Brodalumab for Immune-Related Side Effects from Cancer Immunotherapy
This study is testing brodalumab to see if it can safely and effectively treat immune-related side effects (irAEs) that can happen after cancer immunotherapy. These side effects occur when your immune system becomes overactive. Brodalumab is a drug already used for autoimmune diseases, which are similar conditions where the immune system attacks healthy parts of the body. We are looking for about 11 adults (18 or older) with advanced or metastatic solid cancers (like breast, esophageal, kidney, lung, or thyroid cancer) who have developed an irAE that doctors suspect is related to IL-17 and are being treated or plan to be treated with steroids for it. The study will measure how many side effects occur and how much the severity of the irAE decreases over 24 weeks. The current status of this study is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll about 11 participants.
- What's involved
- You would receive brodalumab injections for 24 weeks and have CT scans within 4 weeks of starting and every 3 months. You'll have study visits at weeks 0, 1, 2, 4, and then every 4 weeks until week 24, with some visits potentially by telemedicine.
- Compensation
- Not stated in the trial record.
- Follow-up
- After treatment, there will be additional safety follow-up visits at weeks 28 and 36.
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NCT06673329
Brodalumab in the Treatment of Immune-Related Adverse Events
Recruiting
PHASE1Ages 18+InterventionalTreatmentBrian Henick, MDInvestigator-initiated
~11 participants
Updated 2026-05-13 on ClinicalTrials.gov
What's tested:BrodalumabCT scan
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Adverse Events
Measured over Up to 36 weeks
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesNew York1
Study leadership
- Brian Henick, MD · PRINCIPAL_INVESTIGATOR · Columbia University
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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.
Exclusion
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 Follicle-Stimulating Hormone (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
What this trial measures
- Number of Adverse EventsUp to 36 weeks
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 decreased24 weeks
The percentage of patients whose primary irAE severity decreased by \>1 grade per CTCAE criteria from study completion to treatment discontinuation.