NCI-2020-04569

An Open-Label, Phase II Multicenter Study of Rituximab or Tocilizumab for Steroid-dependent or Steroid-refractory Immune-Related Adverse Events due to Immune Checkpoint Blockade.

This is a Phase II reearch study that is open-label and multicenter, focusing on evaluating two different treatments for immune-related adverse events (irAEs) caused by immune checkpoint blockade therapy. The study targets patients who have developed immune-related adverse events (irAEs) due to immune checkpoint blockade therapy. These adverse events can include a variety of side effects caused by the immune system attacking healthy tissues. The trial is comparing two treatments: Rituximab is a monoclonal antibody that targets a specific protein on the surface of immune cells, leading to their depletion. Rituximab is commonly used to treat certain autoimmune conditions and immune-related adverse events. Tocilizumab is another monoclonal antibody that targets the interleukin-6 receptor, which is involved in immune responses. Tocilizumab is used to treat inflammatory conditions and has shown efficacy in managing some immune-related adverse events. The primary goal of the study is to evaluate whether rituximab or tocilizumab can effectively manage steroid-dependent or steroid-refractory immune-related adverse events caused by immune checkpoint blockade therapy. The study will assess both the effectiveness of these treatments in controlling the adverse events and their safety profiles in this specific patient population.

For more information about the trial, click the link below:

https://clinicaltrials.gov/ct2/show/NCT04375228

Clinical Trial Site: Columbia

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