NCT04375228

Study of Rituximab or Tocilizumab for Patients With Steroid-Dependent Immune-Related Adverse Events (irAEs)

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine how effective rituximab or tocilizumab are in treating side effects for people who are receiving immunotherapy treatment requiring prolonged steroid use. Immune-related side effects are caused by the activation of the immune system. Because rituximab and tocilizumab have been shown to effectively in treating other diseased that involve immune system activation, this study seeks to evaluate how effective they will be in treating immune-related side effects in people receiving immunotherapy treatment for cancer.

Detailed description

The purpose of this study is to determine the safety and effectiveness of two drugs, either rituximab or tocilizumab, in patients who develop side effects while on treatment with immunotherapy requiring prolonged steroids. Immune-related side effects are caused by activation of the immune system from treatment with immunotherapy. Both rituximab and tocilizumab have been given to patients with autoimmune diseases (diseases where the immune system is activated against normal organs). Immune-related side effects appear to closely mirror these autoimmune conditions. Participants in this study have developed an immune-related adverse event while on immunotherapy and require a long course of steroids to manage this side effect. Steroids can cause many side effects with prolonged use including problems with sleep, weight gain, diabetes, muscle loss, high blood pressure, high cholesterol, bone loss, and mood disturbances. Drugs such as rituximab and tocilizumab have been shown to be effective in other diseases involving immune system activation. This study is evaluating the effectiveness of these drugs in patients who have immune-related side effects by their ability to help patients discontinue steroids.

Conditions

• Immune-related Adverse Events
• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	Rituximab	375mg/m\^2 IV weekly for 4 doses
DRUG	Tocilizumab	4mg/kg IV once a month for up to 2 doses

Timeline

• Start date: 2020-09-25
• Primary completion: 2025-05-14
• Completion: 2026-12-01
• First posted: 2020-05-05
• Last updated: 2026-02-06

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study