Clinical trial NCT02529072 (phase 1, status: completed)
Conditions: malignant glioma, astrocytoma, glioblastoma
ICD codes: R18.0, C17.3, G21.0, J91.0, C05.2, C10.0, C16.0
Drugs: nivolumab
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-80 years of age

          -  First or second recurrence of MG (WHO Grade III or IV glioma or astrocytoma) in
             surgically accessible areas with prior histologic diagnosis of MG

          -  Bevacizumab-naïve - no prior exposure to Bevacizumab

          -  Karnofsky Performance Status (KPS) of ≥ 70%

          -  Radiation Therapy (RT) with ≥ 45 Gray (Gy) tumor dose, completed ≥ 8 weeks prior to
             study entry

          -  Laboratory values must meet the following criteria:

               1. White Blood Count (WBC) ≥ 2000/microliters (uL)

               2. Neutrophils ≥ 1500/uL

               3. Platelets ≥ 100x103/uL

               4. Hemoglobin ≥ 9.0 g/dL

               5. Serum creatinine ≤ 1.5x the upper limit of normal (ULN) or creatinine clearance
                  (CrCl)≥ 40 mL/min (using the Cockcroft-Gault formula) c. Female CrCl = (140 - age
                  in years) x weight in kg x 0.85 /72 x serum creatinine in mg/dL d. Male CrCl =
                  (140 - age in years) x weight in kg x 1.00/72 x serum creatinine in mg/dL

               6. Aspartate Aminotransferase (AST) ≤ 3x ULN

               7. Alanine Aminotransferase (ALT) ≤ 3x ULN

               8. Bilirubin≤ 1.5x ULN (except subjects with Gilbert Syndrome, who can have total
                  bilirubin < 3.0 mg/dL)

               9. Subjects must have resting baseline O2 saturation by pulse oximetry of ≥ 92% at
                  rest.

          -  Patients of child bearing potential or with partners of child-bearing potential must
             practice recommended contraceptive methods to prevent pregnancy during treatment and
             for 5 months after the last dose of nivolumab for women, 7 months after the last dose
             of nivolumab for men, and for 6 months after the last dose of bevacizumab for subjects
             receiving bevacizumab.

        Exclusion Criteria:

          -  Contrast-enhancing tumor component crossing the midline, multi-focal tumor, or tumor
             dissemination (subependymal or leptomeningeal)

          -  Clinically significant increased intracranial pressure (e.g., impending herniation),
             uncontrolled seizures, or requirement for immediate palliative treatment

          -  Pregnant or need to breast feed during the study period (Negative human chorionic
             gonadotropin (β-HCG) test required), or unable to maintain use of contraception while
             on study and for 31 weeks after the last dose of nivolumab

          -  Active infection requiring treatment or an unexplained febrile (> 101.5o F) illness

          -  Known immunosuppressive disease, autoimmune disease or human immunodeficiency virus
             infection, Hepatitis B or Hepatitis C

          -  Known allergy or hypersensitivity to tetanus, or any other tetanus or diphtheria
             toxoid-containing vaccine, or any component of this vaccine (i.e., aluminum phosphate,
             formaldehyde)

          -  Known severe (Grade 3 or 4) infusion-related allergy or hypersensitivity to any
             monoclonal antibody

          -  Previous radiation therapy with anything other than standard radiation therapy (such
             as previous stereotactic radiosurgery) or previous treatment with an immune checkpoint
             inhibitor (i.e., nivolumab, pembrolizumab, ipilimumab)

          -  Unstable or severe intercurrent medical conditions such as severe heart (New York
             Association Class 3 or 4) or lung (FEV1 < 50%) disease, uncontrolled diabetes mellitus

          -  Corticosteroid use > 4 mg/day at time of consent

          -  Prior inguinal lymph node dissection.