CompletedPhase 2

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

United States51 participantsStarted 2020-09-16

Plain-language 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.

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients must have pathologically or cytologically confirmed solid or hematologic cancers. OR * 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 Spectrum disorder OR patients receiving immunotherapy and/or targeted therapy, including but not limited to the following agents, will be eligible for inclusion: * 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: * Total bilirubin ≤ 1.5 x the upper limit of normal (ULN) * Alanine aminotransferase (ALT) and aspartate amino-transferase (AST) ≤ 2.5 x ULN (≤ 5 x ULN for subjects with liver involveme…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial used benralizumab to treat skin side effects caused by cancer therapies — specifically eosinophil-related skin reactions graded as moderate to severe — so could you help me understand whether the skin reactions I'm experiencing match that specific type, and whether this drug might be relevant to my situation?
2Since this was a Phase 2 trial and it has already completed, what do the results actually show about how much benralizumab reduced those eosinophil-related skin reactions, and does the evidence look strong enough to influence my treatment plan?
3The trial measured percent reduction in a very specific category of skin side effects — eosinophil-related ones — so how would you test whether my skin reactions are actually caused by eosinophils, and does that distinction change what treatment options are available to me?
4Given that this trial is now completed, is benralizumab being used in clinical practice for cancer therapy-related skin toxicity, or would I need to look at a different study or wait for further research before it could be an option?
5If my skin side effects are being caused by my current cancer therapy, is managing those reactions with something like benralizumab the right priority right now, or would it be better to first consider adjusting or switching my cancer treatment itself?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 4 weeks

Trial details

NCT IDNCT04552288

SponsorMemorial Sloan Kettering Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-19

Results submitted2025-03-17

View on ClinicalTrials.gov More Solid Tumor trials