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

NCT06807593 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: 2024-0417NCI-2025-00795
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Safety and Adverse Events

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year

Study Arms (1)

Single Arm

EXPERIMENTAL

Participants will be identified per the evaluation of primary oncology and/or gastroenterology consult services.

Drug: Ustekinumab

Interventions

Ustekinumab DRUG

Given by infusion

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who receive any type of ICI therapy
• 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
• Patients with ability to understand and willingness to sign informed consent
• Patients with a diagnosis of any type of solid tumors on ICI systemic therapy
• 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 as per the treating physician based on clinical presentation
• Patient who has been cleared for enrollment by Infectious Diseases consultant or treating physician if positive infection workup or screening tests (e.g. lifelong positive T- spot due to BCG inoculation, chronic colonization) prior to initiation of diarrhea/colitis treatment and/ or imaging (e.g. CXR, CT CAP etc) confirms the absence of active infections (e.g. TB) within 60 days prior to initiation of protocol therapy
• Concurrent or prior cancer therapy (non-checkpoint inhibitors) that are not deemed as a significant contributor of the GI adverse event can be allowed in the study.
• Patients can be on the steroid treatment within 45 days before Ustekinumab
• Patients with non- GI immune-related adverse events (irAEs) can be enrolled if there is no contraindication to the use of ustekinumab in the treatment of the non-GI irAEs present
• Patients with a new index event of . grade 2 immune-related diarrhea and/or colitis may be enrolled if previous IMDC event was . 1 year ago with successful treatment and clinical remission

You may not qualify if:

• Patients younger than 18 years of age
• Patients with persistent gastrointestinal infection confirmed with positive testing despite completing 5 days of antibiotics
• Patients with history of inflammatory bowel disease and/or radiation enterocolitis with active disease status at the time of study treatment initiation
• Pregnant and breastfeeding women
• Women of child-bearing potential who have positive urine or serum pregnancy test or refuse to do pregnancy test unless last menstrual cycle was \> 1 year prior to consent and/ or clear documentation states that patient is peri- or post-menopausal or there was recent supporting objective evidence of 'no pregnancy' status (e.g. blood or imaging) within 30 days prior to enrollment in study
• Patients who develop concurrent non-GI toxicity (irAEs) at the time of study treatment initiation, with contraindication to the use of ustekinumab in the treatment of the non GI irAEs present
• Patients have already received other biologic treatment for IMDC such as infliximab, vedolizumab, EXCEPT if these drugs were used in a previous IMDC event that occurred ≥ 1 year earlier at which time there was complete resolution of the disease

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Janssen Research & Development, LLC: collaborator

Study Sites (1)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Neoplasms

Interventions

Ustekinumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Yinghong Wang, MD,PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yinghong Wang, MD,PHD

CONTACT

(281) 221-9138; ywang59@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 4, 2025
• Study Start: February 24, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

US (1)