Benralizumab for Cancer-related Skin Side Effects

Recruiting at 5 trial locations

Overseen By Alina Markova, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must be taking: Immunotherapies, Targeted therapies

Must not be taking: Prednisone, Anti-IL-5 agents

Disqualifiers: HIV, Hepatitis B/C, Anaphylaxis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

51 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if benralizumab (Fasenra) can safely reduce skin side effects from cancer treatments by lowering eosinophil levels (a type of white blood cell) in the blood. The goal is to improve quality of life and help participants continue their cancer treatment. Suitable candidates have cancer and experience moderate to severe skin reactions, such as rashes or itching, due to their treatment. Participants should plan to continue their current cancer therapy. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to potentially enhance their treatment experience.

Will I have to stop taking my current medications?

The trial requires that cancer patients continue their current cancer treatment medications. If you are using medications for skin rash or itching, you should continue using them for the study duration. However, you cannot start any new medications for these conditions during the trial.

Is there any evidence suggesting that benralizumab is likely to be safe for humans?

Research has shown that benralizumab is generally well-tolerated. Common side effects include headaches and sore throats, occurring in more than 5% of patients. Some individuals might also experience injection site reactions, such as redness or itching. Other studies noted headaches and increased levels of a certain enzyme in the blood in about 32% of patients.

Serious allergic reactions, including anaphylaxis and angioedema, can occur. These are rare but potentially dangerous and require immediate medical attention. The FDA has approved benralizumab for other conditions, indicating a known safety profile. This approval provides some reassurance about its use for skin side effects related to cancer treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Benralizumab is unique because it targets eosinophils, a type of white blood cell involved in certain inflammatory responses, including some skin side effects related to cancer. Most treatments for these skin conditions focus on topical steroids or general anti-inflammatory drugs. What sets benralizumab apart is its ability to specifically reduce eosinophils by blocking the IL-5 receptor, potentially decreasing inflammation more effectively and with fewer side effects. Researchers are excited because this targeted approach could offer a more precise treatment option with quicker results and improved safety compared to existing therapies.

What evidence suggests that benralizumab might be an effective treatment for cancer-related skin side effects?

Research has shown that benralizumab, which participants in this trial will receive, may help reduce skin side effects from cancer treatments. It targets eosinophils, a type of white blood cell that can cause inflammation. Studies have found that benralizumab can help manage skin problems, especially those caused by cancer drugs like alpelisib and enfortumab vedotin. Previous findings suggest that it not only reduces these side effects but also improves patients' overall quality of life. This makes benralizumab a promising option for those experiencing bothersome skin reactions during cancer therapy. ^{1 6 7 8 9}

Who Is on the Research Team?

Alina K Markova, MD, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been treating my skin rash or itchiness with medication for at least a week.

- Surgical Sterilization (i.e., tubal ligation or blockage) Note: If criteria not met, patient should be regarded as having child bearing potential

I have received treatments like ipilimumab or pembrolizumab.

Exclusion Criteria

I have not received any live vaccines in the last 30 days.

I received a vaccine, but it was not within 1 week of any trial treatment.

You have had an allergic reaction in the past to the study medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive benralizumab to reduce eosinophil-related cutaneous adverse events

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Benralizumab

Trial Overview 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.

How Is the Trial Designed?

Group I: Participants with eosinophil-related cutaneous events Experimental Treatment 1 Intervention

Study participants will have grade 2/3 eosinophil-related cutaneous adverse events

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

Sorafenib, a multikinase inhibitor used for treating advanced liver and kidney cancers, has shown significant survival benefits for patients who cannot undergo surgery.

However, it is associated with an increased risk of developing non-melanoma skin cancers, such as squamous cell carcinoma and keratoacanthoma, highlighting the need for regular skin monitoring in patients receiving this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eruptive squamous cell carcinomas with keratoacanthoma-like features in a patient treated with sorafenib. Lynch, MC., Straub, R., Adams, DR.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04552288

Study of Benralizumab in People With Skin Side Effects ... The purpose of this study is to find out whether the study drug benralizumab is a safe treatment that can reduce the skin side effects caused by cancer ...

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2020-07394

Study of Benralizumab in People with Skin Side Effects ... Giving benralizumab may reduce the level of eosinophils in the blood and ultimately reduce the skin side effects which may further improve quality of life and ...

3. aacrjournals.org aacrjournals.org/cancerres/article/84/6_Supplement/3412/740178/Abstract-3412-Benralizumab-for-treatment-of

Abstract 3412: Benralizumab for treatment of eosinophil ... Benralizumab demonstrated favorable safety and efficacy for Grade 2/3 ercAEs from cancer therapies, especially alpelisib and enfortumab vedotin.

4. withpower.com withpower.com/trial/phase-3-hematologic-neoplasms-8-2020-35d9e

Benralizumab for Cancer-related Skin Side Effects Benralizumab is unique because it targets and reduces eosinophils (a type of white blood cell involved in inflammation), which may help manage skin side effects ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10674388/

Safety of Immunomodulatory Systemic Therapies Used in ... 3. Conclusions. Immune-related cutaneous adverse events are a frequent and bothersome complication of ICI therapy. Effective management strategies are needed ...

6. fasenrahcp.com fasenrahcp.com/safety

Safety Profile | FASENRA® (benralizumab) | For HCPs ADVERSE REACTIONS. The most common adverse reactions (incidence ≥ 5%) include headache and pharyngitis. Injection site reactions (eg, pain, erythema, pruritus, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6557265/

Benralizumab for PDGFRA-Negative Hypereosinophilic ... The most common drug-related adverse events, headache and an elevated lactate dehydrogenase level, occurred in 32% of the patients after the ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2024/761070s021lbl.pdf

Reference ID: 5447728 - accessdata.fda.gov The safety data for FASENRA is based on a 48-week, open-label, parallel group ... The most common side effects of FASENRA include headache and sore throat.

9. mayoclinic.org mayoclinic.org/drugs-supplements/benralizumab-subcutaneous-route/description/drg-20406682

Benralizumab (subcutaneous route) - Side effects & dosage This medicine may cause serious allergic reactions, including anaphylaxis and angioedema. These can be life-threatening and require immediate ...