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Protocol No. 2012IS098 Principal Investigator Cooley, Sarah
Phase Phase I
Age Group Adult Scope National
Secondary Protocol No. CA223-002
Title A Phase I Study of BMS-986015, an Anti-KIR Monoclonal Antibody, Administered with Ipilimumab, an Anti-CTLA4 Monoclonal Antibody, in Subjects with Select Advanced Solid Tumors
Objective The purpose of this study is to assess the safety and tolerability of BMS-986015 given in combination with BMS-936558 and to identify dose limiting toxicities (DLTs) and the maximally tolerated dose (MTD) of the combination, in subjects with advanced (metastatic and/or unresectable) solid tumors.
Treatment BMS-986015 given in combination with BMS-936558. BMS-986015 will be given at escalating doses of 0.1, 0.3, 1 and 3 mg/kg with 3 mg/kg of BMS-936558.
Description The aim of this study is to potentiate the anti-tumor activity of ipilimumab by the addition of an anti-KIR antibody in patients with select advanced solid tumors who currently have limited treatment options. This study will address the safety and feasibility of the combination of BMS-986015 and ipilimumab.
Key Eligibility Subjects must have histologic confirmation of one of the following solid tumors that is advanced (unresectable or metastatic); Non-Small Cell Lung Cancer, Castrate Resistant Prostate Cancer, or Melanoma.
Applicable Disease Sites Lung
Melanoma, skin
Drugs Involved Ipilimumab
Status Open
Participating Institutions Masonic Cancer Center
Detailed Eligibility Must be at least 18 years of age. Subjects must have received and either progressed or been intolerant to a minimum of ONE standard treatment regimen and to a maximum of FIVE prior treatment regimens. Subjects with MEL may be treatment naive. All subjects must have at least one measurable lesion at baseline by CT or MRI. Women who are pregnant or nursing are not eligible. Must have adequate organ function as noted by laboratory values. Anyone with brain metastases, significant cardiac disease, prior bone marrow transplant or chronic hepatitis is not eligible. A signed informed consent and HIPAA authorization are required.
Treatment Type Treatment
Contact Elizabeth Kerr Phone:952-836-3740
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