OncoMatch/Clinical Trials/NCT06673329
Brodalumab in the Treatment of Immune-Related Adverse Events
Is NCT06673329 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Brodalumab for breast cancer.
Treatment: Brodalumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Esophageal Carcinoma
Renal Cell Carcinoma
Non-Small Cell Lung Carcinoma
Thyroid Cancer
Pancreatic Cancer
Gastric Cancer
Glioblastoma
Colorectal Cancer
Head and Neck Squamous Cell Carcinoma
Hepatocellular Carcinoma
Prostate Cancer
Testicular Germ Cell Tumor
Tumor Agnostic
Disease stage
Metastatic disease required
Prior therapy
Must have received: immunotherapy
treated with immunotherapy
Cannot have received: brodalumab (brodalumab)
Prior treatment with brodalumab
Lab requirements
Blood counts
Bone marrow insufficiency unrelated to the irAE (according to investigator judgment) with WBC <2000/mm3, ANC <1500/mm3, platelets <50,000/mm3, hemoglobin <8.0 g/dL
Kidney function
Estimated creatinine clearance < 40 mg/min [excluded]
Liver function
AST and/or ALT >2x ULN or >3x ULN in patients with liver metastases measured on at least two separate occasions; Direct bilirubin ≥1.5 mg/dL in patients with or without liver metastases
Cardiac function
Myocardial infarction, unstable angina pectoris or stroke within the past 12 months prior to the first investigational product dose; Severe cardiovascular disease, including advanced heart failure (American Heart Association Stage D)
AST and/or ALT >2x ULN or >3x ULN in patients with liver metastases measured on at least two separate occasions; Direct bilirubin ≥1.5 mg/dL in patients with or without liver metastases; Estimated creatinine clearance < 40 mg/min; Bone marrow insufficiency unrelated to the irAE (according to investigator judgment) with WBC <2000/mm3, ANC <1500/mm3, platelets <50,000/mm3, hemoglobin <8.0 g/dL; Myocardial infarction, unstable angina pectoris or stroke within the past 12 months prior to the first investigational product dose; Severe cardiovascular disease, including advanced heart failure (American Heart Association Stage D)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Columbia University Irving Medical Center · New York, New York
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