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

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 2 of 2 changed
Enrollment reduced 12% 8 → 7 participants
See other at-risk trials from Columbia University

Record History

  1. Primary endpoint(s) modified Results first posted: Aug 3, 2026 · Enrollment reduced: 8 → 7 participantsv10 Show 2 more changesShow less
    • Results first posted: Aug 3, 2026
    • Enrollment reduced: 8 → 7 participants

    See this version in full on ClinicalTrials.gov ↗

  2. Primary endpoints revised (2) Enrollment target: 8 to 7 · Secondary endpoints revised (2)v9 Show 2 more changesShow less
    • Enrollment target: 8 to 7
    • Secondary endpoints revised (2)

    See this version in full on ClinicalTrials.gov ↗

  3. Primary completion date changed from estimate of Dec 2025 to May 14, 2025 Completion date: Feb 2026 to Dec 2026v8 Show 1 more changeShow less
    • Completion date: Feb 2026 to Dec 2026
  4. Primary completion date: Feb 2025 to Dec 2025 Trial status: Recruiting to Active, Not Recruiting · Enrollment target: estimated 30 to confirmed 8 · Site details revised at 3 of 3 sitesv7 Show 3 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 30 to confirmed 8
    • Site details revised at 3 of 3 sites
  5. Primary completion date: May 2024 to Feb 2025 Completion date: May 2025 to Feb 2026 · Site contacts updated at 3 of 3 sitesv6 Show 2 more changesShow less
    • Completion date: May 2025 to Feb 2026
    • Site contacts updated at 3 of 3 sites
Show 4 earlier versionsHide 4 earlier versions
  1. Primary completion date: May 2023 to May 2024 Completion date: Feb 2024 to May 2025 · Site contacts updated at 1 of 3 sitesv5 Show 2 more changesShow less
    • Completion date: Feb 2024 to May 2025
    • Site contacts updated at 1 of 3 sites
  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jun 2021 to Sep 25, 2020 · Site details revised at 3 of 3 sitesv4 Show 2 more changesShow less
    • Start date changed from estimate of Jun 2021 to Sep 25, 2020
    • Site details revised at 3 of 3 sites
  3. Start date: Dec 2020 to Jun 2021 Site contacts updated at 1 of 3 sitesv3 Show 1 more changeShow less
    • Site contacts updated at 1 of 3 sites
  4. Start date: May 2020 to Dec 2020v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04375228
Lead Sponsor Columbia University
Collaborators: Genentech, Inc.
Conditions Immune-related Adverse Events, Advanced Solid Tumor
Enrollment 7 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov