What side effects are associated with this type of intervention?

Common treatments for ovarian cancer, including antibody-drug conjugates like Mirvetuximab Soravtansine, often target specific cancer cell markers such as folate receptor-alpha. These treatments can cause side effects such as fatigue, nausea, vomiting, and anemia. Other targeted therapies and chemotherapies, like carboplatin and paclitaxel, may also lead to neuropathy, hair loss, and increased risk of infection. It's important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

Mirvetuximab Soravtansine is an Antibody-Drug Conjugate (ADC) targeting folate receptor-alpha, currently being studied for ovarian cancer. Similar FDA-approved treatments include Bevacizumab, a monoclonal antibody targeting VEGF, used in combination with chemotherapy for advanced ovarian cancer. Additionally, PARP inhibitors like Olaparib, Niraparib, and Rucaparib have been approved for maintenance therapy in patients with recurrent, platinum-sensitive ovarian cancer, particularly those with BRCA mutations. These treatments represent significant advancements in targeted therapy for ovarian cancer.

What other types of research exist?

Promising novel alternatives to Mirvetuximab Soravtansine for ovarian cancer patients include: 1) Olaparib, a PARP inhibitor, which has shown efficacy as maintenance therapy in platinum-sensitive relapsed disease, particularly in patients with BRCA mutations. 2) Niraparib, another PARP inhibitor, which has demonstrated benefits in progression-free survival for patients with platinum-sensitive ovarian cancer. 3) Rucaparib, also a PARP inhibitor, effective as both maintenance therapy and monotherapy for recurrent, platinum-sensitive ovarian cancer. These alternatives offer targeted approaches that have shown significant clinical benefits.

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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

Must not have

Patients with a history of other malignancy within 3 years prior to enrollment

Patients with a history of cirrhotic liver disease (Child-Pugh Class B or C)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests Mirvetuximab Soravtansine, a treatment that targets and kills specific cancer cells, in patients with certain recurrent ovarian, primary peritoneal, or fallopian tube cancers. It works by using an antibody to deliver a cancer-killing drug directly to the cancer cells. Mirvetuximab Soravtansine has shown promise in treating certain types of ovarian cancer.

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.

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.

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.

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had any other cancer in the last 3 years.

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I have severe liver disease.

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I have previously been treated with MIRV or drugs targeting FRα.

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

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My ovarian cancer is of a specific type, such as endometrioid or clear cell.

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I have ongoing eye problems like uncontrolled glaucoma or need treatments for my eyes.

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

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I have been diagnosed with a non-infectious lung condition.

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I am not pregnant or breastfeeding.

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

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

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

Assess Objective Response Rate

Secondary study objectives

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%

Visual acuity reduced

21%

Asthenia

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

Insomnia

Back pain

Myalgia

Blood alkaline phosphatase increased

Hypertension

Weight decreased

Neutropenia

Dizziness

Hypokalaemia

Dyspepsia

Anxiety

Paraesthesia

Hypoalbuminaemia

Abdominal pain upper

Gastrooesophageal reflux disease

Pain in extremity

Nasopharyngitis

Dry mouth

Pruritus

Pneumonitis

Hyperglycaemia

Vitreous floaters

Muscular weakness

Musculoskeletal pain

Upper respiratory tract infection

Nasal congestion

Neurotoxicity

Dehydration

Intestinal obstruction

Abdominal pain lower

Stomatitis

Ascites

Visual impairment

Leukopenia

Rash

Foreign body sensation in eyes

Hyponatraemia

Non-cardiac chest pain

Tachycardia

Epistaxis

Oedema peripheral

Cystitis

Erythema

Flushing

Haematuria

Gamma-glutamyltransferase increased

Abdominal discomfort

Flatulence

Keratitis

Eye irritation

Infusion related reaction

Lymphopenia

Alopecia

Chills

Dysphonia

Productive cough

Blood creatinine increased

Weight increased

Fall

Peripheral swelling

Lacrimation increased

Corneal deposits

Hypoaesthesia

Influenza

Conjunctivitis

Dry skin

Hot flush

Pollakiuria

Dysuria

Micturition urgency

Urinary incontinence

Depression

Tinnitus

Vaginal haemorrhage

Sciatica

Transaminases increased

Intraocular pressure increased

Pleural effusion

Small intestinal obstruction

Large intestinal obstruction

Influenza like illness

Malaise

Pain

Respiratory tract infection

Pharyngitis

Eye pruritus

Ocular discomfort

Punctate keratitis

Hypophosphataemia

Hyperuricaemia

Hypocalcaemia

Oropharyngeal pain

Flank pain

Blood bilirubin increased

Tremor

Hyperbilirubinaemia

Rectal haemorrhage

Mobility decreased

Musculoskeletal chest pain

Cardiac arrest

Presyncope

Activated partial thromboplastin time prolonged

Haematoma

Deep vein thrombosis

Retching

Gingival bleeding

Odynophagia

Cyst

General physical health deterioration

Mucosal inflammation

Glaucoma

Photopsia

Uveitis

Chalazion

Conjunctival haemorrhage

Conjunctival hyperaemia

Lacrimation decreased

Metamorphopsia

Xerophthalmia

Peripheral motor neuropathy

Neck pain

Arthritis

Musculoskeletal stiffness

Pneumonia

Sinusitis

Cellulitis

Gingivitis

Oral herpes

Viral upper respiratory tract infection

Leukocytosis

Embolism

Urinary retention

Disturbance in attention

Lethargy

Groin pain

Depressed mood

Dyspareunia

Pelvic pain

Laceration

Bone pain

Ligament sprain

Pulmonary embolism

Agitation

Proteinuria

Ear pain

Sepsis

Syncope

Balance disorder

Neuralgia

Dyspnoea exertional

Lung disorder

Palpitations

Hyperhidrosis

Sinus tachycardia

Pleuritic pain

Rhinorrhoea

Hepatic enzyme increased

Urine leukocyte esterase positive

Contusion

Urinary tract obstruction

Vertigo

Ocular hyperaemia

Chest discomfort

Adverse drug reaction

Chest pain

Herpes zoster

Hepatotoxicity

Gastroenteritis

Ear infection

Injection site bruising

Blepharitis

Diplopia

Asthenopia

Hypercalcaemia

Sinus congestion

Photosensitivity reaction

Night sweats

Petechiae

Rash maculo-papular

Vulvovaginal pain

Vulvovaginal pruritus

Aphthous ulcer

100%

80%

60%

40%

20%

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.

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

0 / 20Eligibility criteria met

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 BRCA1-Del ex9-12.Promising novel therapies for the treatment of endometrial cancer.