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Alkylating agents
Mirvetuximab Soravtansine + Carboplatin for Ovarian Cancer
Phase 2
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
CA-125 Response
Duration of Response (DOR)
Overall Response Rate (ORR)
+3 moreOther outcome measures
Correlate biomarker levels with response to treatment
Correlate response in patients with prior PARPi use
Incidence of seroconversion
Trial Design
1Treatment groups
Experimental Treatment
Group I: Open LabelExperimental 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 adjusted ideal body weight (AIBW) along with carboplatin given at area under the concentration curve (AUC) 5 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 patients with investigator determined stable disease, PR, or CR.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
FDA approved
Mirvetuximab Soravtansine
Not yet FDA approved
Find a Location
Who is running the clinical trial?
ImmunoGen, Inc.Lead Sponsor
32 Previous Clinical Trials
3,717 Total Patients Enrolled
5 Trials studying Ovarian Cancer
1,013 Patients Enrolled for Ovarian Cancer
Susana Banerjee, MDPrincipal InvestigatorRoyal Marsden NHS Foundation Trust
Gottfried Konecny, MDPrincipal InvestigatorUniversity of California, Los Angeles
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You need to take supplements that contain folate.I have a serious heart condition.My blood, liver, and kidney functions are all within normal ranges.I have ongoing eye problems that need regular treatment or monitoring.I have brain metastases that are either untreated or causing symptoms.I have been diagnosed with a non-infectious lung condition.I have a history of multiple sclerosis, demyelinating disease, or Lambert-Eaton syndrome.You have had a severe allergic reaction to monoclonal antibodies before.I have had treatment with a PARPi due to my BRCA-positive status.I am not pregnant or breastfeeding.I have previously been treated with MIRV or drugs targeting FRα.I am fully active or restricted in physically strenuous activity but can do light work.My cancer returned more than 6 months after my last platinum-based treatment.If you are able to become pregnant, you must have a negative pregnancy test within 4 days before starting the trial.My tumor is confirmed to be FRα positive with at least 25% of it showing high intensity.I had major surgery over 4 weeks ago and have recovered from it.I am 18 years old or older.You must have at least one tumor that can be measured according to specific guidelines.I have had cancer other than my current one within the last 3 years.I have advanced liver disease.I have not had a stroke in the last 6 months.I have had BRCA testing on my tumor or through a blood test.I have been diagnosed with a specific type of ovarian, peritoneal, or fallopian tube cancer.I have recovered from side effects of previous treatments, except for hair loss.I can provide a sample of my tumor for testing.My cancer returned after one platinum-based chemotherapy treatment.I do not have severe numbness or pain in my hands or feet.I do not have any serious illnesses or active infections.My ovarian cancer is of a specific type (endometrioid, clear cell, mucinous, sarcomatous, mixed, or low-grade).I have undergone more than one chemotherapy treatment.I have had extensive radiation therapy affecting a large part of my bone marrow.My tumor shows FRα expression as per the Ventana FOLR1 Assay.
Research Study Groups:
This trial has the following groups:- Group 1: Open Label
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the FDA sanction Open Label?
"Open Label received a safety score of 2 because, while there is some clinical data supporting its safety profile, there are no studies that suggest it is an effective medication."
Answered by AI
Are people still being recruited for this experiment?
"Indeed, the listing on clinicaltrials.gov reveals that this trial is currently recruiting patients. The original posting date was September 28th, 2022 and there have been subsequent edits on November 10th of the same year. A total of 114 individuals are needed for the study to be conducted across three different locations."
Answered by AI
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