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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Columbia University
Study ID
NCT04375228
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Advanced Solid Tumor
  • Immune-related Adverse Events

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 25, 2020
Status verified
Jan 2026
Primary completion
May 14, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
8 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab
    Patients with histologically confirmed advanced (metastatic or unresectable) solid tumors that have documented irAEs will receive Rituximab.
  • Experimental: Tocilizumab
    Patients with histologically confirmed advanced (metastatic or unresectable) solid tumors that have documented irAEs will receive Tocilizumab.

Primary Outcome Measure

Percentage of Participants to Discontinue Steroid Treatment After Rituximab [ Time Frame: Up to 8 weeks ]

Locations (3)

FacilityCityStateZIPSite coordinators
Johns HopkinsBaltimoreMaryland21224-
Columbia University Irving Medical Center, Herbert Irving Comprehensive Cancer CenterNew YorkNew York10032-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10022-

Find similar trials in Baltimore, MD

By research site
Johns Hopkins· Baltimore, MDColumbia University Irving Medical Center, Herbert Irving Comprehensive Cancer Center· New York, NYMemorial Sloan Kettering Cancer Center· New York, NY

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