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

Trial Summary

What is the purpose of this trial?

This trial is testing benralizumab, a drug that aims to reduce skin problems caused by cancer treatments. It works by lowering certain cells in the blood that cause these issues. The goal is to improve patients' quality of life and help them continue their cancer therapy.

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.

How does the drug Benralizumab differ from other treatments 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 related to cancer treatments. This mechanism is different from other drugs like Sorafenib and Vemurafenib, which are associated with various skin reactions but do not specifically target eosinophils. ^{1 2 3 4 5}

Research Team

Alina K Markova, MD, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Sorafenib induced acral pigmentation: A new entity. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Development of skin hypopigmentation in a patient with metastatic papillary carcinoma thyroid treated with Sorafenib. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Eruptive squamous cell carcinomas with keratoacanthoma-like features in a patient treated with sorafenib. [2018]

4. India pubmed.ncbi.nlm.nih.gov

Vemurafenib-induced bilateral facial palsy. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Cutaneous toxicities of RAF inhibitors. [2022]