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Monoclonal Antibodies

Infliximab vs Vedolizumab for Colitis from Immunotherapy in Cancer Patients

Phase 1 & 2

Recruiting

Led By Yinghong Wang

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients who receive any type of immune checkpoint inhibitor (ICI) therapy

Patients with peak 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 initiation of study treatment (infliximab/ vedolizumab)

Must not have

Patients younger than 18 years of age

Patients with preexisting activehistory of inflammatory bowel disease and/or radiation enterocolitis with active disease status at the time of study treatment initiation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 2 weeks after initiation of infliximab or vedolizumab with corticosteroid taper

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the side effects of two drugs, infliximab and vedolizumab, to treat colitis caused by immunotherapy in patients with genital or urinary cancer or melanoma.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of infliximab and vedolizumab may include infusion reactions like fever or chills, risk of infection due to weakened immunity, possible liver damage indicated by yellowing skin/eyes (jaundice), abdominal pain, coughing up blood.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am receiving or have received immune checkpoint inhibitor therapy.

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I've had severe diarrhea or colitis due to immune therapy in the last 45 days.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am younger than 18 years old.

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I do not have active inflammatory bowel disease or radiation enterocolitis.

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I developed side effects not related to my digestive system when I started the study treatment.

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I still have a GI infection after 5 days of antibiotics.

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I am not on any immunosuppressive therapies except for colitis treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the initiation of infliximab or vedolizumab treatment till death or last follow-up, assessed up to 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the initiation of infliximab or vedolizumab treatment till death or last follow-up, assessed up to 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the initiation of infliximab or vedolizumab treatment till death or last follow-up, assessed up to 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical remission/response rate of immune-mediated colitis (IMC)

Treatment-related adverse events

Secondary study objectives

Clinical remission/response rate of IMC

Complete weaning of corticosteroid

Recurrent immune-related diarrhea/colitis

Other study objectives

Change in frequencies of immune cells in tissue/blood/stool samples

Change in levels of cytokines in tissue/blood/stool samples

Endoscopic remission (Mayo Clinic sub-score 0-1) of immune-related diarrhea/colitis

+3 more

Side effects data

From 2019 Phase 4 trial • 11 Patients • NCT02559713

Colitis ulcerative

Gastrointestinal motility disorder

Viral infection

Crohn's disease

Paronychia

100%

80%

60%

40%

20%

Study treatment Arm

Vedolizumab 300 mg

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (vedolizumab)Experimental Treatment1 Intervention

Patients receive vedolizumab IV over 1 hour at week 0, 2, 6 for a total of 3 doses in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (infliximab)Active Control1 Intervention

Patients receive infliximab IV over 1 hour once at week 0, 2, 6 for a total of 3 doses in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vedolizumab

2009

Completed Phase 4

~10220

0 / 7Eligibility criteria met