Ustekinumab for immune checkpoint inhibitor-related diarrhea and colitis in cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 interventional trial gives ustekinumab to cancer patients who develop grade 2 or higher immune-related diarrhea or colitis while on immune checkpoint inhibitors. Primary outcomes include clinical remission/response and reduction in fecal calprotectin, with secondary outcomes such as steroid-free remission, recurrence timing, endoscopic remission, patient symptoms and quality of life, and overall survival. The study also collects blood and tissue to identify immune signatures linked to GI immune-related adverse events and response to ustekinumab. The trial is sponsored by M.D. Anderson Cancer Center in collaboration with Janssen and enrolls at MD Anderson in Houston, Texas.

Why it matters

Who can join: the full rules

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 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
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.
8. Patients can be on the steroid treatment within 45 days before Ustekinumab
9. 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
10. 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

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 with history of inflammatory bowel disease and/or radiation enterocolitis with active disease status at the time of study treatment initiation
4. Pregnant and breastfeeding women
5. 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
6. 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
7. 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

Where it's running

• The University of Texas M. D. Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Yinghong Wang, MD,PHD — M.D. Anderson Cancer Center
• Study coordinator: Yinghong Wang, MD,PHD
• Email: ywang59@mdanderson.org
• Phone: (281) 221-9138

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Guselkumab after Ustekinumab in adults with moderate-to-severe psoriasis in routine care

  This study looks at how well guselkumab works for people with moderate-to-severe psoriasis after switching from ustekinumab in everyday clinical practice.

  Recruiting Janssen-Cilag Kft. · Budapest · NCT07746583

• Switching to ustekinumab for kids with Crohn's or ulcerative colitis who developed psoriasis after anti-TNF therapy

  This study tests whether switching to ustekinumab helps children with inflammatory bowel disease who developed psoriasis while on anti-TNF drugs.

  Recruiting Centre Hospitalier Universitaire de Nice · Nice, France · NCT07529236

• Guselkumab for adults with Crohn's disease after ustekinumab failure

  This study will try guselkumab for adults with moderate to severe Crohn's disease who did not respond to or could not tolerate ustekinumab to see if they reach remission after 52 weeks.

  Recruiting Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou, Zhejiang · NCT07487480

• Guselkumab vs Ustekinumab for stricturing Crohn's disease

  This study will follow adults with moderate-to-severe Crohn's disease and confirmed intestinal strictures to see if treatment with guselkumab or ustekinumab better controls obstructive symptoms and disease activity.

  Recruiting Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou, Zhejiang · NCT07444060

• Guselkumab for Chinese patients with Crohn's disease who stopped responding to ustekinumab

  This study tests whether guselkumab can help Chinese patients with active Crohn's disease who initially responded to ustekinumab but later lost response.

  Recruiting at 5 sites Phase 4 Xian-Janssen Pharmaceutical Ltd. · Guangzhou and 4 other locations · NCT07310095

• Reducing ustekinumab dosing for Crohn's disease and ulcerative colitis

  This will try giving ustekinumab less often—changing from every 4 or 8 weeks to every 8 or 12 weeks—to see if people with Crohn's disease or ulcerative colitis in deep remission can stay well.

  Recruiting Phase 4 McGill University Health Centre/Research Institute of the McGill University Health Centre · Montreal, Quebec · NCT07303686

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.