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
Brian Henick, MD
Lead sponsor
Columbia University
Sponsor institution
Bausch Health Americas, Inc.
Collaborator