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Monoclonal Antibodies
Mirvetuximab Soravtansine for Ovarian Cancer (MIRASOL Trial)
Seoul, Korea, Republic of
Phase 3
Waitlist Available
Research Sponsored by AbbVie
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
Must not have
Patients with prior treatment with MIRV or other FRα-targeting agents
Patients with clinically significant cardiac disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group
Pivotal 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.
See full description
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.
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.
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My tumor is positive for FRα based on a specific test.
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My condition did not improve with platinum-based chemotherapy.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have been diagnosed with a serious type of ovarian, peritoneal, or fallopian tube cancer.
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I am willing to provide a sample of my tumor for testing.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have previously been treated with MIRV or drugs targeting FRα.
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I have a serious heart condition.
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I do not have severe numbness or pain in my hands or feet.
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I have brain metastases that are either untreated or causing symptoms.
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I have a history of multiple sclerosis, 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 a history of liver cirrhosis.
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I have had radiotherapy that affected a significant part of my bone marrow.
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I am not pregnant or breastfeeding.
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I have ongoing eye problems or have had a cornea transplant.
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I have had cancer other than my current one in the last 3 years.
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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 am not under any form of detention, involuntary psychiatric care, legal protection, or guardianship that prevents me from consenting.
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My cancer did not respond to initial platinum-based chemotherapy.
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I have been diagnosed with a type of lung disease that is not caused by an infection.
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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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Secondary study objectives
Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1
Number of Participants Achieving at Least 15 Point Absolute Improvement at Week 8 or 9 in the Abdominal/GI Scale of European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module 28 (QLQ-OV28)
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
+4 moreOther study objectives
Identification of soluble FRα levels and other biomarkers
Immunogenicity
Patient-reported outcomes using EORTC QLQ-C30 questionnaires
+3 moreSide effects data
From 2024 Phase 3 trial • 453 Patients • NCT0420985541%
Vision blurred
32%
Keratopathy
30%
Fatigue
29%
Abdominal pain
28%
Diarrhoea
28%
Dry eye
27%
Constipation
27%
Nausea
22%
Neuropathy peripheral
19%
Asthenia
18%
Decreased appetite
18%
Photophobia
17%
Vomiting
15%
Arthralgia
15%
Cataract
14%
Headache
12%
Visual acuity reduced
11%
Aspartate aminotransferase increased
11%
Neutropenia
10%
Anaemia
9%
Peripheral sensory neuropathy
9%
Eye pain
9%
Myalgia
9%
Back pain
9%
Alanine aminotransferase increased
9%
Weight decreased
8%
Cough
7%
Thrombocytopenia
7%
Pneumonitis
7%
Urinary tract infection
6%
Gastrooesophageal reflux disease
6%
Pain in extremity
6%
Abdominal distension
6%
Hypokalaemia
6%
COVID-19
6%
Pyrexia
6%
Insomnia
6%
Dyspnoea
5%
Dysgeusia
5%
Paraesthesia
5%
Hypertension
5%
Abdominal pain upper
5%
Vitreous floaters
4%
Oedema peripheral
4%
Hypomagnesaemia
3%
Rash
3%
Stomatitis
3%
Pleural effusion
3%
Ascites
2%
White blood cell count decreased
2%
Epistaxis
2%
Small intestinal obstruction
2%
Intestinal obstruction
1%
Dry skin
1%
General physical health deterioration
1%
Nail disorder
1%
Alopecia
1%
Leukopenia
1%
Clostridium difficile colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Mirvetuximab Soravtansine
Investigator's Choice (IC) Chemotherapy
Awards & Highlights
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.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Mirvetuximab SoravtansineExperimental Treatment1 Intervention
Participants will receive single-agent mirvetuximab soravtansine (MIRV) at 6 milligrams (mg)/kilogram (kg) adjusted ideal body weight (AIBW) administered intravenously (IV) on Day 1 of every 3-week cycle (Q3W).
Group II: Investigator's Choice (IC) ChemotherapyActive Control3 Interventions
Participants will receive a dose of IC chemotherapeutic agent calculated using body surface area (BSA). Paclitaxel administered at 80 milligrams/square meter (mg/m\^2) as a 1-hour IV infusion on Days 1, 8, 15, and 22 of a 4-week cycle; or topotecan administered at 4 mg/m\^2 over 30 minutes on Days 1, 8, and 15 of a 4-week cycle. Alternatively, topotecan could be administered at 1.25 mg/m\^2 over 30 minutes on Days 1 to 5 of a 3-week cycle; or pegylated liposomal doxorubicin administered at 40 mg/m\^2 as a 1 mg/minute IV infusion on Day 1 of a 4-week cycle. After Cycle 1, if tolerated, pegylated liposomal doxorubicin could be administered as a 1-hour infusion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mirvetuximab Soravtansine
2017
Completed Phase 3
~730
Find a Location
Closest Location:Columbus NCORP· Columbus, OH· 1 miles
Who is running the clinical trial?
AbbVieLead Sponsor
1,068 Previous Clinical Trials
531,782 Total Patients Enrolled
7 Trials studying Ovarian Cancer
1,779 Patients Enrolled for Ovarian Cancer
ImmunoGen, Inc.Lead Sponsor
32 Previous Clinical Trials
3,568 Total Patients Enrolled
4 Trials studying Ovarian Cancer
960 Patients Enrolled for Ovarian Cancer
Gynecologic Oncology GroupNETWORK
250 Previous Clinical Trials
64,926 Total Patients Enrolled
50 Trials studying Ovarian Cancer
8,307 Patients Enrolled for Ovarian Cancer
European Network of Gynaecological Oncological Trial Groups (ENGOT)OTHER
40 Previous Clinical Trials
18,700 Total Patients Enrolled
12 Trials studying Ovarian Cancer
5,787 Patients Enrolled for Ovarian Cancer
ABBVIE INC.Study DirectorAbbVie
481 Previous Clinical Trials
169,665 Total Patients Enrolled
1 Trials studying Ovarian Cancer
79 Patients Enrolled for Ovarian Cancer
Graham Walker, MBChB, MBA DICStudy DirectorAbbVie
Michael Method, MPH, MBAStudy DirectorImmunoGen, Inc.
1 Previous Clinical Trials
106 Total Patients Enrolled
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: Mirvetuximab Soravtansine
- Group 2: Investigator's Choice (IC) Chemotherapy
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.