← Back to Search

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

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.

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.

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.

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 below

Select...

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.

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.

Select...

I have a serious heart condition.

Select...

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

Select...

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

Select...

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

Select...

I do not have any serious illnesses or active infections.

Select...

I have a history of liver cirrhosis.

Select...

I have had radiotherapy that affected a significant part of my bone marrow.

Select...

I am not pregnant or breastfeeding.

Select...

I have ongoing eye problems or have had a cornea transplant.

Select...

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

Select...

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

Select...

I am not under any form of detention, involuntary psychiatric care, legal protection, or guardianship that prevents me from consenting.

Select...

My cancer did not respond to initial platinum-based chemotherapy.

Select...

I have been diagnosed with a type of lung disease that is not caused by an infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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

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 more

Other study objectives

Identification of soluble FRα levels and other biomarkers

Immunogenicity

Patient-reported outcomes using EORTC QLQ-C30 questionnaires

+3 more

Side effects data

From 2022 Phase 3 trial • 106 Patients • NCT04296890

46%

Vision blurred

39%

Nausea

32%

Keratopathy

31%

Diarrhoea

30%

Fatigue

30%

Constipation

28%

Dry eye

25%

Abdominal pain

21%

Asthenia

20%

Cataract

19%

Vomiting

19%

Decreased appetite

18%

Neuropathy peripheral

16%

Arthralgia

16%

Photophobia

15%

Aspartate aminotransferase increased

15%

Neutropenia

13%

Anaemia

12%

Gamma-glutamyltransferase increased

12%

Abdominal distension

12%

Abdominal pain upper

11%

Alanine aminotransferase increased

11%

Blood alkaline phosphatase increased

10%

Dyspnoea

10%

Hypokalaemia

10%

Hypomagnesaemia

10%

Myalgia

Headache

Urinary tract infection

Thrombocytopenia

Punctate keratitis

Gastrooesophageal reflux disease

Dysgeusia

Eye pain

Pneumonitis

Back pain

Cough

Erythema

Ascites

Dyspepsia

Weight decreased

Pain in extremity

Oedema peripheral

Small intestinal obstruction

Pleural effusion

Large intestinal obstruction

Intestinal obstruction

Colitis microscopic

Malaise

Atrial fibrillation

Peripheral sensory neuropathy

Disease progression

Cholestasis

Pyrexia

Respiratory failure

Oesophagitis

Infusion related reaction

Cholecystitis acute

Peritonitis bacterial

Intestinal perforation

Cholecystitis

Brain stem syndrome

Intestinal haemorrhage

Hepatitis

Device related infection

General physical health deterioration

Ankle fracture

Clostridium difficile infection

Substance-induced psychotic disorder

Severe protein calorie malnutrition

Vasculitis

Basal cell carcinoma

Administration site extravasation

100%

80%

60%

40%

20%

Study treatment Arm

Mirvetuximab Soravtansine

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

~250

0 / 21Eligibility criteria met