100 Participants Needed

Infliximab vs Vedolizumab for Colitis from Immunotherapy in Cancer Patients

YW
Overseen ByYinghong Wang
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: M.D. Anderson Cancer Center
Must be taking: Immune checkpoint inhibitors
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase I/II trial studies the side effects of infliximab and vedolizumab and to see how well they work in treating inflammation of the colon (colitis) caused by immune checkpoint inhibitor therapy in patients with cancer of the genital and urinary organs (genitourinary) or melanoma. Monoclonal antibodies, such as infliximab or vedolizumab, may help to treat immunotherapy induced colitis/diarrhea. This study may help to identify the optimal treatment strategy for immune checkpoint inhibitor-related colitis in patients with genitourinary cancer or melanoma.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be on other immunosuppressive therapies while participating. It's best to discuss your current medications with the study team.

Is Infliximab or Vedolizumab safe for humans?

Infliximab and Vedolizumab are generally considered safe for treating inflammatory bowel diseases, but they can have side effects. Infliximab may cause severe infections and infusion reactions, while Vedolizumab is linked to adverse events at higher drug levels. More studies are needed to fully understand their safety profiles.12345

How do infliximab and vedolizumab differ from other drugs for colitis in cancer patients?

Infliximab and vedolizumab are unique because they offer different mechanisms of action compared to traditional treatments. Infliximab is an anti-TNF (tumor necrosis factor) drug, while vedolizumab targets the α4β7 integrin, which helps control immune cell movement in the gut, making them suitable for patients who do not respond to or cannot tolerate other treatments.26789

What data supports the effectiveness of the drugs infliximab and vedolizumab for treating colitis in cancer patients?

Research shows that both infliximab and vedolizumab are effective for treating inflammatory bowel diseases like ulcerative colitis and Crohn's disease. Infliximab has been proven to help patients achieve remission without steroids, while vedolizumab has shown safety and effectiveness in real-world settings for similar conditions.710111213

Who Is on the Research Team?

YW

Yinghong Wang

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with genitourinary cancer, melanoma, or non-small cell lung cancer who have developed grade 2 or higher colitis from immune checkpoint inhibitor therapy. They must not have active GI infections, inflammatory bowel disease, radiation enterocolitis, or be on other immunosuppressive drugs. Pregnant women and those under 18 are excluded.

Inclusion Criteria

I don't have an active GI infection as confirmed by tests or my doctor.
I have genitourinary cancer, melanoma, or non-small cell lung cancer.
I can understand and am willing to sign the informed consent.
See 3 more

Exclusion Criteria

I do not have active inflammatory bowel disease or radiation enterocolitis.
I developed side effects not related to my digestive system when I started the study treatment.
I still have a GI infection after 5 days of antibiotics.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive infliximab or vedolizumab intravenously over 1 hour at weeks 0, 2, and 6 for a total of 3 doses

6 weeks
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months
Weekly visits for 1 month, then at 2 and 3 months

Long-term follow-up

Participants are monitored for long-term outcomes and survival

Up to 3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Infliximab
  • Vedolizumab
Trial Overview The study is testing the effectiveness of monoclonal antibodies infliximab and vedolizumab in treating colitis caused by immune checkpoint inhibitors in patients with certain cancers. It aims to determine the best treatment strategy for this condition.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (vedolizumab)Experimental Treatment1 Intervention
Group II: Arm I (infliximab)Active Control1 Intervention

Infliximab is already approved in European Union, United States, Canada, Japan for the following indications:

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Approved in European Union as Remicade for:
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Approved in United States as Remicade for:
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Approved in Canada as Remicade for:
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Approved in Japan as Remicade for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

This study provides real-world evidence from 9 Irish hospitals supporting the safety and efficacy of vedolizumab in treating inflammatory bowel disease (IBD), particularly in patients who have previously been treated with anti-TNF agents.
The results align with larger international studies and offer insights into potential predictors of treatment response, helping to clarify vedolizumab's role in the treatment algorithm for IBD.
Irish data on the safety and efficacy of vedolizumab in the treatment of inflammatory bowel disease.Judge, C., McGettigan, N., Ryan, T., et al.[2021]
In a study of 795 biologic-naïve ulcerative colitis patients, infliximab and vedolizumab showed similar effectiveness in achieving clinical remission and response at week 6.
However, infliximab was associated with significantly higher rates of corticosteroid-free clinical remission and endoscopic remission after one year compared to vedolizumab, suggesting it may offer additional long-term benefits.
Comparative Efficacy for Infliximab Vs Vedolizumab in Biologic Naive Ulcerative Colitis.Narula, N., Wong, ECL., Marshall, JK., et al.[2022]
Infliximab has shown significant efficacy in treating inflammatory bowel disease, particularly Crohn's disease and ulcerative colitis, leading to increased rates of steroid-free remission and improved quality of life for patients.
Real-world data supports the findings from randomized controlled trials, indicating that infliximab not only helps manage symptoms but may also reduce hospitalization and the need for surgery in patients with these conditions.
Efficacy of infliximab for luminal and fistulizing Crohn's disease and in ulcerative colitis.Behm, BW., Bickston, SJ.[2022]

Citations

Irish data on the safety and efficacy of vedolizumab in the treatment of inflammatory bowel disease. [2021]
Comparative Efficacy for Infliximab Vs Vedolizumab in Biologic Naive Ulcerative Colitis. [2022]
Efficacy of infliximab for luminal and fistulizing Crohn's disease and in ulcerative colitis. [2022]
Uptake of a Switching Program for Patients Receiving Intravenous Infliximab and Vedolizumab to Subcutaneous Preparations. [2022]
Efficacy and safety of vedolizumab and infliximab treatment for immune-mediated diarrhea and colitis in patients with cancer: a two-center observational study. [2022]
Safety aspects of infliximab in inflammatory bowel disease patients. A retrospective cohort study in 100 patients of a German University Hospital. [2019]
Vedolizumab as a Treatment for Crohn's Disease and Ulcerative Colitis. [2022]
Association of Infliximab and Vedolizumab Trough Levels with Reported Rates of Adverse Events: A Cross-Sectional Study. [2021]
Incidence comparison of adverse events in patients with inflammatory bowel disease receiving different biologic agents: retrospective long-term evaluation. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Infliximab use in children and adolescents with inflammatory bowel disease. [2015]
Comparative efficacy and safety of infliximab and vedolizumab therapy in patients with inflammatory bowel disease: a systematic review and meta-analysis. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Vedolizumab for inflammatory bowel disease: From randomized controlled trials to real-life evidence. [2018]
Use of Vedolizumab in Inflammatory Bowel Disease: A Single-Center Experience. [2022]
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