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NCT06365853 · ClinicalTrials.gov record · last posted 2026-08-21

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

StatusActive, Not Recruiting
PhasePhase 2
SponsorAbbVie
Started2024-07-29
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Protocol amendment history 3 changes detected by DataLookout

2026-08-22
Enrollment closed, study ongoing
2026-08-22
Primary completion pushed: 2026-06 → 2027-02
2026-08-22
Completion moved earlier: 2027-06 → 2027-02
Trial Details
NCT Number NCT06365853
Lead Sponsor AbbVie
Conditions Recurrent Ovarian Cancer, Folate Receptor-Alpha Positive
Enrollment 108 participants
Start Date 2024-07-29
Primary Completion 2027-02 (estimated)
Study Completion 2027-02 (estimated)
Updated on ClinicalTrials.gov 2026-08-21