Phase II Study of Rindopepimut (CDX-110) in Patients With Glioblastoma Multiforme

Study Overview
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Brief Summary
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This study is designed to evaluate the clinical activity of CDX-110 vaccination when given with standard of care treatment (maintenance temozolomide therapy). Study treatment will be given until disease progression and patients will be followed for long-term survival information. Efficacy will be measured by the progression-free survival status at 5.5 months from the date of first dose.

Official Title
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A Phase II Study of CDX-110 With Radiation and Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme

Conditions
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Malignant Glioma

Intervention / Treatment
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* Drug: CDX-110 with GM-CSF
* Drug: Temozolomide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly diagnosed de novo GBM with documented EGFRvIII expression in tumor tissue. Gross total resection followed by conventional chemoradiation therapy without progression of disease. Exclusion Criteria: Presence of diffuse leptomeningeal disease or gliomatosis cerebri. Systemic corticosteroid therapy > 2 mg of dexamethasone or equivalent (as defined by the investigator) per day at study enrollment. Patients who have undergone stereotactic radiosurgery prior to or following surgical resection, or the placement of Gliadel® Wafers. Known allergy or hypersensitivity to KLH, GM-CSF or yeast derived products, or a history of anaphylactic reactions to shellfish proteins.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CDX-110 with GM-CSF<br> | Drug: CDX-110 with GM-CSF<br>* Three biweekly intradermal injections over four weeks followed by monthly injections until tumor progression. Each dose will be 0.8 mL containing approximately 500 mcg CDX-110 and 150 mcg GM CSF.<br>* Other names: CDX-110 with sargramostim (GM-CSF) (Leukine®);Drug: Temozolomide<br>* Maintenance temozolomide will begin after completion of the three initial injections of CDX-110 plus GM-CSF. 150 to 200 mg/m2 for 5 days during each 28-day cycle for a minimum of six cycles or a maximum of 12 cycles, intolerance or progression.<br>* Other names: Temodar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival status |  | 5.5mo | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability characterized by adverse events (term, grade, frequency). |  | 2 years | 
| Safety and tolerability characterized by physical examinations. |  | 2 years | 
| Safety and tolerability characterized by hematologic and metabolic panel (including CBC with differential, electrolytes, BUN, Cr, liver associated enzymes). |  | 2 years | 
| Safety and tolerability characterized by urinalysis. |  | 2 years | 
| Safety and tolerability characterized by vital signs. |  | 2 years | 
| Immune response; T-cell response to vaccine. |  | 2 years | 
| Immune response; antibody response to vaccine. |  | 2 years | 
| Immune response; HLA typing. |  | 2 years | 
| Overall survival. |  | indeterminate | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EGFRvIII vaccinetemozolomidecancer vaccineimmunotherapy