Vedolizumab for Cancer-Related Diarrhea or Colitis
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to assess the prevention of immune checkpoint inhibitors (ICI) related diarrhea/colitis using vedolizumab in participants with unresectable stage III or metastatic stage IV cancer, starting standard of care (SOC) immunotherapy
Are You a Good Fit for This Trial?
This trial is for adults with advanced or metastatic cancer who are about to start standard immunotherapy and have signs suggesting a higher risk of developing diarrhea or colitis from treatment. Participants must be able and willing to receive IV study medication.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Vedolizumab
Trial Overview
The study compares vedolizumab (an IV medicine) versus placebo, given alongside usual cancer immunotherapy, to see if it can prevent diarrhea or colitis caused by immune checkpoint inhibitors. Patients are randomly assigned to either group.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants receive 300 mg vedolizumab IV at Baseline (Week 0) Weeks 2, 6, 14, and 22.
Participants receive 300 mg placebo IV at Baseline (Week 0) Weeks 2, 6, 14, and 22.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Calgary
Lead Sponsor
AHS Cancer Control Alberta
Lead Sponsor
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