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

NCT06337695 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-08-27

No results posted yet for this study

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

Conditions

Interventions

BIOLOGICAL

Vedolizumab

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

BIOLOGICAL

Placebo

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

Sponsors & Collaborators

  • AHS Cancer Control Alberta

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-13
Primary Completion
2030-12-01
Completion
2030-12-01

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06337695 on ClinicalTrials.gov