Nivolumab in Combination With Temozolomide and Radiotherapy in Children and Adolescents With Newly Diagnosed High-grade Glioma

Exclusion Criteria

• •7. Local histological diagnosis after either stereotactic biopsy or surgical procedure has been confirmed centrally by a designated reference pathologist.
• •8. Able to commence trial treatment within 6 weeks following the last major surgery.
• •9. Adequate Bone Marrow Function : Hemoglobin \>/= 10 g/dL (transfusion independent), Neutrophil count \>/= 1.0 x 10\^9/L.
• •Platelet count \>/= 1.0 x 10\^9/L (transfusion independent)
• •10. Absence of Coagulation Disorder
• •11. Adequate Liver Function : AST \</= 2.5x institutional ULN for age, ALT \</= 2.5x institutional ULN for age, Total Bilirubin \</= 1.5x institutional ULN for age
• •12. Adequate Renal Function : Serum creatinine must be \</= 1.5x ULN for age, absence of clinically significant proteinuria as defined by a screening early morning urine (first sample) dipstick urinalysis of \</= 2
• •1. Any disease or condition that contraindicates the use of the study medication/treatment (for TMZ, see the approved product labelling) or places the patient at an unacceptable risk of experiencing treatment related complications.
• •2. Patients should not be on high-dose steroids (ie \> 1mg/kg) before study entry; doses should be stable for at least two weeks or decreasing.
• •3. Low probability of protocol compliance.
• •4. Radiological evidence of surgically related intracranial bleeding (excluding asymptomatic, resolving hemorrhagic changes associated with recent surgery and the presence of punctuate hemorrhage in the tumor).
• •5. Subjects with concommitant second malignancies are excluded unless a complete remission is achieved as it is empirically determined based on the malignancy and treatment provided prior to study entry and no additional therapy is required or anticipated to be required during the study period.
• •6. Previous cranial irradiation.
• •7. Any known auto-immune disease, previous or ongoing.
• •8. Known chronic inflammatory digestive disease, previous or ongoing.
• •9. Chronic asthma receiving corticotherapy, even only with inhalation.
• •10. Vaccinated with live attenuated vaccines within 4 weeks of the first dose of study drug
• •11. Pregnant or breastfeeding women
• •12. Known hypersensitivity to any component of the products (study drug or ingredients)
• •13. Clinically significant, uncontrolled heart disease (including history of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality within 12 months of screening).
• •14. Patients who are currently receiving another investigational drug or anticancer agent
• •15. Patient who have an uncontrolled infection
• •16. Patient with known human immunodeficiency virus (HIV) / AIDS infection or acute / chronic Hepatitis B or C