RecruitingPhase 2Phase 3NCT06337695

Vedolizumab for the Prevention of ICI Related Diarrhea or Colitis in Patients With Cancer

VERIFY: Vedolizumab for the Prevention of Immune Checkpoint Inhibitor Related Diarrhea or Colitis in Patients With Cancer: A Randomized, Double-Blinded, Placebo Controlled Trial

Sponsor

AHS Cancer Control Alberta

Enrollment

36 participants

Start Date

Aug 13, 2026

Study Type

INTERVENTIONAL

Conditions

Colitis Diarrhea Immune-related Adverse Event IrAE

Summary

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Placebo and a biological treatment called Vedolizumab for people with colitis, diarrhea, and other related conditions. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALVedolizumab

300 mg IV at weeks Baseline (Week 0) Weeks 2, 6, 14, and 22.

BIOLOGICALPlacebo

300 mg IV at Baseline (Week 0) Weeks 2, 6, 14, and 22.

Locations(2)

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

Cross Cancer Institute

Edmonton, Alberta, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06337695

Related Trials

A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)

NCT0754575989 locations

A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis

NCT07012395259 locations

Rifaximin 200 mg Plus Oral Rehydration vs Oral Rehydration Alone in Children With Acute Diarrhea

NCT072857855 locations

Inhaled Budesonide for REcurrence Prevention and Adjuvant THerapy in Checkpoint Inhibitor Pneumonitis

NCT068605421 location

The Safety and Efficacy of Ondansetron in Reducing Immune Checkpoint Inhibitor-Related Toxicities

NCT07381634