Multi Peptide Vaccination with XS15 in Addition to Standard Postoperative Radiation Therapy and Temozolomide Chemotherapy in Newly Diagnosed Glioblastoma

Exclusion Criteria

• •Subjects presenting with any of the following criteria will not be included in the trial:
• •1. Karnofsky performance score (KPS) \< 70%
• •2. Patient who cannot undergo MRI assessments
• •3. Only Biopsy available
• •4. Women during pregnancy and lactation.
• •5. History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.
• •6. Participation in other clinical trials or observation period of competing trials.
• •7. Platelet count decrease \< 75 x109/L
• •8. Bilirubin \> 1.5 x ULN (upper limit of normal according to the performing lab's reference range)
• •9. ALT4 \> 3 x ULN
• •10. AST5 \> 3 x ULN
• •11. GGT \> 2.5 x ULN
• •12. Serum creatinine increased \> 1.5 x ULN
• •13. HIV infection or active Hepatitis B or C infection, or active infections requiring oral or intravenous antibiotics or that can cause a severe disease and pose a severe danger to lab personnel working on patients' blood or tissue (e.g. rabies).
• •14. Prior therapy for glioma (except surgery and steroids) including but not limited to carmustine wafers and immunotherapy. Note: History of low grade glioma that did not require prior treatment with chemotherapy or radiotherapy is not an exclusion criterion.
• •15. Clinically relevant autoimmune diseases (with the exception of thyroid diseases).
• •16. Immunosuppression, not related to prior treatment for malignancy, or prior drug reaction
• •17. Other vaccinations with active or attenuated viruses should be restricted during the peptide vaccination period.
• •18. Enzyme-inducing antiepileptic drugs
• •19. Patients with prior stem cell transplantation or solid organ transplantation.
• •20. Any condition that in the judgment of the investigator interferes with the probability that an individual patient may receive and benefit from APVAC vaccinations (e.g. high risk of early disease progression / recurrence; immunocompromised status; anticipated compliance problems)
• •21. Serious illness or condition, which according to the investigator, poses an undue risk for the patient when participating in the trial, including, but not limited to, any of the following:
• •* Clinically symptomatic cardiovascular disease:(New York Heart Association class III-IV congestive heart failure)
• •* Symptomatic peripheral vascular disease (Definition z.B. \> Stage III)
• •* Severe pulmonary dysfunction (Definition: z.B. requirement for oxygen supplement
• •* Severe diabetes
• •* History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 5 years unless the patient has been disease-free for 5 years