Mirvetuximab Soravtansine for Ovarian Cancer

Phase 2

Recruiting

Research Sponsored by ImmunoGen, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up cycle 1 day 1 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study how often and how severe eye-related side effects are in patients with recurrent ovarian cancer who are treated with mirvetuximab soravtansine. The study will also

Who is the study for?

This trial is for individuals with recurrent ovarian cancer showing high folate receptor-alpha expression. It's open to those who've had either platinum-sensitive or platinum-resistant types of the disease.

What is being tested?

The study tests if eye drops like Prednisolone acetate and Brimonidine tartrate can prevent or reduce eye problems caused by Mirvetuximab Soravtansine, a drug used in treating this cancer.

What are the potential side effects?

Possible side effects include ocular issues such as blurred vision, dry eyes, irritation, and potentially toxic optic neuropathy related to Mirvetuximab Soravtansine treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ cycle 1 day 1 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~cycle 1 day 1 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle 1 day 1 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With MIRV-related Corneal AEs (≥ Grade 2) in Asymptomatic Participants

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Primary Prophylactic Vasoconstricting Eye DropsExperimental Treatment3 Interventions

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.

Group II: Primary Prophylactic Steroid Eye DropsExperimental Treatment3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mirvetuximab Soravtansine

2017

Completed Phase 3

~250

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