Brodalumab in the Treatment of Immune-Related Adverse Events

NCT06673329 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2026-05-13

No results posted yet for this study

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

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06673329 on ClinicalTrials.gov