RECRUITING

Brodalumab in the Treatment of Immune-Related Adverse Events

Conditions

Breast Cancer Esophageal Cancer Kidney Cancer Lung Cancer Thyroid Cancer Gynecologic Cancer Pancreatic Cancer Stomach Cancer Brain Tumor Colon Cancer Rectal Cancer Head and Neck Cancer Oral Cancer Liver Cancer Skin Cancer Prostate Cancer Testicular Cancer Solid Tumor

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to test the safety and effectiveness of using brodalumab in patients who develop side effects from cancer immune therapy. Immune-related side effects are due to activation of the immune system in patients who previously received immunotherapy and the goal of this study is to help better control these side effects. Brodalumab is often used to treat patients with autoimmune diseases (diseases where the immune system is activated against normal organs) and safe doses and treatment schedules have been determined in these patients. Immune-related side effects appear to closely mirror these autoimmune conditions. Brodalumab has not been approved by the United States Food and Drug Administration (FDA) for use in immunotherapy side effects but it has been approved for treatment of autoimmune conditions.

Official Title

Safety and Efficacy of Brodalumab in the Treatment of Immune-Related Adverse Events: a Pilot Study

Quick Facts

Study Start:2024-11

Study Completion:2026-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06673329

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Ability to provide written informed consent by subject or guardian * Individuals \>18 years of age * Diagnosis of an irAE clinically suspected to be IL-17 mediated * Intent-to-treat or prior treatment with systemic steroids for irAE management * Histology-proven primary advanced or metastatic solid organ malignancy treated with immunotherapy. Patients being treated with curative intent are not eligible to enroll. * Subject has a negative test for tuberculosis during screening defined as either: negative purified protein derivative (PPD) (\< 5 mm of induration at 48 to 72 hours after test is placed) OR negative QuantiFERON test. Tuberculosis testing must be performed within 30 days prior to trial initiation. * Subjects with a positive PPD and a history of Bacillus Calmette-Guérin vaccination are allowed with a negative QuantiFERON test. * Subjects with a positive PPD test (without a history of Bacillus Calmette-Guérin vaccination) or subjects with a positive or indeterminate QuantiFERON test are allowed if they have all of the following: no symptoms of tuberculosis (defined as fever, shortness of breath, cough or night sweats), documented history of a completed course of adequate prophylaxis (per local standard of care), no known exposure to a case of active tuberculosis after most recent prophylaxis, no evidence of active tuberculosis on chest radiograph within 3 months prior to the first dose of brodalumab.	* Estimated creatinine clearance \< 40 mg/min * Active suicidal ideation or severe depression (as defined by the Diagnostic and Statistical Manual of Mental Disorders Version IV criteria (DSM-IV)) at the time of enrollment or a PHQ-9 score \> 20 * History of prior suicide attempts * PHQ-9 score greater \>5 and \< 20 without an established mental health provider who verifies stability in their depression * Current or prior drug or alcohol abuse within the past 6 months (as defined by the DSM IV) * In the opinion of the investigator, the patient requires additional immunosuppressive treatment (other than corticosteroids and brodalumab) * Known hypersensitivity or contraindication to brodalumab, corticosteroids or any components of brodalumab * Prior treatment with brodalumab * Pregnancy, breastfeeding, or use of a nonreliable method of contraception * For patients assigned female at birth: lack of willingness to use highly effective methods of birth control during treatment and for at least 4 weeks after the last dose of brodalumab (except if surgically sterile or at least 2 years postmenopausal, with postmenopausal status confirmed by FSH in the postmenopausal range). * Highly effective methods of birth control include: use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. Oral contraceptive pills must be supplemented by a barrier method. * Patients planning to become pregnant while enrolled in the study and within 4 weeks after the last dose of brodalumab will not be permitted to enroll * Chronic or current severe infection requiring IV therapy * Evidence of active hepatitis B, C, or tuberculosis. * History of latent tuberculosis infection which is incompletely treated based upon local standard of care or which was never treated * History of or active Crohn's disease. * Myocardial infarction, unstable angina pectoris or stroke within the past 12 months prior to the first investigational product dose * Any concurrent medical condition or electrocardiogram (ECG) abnormality that, in the opinion of the investigator, could cause this study to be detrimental to the subject. * Any medical condition or treatment for a condition that, in the opinion of the investigator, might interfere with participation in the study or affect the reliability of clinician assessment or patient self-report * Other known clinically significant active medical conditions, such as: * Severe cardiovascular disease, including advanced heart failure (American Heart Association Stage D) * Aspartate aminotransferase (AST) and or alanine aminotransferase (ALT) greater than 2 times the upper limit of normal or greater than 3 times the upper limit of normal in patients with liver metastases measured on at least two separate occasions * Direct bilirubin greater than or equal to 1.5 mg/dL in patients with or without liver metastases * Bone marrow insufficiency unrelated to the irAE (according to investigator judgment) with White Blood Cell (WBC) \<2000/mm3, absolute neutrophil count \<1500/ mm3, thrombocytopenia (platelet count) \<50,000/mm3, hemoglobin \< 8.0 g/dL * Plan to proceed with further curative intent treatment for cancer at the time of enrollment despite the presence of irAE * Participation in another therapeutic clinical trial and receipt of investigational drugs within 4 weeks before the screening visit * Previous diagnosis of an autoimmune disease or administration of immunosuppressants in a time frame that would impede interpretation of brodalumab administration * Planned use of immunosuppressive agents other than steroids (including infliximab, vedolizumab, tocilizumab etc.) or administration of such agents within 28 days of trial initiation * Administration of live-virus vaccines within 4 weeks before the first dose of brodalumab

Inclusion Criteria

Exclusion Criteria

* Ability to provide written informed consent by subject or guardian
* Individuals \>18 years of age
* Diagnosis of an irAE clinically suspected to be IL-17 mediated
* Intent-to-treat or prior treatment with systemic steroids for irAE management
* Histology-proven primary advanced or metastatic solid organ malignancy treated with immunotherapy. Patients being treated with curative intent are not eligible to enroll.
* Subject has a negative test for tuberculosis during screening defined as either: negative purified protein derivative (PPD) (\< 5 mm of induration at 48 to 72 hours after test is placed) OR negative QuantiFERON test. Tuberculosis testing must be performed within 30 days prior to trial initiation.
* Subjects with a positive PPD and a history of Bacillus Calmette-Guérin vaccination are allowed with a negative QuantiFERON test.
* Subjects with a positive PPD test (without a history of Bacillus Calmette-Guérin vaccination) or subjects with a positive or indeterminate QuantiFERON test are allowed if they have all of the following: no symptoms of tuberculosis (defined as fever, shortness of breath, cough or night sweats), documented history of a completed course of adequate prophylaxis (per local standard of care), no known exposure to a case of active tuberculosis after most recent prophylaxis, no evidence of active tuberculosis on chest radiograph within 3 months prior to the first dose of brodalumab.

* Estimated creatinine clearance \< 40 mg/min
* Active suicidal ideation or severe depression (as defined by the Diagnostic and Statistical Manual of Mental Disorders Version IV criteria (DSM-IV)) at the time of enrollment or a PHQ-9 score \> 20
* History of prior suicide attempts
* PHQ-9 score greater \>5 and \< 20 without an established mental health provider who verifies stability in their depression
* Current or prior drug or alcohol abuse within the past 6 months (as defined by the DSM IV)
* In the opinion of the investigator, the patient requires additional immunosuppressive treatment (other than corticosteroids and brodalumab)
* Known hypersensitivity or contraindication to brodalumab, corticosteroids or any components of brodalumab
* Prior treatment with brodalumab
* Pregnancy, breastfeeding, or use of a nonreliable method of contraception
* For patients assigned female at birth: lack of willingness to use highly effective methods of birth control during treatment and for at least 4 weeks after the last dose of brodalumab (except if surgically sterile or at least 2 years postmenopausal, with postmenopausal status confirmed by FSH in the postmenopausal range).
* Highly effective methods of birth control include: use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. Oral contraceptive pills must be supplemented by a barrier method.
* Patients planning to become pregnant while enrolled in the study and within 4 weeks after the last dose of brodalumab will not be permitted to enroll
* Chronic or current severe infection requiring IV therapy
* Evidence of active hepatitis B, C, or tuberculosis.
* History of latent tuberculosis infection which is incompletely treated based upon local standard of care or which was never treated
* History of or active Crohn's disease.
* Myocardial infarction, unstable angina pectoris or stroke within the past 12 months prior to the first investigational product dose
* Any concurrent medical condition or electrocardiogram (ECG) abnormality that, in the opinion of the investigator, could cause this study to be detrimental to the subject.
* Any medical condition or treatment for a condition that, in the opinion of the investigator, might interfere with participation in the study or affect the reliability of clinician assessment or patient self-report
* Other known clinically significant active medical conditions, such as:
* Severe cardiovascular disease, including advanced heart failure (American Heart Association Stage D)
* Aspartate aminotransferase (AST) and or alanine aminotransferase (ALT) greater than 2 times the upper limit of normal or greater than 3 times the upper limit of normal in patients with liver metastases measured on at least two separate occasions
* Direct bilirubin greater than or equal to 1.5 mg/dL in patients with or without liver metastases
* Bone marrow insufficiency unrelated to the irAE (according to investigator judgment) with White Blood Cell (WBC) \<2000/mm3, absolute neutrophil count \<1500/ mm3, thrombocytopenia (platelet count) \<50,000/mm3, hemoglobin \< 8.0 g/dL
* Plan to proceed with further curative intent treatment for cancer at the time of enrollment despite the presence of irAE
* Participation in another therapeutic clinical trial and receipt of investigational drugs within 4 weeks before the screening visit
* Previous diagnosis of an autoimmune disease or administration of immunosuppressants in a time frame that would impede interpretation of brodalumab administration
* Planned use of immunosuppressive agents other than steroids (including infliximab, vedolizumab, tocilizumab etc.) or administration of such agents within 28 days of trial initiation
* Administration of live-virus vaccines within 4 weeks before the first dose of brodalumab

Contacts and Locations

Study Contact

Research Nurse Navigator

CONTACT

212-342-5162

cancerclinicaltrials@cumc.columbia.edu

Principal Investigator

Brian Henick, MD

PRINCIPAL_INVESTIGATOR

Columbia University

Study Locations (Sites)

Columbia University Irving Medical Center

New York, New York, 10032

United States

Collaborators and Investigators

Sponsor: Brian Henick, MD

Brian Henick, MD, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11

Study Completion Date2026-11

Study Record Updates

Study Start Date2024-11

Study Completion Date2026-11

Terms related to this study

Additional Relevant MeSH Terms

Breast Cancer
Esophageal Cancer
Kidney Cancer
Lung Cancer
Thyroid Cancer
Gynecologic Cancer
Pancreatic Cancer
Stomach Cancer
Brain Tumor
Colon Cancer
Rectal Cancer
Head and Neck Cancer
Oral Cancer
Liver Cancer
Skin Cancer
Prostate Cancer
Testicular Cancer
Solid Tumor