Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2026-01-01 @ 6:17 PM
Study NCT ID:
NCT01489059
Status:
COMPLETED
Last Update Posted:
2014-08-29
First Post:
2011-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of IL-21/Ipilimumab Combination in the Treatment of Melanoma
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': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-28', 'studyFirstSubmitDate': '2011-12-07', 'studyFirstSubmitQcDate': '2011-12-07', 'lastUpdatePostDateStruct': {'date': '2014-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part1 (Dose Escalation): The Maximum tolerated dose (MTD) of BMS-982470 using 2 distinct schedules when administered in combination with Ipilimumab', 'timeFrame': 'Within the first 63 days', 'description': 'Based on the dose-limiting toxicity (DLT) rate'}, {'measure': 'Part 2 (Cohort Escalation): Safety and tolerability of the MTD dose for each of the schedules', 'timeFrame': '84 days on treatment', 'description': 'Based on medical review of AE reports and the results of vital sign measurements, physical examinations, medical history, and clinical laboratory tests'}], 'secondaryOutcomes': [{'measure': 'Efficacy of BMS-982470 in combination with Ipilimumab as measured by objective response', 'timeFrame': 'Baseline (Day 1), End of Treatment (EOT) [3 weeks after last dose of Ipilimumab], 3 and 6 months Follow-up'}, {'measure': 'Area under the serum concentration-time curve from time zero to the last quantifiable concentration [AUC(0-T)] of BMS-982470 and Ipilimumab', 'timeFrame': '20 time points during Lead-In Cycle; Up to 11 time points during Cycle 3'}, {'measure': 'Area under the serum concentration-time curve in one dosing interval [AUC(TAU)] of BMS-982470 and Ipilimumab', 'timeFrame': '20 time points during Lead-In Cycle; Up to 11 time points during Cycle 3'}, {'measure': 'Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-982470 and Ipilimumab', 'timeFrame': '20 time points during Lead-In Cycle; Up to 11 time points during Cycle 3'}, {'measure': 'The maximum observed serum concentration (Cmax) of BMS-982470 and Ipilimumab', 'timeFrame': '20 time points during Lead-In Cycle; Up to 11 time points during Cycle 3'}, {'measure': 'Trough observed serum concentration (Cmin) of BMS-982470 and Ipilimumab', 'timeFrame': '1 time point each 3-week Cycle'}, {'measure': 'The time of maximum observed serum concentration (Tmax) of BMS-982470 and Ipilimumab', 'timeFrame': '20 time points during Lead-In Cycle; Up to 11 time points during Cycle 3'}, {'measure': 'Serum half-life (T-HALF) of BMS-982470 and Ipilimumab', 'timeFrame': '20 time points during Lead-In Cycle; Up to 11 time points during Cycle 3'}, {'measure': 'Apparent total body clearance (CLT) of BMS-982470 and Ipilimumab', 'timeFrame': '20 time points during Lead-In Cycle; Up to 11 time points during Cycle 3'}, {'measure': 'Apparent volume of distribution at steady state (Vss) of BMS-982470 and Ipilimumab', 'timeFrame': '20 time points during Lead-In Cycle; Up to 11 time points during Cycle 3'}, {'measure': 'Incidence of BMS-984270 and Ipilimumab Anti-Drug Antibodies', 'timeFrame': 'Up to 6 months following last dose'}]}, '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 purpose of this study is to determine whether the combination of interleukin-21 (IL-21) and Ipilimumab in subjects with melanoma is safe, and provide preliminary information on the clinical benefits of the combination compared with Ipilimumab alone', 'detailedDescription': 'Allocation: Part 1 Dose Escalation Phase: Non-randomized; Part 2 Cohort Expansion Phase: Randomized'}, '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* Unresectable Stage III or Stage IV melanoma\n* Part 1 Dose Escalation: Prior melanoma treatment allowed except for the following: ipilimumab, BMS-982470 (rIL-21), anti-Programmed Death-1 (anti-PD-1), anti-programmed death-ligand 1 (anti-PD-L1), anti-PD-L2 or anti-CD137\n* Part 2 Cohort expansion: Prior treatment for melanoma is not allowed, except for adjuvant therapy with interferon alpha or melanoma vaccines which are permitted\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI)\n* Normal liver function tests\n\nExclusion Criteria:\n\n* Part 1 Dose escalation: subjects with ≤ 2 brain metastases of stable size, ≥ 4 weeks post-radiation treatment, and off steroids are allowed\n* Part 2 Cohort expansion: subjects with known or suspected brain metastases and uveal melanoma are excluded\n* Autoimmune disease'}, 'identificationModule': {'nctId': 'NCT01489059', 'briefTitle': 'Safety Study of IL-21/Ipilimumab Combination in the Treatment of Melanoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase I Dose Escalation Study of BMS-982470 (Recombinant Interleukin 21, rIL-21) in Combination With Ipilimumab in Subjects With Unresectable Stage III or Stage IV Melanoma', 'orgStudyIdInfo': {'id': 'CA220-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1 - Arm 1: BMS-982470 (Daily x 5) + Ipilimumab', 'description': 'Dose Escalation', 'interventionNames': ['Biological: BMS-982470 (recombinant interleukin-21)', 'Biological: Ipilimumab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1 - Arm 2: BMS-982470 (Weekly) + Ipilimumab', 'description': 'Dose Escalation', 'interventionNames': ['Biological: BMS-982470 (recombinant interleukin-21)', 'Biological: Ipilimumab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 - Arm 1: BMS-982470 (Daily x 5) + Ipilimumab', 'description': 'Cohort Expansion', 'interventionNames': ['Biological: BMS-982470 (recombinant interleukin-21)', 'Biological: Ipilimumab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 - Arm 2: BMS-982470 (Weekly) + Ipilimumab', 'description': 'Cohort Expansion', 'interventionNames': ['Biological: BMS-982470 (recombinant interleukin-21)', 'Biological: Ipilimumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part 2 - Arm 3: Ipilimumab monotherapy', 'description': 'Cohort Expansion', 'interventionNames': ['Biological: Ipilimumab']}], 'interventions': [{'name': 'BMS-982470 (recombinant interleukin-21)', 'type': 'BIOLOGICAL', 'description': 'Solution, Intravenous, 10,30,50 μg/kg, daily for 5 days every 3 weeks (daily x 5), 16-20 weeks depending on response', 'armGroupLabels': ['Part 1 - Arm 1: BMS-982470 (Daily x 5) + Ipilimumab']}, {'name': 'BMS-982470 (recombinant interleukin-21)', 'type': 'BIOLOGICAL', 'description': 'Solution, Intravenous, 30,100,150 μg/kg, weekly, 16-20 weeks depending on response', 'armGroupLabels': ['Part 1 - Arm 2: BMS-982470 (Weekly) + Ipilimumab']}, {'name': 'BMS-982470 (recombinant interleukin-21)', 'type': 'BIOLOGICAL', 'description': 'Solution, Intravenous, Maximum tolerated dose from Part 1, daily for 5 days every 3 weeks (daily x 5), 12-16 weeks depending on response', 'armGroupLabels': ['Part 2 - Arm 1: BMS-982470 (Daily x 5) + Ipilimumab']}, {'name': 'BMS-982470 (recombinant interleukin-21)', 'type': 'BIOLOGICAL', 'description': 'Solution, Intravenous, Maximum tolerated dose from Part 1, Weekly, 12-16 weeks depending on response', 'armGroupLabels': ['Part 2 - Arm 2: BMS-982470 (Weekly) + Ipilimumab']}, {'name': 'Ipilimumab', 'type': 'BIOLOGICAL', 'otherNames': ['Yervoy®'], 'description': 'Solution, Intravenous, 1,3,10 mg/kg, every 3 weeks, 16-20 weeks depending on response', 'armGroupLabels': ['Part 1 - Arm 1: BMS-982470 (Daily x 5) + Ipilimumab', 'Part 1 - Arm 2: BMS-982470 (Weekly) + Ipilimumab']}, {'name': 'Ipilimumab', 'type': 'BIOLOGICAL', 'otherNames': ['Yervoy®'], 'description': 'Solution, Intravenous, Maximum tolerated dose from Part 1, every 3 weeks, 12-16 weeks depending on response', 'armGroupLabels': ['Part 2 - Arm 1: BMS-982470 (Daily x 5) + Ipilimumab', 'Part 2 - Arm 2: BMS-982470 (Weekly) + Ipilimumab']}, {'name': 'Ipilimumab', 'type': 'BIOLOGICAL', 'otherNames': ['Yervoy®'], 'description': 'Solution, Intravenous, 3mg/kg, Every 3 weeks, 12-16 weeks depending on response', 'armGroupLabels': ['Part 2 - Arm 3: Ipilimumab monotherapy']}]}, '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': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Ucla Hematology/Oncology.', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'H. Lee Moffitt Cancer Center & Research Inst, Inc', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Health Melvin And Bren Simon Cancer Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University Of Louisville Medical Center, Inc., Dba', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '97213', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Portland Providence Medical Center', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Md Anderson Can Cnt', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Seattle Cancer Care Alliance', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '00927', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Local Institution', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}