Molecular Monitoring With Circulating Tumor DNA and Nivolumab Maintenance

Exclusion Criteria

• •Patients with second malignancies (except monoclonal B cells of undetermined significance, antecendant indolent non Hodgkin lymphoma, non-melanomatous skin cancers, papillary thyroid carcinomas, ductal carcinoma in-situ, superficial bladder cancer, prostate cancer or in situ cervical cancers) are excluded unless a complete remission was achieved at least 3 years prior to enrollment and no additional therapy is required or anticipated to be required during the treatment.
• •Subjects with active autoimmune disease or a syndrome that requires systemic corticosteroids
• •Subjects who received non-oncology vaccine therapies for prevention of infectious disease within 4 weeks of study drug administration.
• •Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 agent
• •Any contraindication to therapy with nivolumab
• •Prior allogeneic transplantation
• •Known hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Patients with documented cure from HCV infection will be included
• •Known uncontrolled human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS). Patients with documented controlled HIV infection (CD4 \> 200 and undetectable viral load) will be included.
• •Any condition requiring systemic treatment with corticosteroids (\> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days prior to first dose of study drug. Inhaled or topical steroids and adrenal replacement steroid doses \> 10 mg daily prednisone or equivalent are permitted in the absence of active autoimmune disease.
• •History of anaphylactic reaction to monoclonal antibody therapy
• •Poor psychiatric risk
• •Patients receiving other investigational agents
• •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• •Pregnant or breast feeding. Refer to section 4.4 for further details