NCT06673329

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (estimated)
• Sponsor: Brian Henick, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The proposed study will evaluate the safety and efficacy of brodalumab in improving and resolving Immune-Related Adverse Events (irAEs) in patients treated with brodalumab. Eligible subjects must have an immune-related adverse event with the intent to treat it with steroids. Subjects will receive subcutaneous brodalumab for 24 weeks. Peripheral blood will be collected at all in-person study visits for mechanistic studies. Participants will be evaluated at week 0, 1, 2, 4, and then every 4 weeks after that until week 24 as dictated by the standard of care using a combination of telemedicine and face-to-face evaluations. Additional safety follow-up visits will occur at weeks 28 and 36. All patients will have the Columbia Suicide Severity Rating Scale (C-SSRS), and Patient Health Questionnaire-9 (PHQ-9) administered at all visits. The treatment protocol consists of subcutaneous brodalumab 210 mg administered at baseline and then at weeks 0, 1, and 2, then bi-weekly for a total of 24 weeks (the current FDA-approved dosing for plaque psoriasis). Glucocorticoids may be used at baseline at the discretion of the investigators, with the goal of tapering off of steroids over 4-8 weeks if tolerated (see proposed taper in appendix). Continued treatment beyond the 24-week course can be evaluated by the treating investigator and the Sponsor-Investigator, weighing risks versus clinical benefit.

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

Type	Name	Description
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

Timeline

• Start date: 2025-03-11
• Primary completion: 2026-05-01
• Completion: 2026-11-01
• First posted: 2024-11-04
• Last updated: 2025-05-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study