NP-101 (TQ Formula) With Nivolumab and Ipilimumab in Advanced or Metastatic Extra-pulmonary Neuroendocrine Carcinomas

Inclusion Criteria: * Subjects must have histologically or cytologically confirmed of relapsed and/or refractory unresectable advanced and/or metastatic high-grade extra-pulmonary neuroendocrine carcinoma (EP-NECAs), and have failed at least one standard line of therapy. * Subjects must have received at least one prior therapy for this disease. Subjects must have recovered from acute toxicities of prior chemotherapy. Any prior non-hematologic vital organ toxicity (cardiac, pulmonary, hepatic, and renal) of previous therapy must have resolved to grade 1 or less. Neurological toxicities must have resolved to grade 2 or less. * Age \>18 years. * Subjects must have radiologic disease measurable by RECIST criteria. * All previous chemotherapy or radiation must be completed at least three weeks prior to starting study treatment. * Performance status ECOG Performance status ≤ 2 * Subjects must have normal organ and marrow function as defined below: * Hemoglobin ≥ 7.0 g/dl * Absolute neutrophil count ≥ 1,500/mcL * Platelet count ≥ 75,000/mcL * Total bilirubin ≤ 3 X institutional upper limit of normal (except subjects with elevated bilirubin unrelated to liver dysfunction) * AST (SGOT) ≤ 2.5 X institutional upper limit of normal * ALT (SGPT) ≤ 2.5 X institutional upper limit of normal * Serum Creatinine ≤ 1.5 X institutional upper limit of normal * Subjects must have the ability to understand and the willingness to sign a written informed consent document. * Subjects o…