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Alkylating agents

Mirvetuximab Soravtansine + Carboplatin for Ovarian Cancer

Phase 2

Waitlist Available

Led By Susana Banerjee, MD

Research Sponsored by ImmunoGen, Inc.

Eligibility Criteria Checklist

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

Must have

Patients must have confirmation of FRα positivity of ≥ 25% of tumor staining at ≥ 2+ intensity for entry into the study

Patients must have received prior treatment with a PARPi if somatic and germline BRCA-positive

Must not have

Patients with clinically significant cardiac disease

Patients with active or chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Approved for 5 Other Conditions

Summary

This trial tests a new combo of drugs to treat ovarian cancer that has come back after 1 round of chemotherapy.

Who is the study for?

This trial is for adults with high-grade ovarian, primary peritoneal, or fallopian tube cancer that's sensitive to platinum-based chemo and has returned after one treatment round. Participants must have a certain level of tumor cell positivity for FRα, be in good physical condition (ECOG 0-1), and not pregnant. They can't join if they've had more than one chemo round, severe eye conditions, prior MIRV treatments, certain other cancers within the last three years or serious health issues.

What is being tested?

The study tests carboplatin combined with mirvetuximab soravtansine followed by just mirvetuximab soravtansine in patients whose tumors express folate receptor-alpha (FRα) and are recurrent but respond to platinum drugs. It's an open-label phase 2 trial where all participants receive the experimental therapy.

What are the potential side effects?

Possible side effects include reactions related to the immune system due to monoclonal antibodies like MIRV; nerve damage symptoms; liver or kidney function changes; eye problems such as corneal disorders; fatigue; allergic reactions; and potential blood count variations.

Eligibility Criteria

Inclusion Criteria

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

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My tumor is confirmed to be FRα positive with at least 25% of it showing high intensity.

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I have had treatment with a PARPi due to my BRCA-positive status.

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

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I am 18 years old or older.

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I have been diagnosed with a specific type of ovarian, peritoneal, or fallopian tube cancer.

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

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I can provide a sample of my tumor for testing.

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My cancer returned after one platinum-based chemotherapy treatment.

Exclusion Criteria

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

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I have a serious heart condition.

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

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

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

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I have a history of multiple sclerosis, demyelinating disease, or Lambert-Eaton syndrome.

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I am not pregnant or breastfeeding.

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

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I have had cancer other than my current one within the last 3 years.

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I have advanced liver disease.

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I do not have severe numbness or pain in my hands or feet.

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I do not have any serious illnesses or active infections.

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My ovarian cancer is of a specific type (endometrioid, clear cell, mucinous, sarcomatous, mixed, or low-grade).

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I have undergone more than one chemotherapy treatment.

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I have had extensive radiation therapy affecting a large part of my bone marrow.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 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

Overall Response Rate (ORR)

Secondary study objectives

Cancer Antigen (CA)-125 Response

Duration of Response (DOR)

Overall Survival (OS)

+1 more

Other study objectives

Correlate biomarker levels with response to treatment

Correlate response in patients with prior PARPi use

Incidence of seroconversion

Awards & Highlights

No Placebo-Only Group

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

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Trial Design

1Treatment groups

Experimental Treatment

Group I: MIRV + CarboplatinExperimental Treatment2 Interventions

On Day 1 of every 3-week cycle (Q3W) for 6 cycles, MIRV will be given at the dosage of 6 mg/kg of AIBW along with carboplatin given at area under the AUC5 administered through intravenous (IV) infusion (maximum dosing per National Comprehensive Cancer Network \[NCCN\] guidelines \[NCCN 2021\]). Upon completion of carboplatin plus MIRV treatment, single-agent MIRV will be continued at the tolerated dose on Day 1 Q3W in participants with investigator determined stable disease (SD), complete response (CR) or partial response (PR).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mirvetuximab Soravtansine

Not yet FDA approved

Carboplatin

FDA approved

0 / 22Eligibility criteria met