Your session is about to expire
← Back to Search
Monoclonal Antibodies
Mirvetuximab for Ovarian Cancer
Phase 2
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 at least 1 lesion that meets the definition of measurable disease by RECIST v1.1 (radiologically measured by the Investigator)
Patients must be ≥ 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
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.
Who is the study for?
This trial is for adults over 18 with high-grade serous ovarian, primary peritoneal, or fallopian tube cancer that's sensitive to platinum-based therapy. They must have had at least two prior platinum treatments (or one if allergic) and show progression after the last treatment. Participants need measurable disease by RECIST v1.1 standards, confirmed FRα positivity, and adequate organ function. Women of childbearing age must use contraception.Check my eligibility
What is being tested?
The PICCOLO study is testing Mirvetuximab Soravtansine as a single-agent treatment in participants with specific types of cancer that express high levels of folate receptor-alpha (FRα). It's an open-label Phase 2 trial focusing on safety and effectiveness in those who've shown sensitivity to platinum-based chemotherapy.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include typical reactions to monoclonal antibodies such as infusion-related reactions, fatigue, digestive issues like nausea or diarrhea, skin rash or itching, low blood counts leading to increased infection risk or bleeding tendencies.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have at least one tumor that can be measured with a scan.
Select...
I am 18 years old or older.
Select...
I am willing to provide a sample of my tumor for testing.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I have been tested for BRCA mutation and received PARP inhibitor therapy if positive.
Select...
I have been diagnosed with high-grade serous ovarian, peritoneal, or fallopian tube cancer.
Select...
My cancer has worsened after my last cancer treatment.
Select...
My tumor is positive for a specific protein according to a special test.
Select...
My cancer returned more than 6 months after my last platinum-based treatment.
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
Assess Objective Response Rate
Secondary outcome measures
Assess Cancer Antigen-125
Assess Duration of response (DOR)
Assess Overall survival (OS)
+3 moreSide effects data
From 2020 Phase 3 trial • 366 Patients • NCT0263187654%
Nausea
44%
Diarrhoea
43%
Vision blurred
34%
Fatigue
33%
Abdominal pain
32%
Keratopathy
28%
Dry eye
26%
Constipation
26%
Vomiting
25%
Decreased appetite
23%
Headache
21%
Asthenia
21%
Visual acuity reduced
20%
Neuropathy peripheral
18%
Aspartate aminotransferase increased
16%
Alanine aminotransferase increased
16%
Cough
16%
Hypomagnesaemia
15%
Cataract
15%
Dyspnoea
15%
Arthralgia
14%
Photophobia
14%
Anaemia
13%
Eye pain
12%
Urinary tract infection
12%
Dysgeusia
11%
Abdominal distension
11%
Thrombocytopenia
10%
Pyrexia
10%
Peripheral sensory neuropathy
10%
Muscle spasms
9%
Insomnia
9%
Back pain
9%
Myalgia
8%
Blood alkaline phosphatase increased
7%
Hypertension
7%
Weight decreased
7%
Neutropenia
7%
Dizziness
7%
Hypokalaemia
7%
Dyspepsia
6%
Anxiety
6%
Paraesthesia
6%
Hypoalbuminaemia
6%
Abdominal pain upper
6%
Gastrooesophageal reflux disease
6%
Pain in extremity
5%
Dry mouth
5%
Nasopharyngitis
5%
Pruritus
5%
Pneumonitis
5%
Hyperglycaemia
5%
Vitreous floaters
5%
Muscular weakness
5%
Musculoskeletal pain
4%
Upper respiratory tract infection
4%
Nasal congestion
4%
Neurotoxicity
4%
Dehydration
4%
Intestinal obstruction
4%
Abdominal pain lower
4%
Stomatitis
4%
Ascites
4%
Visual impairment
4%
Leukopenia
4%
Rash
4%
Foreign body sensation in eyes
4%
Hyponatraemia
4%
Non-cardiac chest pain
3%
Erythema
3%
Oedema peripheral
3%
Tachycardia
3%
Epistaxis
3%
Cystitis
3%
Flushing
3%
Haematuria
3%
Gamma-glutamyltransferase increased
3%
Abdominal discomfort
3%
Flatulence
3%
Keratitis
3%
Eye irritation
3%
Infusion related reaction
3%
Lymphopenia
3%
Alopecia
3%
Chills
2%
Peripheral swelling
2%
Productive cough
2%
Dysuria
2%
Weight increased
2%
Micturition urgency
2%
Hypoaesthesia
2%
Dysphonia
2%
Blood creatinine increased
2%
Influenza
2%
Lacrimation increased
2%
Corneal deposits
2%
Dry skin
2%
Pollakiuria
2%
Conjunctivitis
2%
Urinary incontinence
2%
Hot flush
2%
Depression
2%
Tinnitus
2%
Vaginal haemorrhage
2%
Sciatica
2%
Transaminases increased
2%
Intraocular pressure increased
2%
Pleural effusion
2%
Small intestinal obstruction
2%
Large intestinal obstruction
2%
Influenza like illness
2%
Malaise
2%
Pain
2%
Fall
2%
Respiratory tract infection
2%
Pharyngitis
2%
Eye pruritus
2%
Ocular discomfort
2%
Punctate keratitis
2%
Hypophosphataemia
2%
Hyperuricaemia
2%
Hypocalcaemia
2%
Oropharyngeal pain
2%
Flank pain
1%
Conjunctival haemorrhage
1%
Conjunctival hyperaemia
1%
Presyncope
1%
Gingivitis
1%
Deep vein thrombosis
1%
Gingival bleeding
1%
Lacrimation decreased
1%
Metamorphopsia
1%
Xerophthalmia
1%
Musculoskeletal chest pain
1%
General physical health deterioration
1%
Tremor
1%
Pneumonia
1%
Glaucoma
1%
Chalazion
1%
Peripheral motor neuropathy
1%
Neck pain
1%
Embolism
1%
Leukocytosis
1%
Odynophagia
1%
Photopsia
1%
Uveitis
1%
Mobility decreased
1%
Arthritis
1%
Blood bilirubin increased
1%
Sinusitis
1%
Cellulitis
1%
Oral herpes
1%
Viral upper respiratory tract infection
1%
Mucosal inflammation
1%
Cyst
1%
Retching
1%
Haematoma
1%
Musculoskeletal stiffness
1%
Urinary retention
1%
Hyperbilirubinaemia
1%
Activated partial thromboplastin time prolonged
1%
Cardiac arrest
1%
Disturbance in attention
1%
Lethargy
1%
Groin pain
1%
Depressed mood
1%
Dyspareunia
1%
Pelvic pain
1%
Laceration
1%
Bone pain
1%
Ligament sprain
1%
Pulmonary embolism
1%
Agitation
1%
Proteinuria
1%
Ear pain
1%
Sepsis
1%
Syncope
1%
Balance disorder
1%
Neuralgia
1%
Dyspnoea exertional
1%
Lung disorder
1%
Palpitations
1%
Hyperhidrosis
1%
Sinus tachycardia
1%
Pleuritic pain
1%
Rhinorrhoea
1%
Hepatic enzyme increased
1%
Urine leukocyte esterase positive
1%
Contusion
1%
Urinary tract obstruction
1%
Vertigo
1%
Ocular hyperaemia
1%
Chest discomfort
1%
Adverse drug reaction
1%
Chest pain
1%
Herpes zoster
1%
Hepatotoxicity
1%
Gastroenteritis
1%
Ear infection
1%
Injection site bruising
1%
Blepharitis
1%
Diplopia
1%
Asthenopia
1%
Hypercalcaemia
1%
Sinus congestion
1%
Photosensitivity reaction
1%
Night sweats
1%
Petechiae
1%
Rash maculo-papular
1%
Vulvovaginal pain
1%
Vulvovaginal pruritus
1%
Aphthous ulcer
1%
Rectal haemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Mirvetuximab Soravtansine
Investigator's Choice (IC) Chemotherapy
Trial Design
1Treatment groups
Experimental Treatment
Group I: Mirvetuximab SoravtansineExperimental Treatment1 Intervention
Participants will receive MIRV 6.0 mg/kg adjusted by ideal body weight (AIBW)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mirvetuximab soravtansine
2012
Completed Phase 3
~840
Find a Location
Who is running the clinical trial?
ImmunoGen, Inc.Lead Sponsor
32 Previous Clinical Trials
3,826 Total Patients Enrolled
4 Trials studying Ovarian Cancer
934 Patients Enrolled for Ovarian Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Mirvetuximab Soravtansine
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger