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 of childbearing potential must agree to practice reliable contraception or to practice abstinence for at least 28 days before and for 60 days after the last dose of study drug. Reliable contraception is defined as:
• •* One highly effective method and one additional effective (barrier) method:
• •* Examples of highly effective methods:
• •Intrauterine device (IUD)
• •Hormonal (injections, implants, levonorgestrel-releasing intrauterine system \[IUS\], medroxyprogesterone acetate depot injections, ovulation inhibitory progesterone-only pills \[e.g. desogestrel\])
• •Tubal ligation
• •Partner's vasectomy
• •* Examples of additional effective methods:
• •Male condom
• •Diaphragm
• •Cervical Cap
• •Inclusion of Women and minorities
• •People of all races and ethnic groups are eligible for this trial.