hospital /ID# 269347
Houston, Texas, 77089