Treatment of Immune Checkpoint Inhibitor-related Diarrhea and/ or Colitis With Ustekinumab in Cancer Patients
M.D. Anderson Cancer Center
Summary
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.
Description
Primary Objectives: To assess the efficacy of ustekinumab for clinical remission/response of immune-related diarrhea and/or colitis To assess the efficacy of ustekinumab in reducing fecal calprotectin levels Secondary Objectives: To assess steroid free IMDC remission by week 4 and 8 To assess the IMDC recurrence by week 4 and 8 To assess the time duration to IMDC recurrence and overall survival To assess the efficacy of ustekinumab to achieve endoscopic remission of immune-related diarrhea and/or colitis To identify immune signatures related to GI irAEs and those specific to responsive…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients who receive any type of ICI therapy 2. Patients with ≥ grade 2 immune-related diarrhea and/or colitis according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 within 45 days prior to enrollment in study 3. Patients with ability to understand and willingness to sign informed consent 4. Patients with a diagnosis of any type of solid tumors on ICI systemic therapy 5. No concern for active concomitant GI infection for immune-related diarrhea and/or colitis work up at the time of protocol therapy initiation as confirmed by stool tests or a…
Interventions
- DrugUstekinumab
Given by infusion
Location
- The University of Texas M. D. Anderson Cancer CenterHouston, Texas