protocolSection identificationModule nctId: NCT06337695, orgStudyIdInfo id: HREBA.CC-23-0271, briefTitle: VERIFY: Vedolizumab for the Prevention of Immune Checkpoint Inhibitor Related Diarrhea or Colitis in Patients With Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2026-11-01, completionDateStruct date: 2026-12-01, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: University of Calgary, class: OTHER, descriptionModule briefSummary: 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, conditionsModule conditions: Cancer, conditions: Cancer Metastatic, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A Randomized, Double-Blinded, Placebo Controlled Trial, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 298, type: ESTIMATED, armsInterventionsModule interventions name: Vedolizumab, interventions name: Placebo, outcomesModule primaryOutcomes measure: Hazard Ratio of Patients achieving ICI-related diarrhea and colitis-free survival a 6-months, secondaryOutcomes measure: Proportion of patients with histologically confirmed colitis-free survival at 6 months, secondaryOutcomes measure: Proportion of patients with severe diarrhea or colitis at 6 months, secondaryOutcomes measure: Hazard Ratio of patients with diarrhea or colitis after 6 months, secondaryOutcomes measure: Total average dose of checkpoint inhibitor therapy received within 6 and 12 months, secondaryOutcomes measure: Proportion of participants who require temporary ICI discontinuation due to immune-related adverse events (irAEs), secondaryOutcomes measure: Proportion of participants who require permanent ICI discontinuation due to irAEs, secondaryOutcomes measure: Proportion of patients requiring rescue corticosteroids for ICI related diarrhea/colitis, secondaryOutcomes measure: Total average prednisone equivalent dose of rescue corticosteroids required, secondaryOutcomes measure: Proportion of participants requiring all-cause hospitalization by Day +180 and Day +365, secondaryOutcomes measure: Proportion of participants requiring ICI-related diarrhea/colitis-specific hospitalization by Day +180 and Day +365, secondaryOutcomes measure: Mean change in the EuroQol EQ-5D instrument at Day +180 and Day +365 compared to baseline, secondaryOutcomes measure: Overall survival (measured as death) at +180 and Day +365 compared to baseline, secondaryOutcomes measure: Progression-free survival at 6- and 12-months, defined using the Response Evaluation Criteria in Solid Tumors (RECIST), v1.176, secondaryOutcomes measure: Proportion of participants experiencing any adverse events (AEs), secondaryOutcomes measure: Proportion of participants experiencing serious AEs, secondaryOutcomes measure: Proportion of participants experiencing other irAEs, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False