Brodalumab in the Treatment of Immune-Related Adverse Events

NCT06673329 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: AAAV1382
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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

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

Outcome Measures

Primary Outcomes (2)

• Number of Adverse Events

  The number of adverse events of each grade that occur and the number of adverse events attributed to brodalumab, as per the Common Terminology Criteria for Adverse Events version 5 (CTCAE v5).

  Up to 36 weeks

• Percentage of primary Immune-Related Adverse Event (irAE) severity decreased

  The percentage of patients whose primary irAE severity decreased by \>1 grade per CTCAE criteria from study completion to treatment discontinuation.

  24 weeks

Secondary Outcomes (9)

• Percentage net decrease in the average steroid dose required for irAE management

  Up to 36 weeks

• Proportion of Patients Successfully Tapered Off Steroids

  Up to 36 weeks

• Mean Time to Complete Resolution of irAE Symptoms

  Up to 36 weeks

• Change in Tumor Burden Assessed by RECIST Criteria at 24 Weeks

  24 weeks

• Proportion of Patients with Grade 3 or Higher Infection Events

  Up to 36 weeks

Study Arms (1)

brodalumab to treat irAEs in patient with solid tumors

EXPERIMENTAL

Brodalumab 210 mg subcutaneous injection on weeks 0, 1, 2 followed by administration every 2 weeks until week 24

Drug: Brodalumab; Radiation: CT scan

Interventions

Brodalumab DRUG

Brodalumab 210 mg subcutaneous injection

Also known as: SILIQ

brodalumab to treat irAEs in patient with solid tumors

CT scan RADIATION

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

brodalumab to treat irAEs in patient with solid tumors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to provide written informed consent by subject or guardian
• Individuals \>18 years of age
• Diagnosis of an irAE clinically suspected to be IL-17 mediated
• Intent-to-treat or prior treatment with systemic steroids for irAE management
• Histology-proven primary advanced or metastatic solid organ malignancy treated with immunotherapy. Patients being treated with curative intent are not eligible to enroll.
• Subject has a negative test for tuberculosis during screening defined as either: negative purified protein derivative (PPD) (\< 5 mm of induration at 48 to 72 hours after test is placed) OR negative QuantiFERON test. Tuberculosis testing must be performed within 30 days prior to trial initiation.
• Subjects with a positive PPD and a history of Bacillus Calmette-Guérin vaccination are allowed with a negative QuantiFERON test.
• Subjects with a positive PPD test (without a history of Bacillus Calmette-Guérin vaccination) or subjects with a positive or indeterminate QuantiFERON test are allowed if they have all of the following: no symptoms of tuberculosis (defined as fever, shortness of breath, cough or night sweats), documented history of a completed course of adequate prophylaxis (per local standard of care), no known exposure to a case of active tuberculosis after most recent prophylaxis, no evidence of active tuberculosis on chest radiograph within 3 months prior to the first dose of brodalumab.

You may not qualify if:

• Estimated creatinine clearance \< 40 mg/min
• Active suicidal ideation or severe depression (as defined by the Diagnostic and Statistical Manual of Mental Disorders Version IV criteria (DSM-IV)) at the time of enrollment or a PHQ-9 score \> 20
• History of prior suicide attempts
• PHQ-9 score greater \>5 and \< 20 without an established mental health provider who verifies stability in their depression
• Current or prior drug or alcohol abuse within the past 6 months (as defined by the DSM IV)
• In the opinion of the investigator, the patient requires additional immunosuppressive treatment (other than corticosteroids and brodalumab)
• Known hypersensitivity or contraindication to brodalumab, corticosteroids or any components of brodalumab
• Prior treatment with brodalumab
• Pregnancy, breastfeeding, or use of a nonreliable method of contraception
• For patients assigned female at birth: lack of willingness to use highly effective methods of birth control during treatment and for at least 4 weeks after the last dose of brodalumab (except if surgically sterile or at least 2 years postmenopausal, with postmenopausal status confirmed by Follicle-Stimulating Hormone (FSH) in the postmenopausal range).
• Highly effective methods of birth control include: use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. Oral contraceptive pills must be supplemented by a barrier method.
• Patients planning to become pregnant while enrolled in the study and within 4 weeks after the last dose of brodalumab will not be permitted to enroll
• Chronic or current severe infection requiring IV therapy
• Evidence of active hepatitis B, C, or tuberculosis.
• History of latent tuberculosis infection which is incompletely treated based upon local standard of care or which was never treated

Sponsors & Collaborators

• Brian Henick, MD: lead
• Bausch Health: collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

Related Links

• Description Herbert Irving Comprehensive Cancer Center (HICCC) Clinical Trials page

MeSH Terms

Conditions

Breast Neoplasms; Esophageal Neoplasms; Kidney Neoplasms; Lung Neoplasms; Thyroid Neoplasms; Pancreatic Neoplasms; Stomach Neoplasms; Brain Neoplasms; Colonic Neoplasms; Rectal Neoplasms; Head and Neck Neoplasms; Mouth Neoplasms; Liver Neoplasms; Skin Neoplasms; Prostatic Neoplasms; Testicular Neoplasms

Interventions

brodalumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Endocrine System Diseases; Thyroid Diseases; Pancreatic Diseases; Stomach Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Mouth Diseases; Stomatognathic Diseases; Liver Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Genital Diseases; Prostatic Diseases; Testicular Diseases; Gonadal Disorders

Study Officials

• Brian Henick, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Nurse Navigator

CONTACT

212-342-5162; cancerclinicaltrials@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Medicine, Division of Hematology/Oncology

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 4, 2024
• Study Start: March 11, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)