Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2025-12-27 @ 10:46 PM
Study NCT ID:
NCT06337695
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-03-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VERIFY: Vedolizumab for the Prevention of Immune Checkpoint Inhibitor Related Diarrhea or Colitis in Patients With Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C543529', 'term': 'vedolizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A Randomized, Double-Blinded, Placebo Controlled Trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 298}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-01', 'studyFirstSubmitDate': '2024-03-22', 'studyFirstSubmitQcDate': '2024-03-22', 'lastUpdatePostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hazard Ratio of Patients achieving ICI-related diarrhea and colitis-free survival a 6-months', 'timeFrame': 'Start of immunotherapy therapy and for 6 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients with histologically confirmed colitis-free survival at 6 months', 'timeFrame': '6 months', 'description': '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.'}, {'measure': 'Proportion of patients with severe diarrhea or colitis at 6 months', 'timeFrame': '6 months', 'description': 'Severe diarrhea or colitis will be defined as CTCAE grade ≥3'}, {'measure': 'Hazard Ratio of patients with diarrhea or colitis after 6 months', 'timeFrame': '6-12 months', 'description': 'Diarrhea or colitis will be defined as CTCAE grade ≥2'}, {'measure': 'Total average dose of checkpoint inhibitor therapy received within 6 and 12 months', 'timeFrame': '0 to 6 months; and 0 to 12 months', 'description': 'The total average dose of ICI therapy will be used'}, {'measure': 'Proportion of participants who require temporary ICI discontinuation due to immune-related adverse events (irAEs)', 'timeFrame': '0 to 12 months', 'description': 'Temporary discontinuation of ICI therapy will be defined as any delay of 1-week or more resulting from an immune-related adverse event (irAE), as identified and graded using the Common Terminology Criteria for Adverse Events (CTCAE v5.0).'}, {'measure': 'Proportion of participants who require permanent ICI discontinuation due to irAEs', 'timeFrame': '0 to 12 months', 'description': 'Permanent discontinuation of ICI therapy will be defined as stopping ICI therapy, and not restarting within the 1-year time window of the trial resulting from an immune-related adverse event (irAE), as identified and graded using the Common Terminology Criteria for Adverse Events (CTCAE v5.0).'}, {'measure': 'Proportion of patients requiring rescue corticosteroids for ICI related diarrhea/colitis', 'timeFrame': 'at 6-months and 12-months', 'description': 'Any patient who receives rescue corticosteroids within the first 6 months or within the first 12 months will be considered an event.'}, {'measure': 'Total average prednisone equivalent dose of rescue corticosteroids required', 'timeFrame': 'at 6-months and 12-months', 'description': 'The prednisone equivalent dose will be calculated using the following conversions:\n\nCortisone 5mg = Prednisone 1mg Hydrocortisone 4mg = Prednisone 1mg Prednisolone 1mg = Prednisone 1mg Methylprednisolone 0.8mg = Prednisone 1mg Dexamethasone 0.15mg = Prednisone 1mg'}, {'measure': 'Proportion of participants requiring all-cause hospitalization by Day +180 and Day +365', 'timeFrame': 'at day 180 and 365', 'description': 'Chart review will be used to identify hospitalizations.'}, {'measure': 'Proportion of participants requiring ICI-related diarrhea/colitis-specific hospitalization by Day +180 and Day +365', 'timeFrame': 'at day 180; at day 365', 'description': 'Chart review will be used to identify hospitalization and determine the cause of hospitalization.'}, {'measure': 'Mean change in the EuroQol EQ-5D instrument at Day +180 and Day +365 compared to baseline', 'timeFrame': 'baseline to day 180; baseline to day 365', 'description': 'The EuroQol EQ-5D is a validated questionnaire for patients with inflammatory bowel disease.'}, {'measure': 'Overall survival (measured as death) at +180 and Day +365 compared to baseline', 'timeFrame': 'Day +180 and Day +365', 'description': 'All-cause mortality will be used to compare the survival rate of the therapy and placebo arms. The rates will be calculated for 6 months (defined at day 180) and 1-year (day 365).'}, {'measure': 'Progression-free survival at 6- and 12-months, defined using the Response Evaluation Criteria in Solid Tumors (RECIST), v1.176', 'timeFrame': 'At Day +180 and Day +365', 'description': 'Progression-free survival will be defined using the Response Evaluation Criteria in Solid Tumors (RECIST), v1.176'}, {'measure': 'Proportion of participants experiencing any adverse events (AEs)', 'timeFrame': 'At Day +180 and Day +365', 'description': 'Adverse events will be defined as described in good clinical practice.'}, {'measure': 'Proportion of participants experiencing serious AEs', 'timeFrame': 'At Day +180 and Day +365', 'description': 'Serious adverse events will be defined as described in good clinical practice.'}, {'measure': 'Proportion of participants experiencing other irAEs', 'timeFrame': 'At Day +180 and Day +365', 'description': 'Adverse events will be defined as described in good clinical practice. Those that are immune related will be used for this outcome.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immune Checkpoint Inhibitors'], 'conditions': ['Cancer', 'Cancer Metastatic']}, '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', 'detailedDescription': 'After being informed about the study and potential risks, all patients giving written informed consent will undergo up to a 2-week screening period to confirm their eligibility. Eligible patients will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to Vedolizumab or placebo and given their first dose within 2 weeks of starting their SOC immunotherapy. Vedolizumab or placebo will be administered at Weeks 0, 2, 6, 14, and 22.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Signed informed consent prior to initiation of any study specific activities or procedures\n* Diagnosed with unresectable advanced stage III or metastatic stage IV malignancy\n* Planned for initiation of SOC immunotherapy and development of prognostic biomarker evidence that predisposes to ICI diarrhea/colitis risk\n* Ability to and willingness to adhere to the randomized treatment interventions (vedolizumab or placebo), administered intravenously\n\nExclusion Criteria:\n\n* Condition(s) for which vedolizumab is contraindicated (e.g., hypersensitivity reaction, known allergic reaction to vedolizumab or its components)\n* Current or prior use of vedolizumab or prior immunotherapy exposure for cancer\n* Presence of inflammatory bowel disease (Crohn's disease, ulcerative colitis), indeterminate colitis, or microscopic colitis\n* Presence of ileostomy, colostomy, or short bowel syndrome\n* Presence of known luminal gastrointestinal metastases at baseline\n* Presence of significant pre-existing autoimmune disease (at investigator's discretion)\n* Presence of severe infection(s) or opportunistic infection(s)\n* Active enteric infection with viral, bacterial, or parasitic pathogens\n* Presence of untreated latent or active tuberculosis, or untreated chronic hepatitis B virus\n* Baseline ECOG status grade ≥3\n* Pregnancy or lactation\n* Treatment with another investigational product within 8 weeks of randomization\n* Requirement for baseline anti-diarrheal treatment(s) (including but not limited to loperamide, diphenoxylate-atropine, octreotide, tincture of opium), anticholinergic drug(s), or opioid-based analgesic(s) used specifically for diarrhea control within 14 days of randomization\n* Any condition or diagnosis, that could in the opinion of the Qualified Investigator or delegate interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put the participant at risk"}, 'identificationModule': {'nctId': 'NCT06337695', 'briefTitle': 'VERIFY: Vedolizumab for the Prevention of Immune Checkpoint Inhibitor Related Diarrhea or Colitis in Patients With Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': 'VERIFY: Vedolizumab for the Prevention of Immune Checkpoint Inhibitor Related Diarrhea or Colitis in Patients With Cancer: A Randomized, Double-Blinded, Placebo Controlled Trial', 'orgStudyIdInfo': {'id': 'HREBA.CC-23-0271'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vedolizumab', 'description': 'Participants receive 300 mg vedolizumab IV at weeks 0, 3, 6, 14, and 22.', 'interventionNames': ['Biological: Vedolizumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants receive 300 mg placebo IV at weeks 0, 3, 6, 14, and 22.', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'Vedolizumab', 'type': 'BIOLOGICAL', 'description': '300 mg IV at weeks 0, 3, 6, 14, and 22', 'armGroupLabels': ['Vedolizumab']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': '300 mg IV at weeks 0, 3, 6, 14, and 22', 'armGroupLabels': ['Placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Calgary', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}