Actively Recruiting
Brodalumab in the Treatment of Immune-Related Adverse Events
Led by Brian Henick, MD · Updated on 2026-05-13
11
Participants Needed
1
Research Sites
137 weeks
Total Duration
On this page
Sponsors
B
Brian Henick, MD
Lead Sponsor
B
Bausch Health Americas, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Brodalumab in the Treatment of Immune-Related Adverse Events
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to provide written informed consent
- Age over 18 years
- Diagnosis of an immune-related adverse event suspected to be mediated by IL-17
- Intent to treat or prior treatment with systemic steroids for immune-related adverse event management
- Histology-proven advanced or metastatic solid organ cancer treated with immunotherapy (no curative intent treatment)
- Negative tuberculosis test within 30 days before starting the trial (negative PPD or QuantiFERON test)
- Patients with positive PPD but negative QuantiFERON test allowed if history of BCG vaccination
- Patients with positive PPD or indeterminate QuantiFERON test allowed if no tuberculosis symptoms, completed prophylaxis, no recent exposure, and no active tuberculosis on chest X-ray within 3 months prior to brodalumab
You will not qualify if you...
- Estimated creatinine clearance less than 40 mg/min
- Active suicidal thoughts or severe depression at enrollment or PHQ-9 score greater than 20
- History of prior suicide attempts
- PHQ-9 score between 6 and 19 without stable mental health care
- Drug or alcohol abuse within past 6 months
- Need for additional immunosuppressive treatment other than corticosteroids and brodalumab
- Known allergy or contraindication to brodalumab or corticosteroids
- Prior treatment with brodalumab
- Pregnancy, breastfeeding, or unwillingness to use effective contraception during and 4 weeks after treatment
- Severe or chronic infections requiring IV therapy
- Active hepatitis B, C, or tuberculosis
- Incomplete or untreated latent tuberculosis
- History or active Crohn's disease
- Heart attack, unstable angina, or stroke within past 12 months
- Other medical conditions judged unsafe by investigator including severe cardiovascular disease, significant liver enzyme elevations, bone marrow insufficiency
- Planned curative cancer treatment despite immune-related adverse event
- Participation in other therapeutic trials with investigational drugs within 4 weeks
- Prior autoimmune disease or recent immunosuppressant use that interferes with brodalumab
- Planned or recent use of immunosuppressive agents other than steroids
- Live-virus vaccines within 4 weeks before first dose of brodalumab
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
Research Team
R
Research Nurse Navigator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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