Study of Rituximab or Tocilizumab for Patients With Steroid-Dependent Immune-Related Adverse Events (irAEs)
NCT04375228 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8
Last updated 2026-02-06
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.
Conditions
- Immune-related Adverse Events
- Advanced Solid Tumor
Interventions
- DRUG
-
375mg/m\^2 IV weekly for 4 doses
- DRUG
-
4mg/kg IV once a month for up to 2 doses
Sponsors & Collaborators
-
Genentech, Inc.
collaborator INDUSTRY - lead OTHER
Principal Investigators
-
Brian Henick, MD · Assistant Professor of Medicine in the Division of Hematology and Oncology
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-09-25
- Primary Completion
- 2025-05-14
- Completion
- 2026-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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