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Mirvetuximab for Ovarian Cancer
Study Summary
This trial is testing a new drug, mirvetuximab soravtansine, to treat ovarian, primary peritoneal, or fallopian tube cancers that have come back after treatment and have high levels of a protein called folate receptor-alpha.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 3 trial • 366 Patients • NCT02631876Trial Design
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Who is running the clinical trial?
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- I have not had any other cancer in the last 3 years.I have had only one non-platinum chemotherapy treatment.I have at least one tumor that can be measured with a scan.You have had a bad reaction to monoclonal antibodies before.I am 18 years old or older.I am willing to provide a sample of my tumor for testing.I've had at least 2 platinum treatments and can't have more due to side effects.My treatment was changed due to side effects, not because my cancer got worse.I am fully active or restricted in physically strenuous activity but can do light work.I do not have serious heart conditions.I have severe liver disease.I have been tested for BRCA mutation and received PARP inhibitor therapy if positive.Women of childbearing potential must have a negative pregnancy test within 4 days before starting the study medication.My maintenance therapy is counted as part of my previous cancer treatment.I have previously been treated with MIRV or drugs targeting FRα.I have brain metastases that are either untreated or causing symptoms.My ovarian cancer is of a specific type, such as endometrioid or clear cell.I have ongoing eye problems like uncontrolled glaucoma or need treatments for my eyes.I do not have any serious illnesses or active infections.I have a history of MS, demyelinating disease, or Lambert-Eaton syndrome.My cancer treatment before or after surgery counts as one round of therapy.I have been diagnosed with a non-infectious lung condition.I am not pregnant or breastfeeding.I have been diagnosed with high-grade serous ovarian, peritoneal, or fallopian tube cancer.My cancer has worsened after my last cancer treatment.My tumor is positive for a specific protein according to a special test.I have not had a stroke in the last 6 months.You need to take folate supplements because you have low levels of folate.I do not have severe numbness or pain in my hands or feet.I have had radiotherapy that affected a significant part of my bone marrow.My cancer returned more than 6 months after my last platinum-based treatment.My blood, liver, and kidney functions are all within normal ranges.
- Group 1: Mirvetuximab Soravtansine
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Are there still opportunities for volunteers to join this experiment?
"That is correct. Clinicaltrials.gov has updated data which reveals that the trial, first posted on August 31st 2021, still requires participants and is enrolling 75 patients at 38 sites."
In which regions is this experiment being conducted?
"This research is being conducted in various places, with the most prominent locations being McGill University Health Center in Montréal, Quebec; University of Miami in Miami, Florida; and City of Hope in Duarte, California. An additional 38 sites are also included."
Is there any prior research on the use of Mirvetuximab soravtansine for medical treatment?
"Currently, there are 8 trials for Mirvetuximab soravtansine being conducted. One of these studies is in the advanced Phase 3 stage and 318 locations are hosting research related to this medication. Most of these ongoing investigations take place in Columbus, Ohio."
Has Mirvetuximab soravtansine been granted clearance by the FDA?
"Our team at Power gauged the safety of Mirvetuximab soravtansine to be a 2, as this is currently in Phase 2. This suggests that there is evidence validating its security but limited reliability regarding its efficacy."
What is the estimated sample size of participants in this clinical trial?
"To conduct the study, ImmunoGen must enlist 75 patients that fulfill criteria set by the trial. The company has selected McGill University Health Center in Montréal and University of Miami to join their operation."
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