Nivolumab and HPV-16 Vaccination in Patients With HPV-16 Positive Incurable Solid Tumors

Inclusion Criteria

• Signed Written Informed Consent: a. Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care. b) Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.
• Target Population: a. Men and women >/= 18 years of age. b. Eastern Cooperative Oncology Group (ECOG) performance status of /= 2000/uL; ii) Neutrophils >/= 1500/uL; iii) Platelets >/= 100 x 10^3/uL; iv) Hemoglobin >/= 9.0 g/dL; v) Serum creatinine of 40 mL/minute (using Cockcroft/Gault formula). Female CrCl= (140- age in years) x weight in kg x 0.85 72 x serum creatinine in mg/ dL. Male CrCl= (140- age in years) x weight in kg x 1.00 72 x serum creatinine in mg/ dL; vi) AST 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
• Medical History and Concurrent Diseases: c. Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways). d. Subjects with a history of interstitial lung disease. e. Other active malignancy requiring concurrent intervention. f. Subjects with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period.
• Medical History and Concurrent Diseases: g. Subjects with toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue that have not resolved to grade 1 (NCI CTCAE version 4) or baseline before administration of study drug. h. Subjects who have not recovered from the effects of major surgery or significant traumatic injury at least 14 days before the first dose of study treatment. i. Treatment with any investigational agent within 28 days of first administration of study treatment.
• Physical and Laboratory Test Findings: a) Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). b) Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection.
• Allergies and Adverse Drug Reaction: a) History of severe hypersensitivity reactions to other monoclonal antibodies. b) History of allergy or intolerance (unacceptable adverse event) to study drugs components.
• Sex and Reproductive Status: a) WOCBP who are pregnant or breastfeeding. b) Women with a positive pregnancy test at enrollment or prior to administration of study medication
• Prohibited Treatments and/or Restricted Therapies: a) Ongoing or planned administration of anti-cancer therapies other than those specified in this study. b) Use of corticosteroids or other immunosuppressive medications as per Exclusion Criteria 2b.
• Other Exclusion Criteria: a) Any other serious or uncontrolled medical disorder, active infection, physical exam finding, laboratory finding, altered mental status, or psychiatric condition that, in the opinion of the investigator, would limit a subject's ability to comply with the study requirements, substantially increase risk to the subject, or impact the interpretability of study results. b) Prisoners or subjects who are involuntarily incarcerated. c) Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.