This phase I trial studies how well ibrutinib and nivolumab work in treating participants with solid tumors that have spread to other places in the body. Ibrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Giving ibrutinib and nivolumab may work better in treating participants with solid tumors.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Circulating levels of myeloid derived suppressor cells
Will be summarized using descriptive statistics (N, mean, standard deviation, median, minimum, and maximum) and/or frequency and percentages for medically relevant categories. Changes of the continuous variables will be estimated using mixed model for repeated measures with proper data transformation as needed, and two-way tables and Chi-Square test will be used to summarize the changes of the categorical data.
Time frame: Up to 2 years
Incidence of adverse events
Will be assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Will be presented using frequencies and percentages.
Time frame: Up to 2 years
Progression free survival
One year progression free survival will be defined as proportion of patients who are free of disease progression or death (whichever occurs first) after 1 year of follow up. Progression free survival will be summarized using Kaplan and Meier methods, where patients who are event-free at the time of their last evaluation will be censored at that time point.
Time frame: Interval from study enrollment to first documented disease progression according to Response Evaluation Criteria in Solid Tumors 1.1 or death from any cause (whichever occurs first), assessed at 1 year
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