Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-04-18 @ 2:03 PM
Study NCT ID:
NCT02050594
Status:
COMPLETED
Last Update Posted:
2015-07-07
First Post:
2014-01-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ipilimumab 12-month Intensive Pharmacovigilance Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000074324', 'term': 'Ipilimumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-03', 'studyFirstSubmitDate': '2014-01-14', 'studyFirstSubmitQcDate': '2014-01-29', 'lastUpdatePostDateStruct': {'date': '2015-07-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Descriptive statistics of observed adverse events (AEs) while on treatment with Ipilimumab for advanced melanoma in Venezuela', 'timeFrame': 'Up to 12 months of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Melanoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/studyconnect/Pages/home.aspx', 'label': 'BMS clinical trial educational resource'}, {'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the protocol is to identify and describe observed adverse events (AEs) while on treatment with Ipilimumab for advanced melanoma in Venezuela during the study period'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Bristol Myers de Venezuela S.A.C. has in place a Customer Model registry, which tracks every Ipilimumab prescription in Venezuela. Therefore, any oncologist who treats a patient with Ipilimumab will be identified by BMS. Use of this registry will ensure all patients who are infused with Ipilimumab are included in this study', 'healthyVolunteers': False, 'eligibilityCriteria': 'For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.\n\nInclusion Criteria:\n\n* Age of 18 years or older on date of first dose of Ipilimumab\n* Subjects who received at least 1 dose of Ipilimumab for the treatment of unresectable, recurrent or metastatic melanoma in Venezuela\n\nExclusion Criteria:\n\n* Subjects who received Ipilimumab as part of a clinical trial\n* Subjects who received Ipilimumab for any indication other than local approval (ie, unresectable or metastatic melanoma)'}, 'identificationModule': {'nctId': 'NCT02050594', 'briefTitle': 'Ipilimumab 12-month Intensive Pharmacovigilance Protocol', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Ipilimumab 12-month Intensive Pharmacovigilance Protocol', 'orgStudyIdInfo': {'id': 'CA184-366'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Melanoma patients on Ipilimumab', 'description': 'All unresectable, recurrent or metastatic melanoma patients', 'interventionNames': ['Drug: Ipilimumab']}], 'interventions': [{'name': 'Ipilimumab', 'type': 'DRUG', 'otherNames': ['Yervoy'], 'armGroupLabels': ['Melanoma patients on Ipilimumab']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Caracas', 'country': 'Venezuela', 'facility': 'Local Institution', 'geoPoint': {'lat': 10.48801, 'lon': -66.87919}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'JSS Medical Research Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}