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Monoclonal Antibodies
Mirvetuximab Soravtansine for Ovarian Cancer (MIRASOL Trial)
Phase 3
Waitlist Available
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 received at least 1 but no more than 3 prior systemic lines of anticancer therapy, and for whom single-agent therapy is appropriate as the next line of treatment
Patient's tumor must be positive for FRα expression as defined by the Ventana FOLR1 (FOLR-2.1) CDx assay
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
MIRASOL Trial Summary
This trial is testing a new drug, mirvetuximab soravtansine, to see if it is more effective and has fewer side effects than existing chemotherapy drugs for people with ovarian cancer.
Who is the study for?
This trial is for women over 18 with high-grade ovarian, primary peritoneal, or fallopian tube cancers that are resistant to platinum-based chemotherapy and have high folate receptor-alpha expression. Participants must have received 1-3 prior cancer treatments and be suitable for single-agent therapy. They should not be pregnant, agree to use contraception, and cannot have certain health conditions or a history of severe reactions to the study drugs.Check my eligibility
What is being tested?
The study compares mirvetuximab soravtansine (a targeted cancer drug) against the investigator's choice of standard chemotherapy (paclitaxel, pegylated liposomal doxorubicin, or topotecan). The goal is to see which treatment is more effective and safer for patients whose tumors express a lot of folate receptor-alpha.See study design
What are the potential side effects?
Possible side effects include allergic reactions to the drugs used in this trial; nerve damage; eye problems like corneal disorders; blood clots; heart issues; liver disease symptoms worsening if pre-existing; increased risk of infections due to weakened immune system.
MIRASOL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I've had 1-3 cancer treatments and need a single-agent therapy next.
Select...
My tumor is positive for FRα based on a specific test.
Select...
My condition did not improve with platinum-based chemotherapy.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I have been diagnosed with a serious type of ovarian, peritoneal, or fallopian tube cancer.
Select...
I am willing to provide a sample of my tumor for testing.
MIRASOL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival (PFS)
Secondary outcome measures
CA-125 response
Duration of response (DOR)
Objective Response Rate (ORR)
+4 moreOther outcome measures
Identification of soluble FRα levels and other biomarkers
Immunogenicity
Patient-reported outcomes using EORTC QLQ-C30 questionnaires
+3 moreSide effects data
From 2019 Phase 2 trial • 96 Patients • NCT0310607750%
Neutropathy
50%
Neutropenia
50%
Grade 1 Blurred Vision
50%
Grade 2 Blurred Vision
50%
Keratopathy
50%
Myalgia
50%
Elevated liver enzymes
50%
Peripheral
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort A: Advanced Triple-Negative Breast Cancer (TNBC)
MIRASOL Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: mirvetuximab soravtansine (MIRV; IMGN853)Experimental Treatment1 Intervention
MIRV 6 mg/kg adjusted ideal body weight (AIBW) every 3 weeks (Q3W)
Group II: Investigator's choice of chemotherapyActive Control3 Interventions
Paclitaxel (Pac; 80 mg/m2) administered once per week (QW) within a 4-week cycle
Pegylated liposomal doxorubicin (PLD; 40 mg/m2) administered every 4 weeks (Q4W)
Topotecan (Topo; 4 mg/m2) administered either on Days 1, 8, and 15 every 4 weeks or for 5 consecutive days (1.25 mg/m2 Days 1-5) every 3 weeks (Q3W)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mirvetuximab Soravtansine
2017
Completed Phase 3
~250
Find a Location
Who is running the clinical trial?
ImmunoGen, Inc.Lead Sponsor
31 Previous Clinical Trials
3,352 Total Patients Enrolled
5 Trials studying Ovarian Cancer
1,013 Patients Enrolled for Ovarian Cancer
Gynecologic Oncology GroupNETWORK
250 Previous Clinical Trials
70,473 Total Patients Enrolled
50 Trials studying Ovarian Cancer
7,847 Patients Enrolled for Ovarian Cancer
European Network of Gynaecological Oncological Trial Groups (ENGOT)OTHER
35 Previous Clinical Trials
16,186 Total Patients Enrolled
10 Trials studying Ovarian Cancer
4,791 Patients Enrolled for Ovarian Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have previously been treated with MIRV or drugs targeting FRα.I have a serious heart condition.I do not have severe numbness or pain in my hands or feet.I have brain metastases that are either untreated or causing symptoms.I have a history of multiple sclerosis, demyelinating disease, or Lambert-Eaton syndrome.I have recovered from side effects of previous cancer treatments.I do not have any serious illnesses or active infections.I have had radiotherapy that affected a significant part of my bone marrow.I have had a stroke in the last 6 months.I am not pregnant or breastfeeding.I have had cancer other than my current one in the last 3 years.I've had 1-3 cancer treatments and need a single-agent therapy next.My tumor is positive for FRα based on a specific test.I have a history of liver cirrhosis.I have ongoing eye problems or have had a cornea transplant.My condition did not improve with platinum-based chemotherapy.I had major surgery over 4 weeks ago and have recovered from it.You had a bad reaction to other medications like the study drug.You must have at least one specific spot of disease that can be measured according to certain guidelines.I am fully active or restricted in physically strenuous activity but can do light work.I have been diagnosed with a serious type of ovarian, peritoneal, or fallopian tube cancer.My ovarian cancer is of a specific type (endometrioid, clear cell, mucinous, sarcomatous, mixed, or low-grade).I am not under any form of detention, involuntary psychiatric care, legal protection, or guardianship that prevents me from consenting.Your condition got worse in imaging tests after your last treatment.Women of childbearing potential must have a negative pregnancy test within 4 days before taking the study drug.My cancer did not respond to initial platinum-based chemotherapy.I am willing to provide a sample of my tumor for testing.I am a woman aged 18 or older.I agree to use effective birth control during and after the study.I have been diagnosed with a type of lung disease that is not caused by an infection.My blood, liver, and kidney functions are all within normal ranges.You are required to take supplements that contain folate.
Research Study Groups:
This trial has the following groups:- Group 1: Investigator's choice of chemotherapy
- Group 2: mirvetuximab soravtansine (MIRV; IMGN853)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
What medical condition is Mirvetuximab Soravtansine usually prescribed for?
"Mirvetuximab Soravtansine is a medication used to treat advanced soft tissue sarcoma and advanced cervical cancer. It can also help patients with neoplasms and esophageal neoplasms malignant."
Answered by AI
What are known side effects of Mirvetuximab Soravtansine?
"The Power team has given Mirvetuximab Soravtansine a safety rating of 3. This is because Phase 3 clinical trials have shown some efficacy and multiple rounds of data have supported its safety."
Answered by AI
Are there any other ongoing or completed investigations utilizing Mirvetuximab Soravtansine?
"The first mirvetuximab soravtansine clinical trial was conducted in 1997 at Spectrum Health Hospital - Butterworth Campus. Since then, there have been a total of 1822 completed trials. Out of these, 1229 are active and ongoing, with a considerable amount taking place in Savannah, Georgia."
Answered by AI
Have similar tests been conducted before?
"Mirvetuximab Soravtansine has undergone 1229 clinical trials in 3350 cities and 81 countries. The first study occurred in 1997 and, sponsored by Alfacell, it involved 300 patients. Phase 3 of the trial concluded with drug approval. Since then, 1822 studies have completed."
Answered by AI
Could you please give the total number of people enrolling in this medical study?
"Presently, this clinical trial is not enrolling patients. According to the study's last update on October 28th, 2022, it is unclear when recruitment will open again. There are 594 other studies seeking patients with fallopian tubes cancer and 1229 studies searching for patients that match the criteria for Mirvetuximab Soravtansine."
Answered by AI
Who else is applying?
What site did they apply to?
Tom Baker Cancer Centre
Cross Cancer Institute
What portion of applicants met pre-screening criteria?
Met criteria
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Phone Call
Most responsive sites:
- Tom Baker Cancer Centre: < 48 hours
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