A Randomized, Double-blind, Controlled Phase IIb Study of the Safety and Efficacy of ICT-107 in Newly Diagnosed Patients With Glioblastoma Multiforme (GBM) Following Resection and Chemoradiation

Inclusion Criteria:

1. Confirmed, initial diagnosis of GBM. Patients must be newly diagnosed with GBM and
not yet received chemoradiation.

2. ≥ 18 years of age

3. HLA-A1 or HLA-A2 positive

4. KPS score of ≥ 70%

5. Baseline hematologic studies and chemistry profiles must meet the following criteria:

Hemoglobin (Hgb) > 9.9 g/dL total granulocyte count > than 1000/mm3 platelet count >
100,000/mm3 blood urea nitrogen (BUN) < 30 mg/dL creatinine < 2 mg/dL alkaline
phosphatase (ALP), aspartate aminotransferase (AST) and alanine aminotransferase
(ALT) < 4x upper limit of normal (ULN) prothrombin time (PT) and activated partial
thromboplastin time (PTT) ≤ 1.6x control unless therapeutically warranted

6. Female patients of child-bearing potential must have negative serum pregnancy test

7. If not surgically sterile, male and female patients of childbearing age must use
double barrier contraception (hormonal; intrauterine device; barrier)

8. Sufficient paraffin embedded tumor sample for analysis MGMT methylation status

9. Written informed consent, Release of Medical Records Form and Health Insurance
Portability and Accountability Act (HIPAA) reviewed and signed by patient or legally
authorized representatives

Exclusion Criteria:

1. Recurrent disease

2. Radiosurgery including Gamma Knife, linear accelerator based radiosurgery, CyberKnife
and placement of Gliadel wafer

3. Presence of any other active malignancy or prior history of malignancy (except for
basal cell carcinoma of the skin)

4. Severe pulmonary, cardiac or other systemic disease

5. Congestive heart failure Class III or IV according to New York Heart Association
(NYHA)

6. Presence of an acute infection requiring active treatment with
antibiotics/antivirals; prophylactic administration is allowed

7. Known history of an autoimmune disorder

8. Known human immunodeficiency virus (HIV) positivity or acquired immunodeficiency
syndrome (AIDS) related illness or other serious medical illness

9. Breastfeeding

10. Received any other therapeutic investigational agent within 30 days of enrollment

11. Reduction of steroids (dexamethasone) to a maximum of 2 mg twice a day (BID) prior to
the first administration of study vaccine