Brodalumab in the Treatment of Immune-Related Adverse Events

Part of paid clinical trials in New York, New York.

Sponsor
Brian Henick, MD
Study ID
NCT06673329
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Brodalumab — DRUG
    Brodalumab 210 mg subcutaneous injection
  • CT scan — RADIATION
    CT scans within 4 weeks of starting brodalumab and every 3 months during the study for tumor assessment

Study Details

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.

Key Dates

Start date
Mar 11, 2025
Status verified
May 2026
Primary completion
May 31, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
11 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: brodalumab to treat irAEs in patient with solid tumors
    Brodalumab 210 mg subcutaneous injection on weeks 0, 1, 2 followed by administration every 2 weeks until week 24

Primary Outcome Measure

Number of Adverse Events [ Time Frame: Up to 36 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Irving Medical CenterNew YorkNew York10032
Brian Henick, MD
[email protected]
212-305-5098

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