Phase III Study of Rindopepimut/GM-CSF in Patients With Newly Diagnosed Glioblastoma

The purpose of this research study is to find out whether adding an experimental vaccine
called rindopepimut (also known as CDX-110) to the commonly used chemotherapy drug
temozolomide can help improve the life expectancy of patients with newly diagnosed, resected
EGFRvIII positive glioblastoma.

The duration of participation in this study may be up to 5 years. After you are screened and
enrolled in the study, you will be administered temozolomide and either rindopepimut/GM-CSF
or KLH until either disease progression or intolerance to the medications. If your tumor
progresses while on this study, your doctor may treat you with other therapies that are not
part of the study.

Inclusion Criteria-

Among other criteria, patients must meet the following conditions to be eligible for the
study:

1. Adult patients, ≥ 18 years old

2. Newly diagnosed glioblastoma

3. Attempted surgical resection followed by conventional chemoradiation

4. Documented EGFRvIII positive tumor status by a Sponsor designated laboratory

5. No evidence of progressive disease from the post-operative period to the
post-chemoradiation period

6. Candidate for, and agrees to receive, adjuvant (maintenance) temozolomide therapy

7. Systemic corticosteroid therapy at ≤2 mg of dexamethasone or equivalent per day for at
least 3 days prior to randomization

8. WHO-ECOG Performance Status ≤ 2

9. Patients of childbearing/reproductive potential will be instructed to use birth
control as defined by your doctor.

Exclusion Criteria-

Among other criteria, patients who meet the following conditions are NOT eligible for the
study:

1. Stereotactic biopsy only (without further surgical resection)

2. Presence of diffuse leptomeningeal disease, gliomatosis cerebri, or infratentorial
disease.

3. History, presence, or suspicion of metastatic disease

4. Patients who have received any additional treatment for glioblastoma, aside from
surgical resection and chemoradiation with temozolomide

5. Active systemic infection requiring treatment

6. History of any malignancy (other than glioblastoma) during the last three years except
non-melanoma skin cancer, in situ cervical cancer, treated superficial bladder cancer,
cured, early-stage prostate cancer in a patient with PSA level less than ULN,or other
carcinoma in situ that has been adequately treated and cured.

7. Planned major surgery

8. Evidence of current drug or alcohol abuse

9. Known allergy or hypersensitivity to keyhole limpet hemocyanin (KLH), GM-CSF
(sargramostim; LEUKINE®), polysorbate 80 or yeast derived products, or a history of
anaphylactic reactions to shellfish proteins

10. Severe acute or chronic medical or psychiatric condition or laboratory abnormality
that could increase the risk associated with participating in a clinical trial

11. Women who are pregnant or lactating