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RECRUITING Phase 2

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

NCT06365853 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG Mirvetuximab Soravtansine
  • DRUG Lubricating Eye Drops
  • DRUG Prednisolone acetate ophthalmic suspension 1% eye drops
  • DRUG Brimonidine tartrate ophthalmic solution eye drops

Study Locations (20)

Oost-Vlaanderen

  • OLV Ziekenhuis Aalst /ID# 269311 — Aalst
  • AZ Sint-Lucas /ID# 269307 — Ghent
  • UZ Gent /ID# 269309 — Ghent

New York

  • New York Oncology Hematology - Albany Cancer Center /ID# 269345 — Albany
  • Women'S Cancer Care Associates /ID# 269980 — Albany

Texas

  • UT Southwestern Medical Center /ID# 269341 — Dallas
  • Memorial Hermann Southeast Hospital /ID# 269347 — Houston

New South Wales

  • Blacktown Hospital /ID# 269305 — Blacktown
  • Newcastle Private Hosptial /ID# 269306 — Lambton Heights

California

  • University of California Los Angeles /ID# 269339 — Los Angeles

Kentucky

  • Norton Cancer Institute - St. Matthews /ID# 269070 — Louisville

Maryland

  • Holy Cross Hospital - Silver Spring /ID# 269344 — Silver Spring

Missouri

  • Mercy David C. Pratt Cancer Center /ID# 269350 — St Louis

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2024-07-29
Est. Completion 2027-06
Phase Phase 2

Sponsor

AbbVie

603 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06365853

The ClinicalTrials.gov registry entry for NCT06365853 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Recurrent Ovarian Cancer appearing as the primary indexed condition, and to 4 interventions — of which Mirvetuximab Soravtansine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06365853 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Oost-Vlaanderen, New York, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06365853 about?

NCT06365853 is a clinical study titled "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". 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 ev...

What is the current status of trial NCT06365853?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2024-07-29. Estimated completion is 2027-06.

What conditions does trial NCT06365853 study?

This clinical trial studies the following conditions: Recurrent Ovarian Cancer, Folate Receptor-Alpha Positive. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06365853?

The interventions under investigation include: Mirvetuximab Soravtansine (DRUG), Lubricating Eye Drops (DRUG), Prednisolone acetate ophthalmic suspension 1% eye drops (DRUG), Brimonidine tartrate ophthalmic solution eye drops (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06365853?

This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06365853 being conducted?

This trial has 20 study locations across California, Kentucky, Maryland, Missouri, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial