Clinical Trial Details
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NCT02529072 : Nivolumab With DC Vaccines for Recurrent Brain Tumors
PhasePhase 1
AgesMin: 18 Years Max: 80 Years
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

- 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 (?-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

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

- Prior inguinal lymph node dissection.
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