Patient description: A 46-year-old man presents with dizziness and frequent headaches. He has a family history of CAD, but no other cardiovascular risk factors such as smoking, high blood pressure, and diabetes mellitus and is physically active. The patient's LDL-C and HDL-C levels were 545 and 53 mg/dL, respectively. His fasting glucose and triglyceride levels (85 and 158 mg/dL, resp.) were within normal limits. The patient reported no use of lipid-lowering medications. Neck auscultation revealed a systolic murmur 3+/6+ in the neck, radiating to the skull. Ultrasonography of the carotid arteries, revealed severe stenosis in the left internal carotid artery (LICA), as well as moderate stenosis in the right internal carotid artery (RICA) estimated between 40% and 50%. For the LICA, the peak-systolic (PSV) and end-diastolic velocity (EDV) cutoff values were 208.5 cm/s and 54.5 cm/s, respectively; RICA PSV was 91.72 cm/s and RICA EDV was 37.37 cm/s. Plaque was observed in the anterior and posterior walls of the internal carotid artery and common carotid artery, which were characterized as bulky plates extending to the middle third of the internal coronary arteries (ICAs) and as predominantly echogenic and hyperechoic, with less than 50% of the area being echolucent with uneven surfaces.

Clinical trial eligibility criteria: eligible ages (years): 18.0-999.0,  Metastatic Cancer Recurrent Cancer Solid Tumor Renal Cell Carcinoma Urothelial Carcinoma NSCLC Squamous Cell Carcinoma Non-Small Cell Lung Cancer Squamous Cell Carcinoma of the Head and Neck At least 18 years of age Participants must have histologically or cytologically confirmed renal cell carcinoma,urothelial carcinoma, non-small cell lung cancer, squamous cell carcinoma of the head and neck or melanoma Participants must have recurrent or metastatic disease that is not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy) Must be willing and able to give informed consent and adhere to protocol therapy; written informed consent and any locally required authorization must be obtained from the participant prior to performing any protocol-related procedures, including screening evaluations Prior exposure to PD-1/PD-L1 inhibitor monotherapy, or prior exposure to CTLA-4 inhibitor monotherapy is allowed Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Adequate normal organ and marrow function Participants who are receiving therapeutic anti-coagulant therapy are eligible Palliative radiation therapy is allowed to non-target lesions at the discretion of the treating physician Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as outlined in version 1.1  Prior exposure to a combination of IRX-2 regimen, PD-1/PD-L1 inhibitors and CTLA-4 inhibitors are excluded. Prior exposure to PD-1/PD-L1 inhibitors is allowed Radiation therapy with a curable intent within 30 days of first dose of study treatment is excluded. However, radiation therapy with a palliative intent is allowed to treat after 14 days from the last dose of radiation Any medical contraindications or previous therapy that would preclude treatment with the IRX-2 Regimen, or nivolumab Any unresolved toxicity Grade 2 or greater from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the criteria Participants with irreversible toxicity not reasonably expected to be exacerbated by treatment with IRX-2, or nivolumab may be included only after consultation with the study physician Active or prior documented autoimmune or inflammatory disorders Current or prior use of immunosuppressive medication within 14 days before the first dose of study treatment. Some exceptions apply Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of study treatment. Note: Local surgery of isolated lesions for palliative intent is acceptable History of allogenic organ transplantation Symptomatic cardiopulmonary disease, coronary artery disease, serious arrhythmia or chronic lung disease. Participants with these conditions who are stable with relatively minor symptoms and who are appropriate candidates for systemic treatments need not be excluded