Ustekinumab for Diarrhea and Colitis in Cancer Patients

Overseen By Yinghong Wang, MD,PHD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Immunosuppressive therapies, Biologics

Disqualifiers: Under 18, Pregnancy, Infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

10 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that patients on certain immunosuppressive therapies cannot participate, so it's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the drug Ustekinumab for treating diarrhea and colitis in cancer patients?

Ustekinumab is effective in treating Crohn's disease and ulcerative colitis, which are conditions similar to colitis in cancer patients. It works by blocking certain proteins (interleukins) that cause inflammation, which may help reduce symptoms like diarrhea. ^{1 2 3 4 5}

Is Ustekinumab generally safe for humans?

Ustekinumab is generally considered safe for treating Crohn's disease and ulcerative colitis, with some patients experiencing mild to moderate infusion reactions (like allergic reactions during the drug administration) at a rate of 0.9%-4.5%. ^{4 5 6 7 8}

How is the drug Ustekinumab unique for treating diarrhea and colitis in cancer patients?

Ustekinumab is unique because it is a monoclonal antibody that targets specific proteins (interleukins IL-12 and IL-23) involved in inflammation, which is different from other treatments that may not target these proteins. It is already used for Crohn's disease and ulcerative colitis, suggesting it could be effective for similar inflammatory conditions in cancer patients. ^{1 4 5 9 10}

What is the purpose of this trial?

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.

Research Team

Yinghong Wang, MD,PHD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adult cancer patients with immune-related diarrhea or colitis from checkpoint inhibitor therapy. They must not have GI infections, inflammatory bowel disease, or be on other immunosuppressives. Pregnant women and those under 18 are excluded.

Inclusion Criteria

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

I am receiving immunotherapy.

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

Exclusion Criteria

I am under 18 years old.

Pregnant and breastfeeding women

I am experiencing side effects not related to my digestive system from my current treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ustekinumab to control immune-related diarrhea and/or colitis

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Treatment Details

Interventions

• Ustekinumab

Trial Overview The study tests if ustekinumab can control immune-related diarrhea/colitis in cancer patients who've had grade 2 or higher symptoms within the last 45 days after receiving any type of ICI therapy.

Participant Groups

Group I: Single Arm Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Janssen Research & Development, LLC

Industry Sponsor

Trials

1,022

Recruited

6,408,000+

Giacomo Salvadore

Janssen Research & Development, LLC

Chief Medical Officer since 2023

MD from the University of Rome, Tor Vergata

Ricardo Attar

Janssen Research & Development, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology from the University of Buenos Aires

Findings from Research

A study involving 117 Crohn's disease patients, including 39 elderly (≥65 years) and 78 nonelderly (<65 years), found that ustekinumab (UST) is safe and effective for treating elderly patients, with nearly 90% experiencing a clinical response.

Elderly patients were less likely to achieve complete clinical remission compared to nonelderly patients (28.2% vs. 52.6%), but there were no significant differences in adverse events or complications between the two age groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Effectiveness and Safety of Ustekinumab in Elderly Crohn's Disease Patients. Garg, R., Aggarwal, M., Butler, R., et al.[2023]

In a study of 34 Crohn's disease patients who previously failed anti-TNF therapies, ustekinumab (UST) achieved a clinical remission rate of 70.5%, indicating its efficacy as a treatment option for these patients.

UST was particularly effective in patients with fistulizing disease, with a 70% remission rate, suggesting it may be a preferred treatment for this subgroup.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

P066 Real-World Experience of Ustekinumab in Crohn's Disease Patients With Prior Anti-TNF Therapy at a Tertiary Care Hospital. Tripathi, K., Groudan, K., Chalhoub, J., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Safety of Ustekinumab in Inflammatory Bowel Disease: Pooled Safety Analysis of Results from Phase 2/3 Studies. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Ustekinumab as Induction and Maintenance Therapy for Ulcerative Colitis. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Ustekinumab treatment in ulcerative colitis: Real-world data from the Swedish inflammatory bowel disease quality register. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Real-World Experience With Acute Infusion Reactions to Ustekinumab at 2 Large Tertiary Care Centers. [2023]

5. Spain pubmed.ncbi.nlm.nih.gov

Ustekinumab in Crohn's disease: real-world outcomes and predictors of response. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of ustekinumab for induction of remission in patients with Crohn's disease: A multicenter Israeli study. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Real-World Effectiveness and Safety of Ustekinumab in Elderly Crohn's Disease Patients. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Ustekinumab: "Real-world" outcomes and potential predictors of nonresponse in treatment-refractory Crohn's disease. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

P066 Real-World Experience of Ustekinumab in Crohn's Disease Patients With Prior Anti-TNF Therapy at a Tertiary Care Hospital. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Ustekinumab Does Not Increase Risk of Adverse Events: A Meta-Analysis of Randomized Controlled Trials. [2021]