Ignite Creation Date:
2025-12-26 @ 3:59 PM
Ignite Modification Date:
2026-02-24 @ 12:14 AM
Study NCT ID:
NCT02534506
Status:
COMPLETED
Last Update Posted:
2020-05-18
First Post:
2015-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Urelumab in Subjects With Advanced and/or Metastatic Malignant Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000620833', 'term': 'urelumab'}, {'id': 'D000077594', 'term': 'Nivolumab'}], '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': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2016-11-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-14', 'studyFirstSubmitDate': '2015-08-05', 'studyFirstSubmitQcDate': '2015-08-25', 'lastUpdatePostDateStruct': {'date': '2020-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of urelumab monotherapy as measured by the dose limiting toxicity (DLT) in subjects with advanced and/or metastatic malignant tumors', 'timeFrame': 'From day 1 of treatment up to 60 days of follow-up'}, {'measure': 'Safety of urelumab monotherapy as measured by adverse events (AEs) and serious adverse events (SAEs) in subjects with advanced and/or metastatic malignant tumors', 'timeFrame': 'From day 1 of treatment up to 60 days of follow-up'}, {'measure': 'Tolerability of urelumab monotherapy as measured by the DLT in subjects with advanced and/or metastatic malignant tumors', 'timeFrame': 'From day 1 of treatment up to 60 days of follow-up'}, {'measure': 'Tolerability of urelumab monotherapy as measured by AEs and SAEs in subjects with advanced and/or metastatic malignant tumors', 'timeFrame': 'From day 1 of treatment up to 60 days of follow-up'}], 'secondaryOutcomes': [{'measure': 'Safety of urelumab-nivolumab combination therapy as measured by AEs and SAEs in subjects with advanced and/or metastatic malignant tumors', 'timeFrame': 'From day 1 of treatment up to 100 days of follow-up'}, {'measure': 'Tolerability of urelumab-nivolumab combination therapy as measured by AEs and SAEs in subjects with advanced and/or metastatic malignant tumors', 'timeFrame': 'From day 1 of treatment up to 100 days of follow-up'}, {'measure': 'Cmax (Maximum observed serum concentration) of urelumab when administered alone', 'timeFrame': 'Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up', 'description': '21 days/cycle for Urelumab monotherapy'}, {'measure': 'Ctrough (Trough observed serum concentration) of urelumab when administered alone', 'timeFrame': 'Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up', 'description': '21 days/cycle for Urelumab monotherapy'}, {'measure': 'Tmax (Time of maximum observed serum concentration) of urelumab when administered alone', 'timeFrame': 'Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up', 'description': '21 days/cycle for Urelumab monotherapy'}, {'measure': 'AUC(0-T) [Area under the concentration-time curve from time zero to the last quantifiable concentration] of urelumab when administered alone', 'timeFrame': 'Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up', 'description': '21 days/cycle for Urelumab monotherapy'}, {'measure': 'AUC(TAU) [Area under the concentration-time curve in one dosing interval] of urelumab when administered alone', 'timeFrame': 'Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up', 'description': '21 days/cycle for Urelumab monotherapy'}, {'measure': 'AUC(INF) [Area under the concentration-time curve from time zero to infinity and the extrapolated area] of urelumab when administered alone', 'timeFrame': 'Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up', 'description': '21 days/cycle for Urelumab monotherapy'}, {'measure': 'T-HALF (Elimination half life) of urelumab when administered alone', 'timeFrame': 'Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up', 'description': '21 days/cycle for Urelumab monotherapy'}, {'measure': 'CLT (Total body clearance) of urelumab when administered alone', 'timeFrame': 'Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up', 'description': '21 days/cycle for Urelumab monotherapy'}, {'measure': 'Vss (Volume of distribution at steady state) of urelumab when administered alone', 'timeFrame': 'Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up', 'description': '21 days/cycle for Urelumab monotherapy'}, {'measure': 'AI (Accumulation Index: ratio of AUC(TAU) and Cmax in cycle at steady state to those after the first cycle) of urelumab when administered alone', 'timeFrame': 'Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up', 'description': '21 days/cycle for Urelumab monotherapy'}, {'measure': 'Cmax of urelumab when co-administered', 'timeFrame': 'Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up', 'description': '28 days/cycle for combination therapy of Urelumab and Nivolumab'}, {'measure': 'Coeff of urelumab when co-administered', 'timeFrame': 'Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up', 'description': '28 days/cycle for combination therapy of Urelumab and Nivolumab'}, {'measure': 'Ctrough of urelumab and nivolumab when co-administered', 'timeFrame': 'Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up', 'description': '28 days/cycle for combination therapy of Urelumab and Nivolumab'}, {'measure': 'Tmax of urelumab and nivolumab when co-administered', 'timeFrame': 'Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up', 'description': '28 days/cycle for combination therapy of Urelumab and Nivolumab'}, {'measure': 'AUC(0-T) of urelumab and nivolumab when co-administered', 'timeFrame': 'Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up', 'description': '28 days/cycle for combination therapy of Urelumab and Nivolumab'}, {'measure': 'AUC(TAU) of urelumab and nivolumab when co-administered', 'timeFrame': 'Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up', 'description': '28 days/cycle for combination therapy of Urelumab and Nivolumab'}, {'measure': 'AUC(INF) of urelumab and nivolumab when co-administered', 'timeFrame': 'Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up', 'description': '28 days/cycle for combination therapy of Urelumab and Nivolumab'}, {'measure': 'T-HALF of urelumab when co-administered', 'timeFrame': 'Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up', 'description': '28 days/cycle for combination therapy of Urelumab and Nivolumab'}, {'measure': 'CLT of urelumab when co-administered', 'timeFrame': 'Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up', 'description': '28 days/cycle for combination therapy of Urelumab and Nivolumab'}, {'measure': 'Vss of urelumab when co-administered', 'timeFrame': 'Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up', 'description': '28 days/cycle for combination therapy of Urelumab and Nivolumab'}, {'measure': 'Anti-drug Antibody (ADA) status of the subject in response to Urelumab when administered alone', 'timeFrame': 'Cycle 1, 2, 4, 8, 12, 16, up to 60 days of follow up', 'description': '21 days/cycle for Urelumab monotherapy'}, {'measure': 'ADA status of the subject in response to Urelumab and Nivolumab when co-administered', 'timeFrame': 'Cycle 1, 2, 4, 5, 9, up to 100 days of follow up', 'description': '28 days/cycle for combination therapy of Urelumab and Nivolumab'}, {'measure': 'Best overall response (BOR) of urelumab monotherapy', 'timeFrame': 'Every 6-8 weeks during the treatment period'}, {'measure': 'BOR of urelumab and nivolumab combination therapy', 'timeFrame': 'Every 6-8 weeks during the treatment period'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Advanced malignant tumors', 'Metastatic malignant tumors'], 'conditions': ['Malignant Tumors']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://bms.com/studyconnect/Pages/home.aspx', 'label': 'BMS Clinical Trial Patient Recruiting'}, {'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_inquiry_form.aspx', 'label': 'Investigator Inquiry Form'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and tolerability of BMS-663513 in subjects with advanced and/or metastatic malignant tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com\n\nInclusion Criteria:\n\n* Subjects with previously treated advanced malignant solid tumor\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1\n* For certain subjects, willing and able to provide pre-treatment tumor sample\n\nExclusion Criteria:\n\n* Known or suspected central nervous system metastases or central nervous system as the only source of disease\n* Other concomitant malignancies (with some exceptions per protocol)\n* Active, known or suspected autoimmune disease'}, 'identificationModule': {'nctId': 'NCT02534506', 'briefTitle': 'Study of Urelumab in Subjects With Advanced and/or Metastatic Malignant Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 1 Study of the Safety, Tolerability, Pharmacokinetics and Immunoregulatory Activity of Urelumab (BMS-663513) in Subjects With Advanced and/or Metastatic Malignant Tumors', 'orgStudyIdInfo': {'id': 'CA186-110'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Urelumab (+ Nivolumab) intravenous (IV) infusion', 'interventionNames': ['Drug: Urelumab', 'Drug: Nivolumab']}], 'interventions': [{'name': 'Urelumab', 'type': 'DRUG', 'armGroupLabels': ['Urelumab (+ Nivolumab) intravenous (IV) infusion']}, {'name': 'Nivolumab', 'type': 'DRUG', 'armGroupLabels': ['Urelumab (+ Nivolumab) intravenous (IV) infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6500017', 'city': 'Kobe', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Local Institution', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Ono Pharmaceutical Co. Ltd', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}