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NCT04375228 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Advanced Solid Tumor and Immune Related Adverse Events, sponsored by Columbia University.

Active
Registry status
Phase 2
Development phase
8
Enrollment target
3
Study locations

NCT04375228 is a Phase 2 study of Advanced Solid Tumor and Immune Related Adverse Events that is active but no longer recruiting, run by Columbia University. The registered enrollment target is 8 participants, below the 193-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (96% lower). The trial reports 3 study locations across 2 states.

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The verdict

NCT04375228, a Phase 2 study of Advanced Solid Tumor and Immune Related Adverse Events, is active but no longer recruiting, sponsored by Columbia University.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
8 participants
Enrollment target
3
Study locations

Study 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.

Interventions

  • DRUG Rituximab
  • DRUG Tocilizumab

Study Locations (3)

New York

  • Memorial Sloan Kettering Cancer Center - New York
  • Columbia University Irving Medical Center, Herbert Irving Comprehensive Cancer Center - New York

Maryland

  • Johns Hopkins - Baltimore

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2020-09-25
Est. Completion 2026-12
Phase Phase 2

Sponsor

Columbia University

958 total trials

What the Registry Record Tells You About NCT04375228

The ClinicalTrials.gov registry entry for NCT04375228 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 193-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (96% lower). The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Advanced Solid Tumor appearing as the primary indexed condition, and to 2 interventions - of which Rituximab is the first listed.

NCT04375228 reports 3 study locations spanning 2 distinct geographic areas - top geographies include New York, Maryland.

Frequently Asked Questions

What is clinical trial NCT04375228 about?

NCT04375228 is a clinical study titled "Study of Rituximab or Tocilizumab for Patients With Steroid-Dependent Immune-Related Adverse Events (irAEs)". 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 toci...

What is the current status of trial NCT04375228?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2020-09-25. Estimated completion is 2026-12.

What conditions does trial NCT04375228 study?

This clinical trial studies the following conditions: Advanced Solid Tumor, Immune Related Adverse Events.

What interventions are being tested in trial NCT04375228?

The interventions under investigation include: Rituximab (DRUG), Tocilizumab (DRUG).

Who is sponsoring clinical trial NCT04375228?

This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04375228 being conducted?

This trial has 3 study locations across Maryland, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.