Safety Study of BMS-986015 (Anti-KIR) in Combination With Ipilimumab in Subjects With Selected Advanced Tumor
NCT ID: NCT01750580
Last Updated: 2015-07-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
22 participants
INTERVENTIONAL
2012-12-31
2015-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm 1: Lirilumab + Ipilimumab
Lirilumab and Ipilimumab on specific days
Lirilumab
Ipilimumab
Interventions
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Lirilumab
Ipilimumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Biopsies: Subjects in the melanoma cohort must have at least 1 tumor site that can be biopsied at acceptable clinical risk
* Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
* Estimated life expectancy of ≥ 12 weeks
* White blood cell (WBC) ≥2000/μL, Neutrophils ≥1500/μL, Platelets ≥ 100x1000/μL, Hemoglobin ≥ 8.5 g/dL, creatinine ≤ 1.5 X upper limit of normal (ULN) mL/min, Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 3x ULN
* Normal thyroid function or be on stable hormone supplementation
Exclusion Criteria
* Subjects with known or suspected brain metastasis
* Subjects with active autoimmune disease, uncontrolled or significant cardiovascular disease
* Prior therapy with anti- Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) antibody or anti- Killer cell immunoglobulin-like receptor (KIR) antibody
* Grade 2 neuropathy
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University Of Minnesota
Minneapolis, Minnesota, United States
Memorial Sloan Kettering Cancer Ctr
New York, New York, United States
The Ohio State University
Columbus, Ohio, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Countries
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Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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CA223-002
Identifier Type: -
Identifier Source: org_study_id
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