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Benralizumab for Cancer-related Skin Side Effects

Phase 2
Waitlist Available
Led By Alina Markova, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients using topicals/orals for indication of skin rash/pruritus for at least 7 days should continue using these drugs for the study duration
- Immunotherapies: ipilimumab, nivolumab, pembrolizumab, avelumab, durvalumab, atezolizumab tremelimumab.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

Study Summary

This trial will test whether benralizumab is a safe and effective treatment to reduce skin side effects from cancer treatment.

Who is the study for?
Adults aged 18-85 with blood or solid cancers experiencing grade 2/3 skin side effects from cancer therapies like immunotherapies or targeted therapies, and have a certain level of eosinophils in their blood. They must be able to continue their current cancer treatment, have good organ function, and not be pregnant or breastfeeding. Effective birth control is required for those who can bear children.Check my eligibility
What is being tested?
The trial tests if benralizumab can safely reduce skin side effects caused by cancer treatments by lowering blood eosinophil levels. This could improve life quality and allow patients to maintain their usual cancer therapy regimen.See study design
What are the potential side effects?
Potential side effects are not detailed here but may include reactions similar to other biologic therapies such as allergic responses, injection site reactions, and possible impacts on the immune system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been treating my skin rash or itchiness with medication for at least a week.
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I have received treatments like ipilimumab or pembrolizumab.
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My liver enzymes are within the required range.
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I have a skin reaction from treatment and my blood test shows high eosinophils.
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I am planning to receive or am currently on alpelisib or immunotherapy/targeted therapy for my condition.
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I am currently taking or have taken specific targeted cancer therapies.
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I am taking alpelisib for a growth disorder linked to PIK3CA.
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I am fully active or can carry out light work.
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I can receive shots under my skin.
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My blood counts meet the required levels without transfusions.
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I have had both ovaries and fallopian tubes surgically removed.
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I am a woman who cannot have children.
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I have had a hysterectomy.
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I have had both of my fallopian tubes surgically removed.
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My cancer has been confirmed by lab tests.
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I plan to keep taking my current cancer medication.
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My kidney function, measured by creatinine levels, is within the normal range.
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I have not had a menstrual period for at least one year.
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I have a flat or slightly raised spotted rash.
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I am between 18 and 85 years old.
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My bone marrow, liver, and kidneys are functioning well.
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I am a woman eligible for this trial based on specific criteria.
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I am a woman who can become pregnant and meet specific health conditions.
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I have had both of my ovaries surgically removed.
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I experience severe itching.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent reduction in CTCAE grade 2/3 eosinophil-related cutaneous adverse events

Side effects data

From 2016 Phase 3 trial • 220 Patients • NCT02075255
15%
Nasopharyngitis
8%
Asthma
7%
Sinusitis
7%
Headache
7%
Bronchitis
6%
Upper respiratory tract infection
4%
Influenza
3%
Back pain
3%
Cough
3%
Dyspnoea
3%
Hypertension
3%
Rhinitis
1%
Urosepsis
1%
Nephrolithiasis
1%
Intervertebral disc protrusion
1%
Umbilical hernia
1%
Adverse drug reaction
1%
Hypersensitivity
1%
Vertigo
1%
Nausea
1%
Dermatitis atopic
1%
Urinary tract infection bacterial
100%
80%
60%
40%
20%
0%
Study treatment Arm
Benra 30 mg q.4 Weeks
Placebo
Benra 30 mg q.8 Weeks

Trial Design

1Treatment groups
Experimental Treatment
Group I: Participants with eosinophil-related cutaneous eventsExperimental Treatment1 Intervention
Study participants will have grade 2/3 eosinophil-related cutaneous adverse events
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Benralizumab
2016
Completed Phase 3
~10580

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,927 Previous Clinical Trials
591,357 Total Patients Enrolled
1 Trials studying Blood Cancers
25 Patients Enrolled for Blood Cancers
Alina Markova, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
7 Previous Clinical Trials
797 Total Patients Enrolled
Mario E. Lacouture, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
170 Total Patients Enrolled

Media Library

Benralizumab Clinical Trial Eligibility Overview. Trial Name: NCT04552288 — Phase 2
Benralizumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT04552288 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the eligibility requirements for participating in this research?

"The study's aim is to include 30 individuals that have solid carcinoma and are between 18-85 years old."

Answered by AI

Are there any similar studies to this one that use Benralizumab?

"First researched in 2014 at the National Institutes of Health Clinical Center, Benralizumab has completed 31 studies with 20 more active and ongoing. Most recent research is conducted out of Harrison, New jersey."

Answered by AI

Are there any current openings for this type of trial you're conducting?

"The clinical trial is still recruiting patients, according to the information available on clinicaltrials.gov. The study was originally posted on September 16th, 2020 and was last edited on September 14th, 2020. They are looking for 30 participants at 5 different sites."

Answered by AI

Does this experiment only consider those under 35 years old?

"This study allow for patients that are between 18-85 years old, as long as they meet the other eligibility requirements."

Answered by AI

When was Benralizumab cleared by the FDA?

"Benralizumab is a Phase 2 medication, meaning that while there is some evidence suggesting it is safe, there is no data to support its efficacy."

Answered by AI

Is this study taking place across many hospitals in North America?

"Presently, this trial is being conducted at 5 different locations. While Harrison, Basking Ridge and Hauppauge are the closest to the city, other participating centres are located in 5 additional cities. If you choose to participate in this study, it would be most convenient for you to select a site that is close to your home to cut down on travel time requirements."

Answered by AI

How many individuals are being included in this trial?

"The clinical trial is currently ongoing, as noted by the information available on clinicaltrials.gov. This study was first posted on September 16th 2020 and was last edited 14th September 2022. The research is looking for 30 individuals from 5 different locations."

Answered by AI

Is this study novel in any way?

"Since 2014, Benralizumab has undergone clinical trials. The first one was completed in that same year and sponsored by AstraZeneca. This initial study only had 20 participants. Phase 2 & 3 drug approval was given after the successful completion of the trial. As of now, there are 20 active trials being conducted for Benralizumab in 352 cities across 42 countries."

Answered by AI
~10 spots leftby Mar 2025