A Phase II Study of Rituximab or Tocilizumab to Treat Side Effects After Cancer Immunotherapy that Require Prolonged Steroid Treatment

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Full Title

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

Purpose

People with cancer who receive immunotherapy commonly develop immune-related side effects that are caused by activation of the immune system. Examples of these immunotherapy drugs include nivolumab (Opdivo), pembrolizumab (Keytruda), and atezolizumab (Tecentriq). These patients are usually treated with steroids, but sometimes the side effects persist.

Rituximab or tocilizumab could be effective in treating immune-related side effects from immunotherapy and allow patients to reduce the amount of steroids they need to take. The purpose of this study is to assess the safety and effectiveness of these two drugs for this purpose. Participants will receive either rituximab or tocilizumab. Both medications are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have immune-related side effects after cancer immunotherapy for a solid tumor (such as nivolumab, pembrolizumab, or atezolizumab) and the side effects must persist despite steroid treatment.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for people age 18 and older.

For more information and to ask about eligibility for this study, please contact the office of Dr. Mario Lacouture at 646-608-2337.

Protocol

21-519

Phase

II

Investigator

Co-Investigators