RecruitingPhase 1NCT06673329

Brodalumab in the Treatment of Immune-Related Adverse Events

Safety and Efficacy of Brodalumab in the Treatment of Immune-Related Adverse Events: A Pilot Study

Sponsor

Brian Henick, MD

Enrollment

11 participants

Start Date

Mar 11, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Liver Cancer Esophageal Cancer Pancreatic Cancer Prostate Cancer Lung Cancer Head and Neck Cancer Colon Cancer Solid Tumor Rectal Cancer Thyroid Cancer Gynecologic Cancer Skin Cancer Kidney Cancer Stomach Cancer Brain Tumor Oral Cancer Testicular Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing brodalumab — a drug that blocks an inflammatory molecule called IL-17 — for treating serious side effects caused by cancer immunotherapy. These side effects, called immune-related adverse events (irAEs), happen when cancer immunotherapy mistakenly attacks healthy tissues. **You may be eligible if...** - You are over 18 and being treated with immunotherapy for advanced or metastatic cancer - You have developed an immune-related side effect suspected to be driven by IL-17 inflammation - You are already on or are planning to start systemic steroids for this side effect - You have tested negative for tuberculosis within 30 days before starting the trial **You may NOT be eligible if...** - Your cancer is being treated with curative intent (the study is only for those with advanced or metastatic disease) - You have active tuberculosis or certain other serious infections - You have certain inflammatory bowel conditions (like Crohn's disease) that may be worsened by blocking IL-17 Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBrodalumab

Brodalumab 210 mg subcutaneous injection

RADIATIONCT scan

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

Locations(1)

Columbia University Irving Medical Center

New York, New York, United States

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NCT06673329

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