Pilot Study of Brodalumab to Treat Immune-Related Side Effects in Adults with Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating brodalumab to study its safety and effectiveness in patients who develop immune-related side effects from cancer immunotherapy. These side effects occur when the immune system becomes overactive after immunotherapy treatment. The study focuses on patients with advanced or metastatic solid tumors who experience these side effects, which resemble autoimmune diseases. Brodalumab is currently approved for autoimmune conditions but not yet for treating immune therapy side effects. Participants will receive subcutaneous injections of brodalumab at a dose of 210 mg starting at baseline, then weekly at weeks 1 and 2, followed by injections every two weeks until week 24. Some patients may begin with steroids to manage side effects, with plans to reduce steroid use over 4 to 8 weeks if possible. The study involves blood sample collections and evaluations through telemedicine and face-to-face visits at specific intervals, with additional safety follow-ups at weeks 28 and 36. During the study, participants will be assessed regularly for side effects using scales such as the Columbia Suicide Severity Rating Scale and Patient Health Questionnaire-9. Tumor assessments will be done with CT scans before starting treatment and every three months. Researchers will measure adverse events, steroid use, symptom resolution, tumor changes, and survival outcomes up to 36 weeks. Participants health and safety will be closely monitored throughout the trial.

Brodalumab in the Treatment of Immune-Related Adverse Events