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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
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
Patients with genitourinary cancer or melanoma or non-small cell lung cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 2 weeks after initiation of infliximab or vedolizumab with corticosteroid taper
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I don't have an active GI infection as confirmed by tests or my doctor.
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I have genitourinary cancer, melanoma, or non-small cell lung cancer.
Select...
I can understand and am willing to sign the informed consent.
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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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical remission/response rate of immune-mediated colitis (IMC)
Treatment-related adverse events
Secondary outcome measures
Clinical remission/response rate of IMC
Complete weaning of corticosteroid
Recurrent immune-related diarrhea/colitis
Other outcome measures
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 moreSide effects data
From 2019 Phase 4 trial • 11 Patients • NCT025597139%
Crohn's disease
9%
Gastrointestinal motility disorder
9%
Paronychia
9%
Viral infection
9%
Colitis ulcerative
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vedolizumab 300 mg
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
~10330
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,968 Previous Clinical Trials
1,786,772 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,541 Total Patients Enrolled
Yinghong WangPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
840 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am younger than 18 years old.I do not have active inflammatory bowel disease or radiation enterocolitis.I don't have an active GI infection as confirmed by tests or my doctor.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.I am not on any immunosuppressive therapies except for colitis treatment.I am not pregnant, have evidence of menopause, or have confirmed 'no pregnancy' status recently.I have genitourinary cancer, melanoma, or non-small cell lung cancer.I can understand and am willing to sign the informed consent.I am receiving or have received immune checkpoint inhibitor therapy.I've had severe diarrhea or colitis due to immune therapy in the last 45 days.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (infliximab)
- Group 2: Arm II (vedolizumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the most common reasons that patients take Vedolizumab?
"Vedolizumab is often used when other treatments have failed. Additionally, it can be effective in managing various conditions like psoriasis, ulcerative colitis, and Crohn's disease."
Answered by AI
Are there any other similar drugs to Vedolizumab that have been studied?
"There are 15 phase 3 trials and 66 other active studies investigating vedolizumab. The research is being conducted at 1205 facilities, with a significant portion of the work happening in Houston, Texas."
Answered by AI
Are new patients still being enrolled in this clinical trial?
"Correct, the listed information on clinicaltrials.gov indicates that this research is still recruiting patients. The trial was first advertised on 7/9/2020 and updated as recently as 6/21/2022. They are searching for 100 individuals from 1 location to take part in the study."
Answered by AI
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