Mirvetuximab Soravtansine for Ovarian Cancer

Recruiting in Palo Alto (17 mi)

+56 other locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: ImmunoGen, Inc.

Must be taking: PARP inhibitors

Must not be taking: Corticosteroid eyedrops

Disqualifiers: Corneal disorders, Ocular conditions, others

No Placebo Group

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the drug Mirvetuximab Soravtansine for ovarian cancer?

Mirvetuximab Soravtansine has shown effectiveness in treating ovarian cancer, particularly in patients with high folate receptor alpha expression. In the SORAYA trial, it achieved a 32.4% response rate and a median response duration of 6.9 months for platinum-resistant ovarian cancer. Additionally, when combined with bevacizumab, it showed a 64% response rate and 10.6 months of progression-free survival in a phase I/II trial.

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Is Mirvetuximab Soravtansine safe for humans?

Mirvetuximab Soravtansine has been associated with some safety concerns, including eye problems, lung inflammation, nerve damage, and risks to unborn babies. These issues are important to consider when evaluating its safety for use in humans.

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What makes the drug Mirvetuximab Soravtansine unique for treating ovarian cancer?

Mirvetuximab Soravtansine is unique because it is an antibody-drug conjugate (ADC) that specifically targets folate receptor alpha (FRα) on cancer cells, delivering a potent chemotherapy agent directly to the tumor, which can improve effectiveness and reduce side effects compared to traditional chemotherapy.

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Eligibility Criteria

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.

Trial Timeline

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)

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Holy Name Medical Center Teaneck, NJ

McGill University Health Centre (MUHC) - The Montreal General Hospital (MGH) - Cedars Cancer Centre Montreal, Canada

Norton Healthcare /ID# 269070 Louisville, KY

Holy Cross Hospital - Silver Spring /ID# 269344 Silver Spring, MD

More Trial Locations

Who Is Running the Clinical Trial?

ImmunoGen, Inc. Lead Sponsor

AbbVie Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

"Significant Activity" for ADC in Ovarian Cancer. [2022] Mirvetuximab soravtansine plus bevacizumab may benefit women with recurrent ovarian cancer and high folate receptor alpha (FRα) expression, regardless of platinum sensitivity. In a phase I/II trial, the combination elicited an objective response rate of 64% and a median progression-free survival of 10.6 months in patients with FRα-high tumors.

2. United States 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. [2019] To evaluate the safety profile and preliminary antitumor activity of mirvetuximab soravtansine when administered in combination with carboplatin to relapsed ovarian cancer patients.

3. United States pubmed.ncbi.nlm.nih.gov

New Drug Treats Female Reproductive Cancers. [2023] Mirvetuximab soravtansine-gynx (Elahere) has been granted accelerated approval to treat adult patients with folate receptor α-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens.The drug's labeling includes a boxed warning for ocular toxicity. Other warnings include a risk of pneumonitis, peripheral neuropathy, and embryo-fetal toxicity.

4. England pubmed.ncbi.nlm.nih.gov

Mirvetuximab soravtansine for platinum-resistant epithelial ovarian cancer. [2023] Mirvetuximab soravtansine (mirvetuximab) is an antibody drug conjugate (ADC) comprised of a humanized folate receptor alpha (FRα)-binding monoclonal antibody attached via a cleavable linker to the cytotoxic maytansinoid molecule, DM4. FRα is expressed in several epithelial cancers, including high grade serous ovarian cancer (HGSOC). Mirvetuximab received accelerated approval by the United States Food and Drug Administration (FDA) in November 2022 based on the results of the SORAYA trial, which tested mirvetuximab for the treatment of patients with recurrent platinum resistant HGSOC with high FRα expression and showed an overall response rate (ORR) of 32.4% and a median duration of response of 6.9 months. Mirvetuximab toxicities included low grade ocular and gastrointestinal toxicities. The National Comprehensive Cancer Network (NCCN) ovarian cancer 2023 guidelines adopted mirvetuximab as 2A, and mirvetuximab combined with bevacizumab as 2B, recommendations.

5. England pubmed.ncbi.nlm.nih.gov

A review of mirvetuximab soravtansine in the treatment of platinum-resistant ovarian cancer. [2019] Resistance to platinum-based therapy poses a significant clinical challenge for the management of advanced ovarian cancer, a leading cause of cancer mortality among women. Mirvetuximab soravtansine is a novel antibody-drug conjugate that targets folate receptor-α, a validated molecular target for therapeutic intervention in this disease. Here, we examine mirvetuximab soravtansine's mechanism of action and pharmacology, and review its clinical evaluation in ovarian cancer to date. We focus on the favorable tolerability and encouraging signals of efficacy that have emerged, most notably in patients with platinum-resistant disease. Ongoing Phase III monotherapy and Phase Ib/II combination trials evaluating its activity in the setting of platinum resistance are emphasized, which will help define its role in the evolving landscape of ovarian cancer therapy.

6. United States pubmed.ncbi.nlm.nih.gov

FDA Approval Summary: Mirvetuximab Soravtansine-Gynx for FRα-Positive, Platinum-Resistant Ovarian Cancer. [2023] On November 14, 2022, the FDA granted accelerated approval to mirvetuximab soravtansine-gynx for treatment of adult patients with folate receptor-α (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic therapies. The VENTANA FOLR1 (FOLR-2.1) RxDx Assay was approved as a companion diagnostic device to select patients for this indication. Approval was based on Study 0417 (SORAYA, NCT04296890), a single-arm, multicenter trial. In 104 patients with measurable disease who received mirvetuximab soravtansine-gynx, the overall response rate was 31.7% [95% confidence interval (CI), 22.9-41.6] with a median duration of response of 6.9 months (95% CI, 5.6-9.7). Ocular toxicity was included as a Boxed Warning in the U.S. Prescribing Information (USPI) to alert providers of the risks of developing severe ocular toxicity including vision impairment and corneal disorders. Pneumonitis and peripheral neuropathy were additional important safety risks included as Warnings and Precautions in the USPI. This is the first approval of a targeted therapy for FRα-positive, platinum-resistant ovarian cancer and the first antibody-drug conjugate approved for ovarian cancer. This article summarizes the favorable benefit-risk assessment leading to FDA's approval of mirvetuximab soravtansine-gynx.

7. United States pubmed.ncbi.nlm.nih.gov

Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer. [2023] Ovarian cancer is the second leading cause of death from gynecologic malignancies worldwide. Management of platinum-resistant disease is challenging and clinical outcomes with standard chemotherapy are poor. Over the past decades, significant efforts have been made to understand drug resistance and develop strategies to overcome treatment failure. Antibody drug conjugates (ADCs) are a rapidly growing class of oncologic therapeutics, which combine the ability to target tumor-specific antigens with the cytotoxic effects of chemotherapy. Mirvetuximab soravtansine is an ADC comprising an IgG1 monoclonal antibody against the folate receptor alpha (FRα) conjugated to the cytotoxic maytansinoid effector molecule DM4 that has shown promising clinical activity in patients with FR-α-positive ovarian cancer. This review summarizes current evidence of mirvetuximab soravtansine in platinum-resistant ovarian cancer, focusing on clinical activity, toxicity, and future directions.

8. England 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. [2023] Mirvetuximab soravtansine is a first-in-class antibody-drug conjugate recently approved for the treatment of folate receptor-α positive ovarian cancer. The aim of this study was to develop a population pharmacokinetic model to describe the concentration-time profiles of mirvetuximab soravtansine, the payload (DM4) and a metabolite (S-methyl-DM4).