Stereotactic Radiosurgery and Nivolumab in Treating Patients with Newly Diagnosed Melanoma Metastases in the Brain or Spine

Inclusion Criteria

• Patients must have histologically confirmed diagnosis of melanoma; the pathologic confirmation may be from another metastatic site or from metastatic brain or spine lesions
• Patients must have stage IV melanoma, with newly identified brain or spine metastases
• Patients must have measurable lesion in the brain or spine that is >= 3 mm seen on magnetic resonance imaging (MRI) with contrast; NOTE: contrasted pre-treatment MRI scan must be obtained =< 21 days prior to stereotactic radiosurgery treatment
• Karnofsky performance scale >= 70%
• White blood cells (WBC) >= 3,000/mcL
• Absolute neutrophil count >= 1,500/mcL
• Platelets >= 100,000/mcL
• Total bilirubin =< 2 x institutional upper limit of normal
• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x institutional upper limit of normal
• Creatinine within normal institutional limits OR according to Johns Hopkins MRI policy
• Women of child bearing potential (WOCBP) must use a reliable form of contraception during the study treatment period and for up to 12 weeks following the last dose of study drug; in order for a woman to be determined not of child-bearing potential, she must have >= 12 months of non-therapy-induced amenorrhea or be surgically sterile
• Men must agree to the use of male contraception during the study treatment period and for at least 12 weeks after the last dose of study drug
• Ability to understand and the willingness to sign written informed consent document(s)

Exclusion Criteria

• Prior whole brain radiation or conventional radiation to the spine at the site of new lesion
• Prior chemotherapy within 28 days of starting treatment
• Prior therapy with investigational drugs within 28 days or at least 5 half-lives (whichever is longer) before study administration
• Neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
• Known allergy to compounds of similar chemical or biologic composition to nivolumab
• Pregnant or breastfeeding women
• Known history of human immunodeficiency virus
• Active infection requiring therapy, positive tests for hepatitis B surface antigen or hepatitis C ribonucleic acid (RNA)
• Active autoimmune disease, history of autoimmune disease or history of syndrome that required systemic steroids or immunosuppressive medications, e.g. organ, tissue, or allogenic hematopoietic stem cell transplant (HSCT) recipients; exceptions include those with vitiligo or resolved childhood asthma/atopy; subjects with asthma who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study
• Use of live vaccines against infectious diseases up to 4 weeks (28 days) before receiving nivolumab. (NOTE: Inactivated seasonal influenza vaccines are permitted and do not require a 4 week waiting period before starting study treatment)
• Prisoners or subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g. infectious disease) illness
• Patients with both brain and spine metastases will be excluded from the trial