Clinical trial NCT06807593: Treatment of Immune Checkpoint Inhibitor-related Diarrhea and/ or Colitis With Ustekinumab in Cancer Patients
Official title: Treatment of Immune Checkpoint Inhibitor-related Diarrhea and/ or Colitis With Ustekinumab in Cancer Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: Janssen Research & Development, LLC
First posted: 2025-02-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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 as per the treating physician based on clinical presentation
6. 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
7. 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.

Exclusion Criteria:

1. Patients younger than 18 years of age
2. Patients with persistent gastrointestinal infection confirmed with positive testing despite completing 5 days of antibiotics
3. Patients on concurrent immunosuppressive therapies other than what will be given for colitis
4. Patients with history of inflammatory bowel disease and/or radiation enterocolitis with active disease status at the time of study treatment initiation
5. Pregnant and breastfeeding women
6. 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
7. Patients who develop concurrent non-GI toxicity at the time of study treatment initiation
8. Patients have already received other biologic treatment for IMDC such as infliximab, vedolizumab

Primary outcomes:
measure: Safety and Adverse Events
timeFrame: Through study completion; an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas M. D. Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Yinghong Wang, MD,PHD
role: PRINCIPAL_INVESTIGATOR
References: