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