Brodalumab in the Treatment of Immune-Related Adverse Events
NCT06673329 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11
Last updated 2026-05-13
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
- Gynecologic Cancer
- Pancreatic Cancer
- Stomach Cancer
- Brain Tumor
- Colon Cancer
- Rectal Cancer
- Head and Neck Cancer
- Oral Cancer
- Liver Cancer
- Skin Cancer
- Prostate Cancer
- Testicular Cancer
- Solid Tumor
Interventions
- DRUG
-
Brodalumab
Brodalumab 210 mg subcutaneous injection
- RADIATION
-
CT scan
CT scans within 4 weeks of starting brodalumab and every 3 months during the study for tumor assessment
Sponsors & Collaborators
-
Bausch Health Americas, Inc.
collaborator INDUSTRY -
Brian Henick, MD
lead OTHER
Principal Investigators
-
Brian Henick, MD · Columbia University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-11
- Primary Completion
- 2027-05-31
- Completion
- 2027-11-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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