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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04552288
Recruitment Status : Recruiting
First Posted : September 17, 2020
Last Update Posted : October 28, 2021
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment Phase
Solid Tumor Solid Carcinoma Solid Tumor, Adult Hematologic Malignancy Drug: Benralizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of IL-5-receptor-alpha-chain (IL-5Rα) Inhibition With Benralizumab for Eosinophil-Related Cutaneous Adverse Events in Cancer Patients
Actual Study Start Date : September 16, 2020
Estimated Primary Completion Date : March 16, 2022
Estimated Study Completion Date : March 16, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Participants with eosinophil-related cutaneous events
Study participants will have grade 2/3 eosinophil-related cutaneous adverse events
Drug: Benralizumab
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.




Primary Outcome Measures :
  1. Percent reduction in CTCAE grade 2/3 eosinophil-related cutaneous adverse events [ Time Frame: 4 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have pathologically or cytologically confirmed solid or hematologic cancers.
  • Female and male aged 18 to 85 years, inclusively, at the time of Week 0/Day 1 of treatment.
  • Patients must have a cancer 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.
  • 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 involvement of their cancer)
    • Serum creatinine ≤ 1.8 xULN or calculated creatinine clearance >45 ml/min
    • Platelet count > 50 K/mcL , hemoglobin (Hb) > 8 g/dL, absolute neutrophil count (ANC) >1.0 K/mcL. Blood transfusion to meet the inclusion criteria will not be allowed.
  • ECOG performance status 0-1 (see Appendix C).
  • Subjects must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure.
  • Female patients are authorized to participate if they meet the following criteria:

    • Women of child bearing potential must meet both of the following conditions:
    • Have a negative serum pregnancy test prior to enrollment and within 14 days prior to administration of the investigational product (IP).
    • Patient must use an effective form of birth control (confirmed by the Investigator) throughout the study duration and within 16 weeks after last dose of IP.
    • Female subjects who cannot bear children as evidenced by one or more of the following:
    • Bilateral Oophorectomy
    • Bilateral Salpingectomy
    • Bilateral Salpingectomy-Oophorectomy
    • Hysterectomy
    • Menopause (no menses ≥ 1 year prior to treatment)
    • Surgical Sterilization (i.e., tubal ligation or blockage) Note: If criteria not met, patient should be regarded as having child bearing potential
  • Subject must be able to receive a subcutaneous injection.
  • New/worsening ercAE within 90 days prior to study enrollment. Note: This assessment will be performed by the treating investigator.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04552288


Contacts
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Contact: Mario E. Lacouture, MD 646-608-2337 LacoutuM@mskcc.org
Contact: Alina Markova, MD 646-608-2342 markovaa@mskcc.org

Locations
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United States, New Jersey
Memoral Sloan Kettering Cancer Center Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Mario Lacouture, MD    646-608-2337      
United States, New York
Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities) Recruiting
Commack, New York, United States, 11725
Contact: Mario Lacouture, MD    646-608-2337      
Memorial Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Mario Lacouture, MD    646-608-2337      
Memorial Sloan Kettering Cancer Center Suffolk - Hauppauge (Limited Protocol Activities) Recruiting
Hauppauge, New York, United States, 11788
Contact: Mario Lacouture, MD    646-608-2337      
Memorial Sloan Kettering Cancer Center (All Protocol Activities) Recruiting
New York, New York, United States, 10065
Contact: Mario E. Lacouture,, MD    646-608-2337      
Contact: E. Nelson         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Mario E. Lacouture, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04552288    
Other Study ID Numbers: 20-344
First Posted: September 17, 2020    Key Record Dates
Last Update Posted: October 28, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Benralizumab
hematologic cancer
solid cancer
20-344
Memorial Sloan Kettering Cancer Center
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms
Neoplasms by Site
Hematologic Diseases
Benralizumab
Anti-Asthmatic Agents
Respiratory System Agents