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Monoclonal Antibodies

Carboplatin + Mirvetuximab for Ovarian Cancer

Phase 2

Recruiting

Led By Rebecca Arend, M.D.

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

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

Must have

Patient's tumor must be positive for FRα expression as defined by a score of PS2+ intensity in >75% of cells

Patients must have a performance status of 0 or 1

Must not have

Patients with a history of hepatitis B or C infection (whether or not on active antiviral therapy)

Patients who received prior treatment with MIRV or other FRα-targeting agents

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new combo of drugs to treat ovarian cancer that has come back or hasn't respond to other treatments.

Who is the study for?

This trial is for women with advanced-stage ovarian, fallopian tube, or primary peritoneal cancer who haven't had previous systemic anti-cancer therapy. They must have high-grade serous epithelial ovarian cancer that's positive for FRα expression and be fit enough to undergo chemotherapy and surgery. Women of childbearing potential must use effective contraception and not be pregnant or breastfeeding.

What is being tested?

The study tests a combination of Carboplatin with Mirvetuximab Soravtansine (MIRV) in patients whose tumors over-express the FRα receptor. Participants will receive this treatment every three weeks before surgery, followed by additional cycles after surgery. The option to add Bevacizumab or maintenance therapy later on is at the physician's discretion.

What are the potential side effects?

Potential side effects may include reactions related to the immune system due to monoclonal antibodies like MIRV, liver or kidney function issues from Carboplatin, as well as general side effects from chemotherapy such as fatigue, nausea, and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My tumor is mostly positive for a specific protein marker.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My ovarian cancer is confirmed as high grade serous type.

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My cancer is at stage III or IV and I can start treatment before surgery.

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I am willing to provide a sample of my tumor for testing.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had hepatitis B or C in the past.

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I have previously been treated with MIRV or drugs targeting FRα.

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I have a history of MS, another demyelinating disease, or Lambert-Eaton syndrome.

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I do not have any serious illnesses or active infections.

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I have severe liver disease.

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I have been diagnosed with a non-infectious lung condition before.

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I have brain metastases that are either untreated or causing symptoms.

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I need to take supplements that contain folate due to a deficiency.

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I have not had any other cancer in the last 3 years.

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I have ongoing eye problems that need regular treatment or monitoring.

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I am not pregnant or breastfeeding.

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I have received treatment with drugs that target cancer throughout my body.

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My cancer is of a specific type: low-grade serous, endometrioid, clear cell, or mucinous.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Objective response rate (ORR)

Radiographic tumor assessment per RECIST v1.1 criteria

progression free survival (PFS)

Secondary study objectives

Therapeutic procedure

CA-125 Antigen

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: neoadjuvant chemotherapy regimenExperimental Treatment1 Intervention

* IV Carboplatin AUC 5 (Q21 days) 7 cycles (first cycle is Carbo alone, dosing for C1D1 will be provider's choice) * IV Mirvetuximab 6 mg/kg (adjusted ideal body weight) day 1 (Q21 days) 6 cycles (starting with cycle #2)

0 / 18Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,656 Previous Clinical Trials

2,444,303 Total Patients Enrolled

Rebecca Arend, M.D.5.02 ReviewsPrincipal Investigator - University of Alabama at Birmingham

University of Alabama at Birmingham

5Patient Review

Dr. Arend is a very kind and considerate doctor. She and her whole staff made me feel safe and confident in their abilities. I was most impressed by her compassion, dedication, and knowledge.