Recruiting

Phase 1

BrodalumabBrodalumab in the Treatment of Immune-Related Adverse Events

Sponsor:

Brian Henick, MD

Code:

NCT06673329

Conditions

Breast Cancer

Esophageal Cancer

Kidney Cancer

Lung Cancer

Thyroid Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Brodalumab

CT scan

Study Details

Brief summary:

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

Breast Cancer

Esophageal Cancer

Kidney Cancer

Lung Cancer

Thyroid Cancer

Study ID

NCT06673329

Start date

Mar 11, 2025

Status verified date

May, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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 Criteria:

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

Study Design

Enrollment

11 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: brodalumab to treat irAEs in patient with solid tumors

Brodalumab 210 mg subcutaneous injection on weeks 0, 1, 2 followed by administration every 2 weeks until week 24

Interventions

Brodalumab

Brodalumab 210 mg subcutaneous injection

CT scan

CT scans within 4 weeks of starting brodalumab and every 3 months during the study for tumor assessment

Primary outcome measure

Number of Adverse Events [ Time Frame: Up to 36 weeks ]
Percentage of primary Immune-Related Adverse Event (irAE) severity decreased [ Time Frame: 24 weeks ]

Central Contacts and Locations

Central contacts

Research Nurse Navigator

212-342-5162 cancerclinicaltrials@cumc.columbia.edu

Locations

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Brian Henick, MD

212-305-5098 bh2682@cumc.columbia.edu

More Information

Sponsor

Brian Henick, MD

Last update posted

May 13, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Brian Henick, MD on 2026-05-13.