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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 below
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I have at least one tumor that can be measured with a scan.
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I am 18 years old or older.
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I am willing to provide a sample of my tumor for testing.
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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 tested for BRCA mutation and received PARP inhibitor therapy if positive.
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I have been diagnosed with high-grade serous ovarian, peritoneal, or fallopian tube cancer.
Select...
My cancer has worsened after my last cancer treatment.
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My tumor is positive for a specific protein according to a special test.
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My cancer returned more than 6 months after my last platinum-based treatment.

Timeline

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

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 more

Side effects data

From 2020 Phase 3 trial • 366 Patients • NCT02631876
54%
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%
Thrombocytopenia
11%
Abdominal distension
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%
Pruritus
5%
Nasopharyngitis
5%
Dry mouth
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%
Tachycardia
3%
Erythema
3%
Epistaxis
3%
Cystitis
3%
Flushing
3%
Oedema peripheral
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%
Conjunctivitis
2%
Hot flush
2%
Dry skin
2%
Dysuria
2%
Influenza
2%
Corneal deposits
2%
Weight increased
2%
Dysphonia
2%
Blood creatinine increased
2%
Micturition urgency
2%
Hypoaesthesia
2%
Pollakiuria
2%
Lacrimation increased
2%
Urinary incontinence
2%
Productive cough
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%
Oral herpes
1%
Mobility decreased
1%
Conjunctival haemorrhage
1%
Tremor
1%
General physical health deterioration
1%
Activated partial thromboplastin time prolonged
1%
Urinary retention
1%
Gingival bleeding
1%
Presyncope
1%
Leukocytosis
1%
Lacrimation decreased
1%
Retching
1%
Xerophthalmia
1%
Viral upper respiratory tract infection
1%
Conjunctival hyperaemia
1%
Cellulitis
1%
Deep vein thrombosis
1%
Pneumonia
1%
Odynophagia
1%
Neck pain
1%
Hyperbilirubinaemia
1%
Glaucoma
1%
Chalazion
1%
Peripheral motor neuropathy
1%
Embolism
1%
Photopsia
1%
Uveitis
1%
Arthritis
1%
Blood bilirubin increased
1%
Sinusitis
1%
Metamorphopsia
1%
Musculoskeletal chest pain
1%
Haematoma
1%
Cyst
1%
Musculoskeletal stiffness
1%
Mucosal inflammation
1%
Gingivitis
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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for ovarian cancer include chemotherapy, PARP inhibitors, and antibody-drug conjugates (ADCs). Chemotherapy agents like paclitaxel and carboplatin work by disrupting cell division, leading to cancer cell death. PARP inhibitors, such as olaparib, target cancer cells with BRCA mutations by preventing DNA repair, causing cell death. Mirvetuximab Soravtansine, an ADC, combines an antibody targeting folate receptor-alpha (overexpressed in ovarian cancer cells) with a cytotoxic drug, delivering the drug directly to cancer cells and minimizing damage to healthy cells. These mechanisms are crucial as they offer targeted and effective treatment options, potentially improving outcomes and reducing side effects for ovarian cancer patients.
Clinical Benefits of Olaparib in Mexican Ovarian Cancer Patients With Founder Mutation <i>BRCA1</i>-Del ex9-12.Promising novel therapies for the treatment of endometrial cancer.

Find a Location

Who is running the clinical trial?

ImmunoGen, Inc.Lead Sponsor
32 Previous Clinical Trials
3,735 Total Patients Enrolled
4 Trials studying Ovarian Cancer
934 Patients Enrolled for Ovarian Cancer

Media Library

Mirvetuximab Soravtansine (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05041257 — Phase 2
Ovarian Cancer Research Study Groups: Mirvetuximab Soravtansine
Ovarian Cancer Clinical Trial 2023: Mirvetuximab Soravtansine Highlights & Side Effects. Trial Name: NCT05041257 — Phase 2
Mirvetuximab Soravtansine (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05041257 — Phase 2
~21 spots leftby Jun 2025