Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT01629758
Status:
COMPLETED
Last Update Posted:
2015-03-06
First Post:
2012-06-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety Study of IL-21/Anti-PD-1 Combination in the Treatment of Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009371', 'term': 'Neoplasms by Site'}], 'ancestors': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-05', 'studyFirstSubmitDate': '2012-06-26', 'studyFirstSubmitQcDate': '2012-06-26', 'lastUpdatePostDateStruct': {'date': '2015-03-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety, as measured by the rate of adverse events and serious adverse events', 'timeFrame': 'Approximately up to 4.5 years'}], 'secondaryOutcomes': [{'measure': 'Efficacy as measured by tumor assessment (RECIST)', 'timeFrame': 'Week 6 of for the first 4 cycles, Week 6 of alternate cycle starting with cycle 6, End of Treatment (2 years) and approximately every 12 weeks during follow-up (approximately 1 year)', 'description': 'Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 using Best overall response (BOR), Objective response rate (ORR), Duration of Response (DOR), Progression-Free Survival Rate (PFSR)'}, {'measure': 'Immunogenicity as measured by incidence of specific antidrug antibodies (ADA) to BMS-98470 and BMS-936558', 'timeFrame': 'Up to 2 years + 100 days post-treatment follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Neoplasms by Site']}, '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 purpose of this study is to determine whether the combination of the 2 drugs being investigated (IL-21 and anti-PD-1) is safe, and provide preliminary information on the clinical benefits of two different schedules of the combination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com\n\nInclusion Criteria:\n\n* All subjects will have locally advanced or metastatic solid tumors\n* For Part 2 (Cohort Expansion):\n\n * Tumor types will be restricted to clear cell renal cell carcinoma (ccRCC), non-small cell lung cancer (NSCLC), and melanoma\n* At least 1 lesion with measurable disease\n* Only subjects with tumor samples that are PD-L1 positive or negative are eligible\n\nExclusion Criteria:\n\n* Uncontrolled central nervous system (CNS) or leptomeningeal metastasis\n* Inadequate liver or kidney function\n* History of autoimmune Disease'}, 'identificationModule': {'nctId': 'NCT01629758', 'briefTitle': 'Safety Study of IL-21/Anti-PD-1 Combination in the Treatment of Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 1 Dose Escalation Study of BMS-982470 (Recombinant Interleukin-21, rIL-21) in Combination With BMS-936558 (Anti-PD-1) in Subjects With Advanced or Metastatic Solid Tumors', 'orgStudyIdInfo': {'id': 'CA220-008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1-Arm A: BMS-982470 (weekly x 4) + BMS-936558', 'description': 'Dose Escalation BMS-982470 10, 30, 50, 75 or 100 µg/kg Solution, Intravenous, During each 6 week cycle: weekly x 4 (i.e during weeks 1 through 4), Up to 2 years + BMS-936558 3 mg/kg Solution, Intravenous, During each 6 week cycle: every other week (i.e during weeks 1, 3, and 5), Up to 2 years', 'interventionNames': ['Biological: Denenicokin', 'Biological: Nivolumab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1-Arm B: BMS-982470 (3 times/week) + BMS-936558', 'description': 'Dose Escalation BMS-982470 10, 30, 50, 75 or 100 µg/kg Solution, Intravenous, During each 6 week cycle: 3 times/week during weeks 1 and 3, Up to 2 years + BMS-936558 3 mg/kg Solution, Intravenous, During each 6 week cycle: every other week (i.e during weeks 1, 3, and 5), Up to 2 years', 'interventionNames': ['Biological: Denenicokin', 'Biological: Nivolumab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2-Arm A: BMS-982470 (weekly x 4) + BMS-936558', 'description': 'Cohort Expansion BMS-982470 (dose selected in Part 1) Solution, Intravenous, During each 6 week cycle: weekly x 4 (i.e during weeks 1 through 4), Up to 2 years + BMS-936558 3 mg/kg Solution, Intravenous, During each 6 week cycle: every other week (i.e during weeks 1, 3, and 5), Up to 2 years', 'interventionNames': ['Biological: Denenicokin', 'Biological: Nivolumab']}], 'interventions': [{'name': 'Denenicokin', 'type': 'BIOLOGICAL', 'otherNames': ['BMS-982470', 'rIL-21(recombinant interleukin 21)'], 'armGroupLabels': ['Part 1-Arm A: BMS-982470 (weekly x 4) + BMS-936558', 'Part 1-Arm B: BMS-982470 (3 times/week) + BMS-936558', 'Part 2-Arm A: BMS-982470 (weekly x 4) + BMS-936558']}, {'name': 'Nivolumab', 'type': 'BIOLOGICAL', 'otherNames': ['BMS-936558', 'Anti-PD-1 (Anti-Programmed-Death-1)', 'MDX-1106'], 'armGroupLabels': ['Part 1-Arm A: BMS-982470 (weekly x 4) + BMS-936558', 'Part 1-Arm B: BMS-982470 (3 times/week) + BMS-936558', 'Part 2-Arm A: BMS-982470 (weekly x 4) + BMS-936558']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Oncology Research Associates, Pllc D/B/A', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University School Of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '21231', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Seattle Cancer Care Alliance', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}