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Monoclonal Antibodies

Brodalumab for Cancer Immunotherapy Side Effects

Phase 1
Recruiting
Research Sponsored by Brian Henick, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histology-proven primary advanced or metastatic solid organ malignancy treated with immunotherapy. Patients being treated with curative intent are not eligible to enroll
Be older than 18 years old
Must not have
Other known clinically significant active medical conditions, such as: Severe cardiovascular disease, including advanced heart failure (American Heart Association Stage D), Aspartate aminotransferase (AST) and or alanine aminotransferase (ALT) greater than 2 times the upper limit of normal or greater than 3 times the upper limit of normal in patients with liver metastases measured on at least two separate occasions, Direct bilirubin greater than or equal to 1.5 mg/dL in patients with or without liver metastases, Bone marrow insufficiency unrelated to the irAE (according to investigator judgment) with White Blood Cell (WBC) <2000/mm3, absolute neutrophil count <1500/ mm3, thrombocytopenia (platelet count) <50,000/mm3, hemoglobin < 8.0 g/dL, Plan to proceed with further curative intent treatment for cancer at the time of enrollment despite the presence of irAE
Known hypersensitivity or contraindication to brodalumab, corticosteroids or any components of brodalumab
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 weeks
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to see if using brodalumab can safely and effectively manage side effects that occur in cancer patients who have received immunotherapy. These side effects are caused by the immune system becoming over

Who is the study for?
This trial is for patients with various types of cancer who have experienced side effects from previous immunotherapy treatments. It's aimed at those needing to manage these immune-related adverse events, which are similar to autoimmune disease symptoms.
What is being tested?
The study tests the safety and effectiveness of brodalumab, a drug approved for autoimmune diseases, in controlling side effects caused by cancer immunotherapies. Participants will undergo regular CT scans to monitor progress.
What are the potential side effects?
Potential side effects of brodalumab may include infections, allergic reactions, gastrointestinal issues, and possible activation or worsening of other autoimmune conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have advanced cancer treated with immunotherapy and am not seeking a cure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not allergic to brodalumab, corticosteroids, or any of their ingredients.
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I am not planning to use, nor have I used, immunosuppressive drugs other than steroids in the last 28 days.
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I have had tuberculosis that was not fully treated or never treated.
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My kidney function is reduced with a creatinine clearance below 40 mg/min.
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I am currently receiving IV therapy for a severe infection.
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I have been treated with brodalumab before.
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I have or have had Crohn's disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Adverse Events
Percentage of primary irAE severity decreased
Secondary study objectives
Change in Tumor Burden Assessed by RECIST Criteria at 24 Weeks
Cumulative Steroid Exposure over 24 Weeks
FACT-G global assessment score
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: brodalumab to treat irAEs in patient with solid tumorsExperimental Treatment2 Interventions
Brodalumab 210 mg subcutaneous injection on weeks 0, 1, 2 followed by administration every 2 weeks until week 24
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brodalumab
2017
Completed Phase 4
~1150
CT scan
2013
Completed Phase 2
~2450

Find a Location

Who is running the clinical trial?

Brian Henick, MDLead Sponsor
1 Previous Clinical Trials
18 Total Patients Enrolled
Bausch HealthUNKNOWN
1 Previous Clinical Trials
25 Total Patients Enrolled
~7 spots leftby May 2026
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