The purpose of this study is to assess the prevention of immune checkpoint inhibitors (ICIs) related diarrhea/colitis using vedolizumab in participants with unresectable stage III or metastatic stage IV cancer, starting standard of care (SOC) immunotherapy
Signed informed consent prior to initiation of any study specific activities or procedures
Diagnosed with unresectable advanced stage III or metastatic stage IV malignancy
Planned for initiation of SOC immunotherapy and development of prognostic biomarker evidence that predisposes to ICI diarrhea/colitis risk
Ability to and willingness to adhere to the randomized treatment interventions (vedolizumab or placebo), administered intravenously
Condition(s) for which vedolizumab is contraindicated (e.g., hypersensitivity reaction, known allergic reaction to vedolizumab or its components)
Current or prior use of vedolizumab or prior immunotherapy exposure for cancer
Presence of inflammatory bowel disease (Crohn's disease, ulcerative colitis), indeterminate colitis, or microscopic colitis
Presence of ileostomy, colostomy, or short bowel syndrome
Parallel
Vedolizumab
Biological/Vaccine300 mg IV at weeks 0, 3, 6, 14, and 22
Placebo
Biological/Vaccine300 mg IV at weeks 0, 3, 6, 14, and 22
Hazard Ratio of Patients achieving ICI-related diarrhea and colitis-free survival a 6-months
ICI-related diarrhea and colitis will be assessed using Common Terminology Criteria for Adverse Events (CTCAE), and a grade ≥2 will be considered an event.
Proportion of patients with histologically confirmed colitis-free survival at 6 months
Colitis-free survival will be defined as CTCAE grade ≥2 based on a biopsy taken at time of patient meeting the primary endpoint or at 6 months.
Proportion of patients with severe diarrhea or colitis at 6 months
Severe diarrhea or colitis will be defined as CTCAE grade ≥3
Hazard Ratio of patients with diarrhea or colitis after 6 months
Diarrhea or colitis will be defined as CTCAE grade ≥2
Total average dose of checkpoint inhibitor therapy received within 6 and 12 months
The total average dose of ICI therapy will be used
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