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.
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
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
Single group
Brodalumab
DrugBrodalumab 210 mg subcutaneous injection
CT scan
RadiationCT scans within 4 weeks of starting brodalumab and every 3 months during the study for tumor assessment
Number of Adverse Events
The number of adverse events of each grade that occur and the number of adverse events attributed to brodalumab, as per the Common Terminology Criteria for Adverse Events version 5 (CTCAE v5).
Percentage of primary Immune-Related Adverse Event (irAE) severity decreased
The percentage of patients whose primary irAE severity decreased by \>1 grade per CTCAE criteria from study completion to treatment discontinuation.
Percentage net decrease in the average steroid dose required for irAE management
The percentage of patients with a net decrease in the average steroid dose required for irAE management (defined by the ratio of the average steroid dose in prednisone equivalents over the 7 days following enrollment compared to the average dose in the 7 days prior to study completion).
Proportion of Patients Successfully Tapered Off Steroids
The proportion of patients who can be tapered completely off of steroids (and remain off for a minimum of 1 week).
Mean Time to Complete Resolution of irAE Symptoms
Mean time to complete resolution of irAE clinical manifestation ((as defined as absence of signs/symptoms consistent with the irAE or return to baseline symptoms prior to irAE development)).
Change in Tumor Burden Assessed by RECIST Criteria at 24 Weeks
Change in tumor burden as measured by RECIST criteria comparing CT/MRI scan at the time of enrollment to CT/MRI scan at 24 weeks.
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Brian Henick, MD
Lead sponsor
Columbia University
Sponsor institution
Bausch Health Americas, Inc.
Collaborator
