Actively Recruiting
Treatment of Immune Checkpoint Inhibitor-related Diarrhea and/ or Colitis With Ustekinumab in Cancer Patients
Led by M.D. Anderson Cancer Center · Updated on 2026-03-05
10
Participants Needed
1
Research Sites
57 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
J
Janssen Research & Development, LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical research study is to learn if ustekinumab can help to control immune-related diarrhea and/or colitis in cancer patients.
CONDITIONS
Official Title
Treatment of Immune Checkpoint Inhibitor-related Diarrhea and/ or Colitis With Ustekinumab in Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who receive any type of immune checkpoint inhibitor therapy
- Patients with grade 2 or higher immune-related diarrhea and/or colitis within 45 days before enrollment
- Ability to understand and willingness to sign informed consent
- Diagnosis of any solid tumor receiving immune checkpoint inhibitor systemic therapy
- No active gastrointestinal infection at treatment start as confirmed by tests or physician assessment
- Cleared for enrollment by infectious disease consultant or treating physician if infection workup is positive
- Concurrent or prior non-checkpoint inhibitor cancer therapy allowed if not a significant cause of gastrointestinal adverse event
- Patients may be on steroid treatment within 45 days before starting ustekinumab
- Patients with non-gastrointestinal immune-related adverse events can participate if ustekinumab is not contraindicated
- Patients with a new event of grade 2 or higher immune-related diarrhea/colitis may enroll if previous event was over 1 year ago and resolved
You will not qualify if you...
- Patients younger than 18 years old
- Persistent gastrointestinal infection despite completing 5 days of antibiotics
- History of inflammatory bowel disease or radiation enterocolitis with active disease at treatment start
- Pregnant or breastfeeding women
- Women of child-bearing potential with positive pregnancy test or refusal to test unless clearly not pregnant
- Patients with concurrent non-gastrointestinal immune-related adverse events that contraindicate ustekinumab use
- Prior use of other biologic treatments for immune-related diarrhea/colitis unless used over 1 year ago with complete resolution
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
Y
Yinghong Wang, MD,PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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