Actively Recruiting
Safety and Efficacy of Brodalumab in the Treatment of Immune-Related Adverse Events: A Pilot Study
Led by Brian Henick, MD · Updated on 2026-05-13
11
Participants Needed
1
Research Sites
26 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
Researchers are evaluating brodalumab to study its safety and effectiveness in patients who develop immune-related side effects from cancer immunotherapy. These side effects occur when the immune system becomes overactive after immunotherapy treatment. The study focuses on patients with advanced or metastatic solid tumors who experience these side effects, which resemble autoimmune diseases. Brodalumab is currently approved for autoimmune conditions but not yet for treating immune therapy side effects. Participants will receive subcutaneous injections of brodalumab at a dose of 210 mg starting at baseline, then weekly at weeks 1 and 2, followed by injections every two weeks until week 24. Some patients may begin with steroids to manage side effects, with plans to reduce steroid use over 4 to 8 weeks if possible. The study involves blood sample collections and evaluations through telemedicine and face-to-face visits at specific intervals, with additional safety follow-ups at weeks 28 and 36. During the study, participants will be assessed regularly for side effects using scales such as the Columbia Suicide Severity Rating Scale and Patient Health Questionnaire-9. Tumor assessments will be done with CT scans before starting treatment and every three months. Researchers will measure adverse events, steroid use, symptom resolution, tumor changes, and survival outcomes up to 36 weeks. Participants’ health and safety will be closely monitored throughout the trial.
CONDITIONS
Brief 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 18 years or older
- Diagnosed with an immune-related adverse event suspected to be IL-17 mediated
- Intent to treat or prior treatment with systemic steroids for immune-related adverse event management
- Histology-proven advanced or metastatic solid organ malignancy treated with immunotherapy (excluding patients treated with curative intent)
- Negative tuberculosis test within 30 days prior to trial start (negative PPD or QuantiFERON test)
- If positive PPD with Bacillus Calmette-Guérin vaccination history, a negative QuantiFERON test is required
- If positive PPD without vaccination history or positive/indeterminate QuantiFERON, must have no tuberculosis symptoms, completed prophylaxis, no recent exposure, and no active tuberculosis on chest X-ray within 3 months
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 over 20
- History of prior suicide attempts
- PHQ-9 score between greater than 5 and less than 20 without stable mental health provider
- Drug or alcohol abuse within past 6 months
- Need for immunosuppressive treatment other than corticosteroids or brodalumab
- Known allergy or contraindication to brodalumab, corticosteroids, or study components
- Prior treatment with brodalumab
- Pregnancy, breastfeeding, or unwillingness to use highly effective contraception if female at birth
- Severe or current infections requiring intravenous therapy
- Active hepatitis B, C, or tuberculosis
- Untreated or incompletely treated latent tuberculosis
- History of or active Crohn's disease
- Recent myocardial infarction, unstable angina, or stroke within past 12 months
- Severe cardiovascular disease or advanced heart failure
- Elevated liver enzymes or bilirubin beyond specified limits
- Bone marrow insufficiency unrelated to immune side effects
- Plans for further curative cancer treatment at enrollment
- Participation in another therapeutic trial or investigational drug use within 4 weeks
- Prior autoimmune disease diagnosis or recent immunosuppressant use that impedes brodalumab interpretation
- Use of other immunosuppressive agents within 28 days before trial
- Live-virus vaccine administration within 4 weeks before brodalumab start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive subcutaneous brodalumab injections to treat immune-related adverse events. Blood samples are collected at each visit for mechanistic studies. Safety and symptom assessments including the Columbia Suicide Severity Rating Scale and Patient Health Questionnaire-9 are performed at all visits.
Visits at weeks 0, 1, 2, 4, and then every 4 weeks until week 24, using a combination of telemedicine and face-to-face evaluations
Duration - 12 weeks
Additional safety follow-up visits occur after treatment ends to monitor participants' health and any lasting effects.
Visits at weeks 28 and 36
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
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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