Mirvetuximab Soravtansine for Ovarian Cancer

Recruiting at 67 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: ImmunoGen, Inc.

Must be taking: PARP inhibitors

Must not be taking: Corticosteroid eyedrops

Disqualifiers: Corneal disorders, Ocular conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 18 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial studies side effects related to an experimental drug called mirvetuximab soravtansine, tested for treating recurrent ovarian cancer. Researchers focus on eye-related side effects and test different eye drops to prevent them. The trial seeks participants with recurring ovarian cancer who have high levels of a specific protein (folate receptor alpha) in their tumors and have previously received certain cancer treatments. As a Phase 2 trial, this research measures how well the treatment works in an initial, smaller group, offering participants a chance to contribute to important findings.

Do I need to stop my current medications to join the trial?

The trial requires that participants stop systemic antineoplastic therapy (cancer treatment drugs) at least 4 weeks or 5 half-lives before starting the study drug. Additionally, participants must not be using corticosteroid or vasoconstricting eyedrops within 5 weeks of starting the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that mirvetuximab soravtansine (MIRV) is safe for treating ovarian cancer. Studies have found that patients who have undergone multiple treatments generally tolerate MIRV well. Some side effects were reported, but they were manageable. Compared to standard chemotherapy, MIRV demonstrated better safety results. The study under consideration will investigate specific eye-related side effects, but overall, other research has found the treatment to be safe. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Mirvetuximab Soravtansine for ovarian cancer because it offers a novel approach compared to standard treatments like chemotherapy and targeted therapies. This drug is an antibody-drug conjugate, which means it combines an antibody with a powerful anti-cancer drug to specifically target and kill cancer cells without harming healthy ones. Additionally, the trial explores the use of prophylactic eye drops to manage potential side effects, which could improve the overall treatment experience for patients. This targeted mechanism and focus on minimizing side effects make it an innovative option in the fight against ovarian cancer.

What evidence suggests that mirvetuximab soravtansine might be an effective treatment for ovarian cancer?

Research has shown that mirvetuximab soravtansine works well for ovarian cancer with high levels of the protein folate receptor alpha (FRα). For ovarian cancer unresponsive to platinum-based treatments, studies have found this drug more effective than traditional chemotherapy, leading to better outcomes. Evidence from various studies indicates it can lower the risk of death and effectively manage this type of cancer. This trial will evaluate mirvetuximab soravtansine combined with either primary prophylactic vasoconstricting eye drops or primary prophylactic steroid eye drops. This suggests that mirvetuximab soravtansine could be a promising option for patients with recurring ovarian cancer with high FRα levels. ^{3 4 5 6 7}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have recovered from side effects of previous treatments, except for hair loss.

Participants must have completed prior therapy within the specified times

Women of childbearing potential (WOCBP) must agree to use highly effective contraceptive method(s) while on MIRV and for ≥ 7 months after the last dose; and must have a negative pregnancy test ≤ 4 days prior to the first dose of MIRV

Exclusion Criteria

I am using or have used corticosteroid or vasoconstricting eyedrops recently.

My ovarian cancer is not borderline, non-epithelial, or mixed histology.

My ovarian cancer did not respond to initial platinum-based chemotherapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MIRV treatment with either prophylactic steroid or vasoconstricting eye drops

18 weeks

Every 3 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Mirvetuximab Soravtansine

Trial Overview 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.

How Is the Trial Designed?

Group I: Primary Prophylactic Vasoconstricting Eye Drops Experimental Treatment 3 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 Drops Experimental Treatment 3 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.

Mirvetuximab Soravtansine is already approved in United States for the following indications:

Approved in United States as Elahere for:

• Platinum-resistant epithelial ovarian cancer
• Fallopian tube cancer
• Primary peritoneal cancer

Who Is Running the Clinical Trial?

ImmunoGen, Inc.

Lead Sponsor

Trials

33

Recruited

4,000+

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Published Research Related to This Trial

Mirvetuximab soravtansine, an antibody-drug conjugate targeting the folate receptor alpha, has shown promising clinical activity in treating platinum-resistant ovarian cancer, which is known for poor outcomes with standard chemotherapy.

This treatment combines a targeted approach with the cytotoxic effects of a chemotherapy agent, potentially offering a new strategy to overcome drug resistance in ovarian cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer. Gonzalez-Ochoa, E., Veneziani, AC., Oza, AM.[2023]

Mirvetuximab soravtansine-gynx (Elahere) has received accelerated approval for treating adult patients with folate receptor α-positive, platinum-resistant ovarian cancer after one to three prior treatments, indicating its efficacy in a challenging patient population.

The drug carries significant safety warnings, including risks of ocular toxicity, pneumonitis, peripheral neuropathy, and embryo-fetal toxicity, which are important considerations for patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Drug Treats Female Reproductive Cancers. Aschenbrenner, DS.[2023]

Mirvetuximab soravtansine-gynx received accelerated FDA approval for treating FRα-positive, platinum-resistant ovarian cancer, showing an overall response rate of 31.7% in a study of 104 patients, with a median response duration of 6.9 months.

The treatment carries significant safety warnings, including risks of severe ocular toxicity, pneumonitis, and peripheral neuropathy, highlighting the importance of monitoring for these adverse effects during therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA Approval Summary: Mirvetuximab Soravtansine-Gynx for FRα-Positive, Platinum-Resistant Ovarian Cancer. Dilawari, A., Shah, M., Ison, G., et al.[2023]

In a study involving 18 patients with recurrent ovarian cancer, the combination of mirvetuximab soravtansine and carboplatin showed a high objective response rate of 71%, indicating significant antitumor activity.

The treatment was generally well-tolerated, with most adverse events being mild, suggesting a favorable safety profile for this combination therapy in patients with platinum-sensitive ovarian cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and activity findings from a phase 1b escalation study of mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in combination with carboplatin in patients with platinum-sensitive ovarian cancer. Moore, KN., O'Malley, DM., Vergote, I., et al.[2019]

Mirvetuximab soravtansine, a new treatment for folate receptor-α positive ovarian cancer, was studied in 543 patients, showing that it can be administered safely at a standard dose of 6 mg/kg without needing adjustments for most patients, including those with mild to moderate renal or hepatic impairment.

The pharmacokinetic model developed in this study indicates that factors like body weight, serum albumin, and age do not necessitate dose adjustments, ensuring consistent efficacy and safety across diverse patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Population pharmacokinetics of mirvetuximab soravtansine in patients with folate receptor-α positive ovarian cancer: The antibody-drug conjugate, payload and metabolite. Tu, YP., Hanze, E., Zhu, F., et al.[2023]

The combination of mirvetuximab soravtansine and bevacizumab shows promising efficacy in treating women with recurrent ovarian cancer that has high folate receptor alpha (FRα) expression, achieving a 64% objective response rate.

Patients treated with this combination therapy experienced a median progression-free survival of 10.6 months, indicating a significant benefit regardless of their platinum sensitivity status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Significant Activity" for ADC in Ovarian Cancer. [2022]

Mirvetuximab soravtansine is a promising antibody-drug conjugate that targets folate receptor-α, showing favorable tolerability and encouraging efficacy, particularly in patients with platinum-resistant ovarian cancer.

Ongoing Phase III and Phase Ib/II trials are currently assessing its effectiveness as a monotherapy and in combination treatments, which will clarify its potential role in treating advanced ovarian cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of mirvetuximab soravtansine in the treatment of platinum-resistant ovarian cancer. Moore, KN., Martin, LP., O'Malley, DM., et al.[2019]

Mirvetuximab soravtansine is an antibody-drug conjugate that received FDA accelerated approval for treating recurrent platinum-resistant high-grade serous ovarian cancer (HGSOC), showing an overall response rate of 32.4% and a median duration of response of 6.9 months in the SORAYA trial.

The treatment has a favorable safety profile, with primarily low-grade ocular and gastrointestinal toxicities, making it a promising option for patients with high FRα expression in their tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mirvetuximab soravtansine for platinum-resistant epithelial ovarian cancer. Porter, RL., Matulonis, UA.[2023]

Citations

1. elaherehcp.com elaherehcp.com/efficacy/confirmatory-study-data

ELAHERE® efficacy and success rate for FRα positive ovarian ... Phase 3 MIRASOL trial: updated overall survival results of mirvetuximab soravtansine (MIRV) versus investigator's choice (IC) chemotherapy in patients (pts) ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38858103/

high platinum-resistant ovarian cancer: final overall survival ... These results support the clinically meaningful efficacy of mirvetuximab soravtansine-gynx in FRα-expressing platinum-resistant ovarian cancer.

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa2309169

Mirvetuximab Soravtansine in FRα-Positive, Platinum- ... Among participants with platinum-resistant, FRα-positive ovarian cancer, treatment with MIRV showed a significant benefit over chemotherapy with ...

4. onclive.com onclive.com/view/final-piccolo-data-underscore-mirvetuximab-soravtansine-s-efficacy-in-later-line-fr-platinum-sensitive-ovarian-cancer

Final PICCOLO Data Underscore Mirvetuximab ... Mirvetuximab soravtansine-gynx shows efficacy in FRα-positive, third-line or later recurrent platinum-sensitive ovarian cancer, with a median OS ...

5. news.abbvie.com news.abbvie.com/2025-03-15-ELAHERE-R-mirvetuximab-soravtansine-gynx-Shows-Consistent-Survival-Benefit-in-Long-Term-Analysis-for-Certain-Ovarian-Cancer-Patients

ELAHERE® (mirvetuximab soravtansine-gynx) Shows ... Final data analysis from Phase 3 MIRASOL trial after 30.5-month median follow-up demonstrated 32% reduction in risk of death with ELAHERE ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40700855/

Safety and efficacy of mirvetuximab soravtansine, a folate ... Conclusions: MIRV plus pembrolizumab demonstrated anti-cancer efficacy and a tolerable safety profile in heavily pretreated patients with PROC.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0090825825008893

Safety and efficacy of mirvetuximab soravtansine, a folate ... Patients with epithelial ovarian cancer (EOC) have poor outcomes; most tumors will relapse within several years and develop resistance to platinum-based therapy ...