Finding studies
Finding studies
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Lead
Ohio State University Comprehensive Cancer Center
PRIMARY OBJECTIVES: I. Evaluate the effect of the ibrutinib therapy on circulating levels of myeloid derived suppressor cells MDSC. SECONDARY OBJECTIVES: I. Assess safety of the study combination in study subjects. EXPLORATORY OBJECTIVES: I. Evaluate the effect of the ibrutinib/nivolumab therapy on circulating levels of MDSC. II. Evaluate the effect of the ibrutinib and ibrutinib/nivolumab therapy on the immunosuppressive function of circulating MDSC by measuring their ability to inhibit T cell proliferation and natural killer cell mediated antibody dependent cell cytotoxicity. III. Study the effect of ibrutinib and ibrutinib/nivolumab therapy on levels of circulating innate and adaptive immune cells such as natural killer cell and T lymphocyte subsets. IV. Study circulating MDSC levels at the time of disease progression. V. Evaluate in a preliminary fashion the effect of the regimen on progression-free survival. OUTLINE: Participants receive ibrutinib orally (PO) daily for 15 days. After 7 days receiving ibrutinib, participants receive nivolumab intravenously (IV) over 60 minutes on days 1 and 15. Courses with nivolumab repeat every 28 days in the absence of disease progression or unaccepted toxicity. After completion of study treatment, participants are followed up every 3 months.
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
