NCT06807593

Treatment of Immune Checkpoint Inhibitor-related Diarrhea and/ or Colitis With Ustekinumab in Cancer Patients

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 responsiveness to ustekinumab To identify pro-inflammatory immune signatures in serum To assess patient symptom and QOL

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	Ustekinumab	Given by infusion

Timeline

• Start date: 2026-02-24
• Primary completion: 2027-03-31
• Completion: 2027-03-31
• First posted: 2025-02-04
• Last updated: 2026-03-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study