Ibrutinib and Nivolumab in Treating Participants With Metastatic Solid Tumors

Exclusion Criteria

• •History of prior therapy with ibrutinib or nivolumab
• •Unable to swallow capsules or having disease that is significantly affecting gastrointestinal function and/or inhibiting small intestine absorption
• •Diagnosis of congenital or acquired immunodeficiency with the exception of chemotherapy induced immune suppression
• •Active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids of greater than or equal to prednisone 10 mg/day or other immunosuppressive agents; patients with history of adequately treated Hashimoto?s thyroiditis will be eligible; patients requiring a short course of a high dose prednisone burst to treat asthma or common obstructive pulmonary disease will also be eligible 5 days following completion of the prednisone treatment
• •Use of systemic steroids at a dose above 10 mg/day of prednisone or prednisone equivalent in cycle 1 of study therapy; systemic steroids must be discontinued at least 5 days prior to initiating study therapy; exception will be given to patients who develop immune related adverse events that necessitate use of steroids or other immune suppressive agents; following cycle 1 of study treatment, the use of systemic steroids will be allowed per discretion of the treating physician
• •Active, non-infectious pneumonitis
• •Ongoing or active infection requiring systemic therapy
• •History of being positive for human immunodeficiency virus (HIV)
• •History of hepatitis B or C
• •History of receiving live vaccine within 30 days of planned start of study therapy
• •Central nervous system (CNS) metastases or leptomeningeal carcinomatosis; patients with history of adequately treated brain metastases that are stable for \> 2 weeks prior to the first dose of study regimen are eligible as long they no longer require steroids and have no seizures or worsening focal neurologic symptoms; anti-epileptic therapy will be allowed
• •Patients who had prior systemic chemotherapy within 3 weeks (or \< 5 half-lives ? whichever is longer)
• •Prior radiation therapy within 2 weeks of study enrollment
• •Prior investigational therapy within 4 weeks
• •Major surgery within 4 weeks or minor surgery within 2 weeks prior to the first dose of study drug; port placement will not be considered major or minor surgery
• •Any inter-current, uncontrolled systemic illness or any medical or psychiatric condition that in the opinion of the investigator would make the study therapy unsafe to the patient
• •Unable to understand and sign informed consent form
• •Uncontrolled, active cardiovascular disease including, but not limited to: symptomatic congestive heart failure, any class 3 or 4 cardiac disease as defined by the New York Heart Association functional classification, unstable angina pectoris, cardiac arrhythmia
• •Any medications or substances that are strong inhibitors or inducers of CYP 3A4 need to be discontinued prior to initiation the study therapy and for the duration of ibrutinib treatment; patients can resume these medications 3 days after completion of ibrutinib course
• •History of allergic reactions attributed to compounds of similar chemical or biologic composition as ibrutinib or nivolumab