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

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celldex Therapeutics
• Treatments: Dacarbazine; Molgramostim; Rindopepimut; Sargramostim; Temozolomide

Criteria

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.