drugset / Trial / NCT04375228

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

NCT04375228

Phase 2 Active not recruiting 8 enrolled Columbia University Genentech, Inc. · collab
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2020-09-25
Primary completion
2025-05-14
Completion
2026-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Subject Tocilizumab Monoclonal antibody 4 mg/kg Intravenous