Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2026-02-22 @ 9:37 AM
Study NCT ID:
NCT01455103
Status:
WITHDRAWN
Last Update Posted:
2011-12-13
First Post:
2011-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1 Biomarker Study of Anti-PDL-1 in Advanced Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000627113', 'term': 'BMS-936559'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2013-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-12-12', 'studyFirstSubmitDate': '2011-10-18', 'studyFirstSubmitQcDate': '2011-10-18', 'lastUpdatePostDateStruct': {'date': '2011-12-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evidence of immunomodulatory effects of BMS-936559 as measured by changes from baseline in biomarkers assessed 1) peripheral blood assays including flow cytometry and soluble factors and 2) tumor based assays including immunohistochemistry', 'timeFrame': 'Baseline and within the first 24 weeks of study participation'}], 'secondaryOutcomes': [{'measure': 'Safety and tolerability of BMS-936559 as measured by the incidence of adverse events (AEs), serious AEs, laboratory test abnormalities, and changes in vital signs', 'timeFrame': 'Every 2 weeks until 70 days after last treatment'}, {'measure': 'Antitumor Activity of BMS-936559 as measured by the objective response rate, disease control rate, duration of response, and progression free survival', 'timeFrame': 'Every 6 weeks for 1 year, every 12 weeks thereafter until confirmed disease progression'}, {'measure': 'Immunogenicity of BMS-936559 as measured by the frequency of subjects with an increase in anti-drug antibody levels from baseline', 'timeFrame': 'Baseline, Week 6, Week 12, and then every 12 weeks until follow-up'}, {'measure': 'Pharmacodynamic activity of BMS-936559 as measured by changes from baseline of the tetramer assay in HLA-A*0210 positive subject only', 'timeFrame': 'Predose (screening) and Cycle 3 Day 1'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Stage III or IV Melanoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate pharmacodynamic changes of BMS-936559 treatment on the biomarkers measured in the peripheral blood and tumor tissues of subjects with unresectable Stage III or IV Melanoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) status = 0 to 1\n* Subjects with unresectable Stage III or IV Melanoma who are either refractory or intolerant to, or have refused standard therapy for treatment of metastatic Melanoma\n* Subject must have histologic or cytologic confirmation of advanced Melanoma\n* Subjects must have at least one measurable lesion at baseline by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria\n* Subjects must have at least 1 tumor site that can be biopsied at acceptable clinical risk and must consent to pre- and post-treatment biopsies\n\nExclusion Criteria:\n\n* Active or progressing brain metastases\n* Other concomitant malignancies (with some exceptions per protocol)\n* Active or history of autoimmune disease\n* Positive test for human immunodeficiency virus (HIV) 1\\&2 or known acquired immunodeficiency syndrome (AIDS)\n* History of any hepatitis\n* Prior therapy with any antibody/drug that targets the T cell coregulatory proteins, including but not limited to, anti Programmed cell death 1 (PD-1), anti Programmed cell death ligand 1 (anti-PD-L1), anti-PD-L2, anti-CD137, anti-OX-40, anti-CD40 or anti Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4) antibodies'}, 'identificationModule': {'nctId': 'NCT01455103', 'acronym': 'PD-L1', 'briefTitle': 'Phase 1 Biomarker Study of Anti-PDL-1 in Advanced Melanoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase I Study of the Biologic Effects of BMS-936559 Treatment in Subjects With Unresectable Stage III or IV Melanoma', 'orgStudyIdInfo': {'id': 'CA210-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: BMS-936559 (1mg/kg)', 'interventionNames': ['Biological: BMS-936559 (Anti-PD-L1)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2: BMS-936559 (3mg/kg)', 'interventionNames': ['Biological: BMS-936559 (Anti-PD-L1)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3: BMS-936559 (10mg/kg)', 'interventionNames': ['Biological: BMS-936559 (Anti-PD-L1)']}], 'interventions': [{'name': 'BMS-936559 (Anti-PD-L1)', 'type': 'BIOLOGICAL', 'otherNames': ['MDX1105'], 'description': 'Solution, Intravenous infusion, 1 mg/kg, Every 2 weeks, Up to 2 years, depending on response', 'armGroupLabels': ['Arm 1: BMS-936559 (1mg/kg)']}, {'name': 'BMS-936559 (Anti-PD-L1)', 'type': 'BIOLOGICAL', 'otherNames': ['MDX1105'], 'description': 'Solution, Intravenous infusion, 3 mg/kg, Every 2 weeks, Up to 2 years, depending on response', 'armGroupLabels': ['Arm 2: BMS-936559 (3mg/kg)']}, {'name': 'BMS-936559 (Anti-PD-L1)', 'type': 'BIOLOGICAL', 'otherNames': ['MDX1105'], 'description': 'Solution, Intravenous infusion, 10 mg/kg, Every 2 weeks, Up to 2 years, depending on response', 'armGroupLabels': ['Arm 3: BMS-936559 (10mg/kg)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}