Study of Benralizumab in People With Skin Side Effects Caused by Cancer Therapies

NCT04552288 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 1 other identifier: 20-344
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 5

Brief Summary

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 treatment by reducing the level of eosinophils in your blood. Reducing the skin side effects of your cancer treatment may improve quality of life and allow participants to continue to receive their usual cancer treatment.

Conditions

Solid Tumor; Solid Carcinoma; Solid Tumor, Adult; Hematologic Malignancy

Keywords

Benralizumab; hematologic cancer; solid cancer; 20-344; Memorial Sloan Kettering Cancer Center

Outcome Measures

Primary Outcomes (1)

• Percent Reduction in CTCAE Grade 2/3 Eosinophil-related Cutaneous Adverse Events

  To evaluate the percent reduction in CTCAE grade 2/3 eosinophil-related cutaneous adverse events to grade ≤1 resulting from checkpoint inhibitors (CPIs) or targeted therapies with absolute blood eosinophil counts of at least .3 K/mcl.

  4 weeks

Study Arms (1)

Participants with eosinophil-related cutaneous events

EXPERIMENTAL

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

Drug: Benralizumab

Interventions

Benralizumab DRUG

All eligible patients will receive a benralizumab dose of 30 mg SC administered by a healthcare provider once every 4 weeks for the first 3 doses, followed by once every 8 weeks for 3 additional doses.

Participants with eosinophil-related cutaneous events

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have pathologically or cytologically confirmed solid or hematologic cancers.
• Patient is receiving alpelisib for PIK3CA-Related Overgrowth Spectrum disorder.
• Female and male aged 18 to 85 years, inclusively, at the time of Week 0/Day 1 of treatment.
• Patients must have a therapy-related CTCAE grade 2/3 (See Appendix A)cutaneous adverse event defined as any cutaneous reaction listed below and blood eosinophil counts of at least .3 K/mcl.
• Rash maculo-papular
• Bullous dermatitis
• Pruritus
• Urticaria
• Eczema
• Patients must plan to continue on culprit drugs (cancer patients).
• Patients planning to receive alpelisib indicated for PIK3CA-Related Overgrowth
• Immunotherapies: ipilimumab, nivolumab, pembrolizumab, avelumab, durvalumab, atezolizumab tremelimumab.
• Targeted therapies: trastuzumab, pertuzumab, alpelisib, osimertinib, everolimus, temsirolimus, sorafenib, regorafenib.
• Patients using topicals/orals for indication of skin rash/pruritus for at least 7 days should continue using these drugs for the study duration
• Adequate bone marrow, liver and renal function:

You may not qualify if:

• Concurrent use of another investigational drug or device for the ercAE (i.e., outside of study treatment) during, or within 4 weeks of treatment.
• Patients receiving prednisone ≥ 20mg a day.
• Known use of anti-IL-5 agents or biologics for the treatment of asthma which are known to decrease blood eosinophil levels.
• Patients cannot use new topicals or medications for indication of pruritus or skin rash
• Known history of anaphylaxis to biologic therapy.
• A helminthic parasitic infection diagnosed within 24 weeks prior to the first treatment, that had not been treated with, or has failed to respond to, standard of care therapy.
• Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy.
• Active infection that would impair the ability of the patient to receive study treatment.
• Women who are pregnant or breast-feeding.
• Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation.
• Receipt of live attenuated vaccines 30 days prior to the date of randomization
• ° Receipt of inactive/killed vaccinations (e.g., inactive influenza) is allowed provided they were not administered within 1 week before/after any investigational product administration.
• Known history of allergy or reaction to the investigational product formulation

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (5)

Memorial Sloan Kettering Cancer Center

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center Suffolk - Hauppauge (Limited Protocol Activities)

Hauppauge, New York, 11788, United States

Location

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

benralizumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Dr. Alina Markova, MD
• Organization: Memorial Sloan Kettering Cancer Center

markovaa@mskcc.org

646-608-2342

Study Officials

• Alina Markova, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2020
• First Posted: September 17, 2020
• Study Start: September 16, 2020
• Primary Completion: July 19, 2024
• Study Completion (Estimated): March 16, 2027
• Last Updated: April 16, 2026
• Results First Posted: April 29, 2025

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (5)