Safety and Efficacy of Brodalumab in the Treatment of Immune-Related Adverse Events: A PilotStudy

Contact:

NCT Number:

Protocol:

AAAV1382

Study Status:

Active/Enrolling

Population:

Adult

Phase:

I

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.

Are you Eligible? (Inclusion Criteria)

  • Ability to provide written informed consent by subject or guardian 2. Individuals >18 years of age 4. Intent-to-treat or prior treatment with systemic steroids for irAE management

Specialty Area(s)

Bladder Cancer , Brain and Spinal Tumors, Breast Cancer, Colon and Rectal Cancer, Esophageal Cancer, Gynecologic Cancers, Ovarian Cancer, Uterine (Endometrial) Cancer, Kidney Cancer/Adrenal Cancer, Liver Cancer, Lung cancer, Skin cancers, Melanoma, Prostate Cancer, Testicular Cancer, Thyroid Cancer

Principal Investigator

Profile Headshot
  • Associate Director, Experimental Therapeutics
  • Director of Translational Research, Upper Aerodigestive Cancers in Medical Oncology

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032